Chembio SCoV-2 Ag Detect™ Rapid Test Kit

Description

• Description 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
• Easy to use POC SARS-CoV-2 Nucleoprotein antigen test that can performed in many settings with symptomatic or asymptomatic patients Identifies acute infection in symptomatic patients with high accuracy: PPA (Sensitivity) 86.67%, NPA (Specificity) 100% Direct nasal sample Results in approximately 20 minutes No instrumentation needed