Sample Requirements
(1) Saliva sample collection: Do not eat or drink chewing gum or cigarette products within 30 minutes after saliva sample collection. Place your tongue on the lid of your mouth to collect saliva roots. Place a disposable sterile swab under your saliva. Sample: Use tongue for at least 10 seconds, immerse completely in saliva, rotate 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: wash the sputum with water, put the sputum into the test bag after coughing, and wipe the sputum with disposable sterile cotton swabs (refer to Figure 2).
(3) Sample processing: Collected samples must be processed with the sample buffer storage contained in the toolbox (samples not immediately processed must be stored in a dry and germicidal sealed container). 2-8 degrees Celsius to 24 hours, -70 degrees Celsius (but please avoid repeated freezing and thawing).
Test Method
Please read the instructions carefully before the exam. All reagents are returned to room temperature, and tests must be performed at room temperature.
Processing example (see Figure 3).
(1) Insert the sample exchanger into the sample buffer storage, the sample rotates around the inner wall for about 10 times, and the sample is soluble in solution as far as possible.
(2) Press the front end of the cotton stick along the inner wall, pour the liquid into the tube, remove the cotton stick and discard it.
(3) Cover with 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 (about 80L) of the processed sample extract into the sample hole of the test card to start the timer.
(3) Read the card for 15 minutes at room temperature, and the result is invalid after 20 minutes.
Interpretation of Test Results
Test card description (refer to Figure 5) :
1. Results: The quality management line (line C) needs to be checked again.
2. Negative results: Quality control line (C line), red ribbon and coloring.
3. Positive results: The test line (T line) and the quality management line (C line) have two red stripes.
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. Results of other sample types may be inaccurate or invalid.
3. In the absence of sputum samples, patients should be examined with a nasopharyngeal swan.
4. Confirm that the appropriate number of additional test samples has been added. With too many or too many samples, the results may be incorrect.
5. The test results of the reagent are only for clinical reference, and should not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease was made after a comprehensive evaluation of all clinical and examination results.
Product Performance Indicators
1. Detection limits: Inactivated SARS-COV-2 virus cultures were used in this study. The minimum detection limit is 612tcid50/ml.
2. Use the company's standard materials for testing, and the test results must meet the requirements of the company's standard materials.
2.1 Qualification rate of positive control: the enterprise actively controls P1-P5.
2.2 Pass rate of negative control: The company's N1-N10 negative control test is negative.
2.3 Detection limit: refer to L1-L3, L1 is negative, L2 and L3 are positive.
2.4 Reproducibility: BOTH J1 and J2 were 10 times positive.
3. Cross-reactivity: To assess potential interference with the 2019 corona virus and antigen detection program, the following microorganisms and viruses were injected into the sample at the concentrations shown.
4. Interference: To evaluate potential interference in the 2019-NCOV Ag test procedure, add the following agents at the specified concentration. The results showed that the various drugs did not interfere with the test results of the reagent.
5. Hook effect: In the high concentration range of 1.0106 TCID50/mL, no hook effect was observed in 2019-NCOV inactive culture.
6. Clinical study: RT-PLR sputum reagent was used as a comparative reagent to detect saliva samples and sputum samples separately. For each sample size (RT-PLR test), 120 positive and negative samples were selected and XIUS reagent was used. The results are 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 reagent instructions 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). It needs to be disinfected in the laboratory after the experiment.
Company profile
Zhongxiu Science And Technology Co.,Ltd., is a high-tech enterprise engaged in the research and development, production and operation of in vitro diagnostic products. The in vitro diagnostic products developed by the company cover POCT series, microbial series, biochemical series and immune series reagents and supporting instruments.
The company has always adhered to the core concept of "fast and accurate, living up to life", committed to providing society with excellent products and services, and contributing to the cause of human health.
