Sold in Packs of 25
Rapid Covid Testing at your finger tips! With a prick of the finger receive results in just 10 minutes!
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a rapid coronavirus 2019 (COVID-19) finger prick antibody test which detects both IgG and IgM antibodies with 98.5% accuracy.
- Detection Window (IgM): 3-5 days after incubation
- Dual band results for simple interpretation
- Multivariable analysis of immunoglobin IgG & IgM
- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
- Procedural internal control included
- Buffer included
- Clinical Evaluation
- Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
- Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
- Clinical Agreement with Characterized Samples
- Sensitivity: IgG 96.7%; IgM 100%; Combined 100%
- Specificity: IgG 97.5%; IgM 100%; Combined 97.5%
- Specimen: Whole Blood, Serum, Plasma
- Time to Results: 10 minutes
- Shelf Life: 24 months from the date of manufacture
- Test to be performed in a CLIA moderate- or high-complexity setting *
FEI Number: 3009238284
FDA EUA Registration Number: 200056
* The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19.