Coronavirus 2019-NCoV Ag Saliva Test Kit Rapid Test Kit Sample

Sample Requirements

(1) Saliva sample collection: Do not eat or drink, including chewing gum or use tobacco products, 30 minutes before saliva sample collection. The tip of the tongue is pressed against the roof of the tongue to collect saliva from the base of the tongue. Place a sterile disposable cotton swab under the base of the tongue for at least 10 seconds, soak it completely in the saliva, and rotate it more than 5 times. (see picture 1)
NOTE: Improper collection of saliva samples may result in false negative results.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: After rinsing with water, cough up the sputum vigorously, put it into a specimen bag, and wipe the specimen with a disposable sterile cotton swab. (See Figure 2)
(3) Sample processing: The collected sample should be processed with the sample buffer provided by this kit as soon as possible (if it cannot be processed immediately, the sample should be stored in a dry, sterilized and sealed container) for future inspection. 2℃~8℃ should not exceed 24 hours, -70℃ should be stored for a long time (but repeated freezing and thawing should be avoided).

Test Method

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

Test card analysis (as shown in 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. Culture results: 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. The results of different sample types may be inaccurate or invalid.
3. If the patient does not have sputum sample, nasopharynx cotton swab sample should be used for examination.
4. Confirm whether the sample to be tested is added appropriately. Too many or too few samples can lead to incorrect results.
5. The test results of the reagent can only be used for clinical reference, not the only basis for clinical diagnosis and treatment. Only after the final clinical diagnosis and comprehensive evaluation of all diseases are issued.

Product Performance Indicators

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1. Detection limit: In this study, sars-cov-2 inactivated cultures were used, and the minimum detection limit of the kit was 6 × 102TCID50/mL.
2. Use enterprise reference materials for testing, and the test results should meet the requirements of enterprise reference materials.
2.1 Qualification rate of positive control samples: The positive control samples p1-p5 of the enterprise are positive.
2.2 Qualified rate of negative control substance: The negative control substance n1-n10 of the enterprise shall be detected as negative.
2.3 Detection limit: The minimum detection limit of the testing enterprise is L1-L3, L1 is negative, and L2 and L3 are positive.
2.4 Reproducibility: The duplicate standards J1 and J2 of the enterprise were tested and both were positive 10 times.
3. Cross-reaction: Add the following concentrations of microorganisms and viruses to the samples at the specified concentrations to evaluate their potential interference to the 2019 ncov Ag test items. The results show that the method has no cross-reaction and is 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: use inactivated 2019 ncov culture × 1.0 detection, no hook effect in the high concentration range of 106tcid50 / ml.
The kit is used to collect 2019 New Coronavirus antigen from human saliva / sputum specimens for qualitative detection.
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 symptoms such as stuffy nose and runny nose. Critical cases usually develop dyspnea and / or hypoxemia after one week. Severe cases can rapidly develop into acute respiratory distress syndrome, septic shock, uncorrectable metabolic acidosis and coagulation dysfunction.
The side stream immunoassay was used to detect the 2019 New Coronavirus antigen in saliva / sputum samples from 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 medical 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 pathogen detected may not be the exact cause of the disease. Negative results should not exclude New Coronavirus infection in 2019, nor should it be used 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 past history of the patient, and whether there are clinical signs and symptoms consistent with the 2019 New Coronavirus disease.
6. Clinical study: RT-PCR detection reagent was used as comparison reagent to evaluate saliva and sputum samples respectively. 120 positive and 120 negative samples (RT-PCR) were selected for each sample size and tested with Zhongxiu reagent. The results are summarized as follows:

Precautions

1. This product is for in vitro diagnostic use only.
2. This product is a one-time product and cannot be recycled.
3. Read the instructions carefully before operation, and conduct experimental operations in strict accordance with the reagent instructions.
4. Avoid conducting experiments under harsh environmental conditions (including 84 disinfectant, sodium hypochlorite, acid-base, acetaldehyde and other environments with high concentrations of corrosive gases, dust, etc.). After the experiment, the laboratory should be disinfected.
5. All samples and reagents used should be considered potentially infectious and handled in accordance with local regulations.
6. Reagents should be used within the expiry date and marked on the outer packaging. Test cards should be removed from the foil bag as soon as possible after removal 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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