ZetaGene COVID-19 Rapid IgM /IgG Test 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.
CE-marked and certified testZetaGene COVID-19 Rapid IgM IgG Test is CE-marked, which indicates that the device is fit for its intended purpose stated, meets legislation relating to safety, and can be freely marketed in the European Union. The test is a registered product at the Swedish Medical Products Agency (Läkemedelsverket).
Clinical validation with high sensitivity and specificity ZetaGene COVID-19 Antibody Test IgM/IgG was validated on total 83 COVID-19 patients and 297 healthy controls in 4 hospitals in Sweden and China, and test results displayed robust performance in detection of IgM and IgG antibodies to SARS-CoV-2 from blood samples.
ZetaGene COVID-19 Antibody Test IgM/IgG has sensitivity 96% and specificity 97%.
TEST PROCEDURE
- Step 1: For fresh samples, begin with Step 2. For frozen samples, bring the specimens and test components to room temperature, and mix the specimen well once thawed.
- Step 2: When ready to test, open the pouch at the notch and remove the test device. Place the test device on a clean, flat surface.
- Step 3: Label the device with specimen ID number.
- Step 4: Using a transfer pipette, transfer serum, plasma or whole blood, careful not to exceed the specimen well. The volume of the specimen is around 10µL. For better precision, transfer specimen by a pipette capable of delivering 10µL of volume. Holding the transfer pipette vertically, dispense 10µL of blood (~ one drop) into the center of the sample well (S well) making sure that there are no air bubbles. Then, add 2 drops of Sample Diluent immediately into the sample well (S well).
- Step 5: Set up a timer.
- Step 6: Read the results in 15-20 minutes. Don’t read results after 20 minutes. To avoid confusion, discard the test device after interpreting the results.
INTERPRETATION OF ASSAY RESULT
Please use our online COVID-19 TEST ANALYZER for analysis.
IgG positive In addition to the presence of the C Line, if only the G Line is developed, the test result indicates the presence of IgG anti- SARS-CoV-2 virus. The result is IgG positive or reactive, consistent with a recent or previous infection.
IgM positive In addition to the presence of the C Line, if only the M Line is developed, the test indicates the presence of IgM anti-SARS-CoV-2 virus. The result is IgM positive or reactive, consistent with an acute or recent SARS-CoV-2 virus infection.
IgG and IgM positive In addition to the presence of the C Line, if both G and M Lines are developed, the test indicates the presence of IgG and IgM anti-SARS-CoV-2 virus. The result is IgG and IgM positive or reactive, suggesting current or recent SARS-CoV-2 virus infection.
*Negative results do not rule out SARS-CoV-2 infection, particularly for patients who have been in contact with known infected persons or in areas with high prevalence of active infection, or for patients very early in infection. Follow-up testing with a molecular diagnostic test is necessary to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection. False positive results may occur due to cross-reacting antibodies from previous infections, such as other coronaviruses, or from other causes. Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnostic determination is made.