CE 30 Minute Covid 19 Antigen Rapid Test Cassette

How To Get Test For Covid 19 High Accurate CE Certification For Covid-19 Antibody Test For Sale

 

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.

 

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

 

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

 

Sample Collection

 

☀ 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.

 

 

☀ 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.

 

 

Swab Preparation (Throat / Nasal)

 

 

1. Remove the pointed nozzle cap out of the sample collection tube. Twist and open the sample preservation solution tube, then add the sample extraction solution into the sample collection tube.

 

2. Insert the patient swab into the sample collection tube. While squeezing the buffer tube, stir the swab more than 5 times.

 

3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.

 

4. Press the pointed nozzle cap tightly onto the tube.

 

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.

 

Storage

 

COVID-19 Antigen Rapid Test Cassette should be stored in dark place at 2~30°C for 24 months from the date of manufacture.

 

Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test beyond the indicated expiration date.