CE TUV Certification Antigen And Antibody Coronavirus Test PCR Antigen Testing For SARS-CoV-2

COVID-19 Antigen Rapid Test Cassette

For the qualitative detection of SARS-CoV-2 antigen in human throat swab or nasal swab

Main Features

☀ High Sensitivity, Some Products can reach 100%

☀ High Specificity, Some Products can reach 100%

☀ Reliable: High Accurate, Early Detection of The Presence Of Virus

☀ Simple: No complicated Instrument Required

☀ Convenient: Room Temperature Storage, patented Built-In Control line for easy operation with high accuracy

☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

☀ Certified by Authoritative Certification System and Standards

☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Intended Use

COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative detection of specific antigens to SARS-CoV-2 present in human throat or nasal cavity. It cannot be used as the basis for the diagnosis and exclusion of COVID-19.

This reagent is used to detect cases with suspected symptoms of COVID-19 within 7 days. If suspected symptoms are more than 7 days, it is recommended to test with COVID-19 antibodies or nucleic acid reagents.

The main clinical symptoms of COVID-19 are: Fever, dry cough, fatigue, a few patients will have stuffy nose, runny nose and diarrhea.

Principle

This kit uses double antibody sandwich immunoassay to detect specific antigens to SARS-CoV-2 in human throat or nasal cavity. The membrane was precoated with SARS-CoV-2 specific antibody on the test zone and goat anti mouse IgG antibody on the control zone.

During the test, the specimen is allowed to react with SARS-CoV-2 specific antibody-colloidal gold particles conjugate, which was predried on the test. The conjugate binds to the SARS-CoV-2 forming an Antibody~Antigen complex.

Reagents and Materials Provided

Materials Required But Not Provided

1. Timer or stopwatch

2. Biohazard disposal container

3. Disposable gloves

4. Disposable sampling swab

Interpretation of Results

☀ Positive: One color line in the control zone (C) and one color line in the test zone (T). This indicates that the sample contains SARS-CoV-2 antigen.

☀ Negative: Only one color line in the control zone (C). This indicates that no SARS-CoV-2 antigen has been detected.

☀ Invalid: If no color line appears in the control zone (C), the test is invalid. Discard the test cassette and perform with new cassette.

Built-In Control

COVID-19 Antigen Rapid Test Cassette has a built-in procedural control that demonstrates assay validity. A color line appeared on the control zone (C) indicates that the test runs correctly.