2019-NCoV Saliva / Sputum Ag Rapid Test Kit Usage Manual Rubber Sheet

Sample Requirements

(1) Saliva sampling: do not eat or drink chewing gum or cigarette products within 30 minutes after saliva sampling. Place the tip of the tongue on the mouth lid to collect the roots of saliva. Place a disposable disinfecting swab under the saliva sample. Use the tip of your tongue for at least 10 seconds, soaking it completely in saliva and rotating it more than 5 times. (See Table 1)
Note: Saliva samples were collected incorrectly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum collection: wash the sputum with water, put the sputum into the test bag, and wipe the sputum with a disposable sterile cotton stick. (Refer to Figure 2)
(3) Sample processing: Use the sample buffer storage contained in the supporting components to process the collected samples (samples that are not immediately discarded must be stored in a dry and germicidal sealed container). 2-8 degrees Celsius to 24 hours, above 70 degrees Celsius (however, please avoid repeated freezing and thawing).

Test Method

Please read the instructions carefully before the test. All reagents are returned to room temperature and tested at room temperature.
Processing example (see Figure 3).
(1) Insert the sample exchanger into the sample buffer memory, rotate it around the inner wall for about 10 times, and dissolve the sample in solution as much as possible.
(2) Press the casing head along the inner wall to make the liquid flow into the pipe, remove the casing and discard it.
(3) Cover with small water drops.

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 well of the test card and start timing.
(3) Read the card for 15 minutes at room temperature, 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 intended only to support INVitro diagnostics.
2. This product is suitable for saliva and sputum samples. Other types of samples may be incorrect or invalid.
3. In the absence of sputum samples, patients should be examined with a nasopharyngeal swan.
4. Please add a suitable amount of samples for testing. Or, if there are too many samples, the results may be incorrect.
5. The test results of the reagent are for clinical reference only, and should not be used as the sole basis for clinical diagnosis and treatment. The combined evaluation of all clinical and examination results leads to a definitive diagnosis of the disease.

Product Performance Indicators

1. Detection limits: Inactive SARS-CCOV-2 virus cultures were used in this study. The minimum detection limit is 610TCID50 / mL.
2. The company's standard materials shall be used in the examination, and the test results shall meet the requirements of the company's standard materials.
2.1 Qualification rate of active management: p1-P5.
2.2 Negative control pass rate: N1-N10 Negative control test is negative.
2.3 Test limit: please refer to L1-L3. L1 is negative, L2 and L3 are positive.
2.4 Reproducibility: J1 and J2 are positive 10 times.
3 cross-reactivity: The following microorganisms and viruses were injected into the sample at specific concentrations to evaluate potential interference with the 2019 new corona virus antigen detection program.
4. Interference: the 2019nCoV Ag detection step evaluates potential interference and adds the following agents at specified concentrations. The results show that various drugs do not interfere with the result of reagent detection.
5. Hook effect: There is no hook effect within the high concentration range of 1.0106 TCID50/mL.
6. Clinical studies: The RT-PLR sputum reagent was used as a control reagent to detect saliva and sputum samples separately. For each sample size (RT-PLR test), 120 positive and negative samples were selected for a second test using the XIUS reagent. The findings are summarized below.

Precautions

1. This product is used for INVitro diagnosis.
This product is disposable and can't be reused.
3. Please strictly follow the instructions of reagents. Please read the instructions carefully before the experiment.
4. Do not perform the test under severe environmental conditions (including 84 disinfectants, dust, sodium hypochlorite, acid and alkali, acetaldehyde and other corrosive gases with high concentration). Disinfection of the laboratory must be carried out after the experiment.

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