2019-NCoV Saliva Sputum Ag Rapid Test Kit Immunochromatography Usage Manual

Sample Requirements

(1) Collection of saliva samples: Do not eat or drink 30 minutes before collecting saliva samples, including chewing gum or using tobacco products. Press the tongue tip against upper jaw, and collect saliva at the root of tongue. Put a sterile disposable swab under the root of tongue for at least 10 seconds, soak it completely in saliva and rotate more than 5 times. (See Figure 1)

Note: False negative results may have if the saliva sample is not collected properly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum sample collection: After rinsing with clean water, cough up sputum forcefully into sample bag, and wipe sample with sterile disposable swab. (see Figure 2)

(3) Sample processing: The collected sample should be processed as soon as possible with the sample buffer provided by this kit (if it cannot be processed immediately, the sample should be stored in a dry, sterilized and strictly sealed container), stored for no more than 24h at 2℃～8℃, and kept for a long time at -70℃ (but avoid repeated freezing and thawing).

Test Method

Read the instructions carefully before testing. Please return all reagents to room temperature before testing, and the test should be performed at room temperature.

1. Sample processing (see Figure 3)

(1) Insert the sampled swab into the sample buffer, and rotate it close to the inner wall about 10 times to dissolve the sample in the solution as much as possible.

(2) Squeeze the swab tip along the inner wall of tube to keep the liquid flow into the tube as much as possible, remove and discard the swab.

(3) Cover the dripper.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test procedure (see Figure 4)

(1) Take out the test card.

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

(3) Read the results when the card is placed at room temperature for 15 minutes. The result is invalid after 20 minutes.

Interpretation of Test Results

Interpretation of test card (see Figure 5):

1. Invalid result: It is invalid with no reaction line on the quality control line (C line ), so the test should be taken again.

2. Negative result: The quality control line (C line), a red color band, is colored.

3. Positive result: Two red bands, the test line (T line) and the quality control line (C line), are both colored.

Figure 5 Interpretation of test results

Limitation of Test Method

1. This product is for qualitative detection and is only used for in vitro auxiliary diagnosis.

2. This product is applicable to saliva and sputum samples. Other sample types may have inaccurate or invalid results.

3. If a sputum sample is not available from the patient, a nasopharyngeal swab sample should be used for test.

4. Make sure to add an appropriate amount of sample for test. Too much or too little sample volume may result in 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. Test limit: This study uses inactivated SARS-CoV-2 virus culture, and the minimum test limit of the kit is 6×10²TCID₅₀/mL.

2. Use corporate reference products for test, and the results should meet the requirements of corporate reference products.

2.1 Conformity rate of positive reference products: The corporate positive reference products P1-P5 shall all be positive for the test.

2.2 Conformity rate of negative reference products: The corporate negative reference products N1-N10 shall all be negative for the test.

2.3 Test limit: Corporate minimum test limit reference products L1-L3 are detected, L1 should be negative, L2 and L3 should be positive.

2.4 Reproducibility: Corporate repeated reference products J1 and J2 are detected, and shall all be positive for 10 times of respective detection.

3. Cross reaction: The following concentrations of microorganisms and viruses were added to the samples at the specified concentrations to evaluate their potential interference in 2019-nCoV Ag test project. The results showed no cross reactions, and were not be interfered by various microorganisms and viruses.

5. Hook effect: No hook effect was observed in detecting high concentration range of 1.0×10⁶TCID₅₀/mL with inactivated 2019-nCoV culture.

6. Clinical research: RT-PCR detection reagents were used as contrast reagents to evaluate saliva and sputum samples individually. 120 positive and 120 negative samples (detected by RT-PCR) were selected for each sample size and detected with Zhongxiu test reagent. The results were summarized as follows:

Precautions

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

2. This product is disposable, which can not be recycled and reused.

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

4. Avoid conducting experiments in bad environmental conditions (the environments containing 84 disinfectant, sodium hypochlorite, high-concentration corrosive gases such as acid and alkali or acetaldehyde, and dust) . Laboratory disinfection should be carried out after the experiment.

5. All samples and used reagents should be regarded 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 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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