Status COVID-19 Antigen Rapid Test for Home Use test kit

Product Description

Status„ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms.

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 product 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.

Specification:

Sample Type: nasopharyngeal swab specimens

Detection Method: Colloidal Gold

Detection Time: 15 minutes

COVID-19 “ Anterior Nasal “ Sensitivity 93.8%,  Specificity 100%

Nasopharyngeal “ Sensitivity 93.1%,    Specificity 100%

Flu A “ Sensitivity 91.4%,  Specificity 95.7%

Flu B “ Sensitivity 87.6%,  Specificity 95.9%

Interim order: IO#326827

All necessary reagents provided and no equipment is needed

Each Box Contains:

25 individually packed test strips the test strips contain mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV

25 Extraction Reagent capsules

25 individually packed sterile Swabs

1 Positive Control Swab: Influenza A, B, and SARS-CoV-2 antigen

1 Negative Control Swab

1 Package Insert /Instructions for use

1 Quick Reference Instructions