Home Use COVID-19 Antigen Rapid Test Swab CE TUV

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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.

 

The complex moves forward on the membrane by the capillary action, then the complex is captured by specific antibody to SARS-CoV-2 on the test zone to produce a visual red color line. The color of line is positive correlated with the amount of SARS-CoV-2 in specimen.

 

Regardless of the presence of SARS-CoV-2, as the mixture continues to move across the membrane to the control zone, the complex is captured by immobilized goat anti mouse IgG antibody to form a distinct red line.

 

 

Reagents and Materials Provided

 

Specification	20 cassettes per kit	1 cassette per kit
Component	20 test cassettes	1 test cassette
	20 desiccant bags	1 desiccant bag
	20 sample extraction solution	1 sample extraction solution
	20 sample collection tubes	1 sample collection tube
	1 Instruction for use	1 Instruction for use
		1 disposable sampling swab

 

Materials Required But Not Provided

 

1. Timer or stopwatch

 

2. Biohazard disposal container

 

3. Disposable gloves

 

4. Disposable sampling swab

 

 

Sample Collection

 

1. Throat Swab Sample

 

Take a disposable sampling swab out, insert it into the throat of the patient. Use the swab to gently wipe the pharyngeal tonsils on both sides of the patient for at least 3 times, and then wipe them on the posterior pharyngeal wall for at least 3times. Withdraw the swab from the throat.

 

 

 

2. Nasal Swab Sample

 

Take a disposable sampling swab out, insert it into the nostril of the patient. Carefully insert the swab into the nostril. Gently rotating, pushing the swab until meet resistance at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then remove it from the nostril.

 

 

 

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.

 

Warning

 

For Medical Professional and In Vitro Diagnostic use ONLY

 

Read the package insert completely before use. It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false result.