Description
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.
Kit contents contains:
10 x Test Cassettes
10 x Pipettes
10 x Lancets
10 x Alcohol Swabs
1 x Buffer Solution
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