2019-NCoV Ag Rapid Saliva / Sputum Test Usage Manual Reagent

Sample Requirements

(1) Saliva sample collection: Do not eat or drink chewing gum or cigarette products within 30 minutes after saliva sample collection. Place your tongue on the lid of your mouth to collect saliva roots. I put the disposable tampons under it. Soak your tongue for at least 10 seconds, completely soaking it in saliva, and rotate it more than 5 times (see table 1).
Note: Saliva sample is not collected correctly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum collection: after rinsing with water, sputum is continuously coughed. Put the sputum into the test bag and wipe the sample with a disposable disinfection cotton swab (refer to Figure 2).
(3) Sample processing: The collected samples are processed with the sample buffer memory contained in the toolbox (the samples not immediately processed are kept in a dry and germicidal sealed container). 2 ~ 8℃ ~ 24 hours above 70 ℃ (but please avoid repeated freezing and thawing).

Test Method

Please read the instructions carefully before the exam. All reagents are returned to room temperature, and tests must be performed at room temperature.
Processing example (see Figure 3).
(1) Insert the sample exchanger into the sample buffer memory, rotate it around the inner wall for about 10 times, and dissolve the sample into the solution as much as possible.
(2) Hold the front end of the casing along the inner wall, pour the liquid into the pipe, remove the casing, and discard the casing.
(3) Cover with water droplets.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test process (see Figure 4).
(1) Remove the test card.
(2) Add 2 drops (about 80L) of the processed sample extract into the sample hole of the test card to start the timer.
(3) After reading the card at room temperature for 15 minutes, the result is 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 the purpose of assisting invitro diagnosis.
2. This product is suitable for saliva and sputum samples. Results of other sample types may be inaccurate or invalid.
3. In the absence of sputum samples, patients should be examined with a nasopharyngeal swan.
4. Confirm that the appropriate number of additional test samples has been added. With too many or too many samples, the results may be incorrect.
5. The test results of the reagent are only for clinical reference, and should not be used as the only basis for clinical diagnosis and treatment. A final diagnosis of the disease must be made after a comprehensive evaluation of all clinical and examination results.

Product Performance Indicators

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1. Detection limits: Inactive SARS-COV-2 virus cultures were used in this study. The minimum detection limit is 612tcid50/ml.
2. Use the company's standard materials for testing, and the test results must meet the requirements of the company's standard materials.
2.1 Qualification rate of positive control: the enterprise actively controls P1-P5.
2.2 Pass rate of negative control: The company's N1-N10 negative control test is negative.
2.3 Test limit: please refer to L1-L3. L1 is negative, L2 and L3 are positive.
2.4 Reproducibility: BOTH J1 and J2 were 10 times positive.
3. Cross-reactivity: The following microorganisms and viruses are injected into the sample at specified concentrations to evaluate potential interference with the 2019 new corona virus antigen detection program.
4. Interference: The 2019-NCOV Ag test procedure evaluates potential interference and adds the following agents at specified concentrations. The results showed that the various drugs did not interfere with the test results of the reagent.
5. Hook effect: In the high concentration range of 1.0106 TCID50/mL, no hook effect was observed in 2019-NCOV inactive culture.
6. Clinical study: RT-PLR sputum reagent was used as contrast agent to detect saliva and sputum samples respectively. For each sample size (RT-PLR test), 120 positive and negative samples were selected and a second test was performed using XIUS reagent. The results are as follows:

Precautions

1. This product is used for INVitro diagnosis.
This product is disposable and can't be reused.
3. Please strictly follow the instructions of reagents and read the instructions carefully before the experiment.
4. Do not perform the test under severe environmental conditions (including 84 disinfectant, dust, sodium hypochlorite, acid and alkali, acetaldehyde and other corrosive gases with high concentration). Laboratory disinfection needs to be carried out after the experiment.

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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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