COVID-19 lgM/lgG Rapid Test
VivaDiag™ COVID-19 IgM/IgG Rapid Test is for the rapid, qualitative detection of IgM and IgG antibodies to COVID-19 in human whole blood (fingertip/venous), serum or plasma. The test is for in vitro diagnostic use only. And it is intended for clinical laboratories and healthcare professional use for point-of-care testing.
Not for at home testing.
Each Test Kit Contains:
- Test Devices (40 Tests/Box)
- Pipettes (optional)
- Package Insert
Note: 720 Tests/Carton
28G Safety Lancets also available: 100/Box; 5,000/Carton
Interpretation of Results
Warnings, Precautions and Limitations
- This test has not been reviewed by the FDA.
Based on the FDA Policy for Diagnostic Tests for Coronavirus Disease published on March 16th, 2020 during the Public Health Emergency, FDA allows the distribution of COVID-19 IgM/IgG Rapid Tests in the US during the EUA application and review.
- Results from IgM/IgG antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Follow-up testing with a molecular diagnostic should be considered to confirm the test results.
- Not for at home testing.
- Not for the screening of donated blood.
Summary of Assay Performance
A total of 350 patients were tested by COVID-19 RT-PCR and confirmed by CT, 150 specimens were positive and 200 specimens were negative from SARS-CoV-2.
Among 80 positive specimens from SARS-CoV-2-infected patients with symptoms that appeared within 4-10 days, 65 specimens tested positive for IgM antibody and 30 tested positive for IgG antibody by using VivaDiag COVID-19 IgM/IgG Rapid Test, resulting in a Relative Sensitivity of 81.3%.
Among 70 positive specimens from SARS-CoV-2-infected patients with symptoms that appeared within 11-24 days, 68 specimens tested positive for IgM antibody and 67 specimens tested positive for IgM antibody by using VivaDiag COVID-19 IgM/IgG Rapid Test, resulting in a Relative Sensitivity of 97.1%.
The Accuracy of patients with symptoms that appeared within 4-10 days was 94.6%, the Accuracy of patients with symptoms that appeared within 11-24 days was 99.3%, and the Total Accuracy was 95.1%.
|Product Name||VivaDiag™ COVID-19 lgM/lgG Rapid Test|
|Test Principle||Colloidal Gold|
|Specimen Type||Whole blood (fingertip/venous), serum or plasma|
|Specimen Size||10 µL|
|Testing Time||15 Minutes|
|Operational Temperature||15°F - 30°F (18°C - 25°C)|
|Storage Temperature||36°F - 86°F (2°C - 30°C)|
|Shelf Life (Unopened)||24 Months|