Sample Requirements

(1) Saliva sample collection: do not eat or drink water, including chewing gum or use tobacco products 30 minutes before saliva sample collection. Put the tip of the tongue against the upper jaw and collect saliva at the root of the tongue. Place the sterile disposable 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: false negative results may occur 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 washing with clean water, cough up sputum forcefully, 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 by this kit as soon as possible (if they cannot be treated immediately, the samples shall be stored in dry, sterilized and strictly sealed containers) for future inspection. 2 ℃ ~ 8 ℃ shall not exceed 24h, and - 70 ℃ shall be stored for a long time (but repeated freezing and thawing shall be avoided).

Test Method

Please read the instructions carefully before testing. Please put all reagents back to room temperature before the test. The test shall be carried out at room temperature.
1. Sample processing (see Figure 3)
(1) Insert the sampling swab into the sample buffer and rotate it close to the inner wall for about 10 times to make the sample dissolve in the solution as much as possible.
(2) Squeeze the tip of the swab along the inner wall of the tube to make the liquid flow into the tube as much as possible, and take out and discard the swab.
(3) Cover the dripper.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test procedure (see Figure 4)
(1) Remove the test card.
(2) Extract 2 drops (about 80%) of the treated sample μ 50) Add it to the sampling hole of the test card, and then start the timer.
(3) Place the card at room temperature for 15 minutes to read the results. The result is invalid after 20 minutes.

Interpretation of Test Results

Interpretation of test card (see Figure 5):
1. Invalid result: the quality control line (line C) has no response, and the line is invalid, so it needs to be retested.
2. Negative results: quality control line (line C), red ribbon, coloring.
3. Positive results: the two red bands of test line (t line) and quality control line (C line) are colored.

Figure 5 Interpretation of test results

Limitation of Test Method

1. This product is a qualitative test and is only used for in vitro auxiliary diagnosis.
2. This product is suitable for saliva and sputum samples. Other sample types may have inaccurate or invalid results.
3. If there is no sputum sample from the patient, a nasopharyngeal swab sample should be used for testing.
4. Ensure that an appropriate amount of sample is added for testing. Too much or too little sample may lead to inaccurate results.
5. The test results of this reagent are only for clinical reference and 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 evaluation of all clinical and laboratory results.

Product Performance Indicators

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1. Detection limit: the inactivated sars-cov-2 virus culture was used in this study, and the minimum detection limit of the kit was 6 × 102TCID50/mL.
2. The enterprise reference material is used for testing, and the results shall meet the requirements of the enterprise reference material.
2.1 qualification rate of positive control samples: p1-p5 of the enterprise's positive control samples were tested as positive.
2.2 qualification rate of negative control samples: the negative control samples n1-n10 of the enterprise were tested as negative.
2.3 detection limit: the minimum detection limit of the testing enterprise is L1-L3, L1 is negative, L2 and L3 are positive.
2.4 reproducibility: the repeated reference materials J1 and J2 of the enterprise were detected, and they were positive for 10 times each.
3. Cross reaction: add the following concentrations of microorganisms and viruses to the sample according to the specified concentration to evaluate their potential interference to the 2019 ncov Ag test project. The results showed that there was no cross reaction and was not disturbed by various microorganisms and viruses.

4. Interfering substances: The following concentrations of drugs were added to the samples at the specified concentrations to evaluate their potential interference in 2019-nCoV Ag test project. The results showed that all kinds of drugs did not interfere with the test results of this reagent.

5. Hook effect: detect 1.0 with inactivated 2019 ncov culture × No hook effect was observed in the high concentration range of 106tcid50 / ml.
The kit is used for qualitative detection of 2019 ncov Ag collected from human saliva / sputum samples.
2019 ncov is a new type of β- COV. Can cause viral pneumonia. The main clinical manifestations were fever, fatigue, dry cough and so on. A few patients have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critical cases usually develop dyspnea and / or hypoxemia after one week. Severe cases will rapidly develop into acute respiratory distress syndrome, septic shock, uncorrectable metabolic acidosis and coagulation dysfunction.
This product uses side flow immunoassay to detect 2019 ncov Ag in saliva / sputum samples of suspected patients. In the acute phase of infection, antigens are usually detected in saliva / sputum samples. Positive results indicate the presence of viral antigens, but the clinical relevance of patient history and other diagnostic information is also a necessary condition for determining the status of infection. Positive results cannot exclude bacterial infection or co infection with other viruses. The detected pathogen may not be the exact cause of the disease. Negative results cannot exclude ncov infection in 2019 and should not be used only as a basis for treatment or patient management decisions (including infection control decisions). If the result is negative, the final decision will be made according to the recent contact history and history of the patient and whether there are clinical signs and symptoms consistent with the 2019 New Coronavirus.

6. Clinical study: RT-PCR detection reagent was used as comparison reagent to evaluate saliva and sputum samples respectively. 120 positive samples and 120 negative samples (RT-PCR) were selected for each sample size and detected with Zhongxiu reagent. The results are summarized as follows:

Precautions

1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be recycled.
3. Read the instructions carefully before operation and carry out the experimental operation in strict accordance with the reagent instructions.
4. Avoid experiments under harsh environmental conditions (including 84 disinfectant, sodium hypochlorite, acid-base, acetaldehyde and other corrosive gases with high concentration, dust and other environments). After the experiment, the laboratory should be disinfected.
5. All samples and used reagents shall be regarded as potentially infectious substances and treated in accordance with local regulations.
6. The reagent shall be used within the validity period marked on the outer package. The test card shall 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.

Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

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