2019-NCoV Saliva Sputum Ag Rapid Test Kit Usage Manual Test Method

Sample Requirements

(1) Saliva sample collection: Do not eat or drink within 30 minutes after saliva sample collection, including chewing gum or using tobacco products. Place the tip of the tongue against the upper jaw and collect the saliva roots. Put the disposable sterile cotton swab under the tongue for at least 10 seconds with the tongue, soak it completely in the saliva, and rotate it more than 5 times. (See Table 1)
Note: If the saliva sample is not collected properly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: After washing with water, expectorate the sputum, put it into the specimen bag, and wipe the specimen with a disposable sterile cotton swab. (See Figure 2)
(3) Sample processing: The collected samples should be processed using the sample buffer provided by this kit (not processed immediately, the samples should be stored in a dry, sterilized, sealed container) for inspection. 2℃~8℃ shall not exceed 24 hours and -70℃ for a longer time (but avoid repeated freezing and thawing).

Test Method

Please read the instructions carefully before testing. Return all reagents to room temperature, and the test should be carried out at room temperature.
Sample processing (see Figure 3).
(1) Insert the sample swab into the sample buffer and rotate it about 10 times close to the inner wall 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, remove and discard the swab.
(3) Cover with water droplets.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test procedure (see Figure 4).
(1) Take out the test card.
(2) Add 2 drops (about 80L) of the processed sample extract to 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 will be invalid after 20 minutes.

Interpretation of Test Results

Explanation of the test card (see Figure 5):
1. Result: The quality control line (line C) should be re-checked.
2. Negative results: quality control line (line C), red ribbon, coloring.
3. Positive result: There are two red strip colors on the test line (line t) and the quality control line (line C).

Figure 5 Interpretation of test results

Limitation of Test Method

1. This product is a qualitative test and is only used to assist in vitro diagnosis.
2. This product is suitable for saliva and sputum samples, other sample types may have inaccurate or invalid results.
3. If the patient does not have a sputum sample, a nasopharyngeal swab should be used for testing.
4. Make sure to add the right amount of sample for testing. Too many or too few samples may lead to inaccurate results.
5. The test results of this reagent are for clinical reference only, and should not be used as the sole basis for clinical diagnosis and treatment. After a comprehensive evaluation of all clinical and laboratory results, the final diagnosis of the disease should be made.

Product Performance Indicators

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1. Detection limit: This study uses inactivated sars-cov-2 virus culture, and the minimum detection limit of the kit is 6102tcid50/ml.
2. Use corporate standard materials for testing, and the test results should meet the requirements of corporate standard materials.
2.1 Pass rate of positive control: The enterprise is positively controlling p1-p5.
2.2 Negative control qualification rate: the company'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 10 times.
3. Cross-reaction: The following microorganisms and viruses are added to the sample at the specified concentration to evaluate their potential interference with the 2019 ncov Ag detection program. 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: In the 2019-NCOV inactivated culture, no hook effect was observed in the high concentration range of 1.0106 TCID50/mL.
6. Clinical research: RT-PCR detection reagents are used as contrast reagents to detect saliva and sputum samples respectively. For each sample size (RT-PCR test), select 120 positive and 120 negative samples, and use XIUS reagent for the second test. The results are summarized as follows:

Precautions

1. This product is used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Strictly follow the instructions of the reagents, and read the instructions carefully before the experiment.
4. Avoid testing under harsh environmental conditions (including high-concentration corrosive gases, such as 84 disinfectant, dust, sodium hypochlorite, acid-base or acetaldehyde). Laboratory disinfection should be carried out after the experiment.
5. The samples and reagents used should be considered as potentially infectious and handled in accordance with local laws and regulations.
6. The reagent should be used within the validity period indicated on 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.

Logo interpretation

	Do not re-use		Store at 2℃～30℃
	Consult instructions for use		In vitro diagnostic medical device
	Batch code		Use-by date
	Keep dry		Keep away from sunlight
	Authorized representative in the European Community		Manufacturer

Basic Information

ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD

Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA

Tel:+86-371-55016575

Email:zosbio@zosbio.com

Web:www.zosbio.com

SUNGO Europe B.V.

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