Serology-based tests for COVID-19

Serology testing for SARS-CoV-2 is at increased demand in order to better quantify the number of cases of COVID-19, including those that may be asymptomatic or have recovered. Serology tests are blood-based tests that can be used to identify whether people have been exposed to a particular pathogen by looking at their immune response. In contrast, the RT-PCR tests currently being used globally to diagnose cases of COVID-19 can only indicate the presence of viral material during infection and will not indicate if a person was infected and subsequently recovered. These tests can give greater detail into the prevalence of a disease in a population by identifying individuals who have developed antibodies to the virus.

The Johns Hopkins Center for Health recently released a report detailing considerations for a national strategy on serology testing, including actions for leaders and areas for continued research. You can find this report here.

This page serves to provide up to date information on serology tests that are in development or available for use. Importantly, many of these tests have been approved for research use only, which indicates that they are not yet approved for use as a public health diagnostic tool or for at-home diagnosis. Some of these tests may move forward to approval for diagnostic use, while others may be appropriate for research only.

Disclaimer

This website is updated twice weekly, and only includes tests for which data and documentation is available and for which their stated intended use aligns with their FDA (or relevant national regulatory body) status. This site does not include tests that are in subsection IV.D of the FDA Policy for Diagnostic Tests for Coronavirus Disease-2019, as these have not been approved by the FDA and may not have indicated to the FDA that they are pursuing EUA approval. This site is not intended to be used as a reference for funding or grant proposals. Non-inclusion in this list should not be interpreted as judgment on validity or legitimacy of tests. If you do not see your test on this list, but would like it to be considered, please fill out the following form. Submission does not guarantee inclusion on this site.

Note on sensitivity and specificity data

Here we list the manufacturer-reported sensitivity and specificity data, where available. A highly sensitive test should capture all true positive results. A highly specific test should rule out all true negative results. These measures are not independently validated by the Johns Hopkins Center for Health Security. If a sensitivity or specificity is not listed, it was not listed/available at the time of posting. When available, the number of samples used for sensitivity/specificity definitions are listed in the product description.

It should also be noted that the terms “sensitivity” and “specificity” may not appear in the manufacturers’ information sheets, but rather these values are often reported as “positive percent agreement” and “negative percent agreement.” The FDA recommends that manufacturers use these terms to indicate that a non-reference standard was used when evaluating the test.

This resource was created and is updated by Amanda Kobokovich, MPH, Rachel West, PhD, and Gigi Gronvall, PhD.

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Description of types of serology assays

Rapid diagnostic test (RDT): This is typically a qualitative (positive or negative) lateral flow assay that is small, portable, and can be used at point of care (POC). These tests may use blood samples from a finger prick, saliva samples, or nasal swab fluids. RDTs are often similar to pregnancy tests, in that the test shows the user colored lines to indicate positive or negative results. In the context of COVID-19, these tests most frequently test for patient antibodies (IgG and IgM), or viral antigen. In some cases, it can be beneficial to measure baseline (before infection) of IgG and IgM titers.

Enzyme-linked immunosorbent assay (ELISA): This test can be qualitative or quantitative and is generally a lab-based test. These tests usually use whole blood, plasma, or serum samples from patients. The test relies on a plate that is coated with a viral protein of interest, such as Spike protein. Patient samples are then incubated with the protein, and if the patient has antibodies to the viral protein they bind together. The bound antibody-protein complex can then be detected with another wash of antibodies that produce a color or fluorescent-based readout. In the context of COVID-19, these tests most frequently test for patient antibodies (IgG and IgM).

Neutralization assay: This test relies on patient antibodies to prevent viral infection of cells in a lab setting. Neutralization assays can tell researchers if a patient has antibodies that are active and effective against the virus, even if they have already cleared the infection. These tests require whole blood, serum, or plasma samples from the patient. Neutralization assays depend on cell culture, a lab-based method of culturing cells that allow SARS-CoV-2 growth (like VeroE6 cells). When virus and cells are grown with decreasing concentrations of patient antibodies, researchers can visualize and quantify how many antibodies in the patient serum are able to block virus replication. This blocking action can happen through the antibody binding to an important cell entry protein on the virus, for example.

Chemiluminescent immunoassay: This test is typically quantitative, lab-based, and uses whole blood, plasma, or serum samples from patients. A variation of this test can use magnetic, protein-coated microparticles, known as a chemiluminescent microparticle immunoassay. The test relies on mixing patient samples with a known viral protein, buffer reagents, and specific enzyme-labeled antibodies that allow a light-based, luminescent read-out. Any antibodies in the patient sample that react to the viral protein will form a complex. Then, (secondary) enzyme-labeled antibodies are added that bind to these complexes. This binding induces a chemical reaction that produces light. The amount of light (radiance) emitted from each sample is then be used to calculate the number of antibodies present in a patient sample. This test can look for multiple types of antibodies, including IgG, IgM, and IgA.

Type of test Time to results What it tells us What it cannot tell us Figure Rapid diagnostic test (RDT) 10-30 minutes The presence or absence (qualitative) of antibodies against the virus present in patient serum. The amount of antibodies in the patient serum, or if these antibodies are able to inhibit virus growth RDT figure Enzyme linked immunosorbent assay (ELISA) 2-5 hours The presence or absence (quantitative) of antibodies against the virus present in patient serum. If the antibodies are able to inhibit virus growth. ELISA figure Neutralization assay 3-5 days The presence of active antibodies in patient serum that are able to inhibit virus growth ex vivo, in a cell culture system. It may miss antibodies to viral proteins that are not involved in replication. PRNT figure Chemiluminescent immunoassay 1-2 hours The presence or absence (quantitative) of antibodies against the virus present in the patient serum. If the antibodies are able to inhibit virus growth. CLIA figure

Tests that have been approved for diagnostic use in the United States

Country of development US/China Type of Serological Test RDT Authors/Company Cellex Inc. Description RDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2. The sensitivity is 93.8% and specificity is 95.6%, when tested at 2 Chinese hospitals in a total of 128 COVID19 positive patients, and 250 COVID19 negative patients (as detected by RT-qPCR). Sensitivity 93.8% Specificity 95.6% Phase of development Approved by FDA for EUA on diagnostics, has CE approval Proposed release available for purchase by research labs/healthcare providers (product number 5513) Date April 1, 2020

Country of development USA Type of Serological Test RDT Authors/Company ChemBio Description This test detects IgM and IgG antibodies to the nucleocapsid (N) protein of SARS-CoV-2. Sensitivity and specificity values were not released. Sensitivity Specificity Phase of development Approved for EUA by the FDA Proposed release April 14, 2020 Date April 15, 2020

Country of development USA Type of Serological Test ELISA Authors/Company Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test Description This test detects, qualitatively, IgG present in the serum of patients. The ELISA based method uses a 1:50 dilution of human serum that is flowed over a plate coated with the spike protein receptor binding domain (RBD). Sensitivity and specificity are not yet available. Sensitivity Specificity Phase of development Approved for EUA by the FDA Proposed release April 15, 2020 Date April 16, 2020

Country of development USA Type of Serological Test Chemiluminescent immunoassay Authors/Company Ortho-Clinical Diagnostics, Inc. Description This test detects IgG and is designed to be used with VITROS Immunodiagnostic Products and the VITROS ECi/ECiQ/3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems. Sensitivity was approximately 87.5% and specificity is approximately 100%. Sensitivity Specificity Phase of development Approved for EUA by the FDA Proposed release Current Date April 24, 2020

Country of development USA Type of Serological Test ELISA Authors/Company DiaSorin Inc. Description This test is designed to run on the LIAISON XL analyzer and detects IgG specific to recombinant spike protein subunits 1 and 2 (S1 and S2). Specificity was approximately 98%. Sensitivity was approximately 90% on samples obtained 5-15 days post-symptom onset. For samples taken greater than 15 days post-symptom onset, the sensitivity was approximately 97%. Sensitivity 90-97% Specificity 98% Phase of development Approved for EUA by the FDA Proposed release Current Date April 24, 2020

Country of development USA Type of Serological Test Chemiluminescent microparticle immunoassay (CMIA) Authors/Company Abbott Laboratories Inc. Description This test detects IgG by measuring antibody-antigen binding in terms of relative light units (RLU). It is intended to be used with the ARCHITECT i1000SR and i2000SR systems. Sensitivity Specificity Phase of development Received EUA by the FDA Proposed release Current Date April 26, 2020

Country of development US Type of Serological Test Modified ELISA Authors/Company Bio-Rad Description The Platelia SARS-CoV-2 Total Ab assay measures IgM, IgG, and IgA antibodies to SARS-CoV-2. The target antigen is recombinant nucleocapsid protein, coupled with peroxidase that provides the read-out. Human serum or plasma samples are required.The sensitivity and specificity are not yet known, though it appears the readout of the assay may be quantiative or qualitative. Sensitivity 98% Specificity 99% Phase of development Received EUA Proposed release Current Date April 29, 2020

Country of development US Type of Serological Test Microsphere immunoassay Authors/Company Wadsworth Center, New York State Department of Health Description This test assays for total antibodies (IgG, IgM, and IgA) in human serum samples. The test uses full-length recombinant nucleocapsid protein from SARS-CoV-1 (it is stated that the sequence is similar enough to use the other virus' N protein-90% homologous). The test should be run with a Luminex FlexMap dual laser cytometer. Sensitivity Not stated Specificity 93-100% Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current Date April 30, 2020

Country of development US/Switzerland Type of Serological Test electro-chemiluminescence immunoassay (ECLIA) Authors/Company Roche Description The test couples chemiluminescence immunoassay technology with an electric pulse that allows for rapid quantifiation of captured antigen-antibody complexes from patient serum samples. The target antigen is the viral N protein.The test assays for IgM and IgG, and takes about 18 minutes. The test should be run on the Elecsys Anti-SARS-CoV-2 on the cobas e 411, cobas e 601, cobas e 602, or cobas e 801 analyzers. Sensitivity was determined from 204 samples, and specificity from 5,272 negative samples. Sensitivity From 0-6 days, 65.5%; from 7-13 days, 88.1%; from 14 days onward, 100% Specificity 99.81% Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current Date May 2, 2020

Country of development Germany Type of Serological Test ELISA Authors/Company Euroimmun AG Description The Euroimmun AG IgG ELISA assay uses the viral S1 region of the spike protein to quantify IgG antibodies present in serum samples. Sensitivity and specificity were determined compared to onset of symptoms in PCR positive and negative samples. Sample sizes varied over time. Sensitivity From 0-10 days, 13.9%; from 11-20 days, 61.1%; from 21 days onward, 100%. 90% by NCI validation Specificity 100% by NCI validation Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current Date May 4, 2020

Country of development US/China Type of Serological Test RDT Authors/Company Healgen Scientific LLC Description This is a lateral flow assay based test, that uses human venous whole blood, plasma from anticoagulated blood, or serum to detect IgG and IgM antibodies. The test takes approximately 10 minutes, and is a qualitative test for presence of antibodies. The antigen target is not stated. Sensitivity was determined from 90 positive clinical samples, and specificity from 101 negative clinical samples from two testing sites in China. The test was also independently validated, with sensitivity of 100% and specificity of 97.5%. Sensitivity 96.7% (IgG),86.7 % (IgM), 96.7% combined Specificity 98% (IgG), 99% (IgM), 97% combined Phase of development Received EUA and CE/IVD, available for purchase by healthcare professionals and researchers. Proposed release Current Date June 1, 2020

Country of development US Type of Serological Test CLIA Authors/Company Siemens Healthcare Diagnostics Inc. Description This CLIA based assay uses the Atellica platform to detect total antibody to the S1 receptor binding domain. The test is fully automated, all-in-one step sandwich chemiluminescent immunoassay. It uses streptavidin-biotin based capture. Sensitivity was from 250 clinical positive samples, with times since PCR positivity listed. Specificity was determined from 1091 samples, including 98 pregnant women. Sensitivity 60.7% (0-6 days post PCR positive),97.5% (7-13 days post PCR positive), 100% (14+ days post PCR positive ). Specificity 99.82%% Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current, their website states that there are already over 20,000 analyzers installed, and there should be mass availability. Date June 1, 2020

Country of development US Type of Serological Test CLIA Authors/Company Siemens Healthcare Diagnostics Inc. Description This CLIA based assay uses the ADVIA Centaur platform to detect total antibody to the S1 receptor binding domain. The test is fully automated, all-in-one step sandwich chemiluminescent immunoassay. It uses streptavidin-biotin based capture. Sensitivity was determined using 262 clinical samples, with times listed post PCR postivity. Specificity was from 1589 people, including 100 pregnant women. Sensitivity 65.1% (0-6 days post PCR positive),97.5% (7-13 days post PCR positive), 100% (14+ days post PCR positive ). Specificity 99.81%% Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current, their website states that there are already over 20,000 analyzers installed, and there should be mass availability. Date June 1, 2020

Country of development US Type of Serological Test ECLIA (electrochemiluminescence immunoassay) Authors/Company Roche Diagnostics Description Elecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum and plasma. This assay is used to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. The Elecsys IL-6 immunoassay is an electrochemiluminescence immunoassay “ECLIA” and is intended for use on cobas e immunoassay analyzers. Sensitivity 84% Specificity 63% Phase of development Received EUA and CE/IVD, available for purchase by healthcare professionals and researchers. Proposed release Current Date June 2, 2020

Country of development US Type of Serological Test CLIA Authors/Company Vibrant America Clinical Labs Description The Vibrant COVID-19 Ab assay is a chemiluminescence immunoassay (CLIA) intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum or Dry Blood Spot (DBS) using fingerstick blood specimen collected by their health care provider. Sensitivity 98.1% Specificity 98.6% Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current Date June 4, 2020

Country of development China Type of Serological Test RDT Authors/Company Hangzhou Biotest Biotech Co., Ltd Description This RDT tests for IgM and IgG in patient whole blood, serum, or plasma. The target antigen is recombinant spike protein receptor binding domain. Results should only be read after 10 minutes of incubation, but before 20 minutes. Clinical samples used for internal validation were from 3 different sites in China. Sensitivity and specificity presented here are for overall measures, though the company provides information for days 1-7 post symptoms, 8-14, and days 15+. Sensitivity and specificity were determined from 320 positive and 210 negative samples. Sensitivity increases after day 8 post symptom onset. Sensitivity 92.5% (IgM), 91.56% (IgG) Specificity 98.1% (IgM), 99.52% (IgG) Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current Date June 4, 2020

Country of development US Type of Serological Test CLIA Authors/Company Siemens Healthcare Diagnostics Inc. Description The Dimension Vista COV2T assay is a chemiluminescent immunoassay used for the detection of total antibodies to SARS‑CoV‑2 in human serum and plasma from patients who may have been exposed to coronavirus disease (COVID‑19). The Dimension Vista COV2T assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI technology. Sensitivity 97.3% Specificity 99.8% Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current Date June 8, 2020

Country of development US Type of Serological Test CLIA Authors/Company Siemens Healthcare Diagnostics Inc. Description The Dimension EXL CV2T assay is a chemiluminescent immunoassay used for the detection of total antibodies to SARS‑CoV‑2 in human serum and plasma from patients who may have been exposed to coronavirus disease (COVID‑19). The Dimension EXL CV2T assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI technology. The LOCI reagents include two synthetic bead reagents and a biotinylated S1 RBD antigen. Sensitivity 97.3% Specificity 99.8% Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current Date June 8, 2020

Country of development US Type of Serological Test ELISA Authors/Company InBios International, Inc. Description The SCoV-2 Detect™ IgG ELISA is a qualitative immunoassay for the detection of IgG antibodies targeting SCoV-2 related antigens. Diluted serum specimens are added to antigencoated wells and incubated. After incubation and washing, human antibodies targeting SARS-CoV-2 antigens remain bound to the plate surface. Secondary antibody conjugated to horseradish peroxidase (HRP) targeting human IgG is then added to each well. After incubation, the ELISA wells are washed once again before a tetramethylbenzidine (TMB) substrate is added. An acidic stopping solution is finally used to stop the reaction and the degree of enzymatic turnover of the substrate is determined by absorbance measurement at 450 nanometers. Sensitivity 97.8% Specificity 98.9% Phase of development Received EUA, available for purchase by healthcare professionals and researchers. Proposed release Current Date June 10, 2020

Country of development US Type of Serological Test ELISA Authors/Company Emory University Description This test detects IgG antibodies specific to a recombinant receptor binding domain (RBD) of the spike protein. It should be run on the BioTek 800 TS Absorbance Reader. Sensitivity was determined from 231 positive samples, and specificity from 388 negative samples--including samples taken prior to the pandemic and rRT-PCR negative health care workers during the pandemic. These results were stratified based on days post-positive rRT-PCR. Sensitivity 73% (days 0-7), 100% (days 8-14), 100% (days 14+) Specificity 97.7% (prior to pandemic), 94.4% (PCR negative HCW) Phase of development Received EUA by the FDA Proposed release Current, Emergency use of this test is limited to the Emory Medical Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Date June 15, 2020

Country of development China Type of Serological Test RDT Authors/Company Biohit Healthcare (Heifei) Co. Ltd. Description This test detects IgM and IgG through immunchromatography. It is not intended for use early in infection, with optimal performance after 15 days post symptom onset. The target antigen is recombinant N-protein. Specificity was determined from 186 negative samples (including 78 samples positive for other respiratory diseases), and sensitivity was determined from 197 serum samples. Sensitivity 33% (IgM, days 1-7), 56.6% (IgG days 8-14), 83.% (IgM days 8-14), 96.2% (IgG days 15+), 97.7% (IgM days 15+) Specificity 99.46% (IgM), 100% (IgG) Phase of development Received EUA by the FDA Proposed release Current Date June 18, 2020

Country of development China Type of Serological Test RDT Authors/Company Hangzhou Laihe Biotech Co., Ltd Description This test is a lateral flow assay/colloidal gold method to detect IgG and IgM antibodies. The target antigen is the S1 region of the spike protein. They used 178 positive samples to determine sensitivity, stratified by day since symptom onset. They determined specificity from 349 negative samples, 239 of which were from patients with non-SARS-CoV-2 coronavirus infections. The test was also independently validated by the NCI, and found 96.7% IgM sensitivity, 100% IgG sensitivity, and 98.8% specificity. Sensitivity 100% (IgM, 0-6 days), 0% (IgG, 0-6 days); 85.7% (IgM, 7-14 days), 76% (IgG, 7-14 days); 99.25% (IgM, 14+ days), 98.5% (IgG, 14+ days) Specificity 99.43% Phase of development Received EUA by the FDA Proposed release Current Date June 19, 2020

Country of development US Type of Serological Test Chemiluminescent immunoassay/indirect sandwich immunoassay Authors/Company Babson Diagnostics Description This test is a CLIA based assay that detects IgG antibodies. The target antigen is the S1 region of the spike protein. The test should be run on the Siemens Atellica IM platform. Sensitivity was determined from 34 positive samples, stratified by time post symptom onset and 2 of which were asymptomatic individuals. Specificity was determined from 100 individuals. Sensitivity 66.7% (8-14 days), 100% (15+ days), 100% (asymptomatic) Specificity 100% Phase of development Received EUA by the FDA Proposed release Current, but only to be used at Babson Diagnostics Date June 23, 2020

Country of development US Type of Serological Test Chemiluminescent immunoassay Authors/Company Beckman Coulter, Inc. Description This is a two step CLIA that uses the target antigen of the receptor binding domain of S1 of the spike protein. It detects IgG in patient samples. Sensitivity was determined using 192 positive clinical samples, stratified by time since symptom onset. Specificity was determined from 1400 samples collected before December 2019. Sensitivity 75% (0-7 days), 95.3% (8-14 days), 96.8% (15+ days) Specificity 100% Phase of development Received EUA by the FDA Proposed release Current Date June 26, 2020

Country of development US Type of Serological Test ELISA Authors/Company InBios International, Inc. Description This kit specifically tests for IgM present in patient serum. The target antigen is not stated. Samples for testing should only be taken between 7 days to 64 days post symptom onset. Samples taken before 12 days post-symptom onset that test negative should be re-tested using a second, molecular method. Samples, taken after 12 days post symptom onset, that are negative should also be tested for IgG. Sensitivity was determined from 120 positive clinical samples, and specificity from 95 negative samples. Sensitivity presented is overall sensitivity, but the company does list varied sensitivity stratified by time post symptom onset. In general, the greater number of days post symptom onset, the more sensitive the assay. Sensitivity 92.5% Specificity 98.5% Phase of development Received EUA Proposed release Current Date June 30, 2020

Country of development China Type of Serological Test RDT Authors/Company Assure Biotech (Hangzhou Co, Ltd.) Description This lateral flow assay tests for both IgM and IgG in patient serum. The target antigens are recombinant Nucleocapsid protein and Spike protein (S1 region). Sensitivity was determined from 61 positive clinical samples, and specificity from 105 negative samples. The company also provides sensitivity stratified by time post symptom onset, though the overall sensitivity is presented here. Overall, the kit had highest sensitivity with venous whole blood. The kit has also been independently validated by the NCI, as presented by the manufacturer. Combined IgG/IgM sensitivity was 100%, and specificity was 98.8%. Sensitivity 95.1% Specificity 100% Phase of development Received EUA Proposed release Current Date July 6, 2020

Country of development US Type of Serological Test CLIA Authors/Company Diazyme Laboratories, Inc. Description The Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit is an indirect chemiluminescence immunoassay. The light signal is measured by the DZ-lite 3000 Plus Chemiluminescence Analyzer as relative light units (RLUs), which is evaluated against the established cutoff to determine the final result. The product contains a Low and a High Calibrator to execute calibration operation. Sensitivity 91.7% Specificity 97.4% Phase of development Received EUA Proposed release Current Date 7/8/2020

Country of development China Type of Serological Test RDT Authors/Company Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Description This is a lateral flow assay that detects total antibody to the RBD region of the spike protein of SARS-CoV-2. Sensitivity was determined from 132 positive clinical cases, and specificity from 271 negative cases. They also post sensitivity and specificity stratified by time since symptom onset.The test has been independently validated by several institutions, including the NCI which found a sensitivity of 100% and specificity of 98.8%. Sensitivity 94.7 Specificity 98.9 Phase of development Received EUA and CE mark. Proposed release Current Date July 10, 2020

Country of development China Type of Serological Test RDT Authors/Company Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Description The WANTAI SARS-CoV-2 Ab Rapid Test is a lateral flow assay for the qualitative detection of total antibodies (including IgG and IgM) to SARS-CoV-2 in human serum, plasma (dipotassium EDTA, lithium heparin, and sodium citrate), and venous whole blood. NCI cross-validation studies reported sensitivity of 100% and specificity of 98.8%. Sensitivity 94.7% Specificity 98.9% Phase of development Received FDA EUA Proposed release Current Date July 10, 2020

Country of development Finland Type of Serological Test RDT Authors/Company Salofa Oy Description The SiennaTM-Clarity COVIBLOCKTM COVID-19 IgG/IgM Rapid Test Cassette is a membrane-based lateral flow immunoassay intended for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma (dipotassium EDTA, sodium citrate, sodium heparin) and venous whole blood (dipotassium EDTA, sodium citrate, sodium heparin). NCI cross-validation studies reported sensitivity of 90% for IgM and 93.3% for IgG and specificity of 100% for IgM and 98.8% for IgG. Sensitivity 100% for IgM and IgG Specificity 100% for IgM and IgG Phase of development Received FDA EUA Proposed release Current Date July 13, 2020

Country of development US Type of Serological Test RDT Authors/Company Megna Health, Inc. Description This is a lateral flow assay RDT that tests for IgM and IgG to SARS-CoV-2 nucleocapsid protein. Sensitivity was determined from 126 positive clinical samples, and specificity was determined from 285 negative samples. They present a combined (IgM and IgG) sensitivity, but also stratify by isotype and time since symptom onset. They also present independent NCI validation results, with combined sensitivity of 100% and specificity of 95%. Sensitivity IgM: 73.81%

IgG, 73.81

Combined: 90.5% Specificity IgM: 99.7%

IgG:99.3%

Combined: 98.9% Phase of development Received FDA EUA Proposed release Current Date July 17, 2020

Country of development US Type of Serological Test Fluorescent microbead-based immunoassay (FMIA) Authors/Company Luminex Description This is a multiplexed, bead based assay that tests for antibodies against the nucleocapsid protein, the receptor binding domain of spike, and the S1 subunit of spike protein. The test should be run using the Luminex® xMAP technology and works with Luminex 200, MAGPIX, and FLEXMAP 3D System. This test is specific for IgG. Sensitivity was determined from 112 serum samples, stratified by time since symptom onset. Specificity was from 309 negative serum samples. They also tested plasma sensitivity, stratified by time (n=46). They validated sensitivity and specificity on all platforms suitable for the test. Sensitivity Serum: 71% (days 0-7), 71.4% (8-14 days), 96.2% (14+ days); Plasma: 100% (0-7 days), 82% (8-14 days), 96.6% (14+ days) Specificity Serum: 100%, Plasma: 99.2% Phase of development Received FDA EUA Proposed release Current Date July 16, 2020

Country of development South Korea Type of Serological Test RDT Authors/Company Access Bio, Inc. Description This is a lateral flow assay that detects IgM and IgG to recombinant nucelocapsid and spike RBD antigens of SARS-CoV-2. Sensitivity was determined from 64 positive clinical samples, and specificity from 182 negative samples. The company also stratifies by time post symptom onset, though most samples were from 15 days onward. This test has also been validated by the NCI, and the combined (IgG/IgM) sensitivity is 100%, and specificity is 97.5%. Sensitivity 96.7% (IgG); 89% (IgM); 98.44% (combined) Specificity 99.45% (IgM); 99.45%(IgG); 98.9% (combined) Phase of development Received EUA Proposed release Current Date July 24, 2020

Country of development China Type of Serological Test RDT Authors/Company Xiamen Biotime Biotechnology Co., Ltd Description This is a lateral flow assay that detects IgM and IgG against SARS-CoV-2 (specific antigen not stated). This has only been authorized for use with potassium EDTA plasma, serum or potassium EDTA venous whole blood. In testing for cross-reactivity with other samples from patients with non-SARS-CoV-2 infections, there was no cross-reactivity found. They provide sensitivity and specificity stratified by time post symptom onset (presented here) and time post positive PCR. Sensitivity was determined from 120 positive clinical samples, and specificity from 315 clinical samples. The manufacturer also did a longitudinal study to determine time of seroconversion. The test was also validated by the NCI, with a combined sensitivity of 100% and specificity of 96.2%. Sensitivity IgG: 46.38% (days 0-7), 67.65% (days 7-14), 100% (days 14+); IgM: 55% (days 0-7), 94% (days 7-14), 100% (days 14+) Specificity 99.23%% Phase of development Received EUA Proposed release Current Date July 24, 2020

Country of development US Type of Serological Test CLIA Authors/Company Siemens Healthcare Diagnostics Inc. Description This is a chemiluminescent immunoassay to detect IgG in patient samples, using the ADVIA Centaur XP or XPT platforms. The target antigen is the RBD of the S1 domain of the spike protein. This assay provides a semi-quantitative (meaning an estimate/relative amount of antibodies) readout within about 25 minutes. Sensitivity and specificity were determined using 189 positive clinical samples and 1831 negative samples. Both measures were stratified by time post symptom onset. Sensitivity 53.5% (0-6 days), 93.4% (7-14 days), 100% (14+ days) Specificity 99.9% Phase of development Received EUA Proposed release Current Date July 31, 2020

Country of development US Type of Serological Test CLIA Authors/Company Siemens Healthcare Diagnostics Inc. Description This is a chemiluminescent immunoassay to detect IgG in patient samples, using the Atellica platform. The target antigen is the RBD of the S1 domain of the spike protein. This assay provides a semi-quantitative (meaning an estimate/relative amount of antibodies) readout within about 25 minutes. Sensitivity and specificity were determined using 197 positive clinical samples and 1841 negative samples. Both measures were stratified by time post symptom onset. Sensitivity 56% (0-6 days), 92%(7-14 days), 100% (14+ days) Specificity 99.9% Phase of development Received EUA Proposed release Current Date July 31, 2020

Country of development China Type of Serological Test ELISA Authors/Company Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Description The WANTAI SARS-CoV-2 Ab ELISA test is an ELISA based assay, detecting IgM and IgG reactive to the spike protein receptor binding domain. Sensitivity was determined from 235 positive samples, and specificity from 501 negative samples stratified by time since symptom onset. The test was also validated by the NCI, finding a sensitivity of 96.7% and specificity of 97.5%. Sensitivity 55.4% (0-7 days), 84.8% (7-14 days), 98.7% (15+ days) Specificity 98.6% Phase of development Received EUA Proposed release Current Date August 5, 2020

Country of development France Type of Serological Test Enzyme linked fluorescent assay (ELFA) Authors/Company bioMérieux SA Description The VIDAS SARS-CoV-2 IgG measures IgG antibody to the S1 unit of the spike protein. This system is completely automated, and provides a fluorescent readout that correlates to titers of antibody present in the patient sample. Sensitivity was determined from 120 positive clinical samples, and specificity from 989 negative samples. The positive samples were stratified by time since symptom onset, and only 17 were from 15 days onward. Sensitivity 49% (0-7 days), 100% (7-14 days), 100% (15+days) Specificity 99.9%% Phase of development Received EUA, has CE mark. Proposed release Current Date August 6, 2020

Country of development France Type of Serological Test Enzyme linked fluorescent assay (ELFA) Authors/Company bioMérieux SA Description The VIDAS SARS-CoV2 IgM measures IgM antibody to the S1 unit of the spike protein. The system is completely automated, and provides a fluorescent readout that correlates to titers of antibody present in the patient sample. Sensitivity was determined from 111 positive clinical samples, stratified by time, and 308 negative clinical samples. Only 20 samples were from after 7 days post symptom onset. 91 were from 0-7 days. Sensitivity 53.8% (0-7 days), 100% (7-14 days), 100%(15+) Specificity 99.4%% Phase of development Received EUA, has CE mark. Proposed release Current Date August 6, 2020

Country of development US Type of Serological Test CLIA Authors/Company Diazyme Laboratories, Inc. Description The Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit detects IgM specific to SARS-CoV-2. The test uses a recombinant virus antigen, though it is not stated which protein is used. The manufacturer recommends that the kit be used at least 15 days post symptom onset. Sensitivity was determined from 155 positive clinical samples, and specificity from 302 negative samples. Sensitivity was stratified by time post symptom onset (108 samples were from after 15 days). Sensitivity 26.1% (0-7 days); 83.3% (7-14 days), 94.4% (15+days) Specificity 98.3% Phase of development Received EUA Proposed release Current Date August 17, 2020

Country of development US Type of Serological Test CLIA Authors/Company BioCheck, Inc. Description The BioCheck SARS-CoV-2 IgG and IgM Combo Test is a CLIA based assay that detects antibodies specific to the S1 region of spike protein. The assay, which uses special casettes, should be run on the MS-Fast Automated Chemiluminescent Immunoassay Analyzing System. Sensitivity was determined from 110 positive clinical samples, and specificity from 143 negative samples. Sensitivity was further stratified by time post symptom onset. Sensitivity 100% (0-7 days, IgM); 93.8% (7-14 days, IgM); 88.9% (15+days, IgM); 100% (0-7 days, IgG); 100%(7-14 days, IgG); 100% (15+days, IgG) Specificity 97.2% (IgM), 100% (IgG) Phase of development Received EUA and CE mark Proposed release Current Date August 17, 2020

Country of development Canada Type of Serological Test RDT Authors/Company Biocan Diagnostics Inc. Description Biocan Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Rapid Test is a lateral flow chromatographic immunoassay. The T2 line is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-SARS-CoV-2, the T1 line is pre-coated with reagents for the detection of IgM anti-SARS-CoV-2. The sensitivity was determined from 30 positive clinical samples and specificity from 79 negative samples. Sensitivity IgG: 93.3% IgM: 90% Specificity IgG: 96.2% IgM: 98.7% Phase of development Received FDA EUA and CE mark Proposed release Current Date August 25, 2020

Country of development Taiwan/China Type of Serological Test RDT Authors/Company TBG Biotechnology Corp. Description The TBG SARS-CoV-2 IgG / IgM Rapid Test Kit is a lateral flow immunoassay intended for qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human serum and plasma. Manufacterer reported sensitivity and specificity was determined from 56 positive samples and 482 negative samples. The test was also validated by the NCI, finding a sensitivity of IgG 93.3%/ IgM 93.3% and specificity of IgG 96.2%/ IgM 95.0%. Sensitivity IgG: 96.4% IgM: 87.5% Specificity 99.8% Phase of development Received FDA EUA and CE mark, NCI validation studies complete Proposed release Current Date August 31, 2020

Country of development US Type of Serological Test ELISA Authors/Company University of Arizona Genetics Core for Clinical Services Description The COVID-19 ELISA pan-Ig Antibody Test is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of total antibodies (including IgA, IgG, and IgM) to SARS-CoV-2 in human serum. Sensitivity and specificity was determined from 40 positive samples and 320 negative samples. Sensitivity 97.5% Specificity 99.1% Phase of development Received FDA EUA Proposed release Current, testing is limited to University of Arizona Genetics Core for Clinical Services Date August 31, 2020

Country of development South Korea Type of Serological Test RDT Authors/Company Sugentech Inc. Description The SGTi-flex COVID-19 IgG is a colloidal gold based lateral flow assay, specific for IgG to SARS-CoV2. The test strip is within a cassette, and the results can be read by eye within about 15 minutes. The assay detects IgG specific to the SARS-CoV-2 nucleocapsid and RBD of the spike protein. This test can use human serum, plasma, or whole blood samples. Sensitivity was determined from 185 positive clinical samples and stratified by time post symptom onset, and specificity from 234 negative clinical samples. The test was also validated by the NCI, with a sensitivity of 96.7%, and a specificity of 100%. Sensitivity 41.2% (0-7 days), 91.7% (7-14 days), 98.6% (15+ days) Specificity 99.15% Phase of development Received FDA EUA, CE mark, Korea MFDS Product license, and Brazil ANVISA certified Proposed release Current Date September 3, 2020

Country of development US Type of Serological Test CLIA Authors/Company BioCheck, Inc. Description The BioCheck SARS-CoV-2 IgG Antibody Test Kit uses an indirect method to determine the presence of SARS-CoV-2 IgG antibodies in a human serum. In the cassette, the SARS-CoV-2 IgG antibodies in a patient serum sample bind to biotinylated SARS-CoV-2 S1 antigens. Excess streptavidin coated magnetic beads bind with high affinity to biotinylated SARS-CoV-2 S1 antigen to form complexes. A luminescent substrate is added, and the enzymes in the complexes catalyze the luminescent substrate to form unstable excited state intermediates. When the excited intermediates return to the ground state, photons are emitted. The number of photons produced is positively correlated with the level of SARS-CoV-2 IgG antibodies in the sample. Sensitivity 100% Specificity 100% Phase of development Received FDA EUA and CE mark Proposed release Current Date September 9, 2020

Country of development US Type of Serological Test CLIA Authors/Company BioCheck, Inc. Description The BioCheck SARS-CoV-2 IgM Antibody Test Kit uses an indirect method to determine the presence of SARS-CoV-2 IgM antibodies in a human serum. In the cassette, the SARS-CoV-2 IgM antibodies in a patient serum sample bind to biotinylated SARS-CoV-2 S1 antigens. Excess streptavidin coated magnetic beads bind with high affinity to biotinylated SARS-CoV-2 S1 antigen to form complexes. A luminescent substrate is added, and the enzymes in the complexes catalyze the luminescent substrate to form unstable excited state intermediates. When the excited intermediates return to the ground state, photons are emitted. The number of photons produced is positively correlated with the level of SARS-CoV-2 IgM antibodies in the sample. Sensitivity 96.2% Specificity 97.2% Phase of development Received FDA EUA and CE mark Proposed release Current Date September 9, 2020

Tests that have been approved for diagnostic use in other countries

Country of development Singapore Type of Serological Test Not explicity stated, though their "gold standard" is a neutralization assay Authors/Company Singapore/ Wang Lab Description The Wang lab developed two tests. One, which has about 90% sensitivity, is rapid and uses recombinant viral proteins to detect reactive antibodies. The second is their "gold standard" and utilizes a viral neutralization assay but takes 3-5 days. Sensitivity 90% Specificity Phase of development Deployed in Singapore Proposed release Not stated Date March 1, 2020

Country of development US/China Type of Serological Test RDT, solid phase immunochromatographic assay Authors/Company Aytu Biosciences/Orient Gene Biotech Description The (COVID-19) IgG/IgM Rapid Test will assay patient antibodies to SARS-CoV-2 from blood or plasma samples. Sensitivity 87.9% (IgM) and 97.2% (IgG) Specificity 100% for IgG and IgM Phase of development CE approved, used in China in clinical settings, awaiting FDA approval Proposed release Shipments should be ready by early April Date March 10, 2020

Country of development US/China Type of Serological Test Proprietary Authors/Company ScanWell Health/INNOVITA Description This kit is for detection of IgG and IgM for SARS-CoV-2 in the blood, taking only 15 minutes, and is an at-home test. Sensitivity 87.3% Specificity 100% Phase of development Cleared by China's National Medical Products Administration (NMPA), and pending approval by US FDA Proposed release 6-8 weeks (May 1 to May 15), depending on FDA approval date Date March 20, 2020

Country of development US Type of Serological Test ELISA Authors/Company MayoClinic/University of Minnesota Description MayoClinic is developing an ELISA to test for antibodies to SARS-CoV-2. The types of antibodies are not stated, nor is sensitivity or specificity. Sensitivity Specificity Phase of development Clinical Proposed release April 6, 2020 Date April 1, 2020

Country of development USA Type of Serological Test RDT Authors/Company Advaite Description RapCov Rapid COVID-19 Test is an in vitro diagnostic test for IgM and IgG antibodies. In a study with 18 healthy and 18 COVID-19 positive patients, the sensitivity was 89% and specificity was 100%. It should be noted that "specificity" was only performed on healthy patient samples, not patient samples from related viruses. Further testing is necessary to validate the test. It is currently being used to study community prevalence in Chester County, PA. https://advaite.com/press-release/advaite-deploys-covid-19-rapid-antibody-test-kits-to-chester-county-and-collaborates-with-pennsylvania-companies-to-scale-up-manufacturing/ Sensitivity Specificity Phase of development Research use only (IVD), not approved for diagnostic use. This company was not found on any FDA categorization of tests Proposed release April 2020 Date April 6, 2020

Country of development Switzerland Type of Serological Test MIRA - Multiplexed Immuno-Refractive Assay Authors/Company Quotient Description An antibody microarray running on the CE marked MosaiQ instrument. The test looks for both IgM and IgM. Time to initial results is 35 minutes and the machine can process 1000 microarrays in an eight hour shift. Sensitivity 100% Specificity 99.8% Phase of development CE/IVD; in process of applying for FDA EUA Proposed release Currently available in Europe; manufacturing capacity of 30M per year rate in 2020, 60M per year within 18 months Date May 1, 2020

Country of development United Kingdom Type of Serological Test RDT Authors/Company Edinburgh Genetics Description Colloidal gold lateral flow assay for the detection of IgM and IgG antibodies in human serum, plasma or whole blood Sensitivity 100% Specificity 98.7% Phase of development Received CE/IVD Proposed release CE/IVD usage in Europe Date

Country of development Mexico Type of Serological Test RDT Authors/Company Kabla Clinical Diagnostics Description Colloidal gold lateral flow assay for the detection of IgM and IgG antibodies in human serum, plasma or whole blood. In collaboration with Certum Diagnostics. Sensitivity 99.9% (IgG) 85% (IgM) Specificity 98% (IgG) 96% (IgM) Phase of development Received CE/IVD, emergency use authorized in Mexico, Brazil, and other countries Proposed release Current Date

Country of development China Type of Serological Test RDT Authors/Company Ringbio Description The kit is based on immunochromatographic assay, to detect COVID-19 IgG & IgM antibody in serum / plasma / blood. Sensitivity and specificity was calculated from 132 clinical samples. Sensitivity IgM: 89.4%

IgG: 97.9% Specificity IgM: 97.7%

IgG: 97.7% Phase of development Received CE mark Proposed release Current Date 5/28/2020

Country of development Spain Type of Serological Test Double Recognition ELISA Authors/Company Ingenasa (via Gold Standard Diagnostics) Description The INgezim COVID assays use the SARS-CoV-2 nucleoprotein (N protein) as the antigen for the detection of antibodies to SARS-CoV-2. This test can use serum or plasma samples. The test uses SARS-CoV-2 recombinant N protein as a coating and conjugate. Sensitivity and specificity were determined using 116 positive samples and 249 negative samples. Sensitivity 98.3% Specificity 99.2% Phase of development Received CE mark; undergoing FDA EUA review Proposed release Current Date

Country of development US Type of Serological Test ELISA Authors/Company Gold Standard Diagnostics Description The GSD SARS-CoV-2 IgG / IgM / IgA ELISA kits are intended for the qualitative detection of antibodies to SARS-CoV-2 virus in human serum and plasma. Sensitivity IgG: 100% (>12 days)

IgM: 44% (>12 days)

IgA: 88.9% (>12 days) Specificity IgG: 100%

gM: 99%

IgA: 100% Phase of development Received CE mark; undergoing FDA EUA review Proposed release Current Date

Country of development Germany Type of Serological Test ELISA Authors/Company VIROTECH Diagnostics GmbH (via Gold Standard Diagnostics) Description The VIROTECH SARS-CoV-2 IgG / IgM / IgA ELISA kits are intended for the qualitative detection of antibodies to SARS-CoV-2 virus in human serum. Sensitivity IgG:100% (>12 days)

IgM: 77.8% (>12 days)

IgA: 77.8% (>12 days) Specificity IgG: 100%

IgM: 100%

IgA: 100% Phase of development Received CE mark; undergoing FDA EUA review Proposed release Current Date

Country of development Germany Type of Serological Test ELISA Authors/Company NovaTec Immundiagnostica GmbH (via Gold Standard Diagnostics) Description There are 3 NovaLisa tests for COVID-19 IgG, IgM, and IgA. The ELISA tests can use serum or plasma samples. Sensitivity IgG: 100% (>12 days)

IgM: 40% (>12 days)

IgA: 88.9% (>12 days) Specificity IgG: 99.3%

IgM: 100%

IgA: 98.3% Phase of development Received CE mark; undergoing FDA EUA review Proposed release Current Date

Country of development Spain Type of Serological Test RDT Authors/Company Ingenasa (via Gold Standard Diagnostics) Description INgezim® COVID 19 CROM qualitatively determines the total antibodies (IgG, IgA, and IgM) specific to SARS-CoV2 virus N in a single blood, serum or plasma sample by using nucleoprotein (N protein) as an antigen for detection of antibodies to the virus. Sensitivity and specificity were determined using 286 positive samples and 146 negative samples. Sensitivity 90.7% Specificity 99.3% Phase of development Received CE mark; undergoing FDA EUA review Proposed release Current Date

Country of development UK Type of Serological Test ELISA Authors/Company Erba Mannheim (IgG test) Description The ErbaLisa COVID-19 IgG Enzyme Immunoassay (ELISA) kit for the detection of IgG antibodies to SARS-CoV-2 in human serum. The total incubation time is 50 min at room temperature with a simple one step serum dilution. Sensitivity 98.3% Specificity 98.1% Phase of development Received CE mark, FDA Notification status (not yet EUA) Proposed release Current Date

Country of development UK Type of Serological Test ELISA Authors/Company Erba Mannheim (IgM test) Description The ErbaLisa COVID-19 IgM Enzyme Immunoassay (ELISA) kit for the detection of IgM antibodies to SARS-CoV-2 in human serum.The total incubation time is 50 min at room temperature with a simple one step serum dilution. Sensitivity 100% Specificity 90% Phase of development Received CE mark, FDA Notification status (not yet EUA) Proposed release Current Date

Country of development US Type of Serological Test Dried blood spot Authors/Company PerkinElmer Description The PerkinElmer® GSP®/DELFIA® Anti-SARS-CoV-2 IgG kit has been designed to run dried blood samples on the fully automated and high throughput screening GSP® instrument, as well as serum/plasma on a manual time-resolved fluorescence reader, e.g. VICTOR2™ D instrument. Sensitivity 96.2% Specificity 98.7% Phase of development Received CE mark Proposed release Current Date

Country of development US Type of Serological Test CLIA Authors/Company PerkinElmer Description The SuperFlex™ Anti-SARS-CoV-2 IgG kit product is an immunoassay intended for qualitative detection of anti-SARS-CoV-2 IgG in human serum, plasma (EDTA, sodium citrate) and venous whole blood on Automated chemiluminescence analyzer. The test is performed using superparamagnetic microparticles together with direct chemiluminescence technology to detect anti-SARS-CoV-2 IgG. Sensitivity 90.3% Specificity 100% Phase of development Received CE mark Proposed release Date Current

Country of development UK Type of Serological Test RDT Authors/Company Abingdon Health Description The “AbC-19TM Rapid Test” uses a small drop of blood from a finger-prick, and shows results in 20 minutes.The test detects IgG antibodies to SARS-CoV-2. Sensitivity and specificity were determined using 203 positive samples and 450 negative samples. Sensitivity 98% Specificity 99.6% Phase of development Received CE mark Proposed release Current, roll-out by the end of August Date July 30. 2020

Country of development US Type of Serological Test RDT Authors/Company NOWDiagnostics Description The ADEXUSDx® COVID-19 Test is a rapid serology, self-contained assay that measures the presence of SARS-CoV-2 antibodies to deliver accurate and reliable results in 15 minutes with no buffers, reagents, or additional equipment. The test uses a drop of fingerstick blood to obtain results. Sensitivity 95.6% Specificity 98.5% Phase of development Received CE mark Proposed release Current Date

Country of development Sweden Type of Serological Test RDT Authors/Company ZetaGene Ltd. Description The ZetaGene COVID-19 Rapid IgM IgG Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum or plasma (EDTA, citrate) specimens from patients suspected of COVID-19 infection by a healthcare provider. Sensitivity 95% Specificity 97% Phase of development Received CE mark Proposed release Current Date

Country of development Singapore Type of Serological Test ELISA Authors/Company Restalyst Description The COVID19N-REAAD test assays for IgG antibodies to SARS-CoV-2 nucleocapsid protein. The sensitivity was determined from 56 positive clinical samples and specificity from 331 negative samples. Sensitivity 98.2% Specificity 100% Phase of development Received CE mark and provisional authorization from the Singapore Health Sciences Authority Proposed release Current Date August 25, 2020

Country of development UK Type of Serological Test RDT Authors/Company Mologic/Visitect Description The lateral flow assay developed by Mologic (also under the name Visitect) detects IgG, IgA, and IgM to SARS-CoV-2. The company stated that the test will be used in primary care settings. Sensitivity Not available Specificity Not available Phase of development Received CE Mark, validated by London School of Tropical Medicine and Hygiene, St. George's, and the University of London. Proposed release According to a press release, the company can produce up to 100,000 tests per week. Date

Country of development Canada Type of Serological Test ELISA Authors/Company Victory Square Description The VS Health’s Safetest Covid-19 IgG /IgM detects antibodies using an ELISA method. There is not currently a product insert or description available beyond the press release. Sensitivity 93.3% Specificity 98.7% Phase of development Received CE mark and Brazilian Anvisa approval. Proposed release Current Date September 14, 2020

Country of development Germany Type of Serological Test ELISA Authors/Company Immunodiagnostik Description IDK® anti-SARS-CoV-2 IgM is an enzyme-linked immunosorbent assay (ELISA) for qualitative measurement of IgM antibodies against the novel coronavirus SARSCoV-2 in human serum or EDTA plasma. The assay is an in vitro diagnostic medical device and is intended to be used by professional users in a laboratory environment. This ELISA can be performed manually or using an automated platform. Sensitivity 95% Specificity 97.6% Phase of development Received CE mark Proposed release Current Date August 25, 2020

Country of development Germany Type of Serological Test ELISA Authors/Company Immunodiagnostik Description IDK® anti-SARS-CoV-2 IgG is an enzyme-linked immunosorbent assay (ELISA) for qualitative measurement of IgG antibodies against the novel coronavirus SARS-CoV-2 in human serum or EDTA plasma. The assay is an in vitro diagnostic medical device and is intended to be used by professional users in a laboratory environment. This ELISA can be performed manually or using an automated platform. Sensitivity 100% Specificity 99.1% Phase of development Received CE mark Proposed release Curent Date August 25, 2020

Country of development Germany Type of Serological Test ELISA Authors/Company Mediagnost Description Mediagnost Anti-SARS-CoV-2 ELISA is a highly specific Enzyme Immunoassay for the detection of IgG antibodies directed against SARS-CoV-2-S1 Receptor Binding Domain (RBD) in human blood. Sensitivity 95.3% Specificity 98.6% Phase of development Received CE mark Proposed release Current Date July 7, 2020

Country of development UK Type of Serological Test RDT Authors/Company SureScreen Description The test is a lateral flow immunoassay test and operates in a similar way to a pregnancy test. Embedded into the test strip are antibodies that bind to a COVID-19 specific biomarker, Immunoglobulin G (IgG), and another infection biomarker, Immunoglobulin M (IgM). When a sample (blood, serum or plasma) is added to one end of the test, it flows along the test strip and interacts with these antibodies. Sensitivity 97.8% Specificity 99.6% Phase of development Received CE mark Proposed release Current Date

Tests that have been approved for research or surveillance purposes only

Country of development US Type of Serological Test RDT Authors/Company BioMedomics Description This assay detects patient antibodies, IgG and IgM, on a lateral flow assay. It uses a recombinant viral antigen, though it does not state the specific antigen. The test is a 3 line read-out, one line for a control, one line to detect IgM, and one to detect IgG. Three lines indicates the patient has both IgG and IgM. Sensitivity was measured from 397 positive patients, and specificity from 128 negative patients. Sensitivity 88.6% Specificity 90.63% Phase of development Under development Proposed release BD has stopped selling the kit, as it is not approved under the new FDA serology test guidelines. They are planning to resubmit the test for a new EUA once they have validated the second generation version of the test. Date May 12, 2020

Country of development US Type of Serological Test ELISA Authors/Company Creative Diagnostics Description Kit DEIASL019 detects patient IgG for SARS-CoV-2, and uses the whole virus lysate as the antibody binding target. The reported sensitivity and specificity are 100% (from 16 and 30 samples, respectively). The DEIA2020 kit only tests for patient IgG that reacts to N protein. Sensitivity 100% Specificity 100% Phase of development Not approved for diagnostic use; for research use only Proposed release available for purchase by research labs/healthcare providers, but not for diagnostic use Date March 20, 2020

Country of development US Type of Serological Test ELISA Authors/Company Eagle Biosciences Description This company has two kits, one (KTR-1032) which targets patient IgG, and one (KTR-1033) that targets IgM. The target antigen is an "HRP-labeled-COVID-19 antigen." Sensitivity was determined from 30 positive patients, and specificity was determined from 54 negative patients. Sensitivity 100% Specificity 100% Phase of development Research use only, CE/IVD outside the US Proposed release available for purchase by research labs/healthcare providers, but not for diagnostic use Date Date not given

Country of development China/US Type of Serological Test RDT, immunofluorescence, colloidal gold Authors/Company BioEasy/Shenzhen BioEasy Biotechnology Co. Description There are three tests: 1) the 2019 nCoV Ag test, which assays sputum or nasal swabs for SARS-CoV-2 antigens and gives a fluorometric read out, 2) the 2019-nCoV Ag GICA test, which uses colloidal gold, and 3) the 2019 nCoV IgG/IgM GICA rapid test which assays for patient antibodies to the virus from blood samples Sensitivity Specificity Phase of development CE/IVD approved Proposed release available for purchase by research labs/healthcare providers, CE/IVD approved Date Date not given

Country of development Germany Type of Serological Test ELISAs Authors/Company Euroimmun AG Description This company has two tests, including EI 2606-9601 A, which tests for patient IgA, and EI 2606-9601 G, which tests for patient IgG. The target antigens were not stated, nor were specificity or sensitivity of tests. Sensitivity Specificity Phase of development Research use only, CE/IVD in EU Proposed release CE/IVD in the EU Date March 12, 2020

Country of development Germany Type of Serological Test RDT, lateral flow assay Authors/Company PharmACT Description This RDT tests for IgM and IgG of patients, with 92-98% sensitivity in later stages of the infection (day 11-24) with 100% sensitivity. Sensitivity 92-98% Specificity 100% Phase of development Research use only Proposed release Appears available for purchase by research labs/healthcare providers, but no clear approvals Date Date not given

Country of development China Type of Serological Test Not listed Authors/Company Snibe Co Description The company provides two tests the 2019-nCoV IgG , and 2019-nCoV IgM tests. The test is a chemiluminescent immunoassay (CLIA). It has been clinically tested in China, though the exact specificity and sensitivity was not stated. Sensitivity Specificity Phase of development CE/IVD approved Proposed release available for purchase by research labs/healthcare providers, CE/IVD approved Date Feb. 19, 2020

Country of development China Type of Serological Test RDT (colloidal gold lateral flow assay) Authors/Company Sanuo Biotech Description The SARS-Cov-2 Antibody Test strip tests for patient IgG and IgM. The press release did not disclose sensitivity or specificity of the test. Sensitivity Specificity Phase of development CE/IVD approved Proposed release available for purchase by research labs/healthcare providers, CE/IVD approved Date March 12, 2020

Country of development China Type of Serological Test RDT (colloidal gold lateral flow assay) Authors/Company BioTime Description The SARS-CoV-2 IgG/IgM kit tests for patient antibodies to the virus from blood or plasma samples. There is no reported sensitivity or specificity. Sensitivity Specificity Phase of development Only approved for in vitro diagnostic use Proposed release available for purchase by research labs/healthcare providers Date Date not given

Country of development The Republic of Korea Type of Serological Test RDT Authors/Company GenBody Description GenBody FIA COVID-19 IgM/IgG (COVI025) Sensitivity Specificity Phase of development Research use only, CE/IVD in EU Proposed release CE/IVD in the EU Date March 2, 2020

Country of development United Kingdom Type of Serological Test RDT Authors/Company Mologic Description Seems to be an RDT (probably to IgM and IgG). No description was given, other than they received 1 million pounds investment from the UK government. Sensitivity Specificity Phase of development They are validating now with Liverpool Trop Med and St. Georges, London Proposed release Date not given Date March 29, 2020

Country of development China Type of Serological Test RDT Authors/Company Livzon Diagnostics Description RDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2. Sensitivity Specificity Phase of development Research use only, CE/IVD approved Proposed release available for purchase by research labs/healthcare providers Date Date not given

Country of development USA Type of Serological Test RDT Authors/Company Confirm Biosciences Description This RDT detects IgM and IgG, though the target antigen is unclear. Sensitivity appears to be 93.8%, and sensitivity is 99.1%, in 704 samples tested. The location of the trial was not disclosed. Sensitivity 93.1% Specificity 99.1% Phase of development Research use only, not approved by the FDA Proposed release Available for purchase by research labs/healthcare providers Date April 15, 2020

Country of development UK Type of Serological Test ELISA Authors/Company Adams et al (Liverpool School of Tropical Medicine and Hygiene) Description The authors developed an in-house ELISA, with recombinant SARS-CoV-2 trimeric spike protein. They were testing for IgM and IgG, against RT-qPCR. They found, in 31 samples, there was 100% sensitivity for IgG after 10 days post symptom onset. Sensitivity 100% Specificity Phase of development Research use only Proposed release Not stated Date April 20 2020

Country of development US Type of Serological Test RDT Authors/Company Abcam Description The Abcam Novel Coronavirus IgM Antibody Detection Kit detects IgM specific to the SARS-CoV-2 nucleocapsid protein. Their Novel Coronavirus IgG Antibody detects IgG specific to the nucleocapsid protein as well. Specificity and sensitivity are not stated. Sensitivity Specificity Phase of development Available for purchase by healthcare/research professionals. Not approved by the FDA. Under section IV.D Proposed release Current Date April 21, 2020

Country of development US Type of Serological Test Not stated Authors/Company Advanced Diagnostics Laboratory, National Jewish Health Description This test can test for IgG or IgM to SARS-CoV-2, and was developed in-house. The assay specificity and sensitivity were not stated. Sensitivity Specificity Phase of development Research use only. Not yet authorized by the FDA, but in th EUA application process Proposed release Current Date April 24, 2020

Country of development Canada Type of Serological Test RDT Authors/Company Artron Description This test is an RDT that detects IgG and IgM to SARS-2-CoV. The target antigen is not stated. The sensitivity is 93.4% and the specificity is 97.7%, in testing over 180 positive samples and over 500 negative samples. The kit was also recently used in a study (https://www.medrxiv.org/content/10.1101/2020.04.22.20075564v1.full.pdf) on IgM and IgG antibodies in COVID-19 patients. After 2 weeks, IgM was detected 95.8% in positive cases, and IgG was detected in 62.5% of cases. Sensitivity 93.4% Specificity 97.7% Phase of development Not FDA authorized (subsection IV.D). For research use only Proposed release Current Date April 27, 2020

Country of development US Type of Serological Test Chemiluminescent immunoassay Authors/Company BioCheck Description The BioCheck MS-FAST system and SARS-CoV-2 chemiluminescence-based tests can process blood, serum, or plasma samples in 30 minutes to detect IgM and IgG antibodies. Sensitivity Specificity Phase of development Applying for FDA EUA Proposed release Available for purchase by research labs/healthcare providers, but not for diagnostic use Date April 15, 2020

Country of development Germany Type of Serological Test RDT Authors/Company AlphaBiolabs Description The Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect both early and late marker IgG/IgM antibodies in human finger-prick blood samples. Sensitivity 99.9% IgM and 91.8% IgM Specificity 99.5% IgG and 99.2% IgM Phase of development CE approved Proposed release Available for purchase by research labs/healthcare providers, CE approved Date

Country of development US Type of Serological Test Protein microarray Authors/Company Krishnamurthy et al. Description This group worked to improve upon ELISA based methods with a protein microarray that allows for multiplexing (pooling) of samples. Dried blood spots were found to be usable for this type of test. For the study, they had 158 positive samples and 1418 negative. Overall sensitivity was varied, and sensitivity/specificity reported here is reflective of when all antigens and all antibodies were combined. There was no cross-reactivity to antibodies to other coronaviruses. Sensitivity 98.1% Specificity 98.6% Phase of development Research use only Proposed release Not stated Date May 5, 2020

Country of development US Type of Serological Test Neutralizing antibodies Authors/Company Vyriad, Inc./Regeneron Description The test relies on a pseudovirus that has been engineered to express the SARS-CoV-2 spike glycoprotein on its surface. Human serum samples are then analyzed for neutralizing antibody titers. The type of cell in which this is tested was not stated in the press release. Sensitivity Specificity Phase of development Under internal validation and submitted for EUA. Proposed release Expected to be available in CLIA certified labs by late May Date May 12, 2020

Country of development US Type of Serological Test Chemiluminescence immunoassay Authors/Company Accelerate Diagnostics/BioCheck Description The test is called BioCheck MS-FAST.This test is run on the BioCheck platform to rapidly detect IgM and IgG to SARS-CoV-2 in patient serum samples. The test takes about 30 minutes. Sensitivity Specificity Phase of development Under development, submitted for EUA Proposed release Date

Country of development US Type of Serological Test ELISA Authors/Company University of Kentucky Description The University of Kentucky College of Medicine FCIM lab is developing an ELISA assay for detection of antibodies to SARS-CoV-2 in patient samples. The target antigen is the spike protein. While the sensitivity and specificity were unavailable, the researchers state that the test is accurately identifying positive COVD-19 cases and did not react to negative samples. Sensitivity Specificity Phase of development Under development Proposed release Date May 11, 2020

Country of development US Type of Serological Test Single molecule array (Simoa) Authors/Company Norman et al Description This group used single molecule array assay to measure total antibodies to SARS-CoV-2. The Simoa protocol has shown, in other cases, 1000-fold improvement in sensitivity over standard ELISA, and it allows analysis of multiple types of antibodies and antigens at once. The target antigens are Spike Protein, S1 subunit, Receptor Binding Domain (RBD), and Nucleocapsid protein. Sensitivity First week of infection, 86%; second week of infection and onward, 100% Specificity 100% Phase of development Preclinical Proposed release Not stated Date May 5, 2020

Country of development US Type of Serological Test ELISA Authors/Company Vitalant/UCSF Description It appears that Vitalant (a blood donation company) and UCSF have teamed up to make an in-house antibody test for SARS-CoV-2. It is an ELISA based assay, though they have not disclosed which antibodies are detected. Sensitivity Specificity Phase of development In development Proposed release Date not given Date March 31, 2020

Country of development Spain Type of Serological Test ELISA Authors/Company Colavita et al./Diesse Diagnostica Description Researchers developed an ELISA to detect IgA, IgG, and IgM from serum samples of patients. The test, ENZY-WELL SARS-CoV-2 ELISA, uses native viral protein (but does not specify which protein). Sensitivity and specificity were determined from 200 positive and 353 negative clinical samples. Sensitivity was optimal in samples obtained greater than 10 days after symptom onset. Sensitivity 92.5% (IgG), 93.6% (IgA), 87% (IgM) Specificity 91.7% (IgG) , 97.9% (IgA), 88% (IgM) Phase of development Research use only, CE/IVD approved Proposed release Date

Country of development US Type of Serological Test Modified neutralization assay Authors/Company Genscript Description This test uses a pseudovirus expressing the RBD of the spike protein to assay the ability of antibodies to block virus interaction with ACE2 receptors. This is not a traditional neutralization assay, in that it does not require live cells. It is a "blocking ELISA" assay. Essentially, if there is an antibody that blocks interaction of the RBD with ACE2, then there is no color change. A lack of neutralizing antibodies results in a color change. Sensitivity was determined from 60 clinical samples, and specificity from 97 negative clinical samples. Sensitivity 93% Specificity 100% Phase of development Research use only; currently has CE/IVD approval (EU) and HSA approval (Singapore) Proposed release Date May 26, 2020

Country of development Republic of Korea Type of Serological Test Lateral flow assay (RDT) Authors/Company GenBody Inc. Description Lateral flow assay for SARS-CoV-2 IgM and IgG. Results can be read within 10 minutes. Samples can be serum, plasma, or whole blood Sensitivity 91.7% Specificity 95.2% Phase of development CE/IVD Proposed release Currently licensed for use in Brazil and Australia in addition to CE/IVD status Date

Country of development Republic of Korea Type of Serological Test fluorescence immunoassay Authors/Company Boditech Med Inc. Description This test is intended to be used with the company's accompanying AFIAS-6 or AFIAS-1 analyzer machine. Results from SARS-CoV-2 IgM and IgM can be read in 10 minutes. Blood can either be whole plasma or finger-stick specimens. Sensitivity 95.8% Specificity 96.7% Phase of development CE/IVD Proposed release Currently licensed for use in Brazil in addition to CE/IVD status Date March 30, 2020

Country of development UK Type of Serological Test RDT Authors/Company BBI Solutions Description The AbC-19 is an RDT, lateral flow assay that detects IgM and IgG. The test is designed for at-home use. Sensitivity was determined from 203 positive samples, and specificity from 450 negative samples. They used the EuroImmun assay as their standard. Further validation will be performed after MHRA approval at Ulster University. Sensitivity 98.03% Specificity 99.6% Phase of development Received CE mark Proposed release The test is still under validation with the MHRA, but the test is designed for at-home use. The test is available for commercial distribution for use by research professionals. Date July 30, 2020

Country of development US Type of Serological Test modified ELISA Authors/Company Promega Description Lumit™ Dx Immunoassay, a SARS-CoV-2-specific protein fragment is labeled with the two subunits of the NanoBiT® Luciferase (Lumit™ Dx CoV-2-SmBiT and Lumit™ Dx CoV-2-LgBiT). When these labeled proteins are incubated with a serum or plasma sample that contains SARS-CoV-2 antibodies, the proteins bind to the antibody, bringing the SmBiT and LgBiT subunits in close proximity to form an active luciferase. A bright luminescent signal is generated following the addition of the Lumit™ Dx Detection Reagent and detected using a luminescent-capable microplate reader. Unlike conventional ELISA assays, the Lumit™ Dx SARS-CoV-2 Immunoassay requires no wash steps. Sensitivity and specificity were determined using 107 positive samples and 31 negative samples. Sensitivity 93.5% Specificity 100% Phase of development Pending FDA EUA, NCI validation ongoing Proposed release Test available for purchase by CLIA labs in the US, but still awaiting EUA Date

Country of development South Korea Type of Serological Test RDT Authors/Company Celltrion Description Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test is an in vitro diagnostic test based on an immunochromatographic assay. It is designed for qualitative detection of Immunoglobulin G and Immunoglobulin M antibodies of the novel Coronavirus (COVID-19) in human whole blood, plasma or serum. Sensitivity and specificity were determined using 50 positive samples and 75 negative samples. Sensitivity IgG: 92% IgM: 96% Specificity IgG: 100% IgM: 98.7% Phase of development Pending FDA EUA, NCI validation ongoing Proposed release By the third week of August 2020 in the US Date

Tests that are still in development

Country of development US Type of Serological Test CRISPR-based lateral flow assay Authors/Company Broughton et al (Mammoth Biosciences) Description Using a CRISPR-Cas12 based method, they can specifically detect virus RNA for the E and N genes. This is called the DETECTR assay, and does not assay for patient antibodies, but the presence of viral RNA. The CRISPR-Cas12 RNA targeting is followed by isothermal amplification of the target, resulting in a visual readout with a fluorophore.This was 90% sensitive and 100% specific. Sensitivity 90% Specificity 100% Phase of development Pre-clinical Proposed release In development Date March 10, 2020

Country of development US Type of Serological Test ELISA Authors/Company CDC Description The CDC is currently using an ELISA based test, with a target antigen of whole Spike (S) protein. Sensitivity was determined from 99 patients, and specificity from over 500 patients, some of whom had other coronavirus infections. They found that using a 1:100 dilution of human serum was optimal. Sera samples from patients with SARS-CoV-1 or MERS-CoV did yield a positive result, but all other sera positive for other coronaviruses did not cross react. Sensitivity 96% Specificity 99% Phase of development Not EUA approved, Research use only Proposed release Currently released for research use only Date May 27, 2020

Country of development Netherlands Type of Serological Test ELISA Authors/Company Okba et al Description Modifying existing beta version ELISA kits (EUROIMMUN Medizinische Labordiagnostika AG) for IgG or IgA, and an in-house ELISA kit, they coated plates with recombinant S1 domain of the spike protein. The commercially available kits are not yet approved for use. They found that the kits were sensitive and specific for the S1 region of SARS-CoV-2, looking at 45 samples overall. Sensitivity Specificity Phase of development Pre-clinical Proposed release Not stated Date March 20, 2020

Country of development China Type of Serological Test RDT Authors/Company Jiangsu bioPerfectus technologies Description This company has two tests, the PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit and the PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit. The IgM/IgG test assays for patient antibodies to the virus from a blood sample, while the Ag Rapid test assays for SARS-CoV-2 antigen from nasal swab samples. Sensitivity Specificity Phase of development Developed, awaiting approval Proposed release Appears available for purchase by research labs/healthcare providers in China, but no clear approvals Date March 3, 2020

Country of development US Type of Serological Test ELISA Authors/Company Klein lab, JHSPH Description They have adapted an ELISA, based on Amanat et al 2020, that tests for IgG and IgM to the full length Spike protien and to the receptor binding domain (RBD). They are now working to get a mucosal IgA ELISA working. So far, they are using the kit to test samples from Johns Hopkins Hospital. Sensitivity Specificity Phase of development Pre-clinical Proposed release Not given, but being used for research use Date April 6, 2020

Country of development China Type of Serological Test ELISA Authors/Company Zhang et al Description This group developed an in-house ELISA testing for patient antibodies (IgM and IgG) to the SARSr-CoV Rp3 nucleocapside (N) protein. They found that on day 5, 81% of patients were positive for IgM and 100% were positive for IgG (of 16 COVID-19 positive patients). Sensitivity 81% (IgM) and 100% (IgG) Specificity Phase of development Pre-clinical Proposed release Not given Date February 17, 2020

Country of development China Type of Serological Test Chemiluminescence immunoassay Authors/Company Qian et al Description Using a fully automated chemiluminescent assay on a YHLO Biotech analyzer, Qian and colleagues processed the serum of patients with or without COVID-19 at 10 hospitals. They tested for IgM and IgG to the nucleocapsid and spike proteins (both recombinant). Clinical sensitivity (in over 500 samples) of IgM was 85.88% and to IgG 96.62%, relative to rRT-qPCR. They used over 900 samples from patients with diseases other than COVID-19, as well as over 500 non-hospitalized (healthy) patient samples to determine specificity. They found the test to be 97.33% for hospitalized patients. Sensitivity 85.6% (IgM) and 96.62% (IgG) Specificity 99.49% (IgM) and 99.1% (IgG) Phase of development Pre-clinical development Proposed release Not stated Date April 21, 2020

Country of development China Type of Serological Test Chemiluminescent immunoassay Authors/Company Ma et al. Description This lab based chemiluminescent assay detects IgM, IgG, and IgA (all serum) against the SARS-CoV-2 nucleocapsid and spike receptor binding domains. Using samples from 87 positive patients, they found that sensitivity was improved when using the RBD rather than the N protein. RBD based test results were used for sensitivity and specificity. Sensitivity 98.6% (IgA), 96.8% (IgM), and 96·8% (IgG) Specificity 98.1% (IgA), 92.3% (IgM), and 99·8% (IgG). Phase of development Pre-clinical Proposed release Not stated Date April 22, 2020

Country of development USA Type of Serological Test Microfluidic ELISA Authors/Company Optofluidic Bioassay Description This startup, based out of the University of Michigan, has a microfluidic chip that allows rapid ELISA assays. The chip can utilize a variety of reagents, so companies that have developed target viral antigens and anti-IgM or IgG antibodies could adapt their assay for use on this chip. The test only takes 15 minutes, and requires a few drops of blood. Sensitivity and specificity were not listed, but will likely depend on the reagents used. Sensitivity Specificity Phase of development Pre-clinical Proposed release Not stated Date April 26, 2020

Country of development Hong Kong/US Type of Serological Test ELISA, micro-neutralisation (MN) and plaque reduction neutralisation tests (PRNT) Authors/Company Perera et al. Description Perera and colleagues sought to create a sensitive ELISA, matched with a novel microneutralization assay. They also performed plaque reduction neutralization assays. The MN assay has the advantage of higher throughput, though results take 4 days. The MN and PRNT assays had significant agreement, validating the MN assay. This shows not only antibody titers, but the neutralizing capability. Several sensitivities were recorded at different time points during the assay. The sensitivities listed here are from 11-18 days post symptom onset, from 14 samples. Sensitivity 92.8% (IgM) and 71.4% (IgG) measured by ELISA; 64% were positive in the MN assay; 92.8% were positive in the PRNT assay Specificity 100% in MN assay Phase of development Pre-clinical Proposed release Not listed Date April 23, 2020

Country of development US Type of Serological Test ELISA Authors/Company McDade et al. Description This group sought to improve ELISA based methods by using dried blood spots, rather than serum samples from venipuncture, for detection of antibodies to SARS-CoV-2. The receptor binding domain of the spike protein was used as a target. They found that both blood spiked with viral antigen, as well as with 9 PCR-positive patient samples, there was a significant signal difference relative to negative samples. Sensitivity Specificity Phase of development Preclinical Proposed release Not stated Date May 5, 2020

Country of development France Type of Serological Test Indirect immunofluorescence assay Authors/Company Colson et al. Description This indirect immunofluorescence test was developed in order to detect three types of antibodies in patient samples. They validated the test using 888 COVID-19 positive patient samples, and 200 negative patient samples as controls. There was limited reactivity in patients with non-SARS-CoV-2 coronavirus infection. Sensitivity Specificity 100% for IgA; 98.6% for IgM; and 96.3% for IgG Phase of development Pre-clinical Proposed release Date May 12, 2020

Country of development France Type of Serological Test Chemiluminescence immunoassay Authors/Company Rosado et al. Description In studying antibody profiles of COVID-19 patients, the researchers developed an assay to detect antibodies to SARS-CoV-2. IgG and IgM antibodies to four SARS-CoV-2 Spike (S) antigens: spike trimeric ectodomain (Stri), its receptor-binding domain (RBD), spike subunit 1 (S1), and spike subunit 2 (S2) could be detected. Sensitivity 96.1 Specificity 99.1 Phase of development Pre-clinical Proposed release Date May 11, 2020

Country of development Germany Type of Serological Test Flow cytometry Authors/Company Lapuente et al. Description Flow cytometric assay to determine SARS-CoV-2 spike protein specific antibodies (IgM and IgM) in serum samples Sensitivity 100% Specificity Not specified Phase of development Pre-clinical Proposed release Date May 13, 2020

Country of development France Type of Serological Test Indirect immunofluorescence assay Authors/Company Edouard et al. Description Detects SARS-CoV-2-specific IgM, IgG, and IgA antibodies through fluoresence readouts of diluted serum samples with inactivated antigen Sensitivity Not specified Specificity 100% for IgA, 98.5% for IgM, and 95.9% for IgG. Phase of development Pre-clinical Proposed release Date May 12, 2020

Country of development Singapore/US Type of Serological Test RDT Authors/Company Singapore-MIT Alliance for Research and Technology (SMART) Description Researchers are developing a paper based RDT that can use saliva or nasal swab samples for an easy to use diagnostic. This RDT is being developed with funding support from the National Medical Research Council (NMRC) to develop a rapid test to detect antibodies against the S and N proteins. This is a collaborative effort between SMART, Nanyang Technological University (NTU), and Massachusetts Institute of Technology (MIT). Sensitivity Specificity Phase of development Pre-clinical Proposed release Not stated Date May 19, 2020

Country of development US Type of Serological Test Nanosensor Authors/Company Pourmand Lab Description Nader Pourmand (UC Santa Cruz) recently received funding to apply his nanosensor biotechnology for use in diagnostics for COVID-19 along with Pinpoint Science. The sensor chip would be fabricated by Analog Devices. This technology would be a point-of-care, rapid test. The nanosensor technology relies on changes in electric current through the nanopipette in the system. In the nanopipette opening, there are viral proteins to which patient antibodies can attach. If there are these complexes, this will disrupt an electric current passed through the pore. So far, they have found that sensitivity is far greater (100 times) in this system than in conventional methods such as ELISA, detecting as low as 1 femtogram per milliliter. Sensitivity Specificity Phase of development Pre-clinical Proposed release Not stated, though sensor chips will be available by April 2020. They are proposing to apply for EUA by September 2020. Date May 14, 2020

Country of development US Type of Serological Test Chemiluminescent immunoassay Authors/Company Prandad et al. Description Researchers at Johns Hopkins University and Emory University developed a bead-based immunoassay to detect IgM, IgG, and IgA antibodies in the saliva of patients. This would be far less invasive in sample collection. The researchers also investigated which viral protein would be optimal for use in this diagnostic. They compared 33 saliva samples with 206 serum samples that were positive, and 134 saliva and 112 serum samples that were negative. There were 28 matched samples, in which IgG and IgM were strongly correlated in saliva and serum. The highest sensitivity and specificity were with the Genscript N protein, and Mt. Sinai RBD (S) protein, after 10 days post symptom onset. Sensitivity 100% (Genscript N protein, IgG), 61% (IgA), 65% (IgM) Specificity 98-100% (IgG, IgA, and IgM) Phase of development Pre-clinical Proposed release Not stated Date May 26, 2020

Country of development US Type of Serological Test ELISA Authors/Company Klumpp-Thomas et al. (NIH) Description Researchers at the NIH developed a highly specific ELISA that can use fresh and dried blood samples. The target antigens are full length Spike protein, and the RBD of Spike protein, to increase specificity. The test can detect IgG, IgM, and IgA. Sensitivity was determined from 14 positive controls, while specificity was from 100 samples. Sensitivity 100% Specificity 100% (IgG), 100% (IgM), 99% (IgA) Phase of development Pre-clinical Proposed release not stated Date My 27, 2020

Country of development The Netherlands Type of Serological Test Multiplex bead-based immunoassay Authors/Company Hartog et al. Description This test detects IgG specific to the spike S1 protein, spike RBD, and N protein by incubating serum with pre-coated microbeads that fluoresce upon antigen-antibody binding. Each target antigen was incubted to bind on their own specific beads and then patient serum was added to allow for binding to occur. Results were read by a Luminex reader. Sensitivity 90.9%-98.8% Specificity 100% Phase of development Pre-clinical Proposed release Not stated, work pre-published in pre-print Date June 20, 2020

Country of development US Type of Serological Test Modified ELISA, surface plasmon resonance (SPR) Authors/Company Wistar Institute Description This is a surrogate neutralization assay, utilizing ELISA and SPR to test for antibodies able to block the interaction between ACE2 and viral spike protein. In both assays, the interaction between patient antibodies and viral spike protein leads to a colorimetric/refraction readout if ACE2 interaction is blocked. This can measure levels of neutralizing antibodies without a BSL-3 setting. Sensitivity and specificity were not listed. Sensitivity Specificity Phase of development Pre-clinical Proposed release not stated Date June 20, 2020

Country of development UK Type of Serological Test ELISA Authors/Company Faustini et al. Description This group from the University of Birmingham developed an in-house ELISA and surface plasmon resonance system to detect IgM, IgA, and IgG antibodies. They used the S1 region, RBD, N protein, and full length spike glycoprotein as target antigens. They also used a truncated version of humane ACE2 protein for surface plasmon resonance. They found that the trimeric Spike glycoprotein was optimal for antibody detection. Sensitivity Specificity Phase of development Pre-clinical Proposed release not stated Date June 18, 2020

Country of development US Type of Serological Test Mass spectrometry (CyTOF) Authors/Company Geanon et al. Description This group used an adapted mass cytometry system, CyTOF, to look at immune cells and cytokine profiles of patients. This assay uses Fluidigm MaxPar Direct Immune Profiling Assay (MDIPA), a dry tube 30-marker immunophenotyping panel, and SmartTube Proteomic Stabilizer,.They did find that the sample preparation can negatively impact the detection of antibodies, as well as chemokines like reduced staining index for CD25 and CD127, which are typical of CD4+ T cells. But, if the SmartTube prep is performed after staining the cells with MDIPA, then the samples are well preserved. They found that this method could allow you to use small blood samples from patients to essentially track how the immune system was reacting--through immune cell development and immune signaling molecules. Sensitivity Specificity Phase of development Pre-clinical Proposed release not stated Date June 28, 2020

Country of development Israel Type of Serological Test Electrochemiluminescent assay Authors/Company Munitz et al. Description This research group developed an ECLIA to detect IgM, IgA, and IgG antibodies to the spike protein RBD and to the nucleoprotein (N). Using a combined IgM, IgA, and IgG detection, the specificity and sensitivity were increased in 96 positive and 190 negative individuals. This was all after 14 days or more post symptom onset. Sensitivity 100% Specificity 95% Phase of development Pre-clinical Proposed release not stated Date June 30, 2020

Country of development Israel Type of Serological Test Electrochemiluminescent assay Authors/Company Munitz et al. Description This research group developed an ECLIA to detect IgM, IgA, and IgG antibodies to the spike protein RBD and to the nucleoprotein (N). Using a combined IgM, IgA, and IgG detection, the specificity and sensitivity were increased in 96 positive and 190 negative individuals. This was all after 14 days or more post symptom onset. Sensitivity 100% Specificity 94.9% Phase of development Pre-clinical Proposed release Not stated Date June 30, 2020

Country of development Canada Type of Serological Test Neutralization assay Authors/Company Abe et al. Description This is a surrogate neutralization assay, using ELISA based methods to quantify patient antibodies that can block virus protein interaction with the human ACE2 receptor. Instead of using an anti-human antibody that is coupled to a reporter, they use a recombinant version of hACE2 with a reporter. Then, they can see if it binds. Essentially, the less ACE2 binding, the better neutralization. Sensitivity and specificity were not stated. Sensitivity Specificity Phase of development Pre-clinical Proposed release Not stated Date July 11, 2020

Country of development US Type of Serological Test Neutralization assay Authors/Company Suhandynata et al. Description This neutralization assay uses a pseudovirus for detection of neutralizing antibodies in patient samples. They developed the assay for both SARS-CoV-2 and SARS-CoV-1. This pseudovirus also has a firefly luciferase reporter, so the infection rate of HeLa cells (that express hACE2) can be measured by luciferase quantification. Sensitivity 96.6% Specificity 98.8% Phase of development Pre-clinical Proposed release Not stated Date July 11, 2020

Country of development US Type of Serological Test Surrogate neutralization assay Authors/Company Zheng et al. Description They made a pseudovirus neutralization assay using murine leukemia virus capsids and a modified minimal MLV genome encoding firefly luciferase for quantification. They did not present a sensitivity or specificity, but this would allow for a neutralization assay in a BSL2 environment. Sensitivity Specificity Phase of development Pre-clinical Proposed release Not stated Date July 18, 2020

Country of development US Type of Serological Test Biolayer interferometry immunosorbent assay (BLI-ISA) Authors/Company Dzimianski et al. Description This is a novel serology assay. This biolayer interferometry immunosorbent assay (BLI-ISA) tests antigen levels, antibody levels, and isotypes all in a point of care format (and only takes 20 minutes). This assay essentially depends on interference of light passage between two layers, a reference and biosensor layer. If molecules bind the biosensor, then the wavelength shifts and the optical fiber can detect it. This is often used to measure binding kinetics. They do not present sensitivity or specificity. Sensitivity Specificity Phase of development Pre-clinical Proposed release Not stated Date July 19, 2020

Country of development Germany Type of Serological Test Surrogate neutralization assay Authors/Company Bosnjak et al. Description This is an ELISA-based surrogate neutralization assay. They found NAbs in the sera of mildly (90%) and severely infected (100%) patients (n=44). Their test also correlated well to a pseudovirus neutralization assay. Sensitivity Specificity Phase of development Pre-clinical Proposed release Not stated Date

Country of development China Type of Serological Test Quantum dot lateral flow assay Authors/Company Liu et al. Description They developed a a quantum-dot lateral flow immunoassay strip (QD-LFIA) based portable fluorescence smart-phone system for detection of specific IgM/IgG to SARS-CoV-2 in human serum samples. This is an easy to use, point of care, 15 minute assay. They validated it with 97 positive clinical samples and 450 negative samples. Rather than colorimetric, the read out is fluorescent and requires a laser-based "strip reader." The paper has a figure on how it works. Sensitivity 99% Specificity 99.7% Phase of development Pre-clinical Proposed release not states Date July 24, 2020

Country of development China Type of Serological Test Pseudovirus neutralization assay Authors/Company Nie et al. Description This test is a pseudovirus-based neutralization assay for evaluation of anti-viral measures for SARS-CoV-2, which would be used to evaluate the inhibition of viral attachment and entry mediated by the S protein. Neutralization was measured by the reduction in luc gene expression. Sensitivity Not stated Specificity Not stated Phase of development Pre-clinical Proposed release Not stated; published in peer-reviewed literature Date March 24, 2020

Country of development US Type of Serological Test ELISA Authors/Company

Stadlbauer et al. Description This test is a two‐stage ELISA in which the first stage includes relatively high‐throughput screening of samples in a single serum dilution against the RBD. This is followed by a second stage in which positive samples from the first stage undergo a confirmatory ELISA against the full‐length spike protein. Sensitivity Not stated Specificity Not stated Phase of development Pre-clinical Proposed release Not stated; published in peer-reviewed literature Date April 17, 2020

Country of development China Type of Serological Test RDT Authors/Company Chen et al. Description Lateral flow immunoassay that uses a recombinant nucleocapsid phosphoprotein and self-prepared lanthanide-doped polysterene nanoparticles to detect anti-SARS-CoV-2 IgG in human serum. After the sample is run on the strip, it is read on a fluorescence reader to confirm results. Sensitivity 100% Specificity 87.5% Phase of development Pre-clinical Proposed release Not stated; published in peer-reviewed literature Date May 19, 2020

Country of development China Type of Serological Test RDT Authors/Company Chen et al. Description Lateral flow immunoassay that uses a recombinant nucleocapsid phosphoprotein and self-prepared lanthanide-doped polysterene nanoparticles to detect anti-SARS-CoV-2 IgG in human serum. After the sample is run on the strip, it is read on a fluorescence reader to confirm results. Sensitivity 100% Specificity 87.5% Phase of development Pre-clinical Proposed release Not stated; published in peer-reviewed literature Date My 19, 2020

Country of development Brazil Type of Serological Test ELISA Authors/Company Huergo et al. Description This test is a bead-based ELISA, which the authors found to be more sensitive in regard to dilution of patient serum (in a single sample) than other commercially available ELISA tests. This can be used for IgM and IgG antibodies, the target antigen is the nucleocapsid protein, and it only takes 12 minutes to run. They had 6 positive clinical samples, and 26 negative samples, to determine sensitivity and specificity. This assay seems optimal for low-titer antibody samples, as it can detect antibodies even in highly diluted samples. Sensitivity 100% Specificity 100% Phase of development Pre-clinical Proposed release Not stated; published in pre-print literature Date July 29, 2020

Country of development Germany Type of Serological Test surrogate neutralization assay Authors/Company Bosnjak et al Description This study focused on creating a novel surrogate neutralization assay to measure the neutralizing antibodies present. It is essentially a modified ELISA that tests blocking of hACE2:Spike interactions. They found that it correlated well with a pseudovirus neutralization assay. Sensitivity not listed Specificity not listed Phase of development Pre-clinical Proposed release Not stated, though it was used in the recent study led by Behrens et al involving seroprevalence of healthcare workers. Date July 14, 2020

Country of development US Type