Carolina Liquid Chemistries, Greensboro, NC, is offering the AllTest 2019-nCoV IgG/IgM rapid screen antibody test cassette, in accordance with sections C and D of 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 SARS-CoV-2 in human plasma, serum, or whole blood. The test can be stored sealed at room temperature or refrigerated. Internal procedural controls are included in the cassette.
The manufacturer has validated the test and evaluated its potential for crossreactivity with the following: anti-adenovirus, anti-Helicobacter pylori, anti-hepatitis C virus, anti-HIV, anti-influenza A virus, anti-influenza B virus, anti-respiratory syncytial virus, anti-syphilis, and HBsAg.
The results showed no cross-reactivity. IgG results have relative sensitivity of 100% (95% confidence interval [CI], 86.0–100), a relative specificity of 98.0% (CI, 89.4–99.9), and accuracy of 98.6% (CI, 92.3–99.96). IgM results have relative sensitivity of 85.0% (95% CI, 62.1–96.5), relative specificity of 96.0% (95% CI, 86.3–99.5), and accuracy of 92.9% (95% CI, 84.1–97.6).
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 such individuals. Results from antibody testing should not be used as the sole basis for diagnosing or ruling-out SARS-CoV-2 infection, or for informing patients about their infection status.
“These are unprecedented times,” says Phillip Shugart, chief executive officer of Carolina Liquid Chemistries. “The rapid screen is a fast and easy screen for antibodies that compliments other tests and symptoms to give a fuller picture.”
For more information, visit Carolina Liquid Chemistries.