2019-NCoV Ag Rapid Saliva / Sputum Test Usage Manual Interpretation Test Card

Sample Requirements

(1) Saliva sample collection: do not eat or drink chewing gum or tobacco products within 30 minutes after collecting the saliva samples.Place the tip of the tongue against the palate and collect the saliva roots.A disposable sterile cotton swab was placed under the tongue for at least 10 seconds, fully immersed in the saliva, and rotated more than 5 times.(See Table 1)
Note: If the saliva samples have not been collected correctly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: after rinsing with water, cough up the sputum, put it into the specimen bag, and wipe the specimen with a disposable sterile cotton swab.(See Figure 2)
(3) Sample treatment: The collected samples shall be treated with the sample buffer provided in this kit (the samples not processed immediately shall be stored in dry, sterile and sealed containers) for inspection.2 to 8 degrees Celsius to 24 hours, longer than-70 degrees Celsius (but avoid repeated freeze and thaw).

Test Method

Read the instructions carefully before testing.All reagents were placed back at room temperature and testing should be performed at room temperature.
Example processing (see Figure 3).
(1) Insert the sample swab into the sample buffer and rotate the sample about 10 times near the inner wall to dissolve the sample in the solution as much as possible.
(2) Squeeze the tip of the swab along the inner wall to flow the liquid into the tube, remove the swab and discard the swab.
(3) Cover it with water droplets.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test process (see Figure 4).
(1) Remove the test card.
(2) Add the addition of 2 drops (approximately 80L) of the treated sample extract to the sample hole of the test card to start the timer.
(3) The card was read for 15 minutes at room temperature, and the results were invalid after 20 minutes.

Interpretation of Test Results

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, and other sample types may have inaccurate or invalid sample results.
3. If the patient does not have sputum samples, a nasopharyngeal swab should be used for testing.
4. Ensure that an appropriate amount of samples is added for testing.Too much or too many samples can lead to inaccurate results.
5. The test results of this reagent are for clinical reference only, and should not be used as the only basis for clinical diagnosis and treatment.After a comprehensive evaluation of all clinical and laboratory results, a final diagnosis of the disease should be made.

Product Performance Indicators

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1. Detection limit: The inactivated sars-cov-2 virus culture was used in this study. The minimum detection limit was 6,102 tcid50 / ml.
2. Use the company's standard materials for testing, and the test results should meet the requirements of the company's standard materials.
2.1 Qualification rate of positive control: enterprise positive control p1-p5.
2.2 Pass rate of negative control: our company n1-n10 negative control test is negative.
2.3 Detection limit: refer to L1-L3, L1 is negative, and L2 and L3 are positive.
2.4 Reproducibility: Both J1 and J2 were 10-fold positive.
3. Cross-reaction: The following microbes and viruses were injected into the samples at the specified concentrations to assess their potential interference with the 2019 Novel Coronavirus antigen detection procedure.virus

4. Interference: To evaluate the potential interference of the 2019-nCoV Ag testing procedure, and add the following drugs according to the prescribed concentration.The results showed that the various drugs did not interfere with the detection results of the reagents.

5. Hook effect: No hook effect was observed in the 2019-NCOV inactivated cultures at a high concentration range of 1.0106 TCID50 / mL.
6. Clinical research: RT-PCR sputum reagent as the contrast reagent to detect saliva and sputum samples respectively.For each sample size (RT-PCR test), 120 positive and negative samples were selected and given a second test using the XIUS reagent.The study 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 reagent instructions, and read the instructions carefully before the experiment.
4. Avoid testing in harsh environmental conditions (including high concentration of corrosive gases, such as 84 disinfectant, dust, sodium hypochlorite, acid-alkali, or acetaldehyde, etc.).Laboratory disinfection shall be carried out after the experiment.

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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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