TUV Home Use 15min Coronavirus Ag Rapid Test Cassette

Product Specification

Spanish CE Certification Home Use Coronavirus Ag Rapid Test Cassette High Accurate COVID-19 Antigen Test

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.

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.

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.

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.

Precautions

☀ If desiccant bag is not present in the pouch, DO NOT USE the test.

☀ Always add accurate volume of specimen by following the instruction.

☀ The test cassette must be used directly after unsealing. It is not allowed to divide it for use.

☀ If the reagent is stored in refrigerator, it should be restored to room temperature before testing.

☀ Observe the result in 15~20 minutes. Interpret the test result after 20 minutes may cause false result.