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COVID-19 ANTIBODY RAPID TEST
Our rapid test kits are manufactured to CE-IVD standard
for specific detection of COVID-19
in the body after the onset of infection.
Our test kits produce a qualitative Pos/Neg result within minutes.
ADVANTAGES OF OUR COVID-19
ANTIGEN AND ANTIBODY
RAPID TEST KITS
Time and cost efficient over lab methods
Results within 10 minutes
Infection in mild or asymptomatic cases identified
Aid in the control of transmission
CE-IVD Marked for professional use
Accuracy of 97.8% (IgM) and 99.6% (IgG)
Easy to use with no specialist equipment
Screen anywhere
The COVID-19 Rapid Test Kit is a qualitative lateral flow immunoassay for the detection of both IgM and IgG antibodies to COVID-19 specific biomarker in whole blood, serum or plasma specimens.
If the patient has contracted COVID-19, the biomarkers in their blood will bind to the antibodies on the test strip, leaving a visible test line.
If the patient doesn’t have COVID-19, no biomarkers should be present in their blood and no test line will be visible.
The test will be able to detect IgM/IgG in asymptomatic people, as they will have an immune response even though they don’t display symptoms. The timeline of infection will be the same as someone displaying symptoms.
IgG and IgM POSITIVE: (Three lines appear):
One coloured line should be in the control line region (C), and two coloured lines should appear in IgG test line region and IgM test line region.
The colour intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary SARS-COV-2 infection.
IgG POSITIVE (Two lines appear):
One colored line should be in the control line region (C), and a colored line appears in IgG test line region.
The result is positive for SARS-COV-2 virus specific-IgG and is probably indicative of secondary SARS-COV-2 infection.
IgM POSITIVE(Two lines appear):
One colored line should be in the control line region (C), and a colored line appears in IgM test line region.
The result is positive for SARS-COV-2 virus specific-IgM antibodies and is indicative of primary SARS-COV-2 infection.
*It is noteworthy that the intensity of the color in the IgG and/or IgM test line region(s) will vary depending on the concentration of SARS-COV-2 antibodies in the specimen.
Therefore, any shade of color in the IgG and/or IgM test line region(s) should be considered positive.
NEGATIVE:
One colored line should be in the control line region (C).
No line appears in IgG and IgM test line region(s).
INVALID:
Control line fails to appear.
Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure.
Review the procedure and repeat the procedure with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
QUALITY CONTROL:
An internal procedural control is included in the test.
A colored line appearing in the control line region (C) is an internal valid procedural control, it confirming adequate membrane wicking.
Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
CLINICAL STUDY FOR COVID-19 ANTIBODY RAPID TEST KITS
Study Details:
902 samples from patients in
Hubei, China. 446 tested for
IgG and 456 tested for IgM
Procedure:
Each sample analysed using test cassette.
Simultaneously, SARS-CoV-2/IgG/IgM
presence confirming using lab test
Results:
For both IgG and IgM.
Sensitivity > 98%
Specificity > 99%
Accuracy > 97%
STUDY DETAILS
Samples were obtained from patients from Hubei, China and were analysed using the same clinical protocol.
446 samples were tested for IgG and 456 samples for IgM.
Blood samples were taken and centrifuged to obtain plasma, which was tested using the Rapid Test Kit and compared with the clinical diagnostic procedure (IgG and IgM analysis).
Results
The test is suitable for both clinical diagnosis and screening of COVID-19.
Providing it is used correctly, it has a high sensitivity, specificity and accuracy against two key biomarkers of COVID-19, IgG and IgM.
The test Kit is a useful tool in the diagnosis of COVID-19 and can act as a first line screening test prior to clinical assessment.
Patients who recovered from the illness, continued to test positive for IgG for at least 33 days after displaying symptoms, indicating that the test could be used to assess longer term immunity.