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COVID-19 Rapid Antibody Test

Product Number: RAPG-COV-019

Product Description

The Biopanda COVID-19 Rapid Test Kit is a qualitative lateral flow immunochromatographic assay for the detection of IgM and IgG antibodies to SARS-CoV-2 in human whole blood, serum or plasma samples.

It is intended for use as a tool to assist in the diagnosis of SARS-CoV-2 infections. It is also intended as a tool for carrying out serological epidemiological investigations.

This test kit is for healthcare professional use only.

Test Attributes

Whole blood, serum, or plasma may be used for testing

Results available in only 10 minutes

Easy to use

Results can be read visually

No need for an analyser

Cost effective method for assisting in diagnosing COVID-19 disease.

Principle

The COVID-19 Rapid Test is a qualitative lateral flow immunoassay for the simultaneous detection of IgM and IgG antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens.

The test cassette contains recombinant SARS-CoV-2 antigen conjugated to coloured particles. When a specimen is added to the sample well of the cassette, any IgM and IgG present in the specimen will bind to the antigen conjugate, forming coloured coronavirus antigen-antibody complexes. This mixture migrates laterally along the membrane to the test region. In this test region, anti-human IgM and anti-human IgG have been immobilised onto the membrane. These capture any IgM and IgG complexes that have formed, resulting in the appearance of coloured lines.

Therefore, if the specimen contains SARS-CoV-2 IgM antibodies, a coloured line will appear in the IgM test line region. If the specimen contains SARS-CoV-2 IgG antibodies, a coloured line will appear in the IgG test line region. To serve as an internal control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen and buffer has been added, and correct procedure has been followed.

Sensitivity and Specificity

To determine specificity, the test has been continuously assessed using pre-pandemic serum and plasma as they become available.



Specificity: 99.2% (95%CI*: 98.5% - 99.7%) *Confidence Interval



To determine sensitivity, samples were taken from 239 patients who were confirmed positive by PCR. Samples were taken at a range of times from onset of symptoms.

Days from onset when sample was taken No. of Samples IgM Positive IgG Positive Combined Positive (Sensitivity) Asymptomatic † 36 55.6% 44.4% 69.4% (95%CI: 51.9-83.7%) 2-10 days 106 80.2% 19.8% 81.1% (95%CI: 72.4-88.1%) 11-20 days 55 88.7% 87.1% 93.5% (95%CI: 84.3-98.2%) 21+ days 35 42.9% 100% 100% (95%CI: 90.0-100%)

† Most of these asymptomatic patients were picked up during screening, and remained asymptomatic throughout the course of their illness.

As these samples have been taken from hospitalised patients, the sensitivity of the test is expected to be lower when used in community testing.

Storage Conditions

+ 2 - 30 °C, DO NOT FREEZE. Unopened test cassettes and buffer are stable for up to 24 months from date of manufacture.

Further reading on COVID-19 diagnostics

Laboratory methods for diagnosing COVID-19 follow two pathways - the detection of the coronavirus itself, and the detection of the body's adaptive immune response to the virus.

The stage of COVID-19 disease progression determines which detection method is most effective. This antibody rapid test complements nucleic acid methods such as RT-PCR to improve speed of diagnosis and monitor disease progression.As the disease primarily attacks the lungs, specimens taken from the upper respiratory tract may be poor in quality and could lead to false-negatives with PCR.

To understand the clinical significance of results obtained from the antibody rapid test, the following information must be considered:

The median incubation period is estimated to be 5.1 days.

Specific IgM antibodies to SARS-CoV-2 can become detectable 3-5 days after onset of symptoms, but the intensity of this response varies between patients.

Therefore, for the application of diagnosing an active infection, this COVID-19 Rapid Test should not be used until symptoms have been present for at least 3 days, and results must be complemented by other tests such as RT-PCR.

If used to determine a suspected infection in the past, this test is best used after 28 days from first onset of symptoms, when the antibody response has peaked.

Kit configurations available

Kit Configuration No. of Tests Kit Ref. 10 Test Cassettes with droppers and buffer 10 Tests COVID-001 20 Test Cassettes with droppers and buffer 20 Tests COVID-002 40 Test Cassettes with droppers and buffer 40 Tests COVID-003 10 Test Cassettes with droppers, buffer, lancets and alcohol pads 10 Tests

COVID-101 25 Test Cassettes with droppers, buffer, lancets and alcohol pads 25 Tests COVID-102

When placing an order, please state the Kit Reference to specify the kit configuration you are interested in.

Before making an enquiry, please be aware that we are unable to dispatch to residential addresses, even if you are a registered healthcare practitioner. Please send your enquiry from your organisation's email address.

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Biopanda Reagents is a test kit provider.

Customer satisfaction is our top priority.