How does the illegal nucleic acid detection agency appear?These verification methods are recruited t

13.06.2022

Number of this text: 3897, the reading time is about 6 minutes older

Introduction: At present, experts in the first financial reporter learned that blind -sample assessment is a regular assessment method in the quality evaluation of inter -room quality testing agencies, not a way of assault inspection.

Author | First Finance Lin Zhiyin Qian Qian Tongxin

In May of this year, three nucleic acid testing agencies in Beijing were investigated for suspected violations. How these problems were discovered, causing the market to be curious.

At the press conference of the State Council ’s joint prevention and control mechanism on June 9, Li Ang, deputy director of the Beijing Municipal Committee of Health and Health, revealed that Beijing was strengthening normalized quality control management. The Moon Organization faces the room quality evaluation of all nucleic acid testing agencies in the city, issues blind samples for assessment. Those who fail to pass the assessment need to stop the testing work.

Therefore, some people speculate that the blind -sample assessment is to secretly plug the sample for random inspections, and the problem agencies investigated and punished in Beijing are related to this way of inspection.

However, this is not the case. At present, experts from the First Financial Reporter learned that blind -sample assessment is a conventional assessment method in the quality assessment of inter -room quality testing agencies in nucleic acid testing agencies, not a way of assault inspection.

Recently, the quality of the detection of new crown nucleic acid has attracted much attention from the market. On June 2nd, the State Council responded to the new type of coronary virus pneumonia. The comprehensive group of the joint prevention and control mechanism of the disease was issued "Notice on Further Strengthening the Supervision of New Coronal Virus Nuclear Nuclear Nucleic acid Detection", and proposed to further increase the supervision of nucleic acid testing.

First Financial reporter learned that some provinces and cities across the country have successively launched special inspections of the new crown virus nucleic acid testing agency.

Blind sample assessment is not secretly plugged samples

At the press conference of the State Council ’s joint prevention and control mechanism on June 9, Li Ang, deputy director of the Beijing Municipal Committee of Health and Health, said that Beijing has always put the quality and safety of nucleic acid testing first. Supervision, one is to take good on to enter the customs, the other is to strengthen normal quality control management, and the third is to establish a third -party evaluation mechanism.

Li Ang said that in terms of strengthening the management of normalized quality control, the North City Medical Inspection and Quality Control Center and the Municipal Clinical Inspection Center organized the room for inter -room quality evaluation of all nucleic acid testing agencies in the city every month. It is necessary to stop the testing work and rectify the rectification before re -examination. In terms of establishing a third -party evaluation mechanism, Beijing also strengthened the quality management of the institution through organizing flight inspections and quality spot checks, comprehensively using multiple supervision methods to strictly check the quality of nucleic acid testing.

In the end, what is a blind -sample assessment?

Several experts told the First Financial reporter that blind -sample assessment is a conventional assessment method in the quality assessment of inter -ventricular quality for nucleic acid testing agencies.

The laboratory director of a nucleic acid testing agency in Guangxi told the First Financial Reporter that during the participation of nucleic acid testing agencies participating in the launch of inter -room quality evaluation work, the clinical inspection center will distribute some samples, generally five or ten, but which are positive which samples are positive. What are negative, the testing agencies involved in the evaluation did not know beforehand. After the test was completed, the results were uploaded and finally compared with the real results. "For example, we will participate in the room quality evaluation of nucleic acid detection agencies carried out every month, but the number of inter -room quality evaluations at the national level may not be so frequent. Certainly."

A public health expert told the First Financial reporter: "The specific operation of the quality evaluation of the room is to send a batch of samples to the test laboratory, which is yin and yang. Whether the results are verified by the Inspection Center correctly and given the corresponding 'qualification certificate'. "

In May this year, the National Health and Health Commission released data that the pass rate of 35,000 sub -nucleic acid testing laboratories reached 99.7%, which means that there are still 105 laboratories unqualified.

"Quality evaluation work in the room can be understood as an open exam for the laboratory, not some of the" sneaky samples 'in the laboratory's detection samples' in the laboratory. " A financial reporter said that the laboratory will definitely do it seriously for the public examination. If it is an unannounced sampling inspection, it may even test the level and ability of the daily operation of the laboratory.

Is it feasible to stuff the sample random check method?

In May of this year, the three problem nucleic acid testing agencies investigated and dealt with in Beijing were Beijing Pushi Medical Inspection Labs Co., Ltd., Beijing Golden League Medical Inspection Lab Co., Ltd., and Beijing Zhongtong Lanbo Medical Inspection Lab. The detection data is significantly less than the number of sample detection, and the latter two are suspected of illegal multi -pipe mixed inspections.

Recently, the Beijing Health and Health Commission has also notified some details of the problems of the problem nucleic acid testing agency.

Specifically, taking the Lanbo Medical Inspection Laboratory of Beijing as an example, the Beijing Municipal Health and Health Commission organized experts to trace the source of the previous negative test results of the positive cases, and found through video inspections and audition of amplification records on the PCR instrument. , Beijing Zhongtong Lanbo Medical Inspection Laboratory's traceability record is incomplete, the recording rules are not clear, and the original paper records of the original specimen and the original paper records of the original specimen. In violation of regulations, the mixing tube detection of multi -pipe samples, the above situation seriously violates the quality and safety regulations, affects the accuracy of the test results, and causes the discovery and control of positive personnel of nucleic acid testing in time, resulting in further risk of the epidemic. From the current point of view, the problem nucleic acid detection agency found in Beijing was mainly discovered during flight inspections. Li Ang said at the press conference of the above -mentioned State Council's joint prevention and control mechanism that since this round of the Beijing epidemic, Beijing has organized a multi -round flight inspection for the quality and safety of the laboratory. In particular, there are false reports on the laboratory. The key inspections were conducted.

According to the First Financial Reporter, in order to ensure the detection quality of the nucleic acid detection laboratory, in addition to the conventional inter -intercourse quality evaluation, the regulatory agency will also adopt the timely "flight inspection" and To check the detection institutions whether the relevant system is implemented, especially whether the measures for quality control are implemented.

A person in the field of testing told the First Financial Reporter: "Flight examination is not notifying the inspection party. If the enterprise violates the rules, through this way of inspection, it will not have a hidden opportunity to the enterprise. "

According to the above -mentioned persons, through the "flight inspection", the content of the expert group inspection covers the records of the original sample and the inspection of on -site items. It requires a complete traceability and results from sampling to labels, sample processing, and experimental processes and results. The evidence chain, if there is a fraudulent situation, it will definitely be discovered. "Even if some companies are not subjective and intentional, they will be held accountable, but they will be held accountable. The technical level of personnel and the grasp of the process are within the scope of the assessment."

Is it feasible for the sampling method of secret samples?

The above -mentioned public health experts told First Financial reporters that regulators in some regions have not heard of this method to conduct random inspections on the laboratory. "The possibility of direct mixing positive samples is not high, because once a positive sample is detected, it will not be easily allowed to be easily allowed to be taken out at will. It is more likely to achieve some target fragments gene plasmid or nucleic acid fragments, although not contagious , But it can be used as a positive control. "

First Financial reporter learned from a large domestic testing agency that they did not know about the random inspections of the "secret sample" of the "secret sample" of the Tingle Inspection Center, and it was unclear whether this method really existed.

A person in charge of a large -scale three -way hospital in Shanghai also told the First Financial Reporter that at present, similar sampling inspections have not been learned from the official channels, and they believe that "the possibility is not great."

Some experts believe that if this method of unannounced visits exist, it can be regarded as a disguised means of quality evaluation in the room. It is not difficult to operate, and it should seem "effective" because it is when the company does not know. It is more "lethal"; but some experts warn that although feasible, they should still pay attention to risk control.

A infectious disease expert who had worked in a large national test laboratory in North America told the First Financial Reporter that the method of "secret samples" was theoretically feasible, but it must be ensured that the operation process was more "controllable" instead of not Just plug in a few positive samples, because this may cause pollution of the overall sample. "In short, one purpose is that the laboratory testing needs standardized operations. Any operations that do not meet the standards, whether it is testing or random inspection, may cause risks."

Rigorous supervision of nucleic acid testing industry

Nucleic acid testing is a key measure to implement the general strategy of "four early", the general strategy of "external prevention input, internal prevention rebound" and the "dynamic clear zero" general policy.

With the recent problems that have been repeatedly discovered by the nucleic acid testing industry, on June 2, the State Council's comprehensive group responded to the new type of coronary virus pneumonia epidemic control mechanism for the "notice on further strengthening the regulatory of new coronary virus nucleic acid testing full chain supervision" (hereinafter referred to as "" "" " ")") Requires further increased nucleic acid testing and supervision. Specifically, the notice put forward six requirements, which are strict testing agencies and personnel qualification management; standardized sample collection, preservation and transfer management; strengthening daily supervision and management of nucleic acid testing agencies; strengthening nucleic acid detection agencies in emergency state; improving nucleic acid detection resources Use efficiency; strictly implement the exit mechanism of nucleic acid detection agencies.

In strengthening daily supervision of nucleic acid detection agencies, the "Notice" requires that local governments should strengthen daily supervision and management on the basis of strict qualification management. By increasing the efforts of medical institutions and adopting flight inspections and random random inspections, the quality of the test has continued to improve the quality. The testing agency should implement the indoor quality control measures, and each batch of tests must be placed in weak positive and negative samples for control detection. Participate in the provincial and above rooms in accordance with regulations, and the frequency of quality evaluation is encrypted. Implement the monthly audit system of the medical inspection laboratory, organize the whole process of its practice and test quality in accordance with the law, and announce the results of the audit to the society. According to daily management, nucleic acid testing agencies are divided into key institutions and general institutions for grading management. Among them, detection agencies with large samples or recent general problems are listed as key institutions, and the health administrative department must organize squatting inspections. If there is no general problem within two months, it can be downgraded to general institutions. At present, the First Financial Reporter learned that some provinces such as Jiangsu and some cities such as Guangzhou have recently been conducting special inspections of new crown virus nucleic acid testing agencies.

The above -mentioned people from the Guangxi nucleic acid testing laboratory told the First Financial Reporter that after the "Notice" was released, a large -scale nationwide was launched by the new crown nucleic acid detection institution. Detective reagents and other aspects.

It is worth mentioning that since this year, fake negative and false conditions on nucleic acid testing have attracted market attention.

At the press conference of the State Council joint prevention and control mechanism on June 9, Guo Yanhong, a supervisory commissioner of the National Health and Health Commission's Medical and Health and Health Medical Management Bureau, said that in the laboratory indoor quality control work, each batch of nucleic acid was required to laboratory During the detection process, negative and positive quality control products should be placed, and the test is tested with the real specimen to ensure the truth and accuracy of the test results.

"In the detection of new crown nucleic acid, quality control products are equivalent to measuring a 'ruler' in the process of detection quality. At present, the national level stipulates that the quality control products should be placed in the clinical specimen and participated in the entire process of extension from extraction, but at present Some areas allow quality control products to not participate in extraction. This approach may be to prevent false positive problems. The key points such as pollution and extraction effectiveness during the extraction of nucleic acids will cause missed inspection problems. This phenomenon is worthy of vigilance. "Other people in the nucleic acid detection industry told First Financial reporters.

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