2019-NCoV Saliva / Sputum Ag Rapid Test Kit Usage Manual Interpretation Validity Period

Sample Requirements

(1) Saliva sample collection: Do not eat or drink gum or tobacco products within 30 minutes after saliva sample collection. Rest the tip of the tongue on the palate to collect the saliva roots. Disposable sterile cotton swabs are placed under a saliva sample. Use the tip of the tongue for at least 10 seconds, completely immersed in saliva, spinning more than 5 times. (See Table 1)
Note: If the saliva sample is taken incorrectly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: rinse with water, cough up phlegm, put it into a specimen bag, and wipe the specimen with a disposable sterile cotton swab. (See Figure 2)
(3) Sample Handling: Handle collected samples using the sample buffer provided in this kit (samples not disposed of immediately should be stored in dry, sterile, and sealed containers). 2-8 degrees Celsius to 24 hours, more than 70 degrees Celsius (but avoid repeated freezing and thawing).

Test Method

Read the instruction manual carefully before testing. Place all reagents back at room temperature and test at room temperature.
Example processing (see Figure 3).
(1) Insert the sample swab into the sample buffer, rotate the sample about 10 times near the inner wall, and dissolve the sample in solution as much as possible.
(2) Press the swab head along the inner wall so that the liquid flows into the pipe, remove the swab and discard.
(3) Cover with small water droplets.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test process (see Figure 4).
(1) Remove the test card.
(2) Add 2 drops (~80L) of treated sample extract to the sample wells of the test card and start timing.
(3) Read the card at room temperature for 15 minutes, and the result is invalid after 20 minutes.

Interpretation of Test Results

Figure 5 Interpretation of test results

Limitation of Test Method

1. This product is a qualitative test and is only used to assist in in vitro diagnosis.
2. This product is suitable for saliva and sputum samples, other types of samples may have inaccurate or invalid sample results.
3. If the patient does not have a sputum sample, a nasopharyngeal swab should be used for testing.
4. Make sure to add an appropriate amount of sample for testing. Or too many 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. A comprehensive evaluation of all clinical and laboratory results resulted in a definitive diagnosis of the disease.

Product Performance Indicators

1. Detection limit: This study used inactivated SARS-COV-2 virus cultures. The minimum detection limit is 6102 tcid50/ml.
2. The test adopts the company's standard materials, and the test results should meet the requirements of the company's standard materials.
2.1 Actively control the pass rate: Enterprises actively control p1-p5.
2.2 Negative control pass rate: Our n1-n10 negative control test was negative.
2.3 Detection limit: refer to L1-L3, L1 is negative, L2 and L3 are positive.
2.4 Reproducibility: J1 and J2 are 10 times positive.
3 Cross-reaction: The following microorganisms and viruses are injected into samples at specific concentrations to evaluate their potential interference with the 2019 novel coronavirus antigen detection procedures.
4. Interference: Evaluate potential interference in the 2019 nCoV Ag detection procedure and add the following drugs at the prescribed concentration. The results show that various drugs do not interfere with the detection results of the reagents.
5. Hook effect: No hook effect in the high concentration range of 1.0106 TCID50/mL.
6. Clinical research: RT-PCR sputum reagent was used as a control reagent to detect saliva and sputum samples respectively. For each sample size (RT-PCR test), 120 positive and negative samples are selected and a second test is performed using XIUS reagents. The findings are summarized below:

Precautions

1. This product is used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Please strictly follow the instructions for reagents, please read the instructions carefully before the experiment.
4. Avoid testing under harsh environmental conditions (including high concentrations of corrosive gases, such as 84 disinfectants, dust, sodium hypochlorite, acid and alkali, acetaldehyde, etc.). Laboratory disinfection should be performed after the end of the experiment.

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