(1) Specimen detection.
Upon receipt of the sample in the disposable virus sampling tube, the laboratory should immediately perform the assay and elution, then shake the elution sufficiently before performing nucleic acid extraction and amplification experiments. Open reading frame lab (ORFlab) and nuclei are recommended for novel coronaviruses. reagents for the nucleocapsid protein (N) gene region. 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 approved by the State Drug Administration and have a registration number. It is recommended to choose a detection kit with low detection limit and high sensitivity
(2) Quality control of the assay.
Each batch of assay should have at least 1 weakly positive QC (third-party QC, usually about 3 times the detection limit), 2 negative controls (kits come with negative controls) and 1 blank control (normal saline or ethyl pyrocarbonate-treated water). Blank controls should be placed open on an extractor or table overnight for environmental contamination evaluation. The quality control substance is randomly placed in the clinical specimen and is involved in the extraction to amplification. The whole process of addition.
(3) Quality control results.
Weakly positive QCs are judged to be positive, and all negative QCs are tested negative. If it is considered to be in control, it is out of control. A test report may be issued. The cause should be analyzed immediately and the specimen in the disposable virus sampling tube should be retested if necessary.
