2019-NCoV Ag Rapid Saliva Sputum Test Usage Manual Room Temperature

Sample Requirements

(1) Saliva sampling: do not eat chewing gum or cigarette products within 30 minutes after saliva sampling. Place your tongue on the mouth lid to collect the roots of saliva. Place a disposable disinfecting swab under the saliva sample. The tip of the tongue should be applied for 10 seconds or more, fully immersed in saliva, and rotated 5 times or more. (See Table 1)
Note: Saliva sample is not collected correctly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum collection: rinse the sputum with clean water, cough continuously, put the sputum into the test bag, and wipe the sample with a disposable germicidal cotton stick. (Refer to Figure 2)
(3) Sample processing: Collected samples are processed by the sample buffer memory provided by the supporting component (samples not immediately processed must be stored in a dry and germicidal sealed container). 2-8 degrees Celsius to 24 hours, longer than 70 degrees Celsius (however, please avoid repeated freezing and thawing).

Test Method

Please read the instructions carefully before the exam. All reagents will be returned to room temperature for testing.
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 far as possible.
(2) Press down the casing head along the inner wall, the liquid flows into the pipe, and the casing is removed and discarded.
(3) Cover with small water drops.

Figure 3 Sample processing

Figure 4 Test procedure

2. The test process (see Figure 4).
(1) Remove the test card.
(2) Add 2 drops (about 80L) of the processed sample extract into 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 only used for qualitative testing as an aid to INVitro diagnosis.
2. This product is suitable for saliva and sputum samples. Other types of samples may be incorrect or invalid.
3. Patients who do not have sputum samples should be examined using nasopharyngeal swans.
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 diagnosis was made after a comprehensive evaluation of all clinical and examination results.

Product Performance Indicators

1. Detection limits: Inactive SARS-COV-2 virus cultures were used in this study. The detection limit was 610TCID50 / mL.
2. The test must use the company's standard materials, and the test results must meet the requirements of the company's standard materials.
2.1 Qualification rate of positive control: P1-P5 of positive control of enterprises.
2.2 Pass rate of negative control: 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 were 10 times positive.
3. Cross-reactivity: Inject samples with the following microorganisms and viruses at specified concentrations to assess potential interference with the new coronavirus antigen testing program in 2019.
4. Interference: To evaluate the potential interference in the 2019-NCOV Ag detection step, add the following agents at the specified concentration. The results showed that all kinds of drugs did not interfere with the results of the reagent.
5. Hook effect: There is no hook effect within the high concentration range of 1.0106 TCID50/mL.
6. Clinical trial: Saliva and sputum samples were detected separately using RT-PPCR sputum reagent as a comparative reagent. 120 positive and negative samples were selected for each sample size (RT-PPCR test), and the second test was performed using XIUS reagent. The research results are summarized as follows.

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 the reagent and read the instructions carefully before the experiment.
4. Do not perform the test under severe environmental conditions (including 84 disinfectant, dust, sodium hypochlorite, acid and alkali, acetaldehyde and other corrosive gases with high concentration). Laboratory disinfection needs to be carried out after the experiment.

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