SARS-CoV-2 Antigen Rapid Test Kit

This product is used for in vitro qualitative detection of SARS-CoV-2 antigen in human oropharyngeal swabs, nasal swabs and nasopharyngeal swabs. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of SARS-CoV-2 infection.

Product Features

Easier No special equipment needed; Easy to use; Intuitive visual interpretation.

Rapid: Results in 10 minutes.

Accurate: Results were validated by PCR and Clinical diagnosis.

Diversity: Works with oropharyngeal swab, nasal swab and nasopharyngeal swab.

How Does the SARS-CoV-2 Antigen Rapid Test Kit Work?

TEST PROCEDURE
Before use, please read the instructions carefully and operate in strict accordance with the instructions:

1. Bring the pouch to room temperature before use.

2. Take out the cassette, put it on a horizontal table.

3. Add 3 drops of the processed sample vertically into the sample well and start the timer.

4. Observe the result after 10 minutes, the result is valid within 30 minutes, read results after 30 minutes is invalid.

Testing Results

INTERPRETATION OF RESULTS

Positive: Both the detection line (T line) and the quality control line (C line) appear colors.

Negative: The test line (T line) does not appear color, only the quality control line (C line) appears color.

Invalid: The quality control line (C line) does not appear color, which means that the test is invalid and the test should be repeated.

Kit Components & Storage

Materials supplied:

1.Test reagent: 1 test/pouch, each test consists of a test cassette and a desiccant. The cassette is composed of a test strip and a test strip shell. The test strip consists of a sample pad and a colloidal gold bonding pad (sprayed with colloid Gold-labeled SARS-CoV-2 monoclonal antibody I), nitrocellulose membrane (NC membrane) (the detection area is coated with SARS-CoV-2 monoclonal antibody II (T line) and goat anti- Mouse IgG (C line)), liner and absorbent pad.

2. Desiccant: 1 piece/pouch, silica gel.

3. Swab: 25 pieces/pack.

4. Sample treatment solution: 25 vials/pack.

5. Sampling tube: 25 pieces/pack.

Storage and Stability:

The test reagent is stored at 2~30 ℃, and the validity period is tentatively set for 18 months.

See the label for the production date and expiration date.

FAQs

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold Immunoassay) is a rapid chromatographic immunoassay for the qualitative detection of the novel coronavirus (SARS-CoV-2) antigen in human oropharyngeal swab, nasal swab and nasopharyngeal swab in vitro. It cannot be used as a basis for the diagnosis and exclusion of novel coronavirus pneumonia and is not suitable for screening of the general population.

The colloidal gold labeled reagent coated on conjugate pad is SARS-CoV-2 monoclonal antibody I.
T Line: SARS-CoV-2 monoclonal antibody II.
C Line: Goat anti-mouse IgG (polyclonal).

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold Immunoassay) are not suitable for new virus/positive patients (no positive results) and are generally used at the onset of infection and symptoms (1-7 days).

Oropharyngeal swab.

VTM is not available for this kit.

No special equipment needed.

Easy to use.

Results in 10 minutes.

Intuitive visual interpretation.

Results were validated by PCR and Clinical diagnosis.

Works with oropharyngeal swab, nasal swab and nasopharyngeal swab sample types.

Limitations of SARS-CoV-2 Antigen Rapid Test Kit

1.This kit is a qualitative test for in vitro auxiliary diagnosis.

2. Due to methodological limitations, the sensitivity of this kit is lower than that of PCR. Therefore, more attention should be paid to the negative results of this experiment, and a comprehensive judgment should be combined with other test results. It is recommended that the suspected results be supplemented with nucleic acid testing or virus isolation and culture in vitro for confirmation.

3. Unreasonable sampling, transportation and handling, or low virus content in the sample will lead to false negative results.

4. The test results of this reagent are for clinical reference only and cannot be used as the only basis for clinical diagnosis. The tester should conduct a comprehensive evaluation based on the patient's clinical manifestations and other laboratory test results.

About UNscience

UNscience (https://www.usciencecorp.com), a wholly owned subsidiary of Elabscience, specializes in the research and development, production and sale of in-vitro diagnostic reagents. Certified with ISO 13485 and other documents, UNscience sell its products all over the world.

The company has 100,000 grade GMP purification workshop and quality management system, three major technical platforms (Colloidal Gold Immunochromatographic Platform, Fluorescence Immunochromatographic Platform, and Pathological Diagnosis Antibody Platform). UNscience has the independent research and development and production capacity of core raw materials, and has successfully developed 27 POCT immunochromatographic quantitative detection products (colloidal gold and fluorescence), mainly covering cardiovascular and cerebrovascular diseases, kidney diseases, diabetes, infectious diseases, reproductive health, health examination and other.