This product is suitable for the qualitative detection of a novel coronavirus in sputum samples. It provides an aid in the diagnosis of infection with the novel coronavirus.
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.
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 the 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.
- Test Card
- Sample Extraction Tube
- Tube Cap
- Paper Cup
- Sputum Dropper
1. Have the patient take a deep breath, and expectorate deep cough sputum into the paper cup or a sputum container.
Note: If the patient has eaten or drunk just before sample collection rinse the mouth with clean water.
2. Use the sputum dropper to transfer 0.6ml of the sputum sample into the sample extraction tube. The dropper draws up 0.3ml sample at a time. Perform the sample transfer procedure twice. 3. Peel off the aluminum foil from a sample extraction tube.
4. Transfer 0.6mL sputum sample into sample extraction tube.
Note: Sputum is highly viscous. Please strictly follow the instructions described above. Adding excessive or insufficient sputum sample may cause inaccurate results.
5. Squeeze the dropper 5 times to mix the sputum sample with the sample extraction solution.
6. Insert the tube cap firmly on the sample extraction tube. Put the tube still for 1 minute to release viral antigens.
Restore the test devices and specimens to room temperature (15-30℃ or 59-86°F) prior to testing.
- Flick the bottom of the tube to mix the sample solution.
- Take out a test card from an aluminum foil pouch. Place the test card on a table. Hold the tube upside down vertically. Squeeze the tube to expel 3 drops of sample solution into the loading well on a test card.
- Read the result after 15 to 30 minutes. The results are considered inaccurate and invalid after 30 minutes.
- Store the product package at temperatures 2-30°C or 38-86°F, and avoid exposure to sunlight. The kit is stable within the expiration date printed on the labeling.
- Once an aluminum foil pouch is opened, the test card inside should be used within one hour. Prolonged exposure to hot and humid environments may cause inaccurate results.
- The lot number and the expiration date are printed on the labeling.
- Read the instructions for use carefully before using this product.
- This product is for professional use.
- This product is applicable to sputum Using other sample types may cause inaccurate or invalid test results.
- Sputum rather than saliva is the type of sample recommended by WHO. Sputum comes from the respiratory tract while saliva comes from the mouth.
- Please make sure that a proper amount of sample is added for testing. Too much or too little sample amount may cause inaccurate results.
- 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.
- This product is disposable. DO NOT recycle used components.
- Dispose of used products, samples, and other consumables as medical wastes under relevant regulations.