SCoV-2 Ag Detect™ Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use 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.
- Point of Care: Can be performed in a variety of settings, from physician offices to school health clinics, with symptomatic or asymptomatic individuals.
- Identifies acute infection in symptomatic patients with high accuracy:
- PPA (Sensitivity): 86.67%
- NPA (Specificity): 100%
- Uses direct nasal samples without transport media.
- Includes everything required to perform test – no instrumentation needed.
- Includes 50 tests, swabs for sample collection, and positive and negative controls.
- Simple to use and requires minimal training.
- Room temperature storage.
- Fast results in ~20 minutes.
- 100% manufactured in the USA.
- SCoV-2 Ag Detect™ Rapid Test is patent pending.