COVID-19 (SARS-CoV-2) Antigen Test Kit(Latex Immunochromatography)

【Product Name】 COVID-19 (SARS-CoV-2) Antigen Test Kit

【Specification】 1 test/kit, 5 tests/kit 20 tests/kit 40 tests/kit

【Product Introduction】

The kit is a solid phase immunochromatography method for the rapid qualitative detection of novel Coronavirus 2019 antigens in human nasopharynx.  This test provides preliminary test results only.  Therefore, the interpretation results of the Novel Coronavirus test must be compared with those of other test methods and clinical validation.  

The novel coronavirus belongs to the β genus which is an acute respiratory infectious disease. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. 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 found in a few cases.

【Principle】

The kit is a method for immunochromatography of latex microspheres.  It detects nucleocapsid proteins on the surface of the Novel Coronavirus.  The product uses novel Coronavirus (SARS-CoV-2) antibodies (test line T) and sheep anti-mouse IgG(control line C) fixed on nitrocellulose membrane.  The fuchsia binding mat contains colloidal gold and mouse antibody-colloidal gold binding to another Novel Coronavirus (SARS-COV-2) antibody.  The treated buffer containing the sample is added to the sample well, and the Novel Coronavirus (SARS-COV-2) binds to the Novel Coronavirus antibody to form an antigen-antibody complex.  The complex migrates through the nitrocellulose membrane by capillary action.  When the complex encounters the Novel Coronavirus antibody line of test line T, the complex is captured, forming a purplish red band and presenting a positive test result.  The absence of colored bands in the test area indicates a negative test result.  This product contains an internal control (control line C), which should show a purplish red band of immune complexes.  Otherwise, the test result is invalid and must be retested.   

uses latex immunochromatography technology to detect the novel coronavirus SARS-CoV-2 N antigen in the sample by using a double-antibody sandwich-type immunoassay method.

The recombinant novel coronavirus anti-N antibody (that is, the capture antibody which is a humanized antibody) is fixed on the nitrocellulose membrane (T line), and the recombinant novel coronavirus anti-N antibody (that is, the detection antibody which is also a humanized antibody) is combined with latex microspheres on the test card.

If the sample contains N antigen, the N antigen will form a complex with the latex microsphere-labeled antibody. Under the action of chromatography, the complex will move along the test strip and bind to the antibody immobilized on the nitrocellulose membrane shows red in the T line.

The test strip fixes the recombinant anti-human antibody on the nitrocellulose membrane above the T line, which is called the C line. The free latex microsphere-labeled antibody moves along the test strip under the action of chromatography and combines with the anti-human antibody immobilized on the nitrocellulose membrane to form a red line.

【Kit Components】

Material which need but don’t contain in the package:

1. Sample collecting container;
2. Timer.

【Storage Conditions and Shelf Life】

The kit should be stored at 4-30℃and the shelf life is 12 months.

See the labels for the date of manufacture and shelf life.

【Warnings and Precautions】

1. It is only used for professional in vitro diagnosis. Do not use it after expiration.

2. Read the instructions before performing the test. Failure to use the instructions will lead to inaccurate test results.

3. Do not use if the tube or packing bag which is damaged.

4. The test is only for one-time use and should not be reused under any circumstances.

5. Process all samples as if they contain infectious pathogens. Observe the established precautions against microbial hazards throughout the test and follow the standard procedures for the proper handling of specimens.

6. Wear protective clothing during operation, such as laboratory work clothes, disposable gloves and goggles.

7. Abnormal humidity and temperature will adversely affect the results.

8. Do not test in a room with strong airflow, such as electric fan or strong air conditioner.

【Specimen Collection】

1. The kit can be sampled by throat swab or nasal swab.

2. The test shall be carried out immediately after the sample is collected.

3. Before the test, place the sample at room temperature.

4. If the specimen is to be transported, it shall be packaged in accordance with local regulations on pathogen transportation.

【Test Procedure】

1. Before the test, balance the test card, specimen and lysis solution to room temperature (15-30 ℃).

2. Remove the test card from the sealed foil bag and use it as soon as possible. If the analysis is carried out within one hour, the best results will be obtained.

3. Place the test card on a clean, level surface.

4. Ask the patient to remove the secretions on the surface of the front nasal cavity, keep the head slightly tilted, gently and slowly insert the swab from the nasal cavity into the nasopharynx. When encountering resistance, the swab will reach the rear nasopharynx, stay for a few seconds to absorb the secretions, and then rotate gently to take out the swab.

5. Place the antigen extraction tube on the workbench. Place the lysis solution bottle vertically downward, squeeze the bottle body so that the buffer drops into the extraction tube without touching the edge of the tube, and drop 6 drops (about 200ul) into the extraction tube.

6. Put the swab sample into the extraction tube prefilled with lysis solution, rotate the swab for 10 times, and press the head of the swab on the tube wall to release the antigen in the swab, and then let it stand for about 1 minute.

7. Squeeze the head of the swab and take out the swab at the same time, so as to drain as much liquid as possible from the swab. Dispose of used swabs according to biohazardous waste treatment methods.

8. Install the dripper on the extraction tube, cover it tightly, and let it stand for about 1 minute.

9. Add 3 drops (about 100ul) into the sample hole of the test card (or add 100ul with a pipette) and start timing.

10. Wait for the color line to appear, the result should be read within 15 minutes, and the result is invalid after 15 minutes.

【Interpretation of Test Results】

There is no line on T line and a red line on C line: there is no detectable SARS-CoV-2 in the sample.

There is a red line on T line and a red line on C line: it is suspected of SARS-CoV-2 infection.

There is no line on C line: the test is invalid.

【Points for Attention】

1. Use fresh samples as much as possible.

2. The best analytical performance requires strict compliance with the operating procedures described in this manual. Deviations may lead to abnormal results.

3. The negative results only show that the SARS-CoV-2 antigen was not detected, and the possibility of exposure or infection of the subjects was not ruled out.

4. If the SARS-CoV-2 antigen is lower than the detection limit or if the SARS-CoV-2 antigen in the nasal cavity can not be correctly collected, negative results may also occur.

5. Like all diagnostic tests, the final clinical diagnosis should not be based on the results of a single test, but should only be made by the doctor after evaluating all clinical and laboratory results.