Rapid Coronavirus Covid-19 Serology testTGA approved in AustraliaOur new Coronavirus (Covid-19) Rapid Serology IgM / IgG test is a diagnostic test for the determination of COVID-19’s IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma.It is a simple and easy to use test with results available after 15 minutes. It is intended for use by healthcare professionals and clinical labs only and is TGA approved.
COVID-19 IgM/IgG Rapid Test dummy
Product Name | VivaDiagTM COVID-19 IgM/IgG Rapid Test |
Test Principle | Colloidal gold |
Sample Type | Whole blood (from vein or fingertip), serum or plasma |
Sample Value | 10 μL |
Test Time | 15 Min |
Operation Temperature | 18-25c |
Storage Temperature | 2-30℃ |
Shelf Life (Unopened) | 12 months |
From the results of 350 negative and positive samples, we can confirm that VivaDiagTM COVID-19 IgM/IgG rapid test has good clinical performance.
Clinical Performance of negative sample
Negative Cases (By PCR&CT) | Negative coincidence rate (VivaDiagTM COVID-19 IgM) | Negative coincidence rate (VivaDiagTM COVID-19 IgG) | Negative coincidence rate (Total) |
---|---|---|---|
200 | 200 (100%) | 200 (100%) | 200 (100%) |
Clinical Performance of positive sample (infection time 4-10 days)
Negative Cases (By PCR&CT) | Negative coincidence rate (VivaDiagTM COVID-19 IgM) | Negative coincidence rate (VivaDiagTM COVID-19 IgG) | Negative coincidence rate (Total) |
---|---|---|---|
80 | 65 (81.25%) | 30 (37.5%) | 65 (81.25%) |
Clinical Performance of positive sample (infection time 11-24 days)
Negative Cases (By PCR&CT) | Negative coincidence rate (VivaDiagTM COVID-19 IgM) | Negative coincidence rate (VivaDiagTM COVID-19 IgG) | Negative coincidence rate (Total) |
---|---|---|---|
70 | 68 (97.1%) | 67 (95.7%) | 68 (97.1%) |
Relative Specificity: 100%
Relative Sensitivity (infection time 4-10 days, IgM & IgG): 81.25%
Relative Sensitivity (infection time 11-24 days, IgM & IgG): 97.1%
Accuracy (infection time 4-10 days, IgM & IgG): 94.6%
Accuracy (infection time 11-24 days, IgM & IgG): 99.3%
Total accuracy: 95.1%