FDA Home In Vitro Diagnostic 20min COVID 19 Test Kit

Product Specification

Where To Get Home Diagnostic COVID 19 Test Kit High Accurate Coronavirus Antigen Test By Throat Swab Or Nasal 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

☀ 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.

Materials Required But Not Provided

☀ Timer or stopwatch

☀ Biohazard disposal container

☀ Disposable gloves

☀ 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.

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.

Performance Characteristics

1. Negative reference sample coincidence rate: 10 negative enterprise reference samples were tested and the

results were all negative.

2. Positive reference sample coincidence rate: 5 antigen positive enterprise reference samples were tested and the

results were all positive.

3. Minimum detectability:

3.1 3 limited detection of enterprise reference samples were used for testing, repeated 3 times, L1 should be negative, L2 and L3 should be positive.

3.2 The minimum detectability of this product for the SARS-CoV-2 virus strain is no more than 1.25×103.2TCID₅₀/ml.

4. Intra-lot repeatability: Parallel determination of enterprise repeatable reference samples, each repeated 10 times,

R1 should be negative, R2 and R3 should be positive.

5. Inter-lot repeatability: Parallel determination of enterprise repeatable reference samples with 3 batches of reagents, each batch repeated 10 times. With 3 batches of reagents, R1 should be negative, R2 and R3 should be positive.

6. Interfering substances: α - interferon, zanamivir, ribavirin, ritonavir, pramivir, lopinavir, abidol, levofloxacin, azithromycin, ceftriaxone, meropenem, tobramycin have no effect on the test results of this product.

7. Cross reaction: There was no cross-reaction with potential cross-reactive substances.

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.