Carolina Liquid Chemistries now offers the AllTest 2019-nCoV IgG/IgM Rapid Screen Antibody Test Cassette in accordance with Sections C and D of the FDA’s March 16, 2020, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.”
The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimen. The test can be stored sealed at room temperature or refrigerated. The 2019-nCoV IgG/IgM Rapid Test Cassette can be performed using whole blood (from venipuncture or fingerstick), serum or EDTA plasma (K2, Heparin sodium, Citrate sodium and Potassium Oxalate). Internal procedural controls are included in the cassette.
Cross-reactivity has been tested for anti-influenza A virus and anti-influenza B virus, anti-RSV, anti-adenovirus, HBsAg, anti-Syphilis, anti-H. pylori, and anti-HIV and anti-HCV positive specimens. The results showed no cross-reactivity. Comparing the test with commercially available PCR, the performance results show that 2019-nCoV IgG/IgM Rapid Test Cassette has a high sensitivity and specificity. IgG Results have relative sensitivity of 100 percent (95 percent confidence interval 86-100 percent), a relative specificity of 98 percent (CI 89.4-99.9 percent), and accuracy of 98.6 percent (CI 92.3-99.96 percent). IgM results have relative sensitivity of 85 percent (95 percent CI 62.1-96.5 percent), relative specificity of 96 percent (95 percent CI 86.3-99.5 percent), and accuracy of 92.9 percent (95 percent CI 84.1-97.6 percent).
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. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
