Evaluation of 9 commercial SARS-CoV-2 immunoassays
The OnSite COVID-19 IgG/IgM Rapid Test is a single use lateral flow immunoassay rapid test intended for qualitative detection and differentiation of anti-SARS-CoV-2 IgG and IgM antibodies in human serum and plasma or whole blood containing EDTA, heparin or citrate anti-coagulants.

The OnSite COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

Currently, the laboratory method for detecting SARS-CoV-2 infection is RT-PCR. However, this method requires sophisticated equipment and highly trained laboratory technicians. Moreover, viral load decreases rapidly 9 or 10 days after onset of symptoms.

During the acute phase of infection, the titer of IgM to SARS-CoV-2 rises rapidly and peaks around 2-3 weeks after the infection. SARS-CoV-2 specific IgG antibodies appear shortly after IgM and persist for months.

It is unknown if SARS-CoV-2 infection leads to lifetime immunity or if a 2nd infection is possible. 

Nevertheless, the SARS-CoV-2 specific antibodies are useful markers for immune response and epidemiologic survey.
IgM Positive
IgG Positive
IgM Positive
IgG Negative
IgM Negative
IgG Positive
Results from the  test
USA production
Not for use in USA
- Finger prick specimen allows testing at point-of-care, saving crucial time
- Results within15 minutes allow doctors to take immediate action 97.1% Sensitivity, 97.8% Specificity (vs. PCR-confirmed specimens)
-  Complementary to PCR by detecting immune response
- Compatible with CTK Rapid Test Reader (RTR-1)
A box contains

30 x Individual Packed Cassette devices (Rapid Tests)
30 x Capillary tubes
1 x Detection Buffer (3 ml/Bottle)
1 x Instructions for Use
OnSite COVID-19 IgG/IgM Rapid Test
The OnSite COVID-19 IgG/IgM Rapid Test is designed for initial screening by detecting anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within 15 minutes.

This test is easy-to-use, requires only minimally skilled personnel with basic equipment needs

The OnSite COVID-19 IgG/IgM Rapid Test has 97.1% sensitivity and 97.8% specificity making it one of the most effective screening tests for COVID-19.
97.1% Sensitivity
97.8% Specificity