I.Introduction

Packing size: 20 tests/kit

Specimen type: Nasal swabs, Throat swabs

Instrumentation: not required

Detection time: 10-15 minutes

Storage: Room temperature (2-30°C)

Shelf Life:12 months

II.Test Design and Principle

Colloidal gold-labeled anti-SARS-CoV-2 antibody and quality control antibody colloidal gold marker are sprayed on conjugation pads.

Test line T is fixed with anti-SARS-CoV-2 antibody for detecting the novel coronavirus. The quality control antibody is fixed on the C line.

Detects SARS-CoV-2 antigens in human Nasopharyngeal Swabs.

Antigen tests have important public health and clinical uses for monitoring and responding to the COVID-19 pandemic. It can be used for many applications in Public Health Surveillance and patients’ health care.

III.COVID-19 Antigen Test Applications

Antigen tests are the best tool to track infection rapidly.

Antigen testing for COVID-19 has many applications. Antigen testing determines whether you had COVID-19 directly if you currently have the disease.

Comparisons for detection performance

Limit of Detection (LOD) studies determined the lowest detectable concentration of SARS-CoV-2 at which 100% of all (true positive) replicates test positive.

Instructions for Sample Collection

• Nasal secretion collection:

Insert the swab into the nasal cavity where there is the most secretion, gently spin and push the swab forward until blocked by the turbinate (about 2.0cm-2.5cm from the nostril). Then rotate and rub the swab on the cavity wall 3 times before taking it out.

• Throat secretion collection:

Insert the whole swab completely into the throat from the mouth, centering on the throat wall and the reddened area of the palate tonsil, wipe both sides of the pharyngeal tonsil and posterior pharyngeal wall with moderate force. Try to avoid the tongue before taking it out.

 Result

IV. Internal Quality Control Procedure

Antigen Rapid Test

•       Each Test Cassette device has a built-in control.

•       A red colored line in the detection window at the Control line can be considered an internal positive procedural control.

•       The Control line will appearif the test procedure has been correctly performed.

•       If the Control line does not appear, the test is invalid and a new test must be performed.

•       If the problem persists, please contact us for technical support.

V. External Quality Control Procedure

•       Test performance can be evaluated using the SARS-CoV-2 Antigen External Control Kit. Follow instructions included in the kit for preparation, use, storage, and determination of appropriate values.

•       Upon confirmation of the expected results, the test is ready to use with patient specimens.

•       The SARS-CoV-2 Antigen External Control Kit includes negative external control. The negative control will yield an affirmative result (red line) for the control (C) line only, when the test has been performed correctly and the test device is properly functioning.

•       The SARS-CoV-2 Antigen External Control Kit includes positive external control. The positive control is formulated by spiking recombinant SARS-Cov-2 antigens in negative control. The positive control may be reactive to the T line.