Throat Swab Nasal Swab COVID-19 Ag Rapid Test Cassette

Where To Get Tested For Covid 19 Throat Swab Or Nasal Swab Screening Test Coronavirus Ag Rapid Test Cassette Swab

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

☀ 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

☀ Simple: No complicated Instrument Required

☀ Certified by Authoritative Certification System and Standards

☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

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.

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.

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.

Reagents and Materials Provided

Materials Required But Not Provided

☀ Timer or stopwatch

☀ Biohazard disposal container

☀ Disposable gloves

☀ Disposable sampling swab

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.

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.

Precautions

☀ This product is an in vitro diagnostic reagent to qualitatively detect the SARS-CoV-2 antigen in human throat or nasal cavity.

☀ The reagent may cause false negative results in COVID-19 patients with asymptomatic infection.

☀ Do not use the test if the pouch is damaged or the seal is broken.

☀ Do not modify the test procedure.

☀ Do not touch the reaction zone of the reagent.

☀ Each test is for single use only.

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.

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.