Sample Requirements

(1) Saliva sample collection: Do not eat or drink, including chewing gum or tobacco products, 30 minutes before saliva sample collection. Press the tip of your tongue against your upper jaw and collect saliva at the base of your tongue. Place a sterile disposable cotton swab under the base of your tongue for at least 10 seconds, immerse it completely in saliva and rotate it more than five 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 rinsing with water, cough up sputum and put it into the specimen bag. Wipe the specimen with a disposable sterile cotton swab. (See Figure 2)

(3) Sample processing: The collected samples should be treated with sample buffer solution provided by the kit as soon as possible (if not immediately treated, the samples should be stored in a dry, sterilized, tightly sealed container) and stored for inspection. 2℃ ~ 8℃ for no more than 24h, long-term storage at -70℃ (but avoid repeated freeze-thaw).

Test Method

Please read the instructions carefully before taking the test. Please put all reagents back to room temperature before test, test should be carried out at room temperature.

1. Sample processing (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 can be dissolved in the solution as much as possible.

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

(3) Cover the dropper.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test procedure (see Figure 4)

(1) Take out the test card.

(2) Add 2 drops of the processed sample extract (about 80μL) to the adding well of the test card, and then start the timer.

(3) The card is placed at room temperature for 15 minutes to read the results. The results were invalid after 20 minutes.

Interpretation of Test Results

Test card interpretation (see Figure 5) :

1. Invalid result: The quality control line (LINE C) without reaction line is invalid and needs to be tested again.

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

3. Positive results: Two red strips 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 a sputum sample from the patient is not available, a nasopharyngeal swab sample should be used for testing.

4. Make sure to add the right amount of samples for testing. Too many or too few 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 sole 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: Inactivated SARS-COV-2 virus culture was used in this study, and the minimum detection limit of the kit was 6×102TCID50/mL.

2. Use the reference product of the enterprise for testing, and the result should meet the requirements of the reference product of the enterprise.

2.1 Qualification rate of positive control substance: P1-P5 positive control substance of the enterprise were all tested positive.

2.2 Qualified rate of negative control substance: Negative control substance N1-N10 of the enterprise was tested negative.

2.3 Limit of detection: The minimum limit of reference materials for detection enterprises is L1-L3, L1 is negative, L2 and L3 are positive.

2.4 Reproducibility: J1 and J2 were both positive for 10 times of repeated reference.

3. Cross-reaction: The following concentrations of microorganisms and viruses are added to the sample in accordance with the specified concentration to evaluate their potential interference to the 2019-NCOV Ag test item. The results showed that there was no cross reaction and no interference from various microorganisms and viruses.

5. Hook effect: no hook effect was observed in the concentration range of 1.0×106TCID50/mL by inactivated 2019-ncov culture.

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

Precautions

1. This product is only used for in vitro diagnosis.

2, this product is a disposable product, can not be recycled.

3. Read the instructions carefully before operation, and perform experimental operations in strict accordance with the reagent instructions.

4, avoid in harsh environmental conditions (containing 84 disinfectant, sodium hypochlorite, acid and alkali or acetaldehyde and other high concentration of corrosive gas, dust and other environment). Laboratory disinfection should be carried out after the experiment.

5. All samples and used reagents should be treated as potentially infectious substances and disposed of in accordance with local regulations.

6. Reagents should be used within the validity period marked on the outer package. The test card should be used as soon as possible after it is removed from 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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