(1) Specimen testing
After the laboratory receives the sample in the virus sampling tube, it should be tested immediately. Before the test, perform sufficient shaking and elution, and then perform nucleic acid extraction and amplification experiments. It is recommended to use an open reading frame lab (ORFlab) for the new coronavirus. And nucleocapsid protein (nucleocapsid protein, N) gene region reagents. If a nucleic acid extractor is used, the nucleic acid extraction reagent should be used in conjunction with the nucleic acid extractor. The amplification kit should be a kit with a registration number approved by the National Medical Products Administration. It is recommended to choose a detection kit with low detection limit and high sensitivity.
(2) Testing quality control
Each batch of testing has at least 1 weak positive quality control product (third-party quality control product, usually about 3 times the detection limit), 2 negative control products (the kit comes with negative control products) and 1 blank Reference substance (normal saline or diethyl pyrocarbonate treated water). The blank reference substance should be opened and placed on the extractor or operating table overnight for environmental pollution assessment. The quality control substance is randomly placed in clinical specimens to participate in the extraction. The whole process of amplification.
(3) Quality control results
Weakly positive quality control products are determined to be positive, and negative quality control products are all tested to be negative, and they are deemed to be in control. Otherwise, it is out of control and a test report should not be issued. The cause should be analyzed immediately, and the specimen in the disposable virus sampling tube should be re-tested if necessary .
