Description
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved, CLIA Waived
Contents: (20) Sealed Test Devices, (20) Assay Buffer, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Positive and (1) Negative Control Swabs , (1) Instructions for Use
Determinations: Detection of the SARS-CoV-2 IgG and IgM antibodies
Storage Requirements: 37° – 86° F
Processing Time: Approximately 15 Minutes
EUA Letter Assure Biotech
Package Insert
Provider Fact Sheet
Recipient Fact Sheet
The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. The Assure COVID-19 IgG/IgM Rapid Test Device 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.
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.
S.C. 263a, that meet requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- FDA EUA Authorized
- Rapid results in 10 minutes
- Small sample sizes
- Sold in packs of 20
