FaStep™ COVID-19 IgG/IgM Rapid Test
In stock
The FaStep COVID-19 Antibody Test is a rapid lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood or serum. The FaStep COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Each box contains 20 tests.
SKU ASR741593
The FaStep COVID-19 Antibody Test is a rapid lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood or serum. The FaStep COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Each box contains 20 tests.
SKU ASR741593
Kit Contents
- Twenty (20) test device strips
- Twenty (20) disposable pipettes
- One (1) desiccant pouch
- One (1) bottle with buffer solution
- One (1) coated aluminum foil for single-pouched test devices
- One (1) package insert
- Finger lance
- Alcohol pad
Performance Measures
- 90% Sensitivity
- 100% Specificity
Features
- Fingerstick whole blood, venous whole blood, serum, or plasma
- 24-month shelf life
- Simultaneous detection of IgG and IgM with control line to ensure test validity
- Room temperature storage or refrigerated (2-30°C / 36-86°F) when not in use
- 10-Minute Test
360 Health Services Acceptable Product Dating
We will ship product with expiration dating >= 30 days from order date.
Disclaimer
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
UOM | Case/1 – 640 tests, Kit/1 – 20 tests, Pallet – 12,800 tests |
---|