ACCEL ELISA® COVID-19 is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Currently, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. ACCEL ELISA® COVID-19 should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 32 U.S.C. §263a, to perform high complexity tests.
Results are for the detection of SARS-CoV-2 antibodies. Antibodies (IgG, IgM and/or IgA) 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.
STORAGE AND STABILITY
Store the ACCEL ELISA® COVID-19 Kit at 2–8 °C. Do not freeze. Return to 2–8 °C immediately after use. Do not use after expiration date indicated on the kit box and/or component and reagent labels.
WARNINGS AND PRECAUTIONS
USE GOOD LABORATORY PRACTICES
This test kit is for in-vitro diagnostic use only. The microplate wells contain dried bovine serum albumin.
Wear gloves while performing this assay and handle all reagents as if they were potentially infectious.
Do not get in eyes, on skin, or on clothing. Do not ingest or inhale fumes. On contact, flush with copious amounts of water for at least 15 minutes. Use Good Laboratory Practices.
Dispose of human specimens and used tests as medical waste.