2019-NCoV Ag Antigen Saliva Test Kit Usage Manual Sample Requirements

Sample Requirements

(1) Saliva sample collection: Do not eat and drink water within 30 minutes of saliva sample collection, including chewing gum or using tobacco products.Place the tip of the tongue against the maxilla and collect the salivary roots.The tongue placed a disposable sterile cotton swab under the root of the tongue for at least 10 seconds, fully immersed in saliva and rotated more than 5 times.(see chart 1)

Note: If the saliva samples are not collected properly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: after rinsing with water, cough out the sputum and put it into the specimen bag, and wipe the specimen with a disposable sterile cotton swab.(see chart 2)

(3) Sample Treatment: collected samples shall be treated with the sample buffer provided in this kit (not treated immediately, samples shall be stored in dried, sterilized, sealed containers) for inspection.2℃ ~8℃ shall not exceed 24h and-70℃ for a long time (but repeated freeze and thaw shall be avoided).

Test Method

Please read the instructions carefully before testing. Put all reagents back to room temperature, and the test should be conducted at room temperature.

Sample treatment (see fig. 3).

(1) Insert the sample swab into the sample buffer, and rotate it close to the inner wall for about 10 times to make the sample dissolve in the solution as much as possible.

(2) Squeeze the tip of the swab along the inner wall to make the liquid flow into the tube, and take out and discard the swab.

(3) Cover with drops.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test procedures (see Figure 4).

(1) take out the test card.

(2) Add 2 drops (about 80L) of processed sample extract into the sample hole of the test card, and start the timer.

(3) Put the card at room temperature for 15 minutes to read the result, and the result is invalid after 20 minutes.

Interpretation of Test Results

Interpretation of test card (see Figure 5):
1. Result: the quality control line (line C) shall be rechecked.
2. Negative results: quality control line (line C), red ribbon, coloring.
3. Positive results: two red bars with color on the test line (t line) and quality control line (C line).

Figure 5 Interpretation of test results

Limitation of Test Method

1, this product is a qualitative test, only for auxiliary in vitro diagnosis.

2, this product is suitable for saliva and sputum samples, other sample types may appear inaccurate or invalid results.

3, if the patient has no sputum specimen, should use nasopharyngeal swab specimen for testing.

4. Make sure that the right amount of samples is added for testing. Too many or too few samples can lead to inaccurate results.

5, the test results of this reagent is for clinical reference only, should not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after a comprehensive assessment of all clinical and laboratory results.

Product Performance Indicators

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1. Detection limit: the inactivated sars-cov-2 virus culture was used in this study, and the minimum detection limit of the kit was 6102tcid50 / ml.
2. The enterprise reference material shall be used for testing, and the results shall meet the requirements of the enterprise reference material.
2.1 pass rate of positive control: p1-p5 of enterprise positive control is positive.
2.2 qualification rate of negative control: the enterprise's n1-n10 negative control test is negative.
2.3 detection limit: refer to L1-L3, L1 is negative, L2 and L3 are positive.
2.4 reproducibility: J1 and J2 were positive for 10 times.
3. Cross reaction: the following microorganisms and viruses were added to the sample at the specified concentration to evaluate their potential interference with the 2019 ncov Ag detection procedure. virus

4. Interference: Assess potential interference with the 2019-nCoV Ag testing procedure and add the following medications at the indicated concentration. The results showed that all kinds of drugs did not interfere with the test results of reagents.

5. Hook effect: No hook effect was observed in the high concentration range of 1.0106 TCID50/mL in 2019-NCOV inactivated cultures.

6. Clinical study: RT-PCR detection reagent was used as contrast reagent to evaluate saliva and sputum samples respectively. 120 positive and 120 negative samples were selected for each sample size (RT-PCR test), and a second test was performed using XIUS reagent. The results are summarized as follows:

Precautions

1. This product is used for in vitro diagnosis.

2. This product is disposable and cannot be recycled.

3, in strict accordance with the reagent instructions, carefully read the instructions before the experiment.

4. Avoid conducting experiments under harsh environmental conditions (including high-concentration corrosive gases such as 84 disinfectant, dust, sodium hypochlorite, acid and alkali or acetaldehyde). Laboratory disinfection should be carried out after the experiment.

5. Samples and used reagents should be regarded as potentially infectious and treated according to local laws and regulations.

6. Reagents shall be used within the validity period indicated in the outer packaging. The test card should be used as soon as possible after being taken out of the aluminum foil bag to prevent moisture.

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