RightSign COVID-19 Antibody Tests - IgG/IgM Rapid Blood Screen Cassettes

Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette

Developer: Hangzhou Biotest Biotech
Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike

Test Facts: 

• Information for Healthcare Providers
• Information for Recipients
• Instructions for Use
• NCI's Frederick National Laboratory for Cancer Research Evaluation Report
• NCI's Frederick National Laboratory for Cancer Research Evaluation Data

The RightSign COVID-19 Antibody Test Cassette is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in in human venous whole blood (sodium heparin, EDTA, and sodium citrate), serum or plasma (sodium heparin, potassium EDTA and sodium citrate). The RightSign COVID-19 Rapid Blood Test Cassette 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. The RightSign COVID-19 IgG/IgM Rapid Test Cassette should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet the requirements to perform moderate or high complexity tests.

Results are for the detection of SARS CoV-2 antibodies. The IgG and IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

The sensitivity of RightSign COVID-19 IgG/IgM Rapid Test Cassette early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False positive results for RightSign COVID-19 IgG/IgM Rapid Test Cassette may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.

The RightSign COVID-19 IgG/IgM Rapid Test Cassette is only for use under the Food and Drug Administration’s Emergency Use Authorization.