PURPOSE OF USE
This Product is suitable for People with COVID-19-like Symptoms, such as Cough, Fever, Fatigue, etc., to assist in the early Diagnosis of SARS-CoV-2 Infection. It can also be used to test People without COVID-19 Symptoms to monitor their Health Status on a regular basis.
The COVID-19 Antigen Detection Kit - Nasal Swabis an immunochromatographic Membrane Test that uses highly sensitive monoclonal Antibodies to detect the Nucleocapsid Protein of SARS-CoV-2 from Nasal Specimens collected with a Swab. The Test Kit consists of the following Parts: the Sample Pad, the Reagent Pad, the Reaction Membrane, and the Absorbent Pad. The Reagent Pad contains the Colloidal Gold conjugated with the monoclonal Antibody to the Nucleocapsid Protein of SARS-CoV-2; the Reaction Membrane contains the Secondary Antibodies to the Nucleocapsid Protein of SARS-CoV-2. The whole Strip is fixed in a plastic Device. When the Sample is placed in well, the conjugates absorbed in the Reagent Pad are dissolved and migrate together with the Specimen. When SARS-CoV-2 Antigen is present in the Specimen, the complex of the anti-SARS-CoV-2 conjugate and the virus is captured by the specific anti-SARS-CoV-2 monoclonal antibodies coated on the test line region (T). Absence of the T line indicates a negative Result. As a procedural Control, a red Line always appears in the Control Line Area ("C") indicating that the correct amount of Specimen has been added and the Membrane Wick Effect has occurred.
SENSITIVITY, SPECIFICITY & OVERALL ACCURACY
The clinical Performance of the COVID-19 Antigen Detection Kit- Nasal Swab was evaluated in prospective Studies using Nasal Swab Samples (Antigen Test) and Nasopharyngeal Swab Samples (RT-PCR Test)from 437 Individual Symptomatic Patients (within 7days of Disease Onset) and Asymptomatic Patients with Suspected COVID-19.The Summarized Data of the COVID-19 Antigen Test Kit are as follows: RT-PCR cycle threshold(Ct)is the relevant Signal Value. A lower Ct Value indicates a higher viral Load. Sensitivity was calculated for Ct Value Ranges of ≤40.