Intended Use
Lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2.
Who Can Perform Testing
This is a point-of-care authorized test. CLIA-certified laboratories with Waiver, Moderate, or High Complexity certification may perform the test at point-of-care or in a laboratory setting.
Time to Result
10-15 minutes
Sample Types
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Finger-prick capillary blood
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Whole blood
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Plasma from anti-coagulated blood (heparin/EDTA/sodium citrate)
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Serum
Controls
Internal control lines appear when test is ready to be read.
Components
Individually sealed test cassettes in aluminum foil pouch with desiccant. Each cassette contains a single IgM/ IgG strip. Buffer solution diluent. Lancet. Alcohol pad.
Storage & Handling
Finger-prick capillary blood may be taken and used at point-of-care. Cap and store the serum or plasma samples at 2-8°C for no more than 24 hours prior to testing. For long-term storage, freeze the serum or plasma samples at -20°C. Avoid multiple freeze-thaw cycles. Mix thawed samples thoroughly by low speed vortexing or by inverting 10 times. Bring samples to room temperature prior to testing for at least 30 minutes. Visually inspect the samples. If layering or stratification is observed, continue mixing until samples are visibly homogeneous.
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