China News Service, June 9th. Li Jinming, deputy director of the National Health and Medical Commission's Clinical Laboratory Center, said on the 9th that if ten samples are mixed together, they will be mixed with three samples and five samples after they arrive in the laboratory, and they will become thirty samples. Putting one sample together and fifty samples together will dilute the sample to a certain extent. It cannot be proved whether the detection rate of this mixed sample is different from that of the single sample book, so there is a risk of positive missed detection.
On the 9th, the Joint Prevention and Control Mechanism of the State Council held a press conference on nucleic acid testing and epidemic prevention and control.
At the meeting, a reporter asked a question that it was mentioned in the previous report that several testing institutions mixed five nucleic acid samples and ten mixed nucleic acid samples for testing by multi-tube mixed testing, and artificially diluted the samples.
How to judge this operation?
How will regulation be strengthened in the future?
Li Jinming said that mixed sampling is to put five sampling swabs, ten sampling swabs, and twenty sampling swabs in one sampling tube. The on-site verification of patient samples shows that there is no significant difference in the detection rate of mixed sampling and single sampling, and the detection is accurate and reliable.
However, if the laboratory mixes ten samples and then mixes three samples and five samples when they arrive in the laboratory, it will become thirty samples combined and fifty samples combined. A certain degree of dilution, which has not been verified by the laboratory and has not been verified by the actual field of clinical samples, cannot prove whether the detection rate of this mixed sample is different from that of the single-sampled version.
So there is a risk of a positive missed test.
In response to the issue of strengthening supervision, Li Ang, deputy director of the Beijing Municipal Health and Health Commission, said that during the supervision and inspection process in Beijing some time ago, it was found that individual nucleic acid testing institutions illegally conducted mixed-tube testing of multiple samples during the testing process. This practice is artificial. The sample is diluted, which violates the relevant regulations on quality and safety, increases the risk of missed detection and the chance of contamination, affects the accuracy of the test results, and interferes with the overall situation of epidemic prevention and control.
Li Ang pointed out that he always adheres to "zero tolerance" for such violations of laws and regulations, and finds one and investigates one.
The institution involved has been suspended from practice, and the illegal behavior of the relevant personnel has been handed over to the public security organ for investigation.
Beijing has always put the quality and safety of nucleic acid testing in the first place, and departments have coordinated and taken multiple measures to strengthen the supervision of nucleic acid testing institutions.
The first is to ensure good access.
The health departments at the two levels in the urban area of Beijing shall strictly manage the access management of nucleic acid testing institutions in accordance with relevant standards. For testing institutions that have passed the preliminary examination of the local health and health department, the municipal level shall organize experts in biosafety inspection and quality control to conduct on-site inspection and acceptance. Nucleic acid testing is only allowed after passing the test.
The second is to strengthen normalized quality control management.
The Beijing Medical Inspection Quality Control Center and the Municipal Clinical Inspection Center organize monthly inter-laboratory quality assessments for all nucleic acid testing institutions in the city, and issue blind samples for assessment. Recheck.
The third is to establish a third-party evaluation mechanism.
According to the requirements of relevant national work, a monthly audit system for third-party nucleic acid testing institutions has also been established. Experts are organized by each district to review the legal practice and nucleic acid testing quality of all third-party laboratories in the jurisdiction on a monthly basis. The list of institutions will be published.
At the same time, through the organization of unannounced inspections, quality random inspections, etc., to strengthen institutional quality management, comprehensively use a variety of supervision methods, strictly control the quality of nucleic acid testing, and ensure the health and safety of the people.
The Beijing Working Group of the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council has also organized experts and compiled a detailed list of laboratory inspection operations for daily supervision and inspection.