Sample Requirements

(1) Saliva sample collection: Do not eat or drink water, including chewing gum or using tobacco products, within 30 minutes of saliva sample collection. Place the tip of the tongue against the upper jaw and collect the saliva roots. Tongue Place a disposable sterile cotton swab under the root of the tongue for at least 10 seconds, completely immerse it in saliva and rotate it more than 5 times. (see Figure 1)

Note: If 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, coughing up sputum into the specimen bag, wipe the specimen with a disposable sterile cotton swab. (see Figure 2)

(3) Sample handling: The collected sample should be treated with the sample buffer provided by this kit as soon as possible (should not be treated immediately, the sample should be kept in a dry, sterilized, sealed container) and left for inspection. No more than 24h at 2C to 8C and no more than -70C in the long term (but repeated freezing and thawing should be avoided).

Test Method

Read the instructions carefully before testing. Put all reagents back at room temperature and the test should be conducted at room temperature.

Sample handling (see Figure 3).

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

(2) Squeeze the tip of the swab along the inner wall so that the liquid flows into the tube, remove and discard the swab.

(3) Cover with drops.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test the program (see Figure 4).

(1) Remove the test card.

(2) Add 2 drops (about 80L) of 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 results, 20 minutes after the results are invalid.

Interpretation of Test Results

Test card interpretation (see Figure 5):

1. Result: The quality control line (c line) should be re-examined.

2, negative results: quality control line (C line), red ribbon, coloring.

3. Positive results: detection line (T line) and quality control line (C line) two red bars with color.

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, the nasopharyngeal swab specimen should be used 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

​

1. Detection limit: In this study, inactivated SARS-CoV-2 virus culture was used, and the minimum detection limit of the kit was 6102TCID50/mL.

2, the use of enterprise reference products for testing, the results should meet the requirements of enterprise reference products.

2.1 Positive control pass rate: Enterprise-positive control P1-P5 is positive.

2.2 Negative control pass rate: Enterprise N1-N10 negative control tested negative.

2.3 Detection limit: Reference L1-L3, L1 is negative, L2, L3 is positive.

2.4 Reproducibility: J1 and J2 have tested positive 10 times.

3. Cross-reaction: Add the following microorganisms and viruses to the sample at the specified concentration to assess their potential interference with the 2019-nCoV Ag testing procedure. virus.

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

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

6, clinical research: RT-PCR test reagents as a comparative reagent, respectively, saliva and sputum samples were evaluated. 120 positive and 120 negative samples (RT-PCR tests) were selected for each sample size, and a secondary test was performed using the xius reagent. The results are summarized as follows:

Precautions

1, this product is used for in vitro diagnosis.

2. This product is a disposable product and is not recyclable.

3, strictly follow the reagent instructions operation, carefully read the instructions before the experiment.

4, avoid in harsh environmental conditions (including 84 disinfectant liquid, dust, sodium hypochlorite, acid base or acetaldehyde and other high concentrations of corrosive gases) to carry out experiments. Laboratory disinfection should be carried out after the experiment.

5. Samples and used reagents should be considered potentially contagious and treated in accordance with local laws and regulations.

6, reagents should be used during the validity period indicated in the outer packaging. The test card should be used as soon as possible after removal from the 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.

Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

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