Coronavirus Saliva Sputum Ag Rapid Test Kit Usage Manual Principle Of Detection

Sample Requirements

(1) Saliva sample collection: Do not eat or drink water, including chewing gum or using tobacco products within 30 minutes before saliva sample collection. Hold the tip of the tongue against the maxilla and collect the root of saliva. Tongue Place sterile disposable cotton swabs under the root of tongue for at least 10 seconds, immerse them completely in saliva and rotate them 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) Collection of sputum specimen: After rinsing with clear water, cough up sputum and 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 should be treated with the sample buffer provided by this kit as soon as possible (they should not be treated immediately, and the samples should be kept in dry, sterilized and sealed containers) and kept for inspection. 2℃ ~ 8℃ shall not exceed 24h, and -70℃ shall not exceed for a long time (but repeated freezing and thawing shall be avoided).

Test Method

Please read the instructions carefully before testing. Please return all reagents to room temperature, and the test should be carried out at room temperature.

1. Sample treatment (see Figure 3).

(1) Insert the sample swab into the sample buffer, and rotate it close to the inner wall for about 10 times, so that the sample can be dissolved 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 the treated sample extract into the sample hole of the test card, and then 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) should be re-inspected.

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

3. Positive results: Two red bands of detection line (T line) and quality control line (C line) were colored.

Figure 5 Interpretation of test results

Limitation of Test Method

1. This product is a qualitative test, which is only used to assist in in vitro diagnosis.

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

3. If there is no sputum specimen in patients, nasopharyngeal swab specimens should be used for testing.

4. Ensure to add appropriate amount of samples for testing. Too much or too little sample may 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. The final diagnosis of the disease should be made after comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

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

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

2.1 Qualified rate of positive reference materials: P1-P5 of enterprise positive reference materials are positive.

2.2 Qualified rate of negative reference materials: all the negative reference materials N1-N10 of enterprises are tested negative.

2.3 detection limit: the reference products L1-L3 and L1 are negative, and L2 and L3 are positive.

2.4 Reproducibility: J1 and J2 were tested, and they were positive 10 times each.

3. Cross-reaction: Add the following microorganisms and viruses to the samples with specified concentrations to evaluate their potential interference to the 2019-nCoV Ag detection program. Viruses.

4. disruptor: Evaluate the potential interference to the test items of 2019-nCoV Ag, and add the following drugs at the indicated concentration. The results showed that all kinds of drugs did not interfere with the detection results of this reagent.

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

6. Clinical research: Using RT-PCR detection reagent as contrast reagent, saliva and sputum samples were evaluated respectively. 120 positive and 120 negative samples were selected from each sample size (RT-PCR detection), and secondary detection of xiu reagent was used. 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. Operate in strict accordance with the reagent instructions and read the instructions carefully before the experiment.

4. Avoid conducting experiments under severe 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 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

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Tel:+86-371-55016575

Email:zosbio@zosbio.com

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