"Science and Technology Board Daily" (Shanghai, reporter Xu Hong) in response to the recent National Health Commission proposed "Spring Festival homecoming nucleic acid testing" policy, as well as "local governments have landed chemical luminescence project collection" market rumors, "Science and Technology Board Daily" reporter specially interviewed senior experts in the in vitro diagnosis industry, professor Song Haibo, vice president of the National Health Industry Enterprise Management Association, president of the Medical Laboratory Industry Branch, vice president of Shanghai Institute of Experimental Medicine, and founder of CACLP.

Is universal nucleic acid testing necessary?

 
"Returned personnel need to hold a negative nucleic acid test certificate within 7 days before they can return home." Recently, the announcement of the new policy for returning home during the Spring Festival has once again put the concept of nucleic acid testing on the cusp.

 
On January 20, the joint prevention and control mechanism of the State Council held a press conference. Wang Bin, inspector of the Disease Control Bureau of the National Health Commission, said at the meeting that returnees need to hold a negative nucleic acid test certificate within 7 days before they can return to their hometown. At the same time, after these returnees return, the local grass-roots government should carry out grid management.
 

 
Kechuang Board Daily: How do you understand the above new policy of nucleic acid testing for returning home during the Spring Festival? Does this mean that all people should be tested for nucleic acid?

 
Song Haibo: I think we should correctly interpret the policy of returning home during the Spring Festival, not one-sided. "Returnees" as referred to in the document should refer to "returnees" from medium-and high-risk areas or people who are susceptible to work and environment. For example, there is a returnee who came back from Tibet, but there is no confirmed patient in Tibet, so what is the significance of nucleic acid testing? Therefore, it is not one-sided to think that people returning home need to do nucleic acid testing. Nucleic acid testing for returning people should be targeted. Excessive and unnecessary testing is a waste of effective public resources, but in any case, the number of tests across the country will There will be a substantial increase, especially at the grassroots level.

 
"Science and Technology Innovation Board Daily": If we want to carry out large-scale nucleic acid testing, such as "national testing", do we have sufficient testing and reagent supply capacity?

 
Song Haibo: Even if we carry out nucleic acid testing for the 1.4 billion population, there is no problem with our existing testing capabilities and reagent supply.

 
Up to now, the daily production of nucleic acid detection reagents in China can reach more than 6.655 million people, the daily production of antibody detection reagents can reach more than 15.46 million people, the daily production of antigen detection reagents can reach more than 1.9 million people, and the cumulative daily production can reach more than 24.015 million people.

 
1.4 billion the population sounds very large, but in fact not 1.4 billion people need to use 1.4 billion reagents to test, because the basic testing method we currently adopt is "mixed testing", that is, mixing several samples into one sample for testing. Once abnormalities are found in the mixed testing screening, the mixed testing samples will be tested one by one.

 
Therefore, we can take one person check or 5 mixed checks in medium-high risk areas, and 10 mixed checks in low-risk areas. If there are 10 cases of mixed examination, in fact, the maximum number of 1.4 billion people is equivalent to the 0.14 billion population for examination, and there are still many that do not need to be examined.

 
"Science and Technology Board Daily": Previously, I have heard that the "mixed inspection" testing method is somewhat controversial, is that right? From the current situation, what do you think of the effect of "mixed inspection?

 
Song Haibo: From the perspective of quality control in laboratory medicine, "mixed examination" is indeed not allowed. However, the new crown outbreak is a special case because of the high frequency of testing and the large number of specimens. Now it seems that there is no obvious problem of missing detection in mixed detection, which is closely related to the high quality of our reagents, and the detection rate and sensitivity are within the controllable range.

 
The CRE Board Daily: This time the new crown epidemic, many in vitro diagnostic enterprise performance outbreak, the epidemic for the industry is not a great development opportunity?

 
Song Haibo: The impact of the new crown epidemic on IVD enterprises is multifaceted, both positive and negative. The epidemic in general is to IVD enterprises to provide an excellent opportunity for future growth, nucleic acid testing projects as the new crown diagnostic "gold standard" to enhance the status of laboratory medicine, but also enhance the status of the IVD industry. Especially for those companies with anti-epidemic-related products, while contributing to the fight against the epidemic, they are also the biggest winners of "opportunity marketing.

 
However, such enterprises are still a small number, from the whole industry level, more enterprises because they did not seize the "opportunity marketing", coupled with the impact of the epidemic, thus under unprecedented operating pressure. At the beginning of the outbreak in 2020, due to the sharp decline in the number of outpatient and inpatient hospitals, the sales of enterprises in the first quarter of 2020 were generally less than 20% of the sales volume in the same period. Although there was an increase afterwards, in fact, until now, the diagnosis and treatment activities of hospitals have not fully recovered to the pre-epidemic level, and only recovered to about 90% of the pre-epidemic level.

 
In addition, in terms of specific segments, the new crown outbreak will greatly promote the development of molecular diagnostics. Before the epidemic, many primary health care institutions, including county-level hospitals, did not have molecular and nucleic acid testing capabilities. However, through this epidemic, the national nucleic acid detection capacity building has been comprehensively strengthened, so the application of molecular diagnosis is expected to be further expanded in the future.

 
Collection pressure of in vitro diagnostic reagents

 
In May 2020, the reporter of the Science and Technology Board Daily reported exclusively that the centralized procurement alliance of medical consumables of public medical institutions in Nanjing intends to purchase in vitro diagnostic products with volume, and Roche Diagnostics and other enterprises received invitation letters. At that time, the market expected, following drugs, high-value supplies, in vitro diagnostic reagents are also expected to usher in the era of price reduction.

 
Although little is known about the subsequent progress of this collection, the large-scale collection of in vitro diagnostic reagents has not come as scheduled. However, the recent market expectations for the collection of in vitro diagnostic reagents have heated up, including according to some pharmaceutical investors, a recent brokerage mentioned in a conference call that there have been places to land the collection of chemical luminescence projects.

 
But at the same time, the market has different views on the question of whether in vitro diagnostic reagents will be collected or not.