Coronavirus 2019-NCoV Ag Saliva Test Kit Rapid Sputum Test Kit Program

Sample Requirements

(1) Collect saliva samples: do not drink water, drink water, smoke or contain chewing gum 30 minutes before collecting saliva samples. Put the root of the tongue on the root of the tongue, put the sterilized disposable cotton swab under the root of the tongue for more than 10 seconds, completely soak it in saliva and rotate it for more than 5 times. (see Figure 1)
Note: if saliva samples are not collected correctly, stomach negative results may occur.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Collect sputum samples: after washing with clean water, spit into the sample bag and wipe the sample with a disposable sterile cotton swab. (see Figure 2)
(3) Sample treatment: the collected sample shall be treated with the sample buffer provided by the kit as soon as possible (if it cannot be treated immediately, the sample shall be stored in a dry, sterilized and sealed container for future detection). 2 ℃ ~ 8 ℃ shall not exceed 24h, and it shall be stored at - 70 ℃ for a long time (but avoid repeated freezing and thawing).

Test Method

Please read the guide carefully before testing. Please restore all reagents to room temperature before testing. The test must be carried out at room temperature.
1. Sample processing (see Figure 3)
(1) Take the cotton swab for examination and put it into the buffer solution of the examination body. Rotate it near the inner wall for about 10 times to make the examination body dissolve in the solution as much as possible.
(2) Twist the tip of the cotton swab along the tube wall to make the liquid enter the tube to the maximum extent, and then extract and discard the cotton swab.
(3) Overlay buffer.

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) put it into the sampling hole of the test card and start the timer.
Place the card at room temperature for 15 minutes and read the results. After 20 minutes, the result failed.

Interpretation of Test Results

Analysis of test card (see Figure 5):
1. Invalid result: the quality management line (line C) does not respond, the line is invalid, and it needs to be retested.
2. Negative results: quality management line (line C), red ribbon, coloring.
3. Positive result: the two red bands of test line (t line) and quality management 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. The product is suitable for saliva and sputum samples. Other sample types may be incorrect or have wrong results.
3. If the patient does not have sputum sample, nasopharynx cotton swab sample should be used for examination.
4. Ensure that an appropriate number of samples are added for testing. If there are too many or too few samples, incorrect results may be produced.
5. The test results of the reagent can only be used for clinical reference, not the only basis for clinical diagnosis and treatment. The final diagnosis of the disease can only be made after a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

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1. Detection limit: in this study, inactive sars-cov-2 virus medium was used, and the minimum detection limit was 6 × 102TCID50/mL.
2. Enterprise reference materials are used for testing, and the results must meet the requirements of enterprise reference materials.
2.1 qualification rate of positive control samples: p1-p5 of positive control samples of enterprises are tested as positive.
2.2 qualification proportion of negative control samples: the negative control samples n1-n10 of the enterprise have been tested as negative.
2.3 detection limit: the minimum detection limit of the detection enterprise is L1-L3, L1 is negative, L2 and L3 are positive.
2.4 reproducibility: the repeated reference substances J1 and J2 of the enterprise are detected and positive for 10 times respectively.
3. Cross reaction: according to the specified concentration, add the following concentrations of microorganisms and viruses to the sample to evaluate the potential interference to the 2019 ncov Ag test project. The results showed that there was no cross reaction and was not disturbed by a variety of microorganisms and viruses.

4.Interfering substances: in the 2019 ncov Ag test project, in order to evaluate potential interference, the following concentrations of drugs have been added to the samples with specified concentrations. The results showed that all types of drugs did not affect the test results.

5. Hooke effect: inactive 2019 ncov culture detected 1.0 × High concentration Hooke effect of 106tcid50 / ml.
The kit was used for qualitative detection of ncov Ag in 2019 and was extracted from human saliva / sputum samples.
2019 ncov is a new type β- COV. Can cause viral pneumonia. The main clinical symptoms are fever, fatigue, dry cough and so on. Some patients have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Fatal cases usually develop dyspnea and / or hypoxemia after one week. In severe cases, acute dyspnea syndrome, septic shock, uncorrectable metabolic acidosis and coagulation dysfunction develop rapidly.
The 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 and sputum samples. The positive results showed the presence of virus antigen, but the clinical correlation between patient history and other diagnostic information was also a necessary condition to determine the infection. Positive results cannot exclude bacterial infection or co infection with other viruses. The pathogen detected may not be the exact cause of the disease. The possibility of infection management decision (ncov) can not be excluded as the basis of infection management decision in 2019. If it is negative, the final contact force and history of the patient will be determined, together with the clinical signs and symptoms of COVID-19 infection (covid - 19) in 2019.
6. Clinical study: use RT-PCR detection reagent as comparison reagent to detect saliva and sputum samples respectively. We selected 120 positive samples and 120 negative samples (RT-PCR), the size of each sample, and then detected it with Zhongxiu reagent. The result is this.
guide

1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be reused.
3. Please read the experiment guide carefully before starting and carry out the experiment according to the reagent guide.
4. Avoid conducting experiments under harsh environmental conditions (including disinfectant, sodium hypochlorite, acid alkali, acetaldehyde and other high concentration corrosive gases, dust and other environments). The laboratory should be disinfected after the experiment.
5. All samples and used reagents should be considered as potential infectious substances and treated in accordance with local regulations.
6. The reagent must be used within the validity period indicated on the outer package. The test card shall be taken out of the aluminum foil bag to prevent moisture, and then used as soon as possible.

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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