COVID-19 rapid test professional

for antigensSARS-COV-2nasopharyngeal

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for SARS-CoV-2 antibodies. Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) can be transmitted from between non-human vertebrates to humans. 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 Shelf Life: 24 months from the date of manufacture