Zhongtong LANBO, jinzhun medicine, Pu Shi medicine... In just 10 days, three nucleic acid tests have been checked in Beijing. It is worth noting that the investigation of these three companies is due to the fact that their human activities have expanded the proportion of mixed mining. This is a desperate move. A number of experts told sina science and technology that there are probably more than three companies taking risks. The main purpose of expanding the proportion of mixed mining is to improve the speed and make huge profits. The characteristics of mixed mining and low positive rate make it difficult to detect counterfeiting.
Some experts said frankly, "it is very difficult for laboratories to store all data, which also makes it difficult to obtain evidence for fraud".
Corporate profits doubled
According to the official reports of the Beijing Municipal Public Security Bureau and other officials, Pu Shi medical was investigated because the original test data were significantly less than the number of samples tested. Jinzhun medicine adopts the method of multi tube mixed test to test the "5 mixed 1" and "10 mixed 1" nucleic acid samples collected in multiple areas. Artificially diluting the samples will affect the accuracy of the test results. Meanwhile, Zhongtong Rambo also adopts the method of multi tube mixed test.
In other words, the three testing companies violated the law by illegally expanding the proportion of mixed sampling, and privately expanding the sample size of "5 mixed 1" and "10 mixed 1" to "30 mixed 1" and "50 mixed 1".
Virology expert changrongshan told sina science and technology that large-scale nucleic acid screening requires extremely high detection flux and speed, while public hospitals have limited equipment and sites, and the detection capacity is unable to cope. Therefore, at present, public medical institutions all over the country account for less than 5% of large-scale nucleic acid testing, and most of the testing tasks are outsourced to third-party testing institutions.
However, the requirements of the mixed test itself are higher than those of the single test. As the mixed test is difficult to avoid the dilution effect, the sample extraction needs to be operated with larger instruments and more strict quality control. In other words, higher hardware requirements and higher management costs. If the capacity is expanded to 50 × 1 without authorization, the profit will increase several times.
In addition, many regions require a batch of results every six hours, which can be guaranteed when the sample size is small. However, for a 10 person team, if it is a single inspection, it is very difficult to complete tens of thousands of samples with both quality and quantity. In such a time requirement, enterprises also want to reduce the pressure by expanding the proportion of mixed inspection.
However, another problem with mixed testing is that it will lead to a decline in accuracy. Chang Rongshan said that 10 mixed 1 mixed testing is to mix 10 samples into one sample. When extracting nucleic acid, if all samples are 0.75ml, the sampling amount of mixed testing is only about 1/6 of the total number of samples sampled by single tube testing. Although adjustments can be made when the nucleic acid is redissolved, the accuracy will still be reduced.
However, if the company further increases the proportion of mixed detection and performs detection according to 50 mixed 1 (only one nucleic acid extraction is performed for the five tube 10 mixed 1 sampling tube), the detection accuracy will be greatly reduced and the probability of false negative will be greater.
Counterfeiting is not easy to be found
Why do these three enterprises choose to fabricate by expanding the proportion of mixed mining? Changrongshan believes that there are two main reasons, namely, the probability of being discovered is very low and the operation is too easy. It was further introduced that in the May epidemic in Beijing, the new positive rate per day was less than 0.5 per 100000. In other words, only one person in 200000 people is positive, so even if 50 mixed with 1 and 100 mixed with 1, there is only one positive detection in 10000 to 2000 amplification. Therefore, under the low positive rate, it is unlikely that illegal operations will be found.
In addition, compared with the single sampling and single inspection with machine records for each sample, it is easier for mixed inspection to fabricate. He explained, for example, that if five sampling tubes ABCDE do five 10 mixed 1 mixed tests, it is only necessary to take a sample from the five detection tubes and put it in tube a at the same time, and only one extraction and amplification is done, while the BCDE record data without single test uses the data of tube a. When the negative ratio is very high, the data can be mixed and then distributed to any other five tubes such as other negative fghij. Even if the five tubes of fghij have not completed the detection, it is difficult to be found. In this way, we can get the data of all samples. In fact, only one fifth of them have completed the test.
In addition, if a third-party laboratory needs to complete the detection of hundreds of thousands of samples every day, in addition to the recorded data generated by the automatic nucleic acid extractor, the amplification of each sample will generate the corresponding amplification curve and CT value data of each gene, which is a huge amount of data.
It is very difficult for the laboratory to store all the data, and it is normal for some data to be deleted. One week later, it is easy to explain that the data other than the test data of positive samples are deleted, which makes it difficult to obtain false evidence.
Therefore, he believes that these three laboratories are not the only ones with problems, but only these laboratories are found when the positive rate is very low.
According to the sky eye survey data, 437 medical inspection related institutions were added in 2021, with an annual growth rate of 25.1%, the highest over the years. Hantao (a pseudonym), a pharmaceutical analyst, also added that such a thing occurred mainly because there was no time for supervision when "big work and fast progress", exposing problems and strengthening supervision, which would make the situation much better.
Why take risks
After several rounds of centralized collection for nucleic acid detection, the profit is diluted. According to the statistics of the National Medical Insurance Bureau, at the beginning of April, 30 provinces across the country have issued documents to reduce the government guidance prices. After several national unified adjustments to the nucleic acid detection price of novel coronavirus, the government procurement price per share has been reduced to around 3 yuan, which also includes virus detection reagents, extraction reagents, sampling tubes and other materials.
On May 2, the Beijing Municipal Medical Insurance Bureau issued the notice on further reducing the price of novel coronavirus nucleic acid detection items, reducing the price of single sample nucleic acid detection from 24.9 yuan per person to 19.7 yuan, a decrease of more than 20%. At the same time, the price of mixed detection decreased from 5.9 yuan to 3.4 yuan, a decrease of 42%.
Two companies involved in nucleic acid detection told sina science and technology that the decline in the unit price of nucleic acid detection, changes in epidemic prevention strategies in some countries and regions, and the sufficient supply of new crown detection products all led to fierce competition in the industry. The final result is a sharp rise in the cost of sales and a decline in the gross profit margin.
When the gross profit rate drops, some enterprises will choose to take risks.
However, Han Tao does not think that this is due to the dilution of profits. For example, he said that even vermicelli pickles can be counterfeited. The profits of these foods are far lower than those of nucleic acid testing. However, some enterprises also fabricate in pursuit of profits. In addition, the business volume of nucleic acid detection is huge after all. Although the gross profit margin decreases, the volume can still accumulate profits.
The latest circular shows that the Beijing Municipal Public Security Bureau has filed a case against Pu Shi medicine for investigation on suspicion of interfering with the prevention and control of infectious diseases. Previously, criminal coercive measures have been taken against 6 people. In addition, the health department has revoked the medical institution license of the laboratory, and the market supervision department has filed a case for investigation. Jinzhun medicine is suspected of obstructing the prevention and control of infectious diseases, and 17 people have been put on file for investigation.
The police have taken criminal coercive measures against 8 people of Chinatown Rambo. The case is under further investigation. The procedure of revoking the practice license of a medical institution has been initiated.
In addition, it is worth mentioning that Zhongtong LANBO was founded on march2,2007, with a registered capital of 103.6 million yuan. It is a wholly-owned subsidiary of Hong Kong listed company China Tongfu. Last year, China Tongfu medical laboratory service revenue exceeded 200million yuan, and is planning to be listed on the science and innovation board.
Corresponding regulatory measures have been initiated
On May 30, at the 350th press conference on epidemic prevention and control in Beijing, xuhejian, spokesman of the Beijing municipal government, said that it was necessary to strengthen the clean-up, rectification, standardization and supervision of nucleic acid testing institutions. Strengthen quality control, improve the quality and efficiency of testing, strengthen the supervision and inspection of sampling, testing and other links, so as to achieve quick inspection and quick delivery. Individual third-party testing institutions will be severely punished in accordance with the law for illegal detection, affecting the accuracy of data detection and other illegal acts for the purpose of illegal profit.
In addition, guoyanhong, the supervisor of the medical administration and medical administration bureau of the National Health Commission, previously said that in addition to the regular indoor quality assessment, the National Health Commission also organized the national clinical examination centers and provincial clinical examination centers to conduct an inter laboratory quality assessment on the testing institutions. At present, the inter laboratory quality assessment on more than 35000 laboratories shows that the pass rate reaches 99.7%.
Xinhua Daily Telegraph previously commented that there is a large volume of nucleic acid testing business, and there is also a chain of interests. In this regard, discipline inspection and supervision departments should intervene to conduct a comprehensive and thorough "test" on the qualification and access procedures of nucleic acid testing institutions, strengthen supervision, and be seriously accountable and severely punished for possible violations of discipline and law, so that all participants in nucleic acid testing do not dare to make trouble.
Wen Yiming, original name of Sina Technology
Editor: Han Dapeng