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Novel coronavirus antigen detection kit (saliva version)

Novel coronavirus antigen detection kit (saliva version)

Novel coronavirus antigen detection kit (saliva version)
Product description

【product name】

Generic name: Novel coronavirus (2019-nCoV) antigen detection kit (BBT-saliva version)

【expected usage】

This product is used for the detection of novel coronavirus N protein antigen in saliva samples of people suspected of novel coronavirus infection pneumonia. Antigen detection is generally used in the acute infection period, that is, the detection of samples within 7 days of the onset of symptoms in the suspected population. Antigen detection cannot be used alone for the diagnosis of new coronavirus infection. It should be combined with other diagnostic information such as nucleic acid detection and imaging, as well as medical history and contact history to determine the infection status. Positive results of antigen testing can be used for early triage and rapid management of suspected populations, but positive results only indicate the presence of novel coronavirus N protein antigen in the sample and cannot be used as the basis for the diagnosis of novel coronavirus infection. A negative result does not rule out novel coronavirus infection, nor should it be used alone as a basis for making treatment and disease management decisions. Both positive and negative antigen results in the suspected population should undergo further nucleic acid testing.

【Inspection Principle】

This kit is based on the principle of latex immunochromatography. The saliva sample is collected by the saliva suction stick at the front of the detection card, and the saliva sample moves forward under the action of capillary. If the sample contains the novel coronavirus N protein antigen, it will be recognized and bound by the latex surface-labeled antibody to form an immune complex. When the formed immune complex migrates to the nitrocellulose membrane detection line, the coated antibody recognizes and binds to form a purple-red detection line (T line), which shows that the new coronavirus antigen is positive; if the T line does not develop color, it is a negative result. The nitrocellulose membrane was additionally coated with anti-chicken IgY antibody as a quality control line (C line), as an indication that the chromatographic process was normal.

【Main components】

1) Test card

2) Instructions

【Storage conditions and validity period】

The kit is stored at 4-30°C and is valid for 18 months. After the aluminum foil bag is unpacked, the validity period is 1 hour under the conditions of temperature 20~30℃ and humidity 30%~50%.

【Sample requirements】

This kit is only suitable for saliva samples, other sample types may not give reliable results. Samples must be tested promptly after collection.

【Testing method】

Please read the manual carefully before use. The test card should be equilibrated to 15-30°C 15 minutes in advance, and the test should be carried out under these conditions.

1. Open the packaging bag, take out the test card, open the cover at one end of the test card, and expose the saliva suction stick.

2. Hold the saliva test card, put the saliva suction stick into the mouth, and start the timer. After holding the saliva suction stick in the mouth for about 90 seconds, cover the end of the suction stick and place the test card horizontally on the workbench.

3. Re-time and read the test result after 15 minutes.

【Explanation of test results】

1. Negative result: If only the C line appears and the T line does not develop color, it means that the N-protein antigen of the new coronavirus has not been detected, and the result is negative.

2. Positive result: If both the C line and the T line appear, it means that the novel coronavirus antigen has been detected, and the result is antigen positive.

3. Invalid result: If the C line cannot be observed, no matter whether there is a T line displayed, it is invalid and the test should be re-tested.

[Limitations of the test method]

1. This reagent is only used for qualitative testing for scientific research purposes.

2. This reagent is only used to detect the new coronavirus N protein in human saliva samples, and the results of other samples may be wrong.

3. This reagent is only a clinical auxiliary diagnostic tool. If the result is positive, it is recommended to use other methods for further examination and the doctor's diagnosis shall prevail.


1. Before using this kit, you must read this manual carefully and strictly control the reaction time.

2. All samples and materials in the testing process should be handled in accordance with the operating norms of infectious disease laboratories.

3. Beware of the product getting wet, do not open the aluminum platinum bag before the test is ready; after the aluminum foil bag is damaged or the test card is damp, it cannot be used; please use it within the validity period.

4. Equilibrate all reagents and samples to room temperature (15-30°C) before use.

5. This kit needs to be stored in strict accordance with the conditions specified in this manual. Do not store this kit under freezing conditions.

6. The interpretation of test methods and results must be carried out in strict accordance with this manual.

7. This kit will give negative results under the following conditions: when the titer of novel coronavirus antigen in the sample is lower than the minimum detection limit of this kit.

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