Details

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Intended Use

This product is suitable for the qualitative detection of novel coronavirus in nasopharyngeal swab or sputum samples. It provides an aid in the diagnosis of infection with novel coronavirus.

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic virus carriers can also be infectious sources. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are also found in some cases.

PRINCIPLE

The COVID-19 Antigen Detection Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, an absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates absorbed in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen is present in the sample, the complex of the anti-SARS-CoV-2 conjugate and the virus will be captured by the specific anti-SARS-CoV-2 monoclonal antibodies coated on the test line region (T). The absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking effect has occurred.

COMPOSITION

1. Test Card
2. Sample Extraction Tube
3. Tube Cap
4. Sampling Swab
5. Paper Cup
6. Sputum Dropper

STORAGE AND STABILITY

1. Store the product package at temperature 2-30°C or 38-86°F, and avoid exposure to sunlight. The kit is stable within the expiration date printed on the labeling.
2. Once an aluminum foil pouch is opened, the test card inside should be used within one hour. Prolonged exposure to a hot and humid environments may cause inaccurate results.
3. The lot number and the expiration date are printed on the labeling.

WARNINGS AND PRECAUTIONS

1. Read the instructions for use carefully before using this product.
2. This product is for professional use ONLY.
3. This product is applicable to nasopharyngeal swabs and sputum Using other sample types may cause inaccurate or invalid test results.
4. Sputum rather than saliva is the type of sample recommended by WHO. Sputum comes from the respiratory tract while saliva comes from the mouth.
5. If sputum samples cannot be obtained from patients, nasopharyngeal swab samples should be used for testing.
6. Please make sure that a proper amount of sample is added for testing. Too much or too little sample amount may cause inaccurate results.
7. If the test line or control line is out of the test window, do not use the test card. The test result is invalid and retests the sample with another one.
8. This product is disposable. DO NOT recycle used components.
9. Dispose of used products, samples, and other consumables as medical wastes under relevant regulations.