FaStep® Rapid Antibody Test

General Details

• Test type: Antibody

• Run time: 10-15 minutes

• Collection type: Finger-prick capillary, or whole blood, plasma, or serum

• Authorization: FDA EUA for professional use. CLIA required.

• Intended Use: Lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2.

• Manufacturer: Assure Tech (China)

• Controls: Internal control lines appear when test is ready to be read. External positive and negative controls available for separate purchase.

Clinical Details

• 100.0% Sensitivity, 98.8% Specificity (FDA study)

• Specificity testing: No cross-reaction with other species

• Interference testing: No interfering drugs or other factors identified

• CPT Codes: 86328

  Read the FDA clinical study.
  
  See Instructions for Use for additional clinical data.

Box Components

• Test cassettes (20)

• Lancets (20)

• Blood collection pipets (20)

• Reagent buffer capsules (20)

• Instructions for Use (1)

Storage and 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.

Disclaimer

• This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.

• This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.

• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

• This product is intended for professional use and not for home use.

• Not for the screening of donated blood.