Coronavirus Test Kit

COVID-19 IgM/IgG Rapid Test dummy

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.

advance_feature
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%

Google Rating
4.9
Based on 34 reviews

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