COVID-19 Antigen Rapid Test

Introduction

The Diagnostic Kit for SARS-CoV-2 is a qualitative membrane-based immunoassay for the detection of SARS- CoV-2 in nasopharyngeal swab. In the Test region, anti-SARS-CoV-2 is coated. During testing, the specimen reacts with SARS-CoV-2 antibody-coated particles in the test strip.

The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-SARS-CoV-2 in test line region.

Benefits

Very high accuracy

Fast, easy, and safe to use

No equipment requirement

Can monitor all phases of COVID-19

High sensitivity

Kit includes:

Test device (individually in a foil pouch with desiccant) (20pcs)
Single-Use Reaction tubes each with 400 ul extraction reagent (20 pcs)
Disposable Tubes (20pcs)
Package insert (1pcs)
Sterile swabs (20 pcs)

Summary

Since the first outbreak reported in December 2019, SARS-CoV-2 has spread rapidly worldwide, and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). Due to its highly contagious nature and global health crises, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO). SARS-CoV-2 continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS- CoV-2 pandemic, systematic screening, and detection of both clinical and asymptomatic COVID-19 cases is critical. Particularly, the identification of subclinical or asymptomatic cases is important to reduce or stop the infection because these individuals may transmit the virus. the virus has spread globally and can cause mild to severe respiratory illness including death.

The SARS-CoV-2 Antigen Rapid Test is a rapid test, instrument-free, single-use molecular diagnostic test kit for the qualitative detection of SARS-CoV-2 RNA from self-collect nasal swab samples in individuals with known or suspected COVID-19. The test kit contains all the components required to perform testing.

Principle

The SARS-CoV-2 Antigen Rapid Test is a lateral flow immunochromatographic technology for the qualitative detection of nucleocapsid protein antigen test. The SARS-CoV-2 Antigen Rapid Test is designed to detect antigen from the SARS-CoV-2 in nasopharyngeal swabs specimens from patients who are suspected of COVID-19 by their healthcare provider within five days of symptom onset.

To perform the test, nasopharyngeal swabs specimen is collected from the patient, sample preparation step in which the sample is eluted into the extraction buffer solution. Extracted swab sample is added to the sample well of the test device to initiate the test. When the swab sample migrates in the test strip, SARS- CoV-2 viral antigens bind to anti-SARS-CoV-2 nucleocapsid protein antibodies conjugated to indicator and capture particles in the test strip forming an immune complex.

Nasopharyngeal Swab Sample Collection

Procedural Notes:

Process the test sample immediately after collection.
Use only provided or recommended nasopharyngeal swab for specimen collection.
Collect the specimen wearing safety gloves to avoid contamination.
Do not touch the tip (specimen collection area) of the swab.
Collect samples as soon as possible after the onset of symptoms.

Test Procedures

Procedural Notes:

Allow test devices, reagents, specimens, and/or controls to equilibrate to room temperature (15~30°C) prior to testing.
Remove the SARS-CoV-2 Antigen Rapid test device and extraction vial from its foil pouch immediately before testing.
The SARS-CoV-2 Antigen Rapid Test kit IS INTENDED to be used only with a direct nasopharyngeal swab specimen.
The SARS-CoV-2 Antigen Rapid Test kit IS NOT INTENDED for testing other liquid samples such as nasal wash or aspirate samples as results can be compromised by over dilution.