ZetaGene Ltd. was founded by scientists from Lund University, Sweden. With expertise in microfluidic technologies for point-of-care diagnostic solutions, ZetaGene provides fast and precise serology assessment on SARS-CoV-2 antibody response in patients with COVID-19.
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 test
ZetaGene 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%.
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 the specimen 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 minutes. Don’t read results after 20 minutes. To avoid confusion, discard the test device after interpreting the resul
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.