Current affairs perspective
From the perspective of the 2019 Coronary Virus epidemic hearing on March 11, the US Congress House of Representatives, a number of members of many members are concerned about the shortage of shortage of coronary virus testing agents in the United States.Some members mentioned that some people want reagents, but they cannot obtain it; some members have questioned the existing detection ability and proposed whether there are some problems that die from flu and actually die in the infection.The amount of quantity compared with the United States, pointing out that the US detection volume is seriously deficient.
Why does the United States, the most powerful and most developed countries in the world, have a serious shortage of testing reagents?From the question and answer of the hearing, and the author's previous experience in in vitro testing agents, from research and development to production, to clinical and market experience, the problem comes from at least the following two aspects.
First of all, in terms of product development and production, according to the explanation of the director of the US Disease Control and Prevention Center (CDC) at the hearing, the CDC only developed a test agent with unprecedented six days.According to his explanation, what he said can only be the prototype of the detection reagent, or even a detection method.
The prototype of the detection reagent refers to the verification in the laboratory that can effectively detect the material combination and method steps of the pathogenesis, rather than the product produced by the manufacturer's mass production of the verified production procedures.This explains why CDC encounters technical problems in the process of production of the virus kit.
The PRIMER DIMER problem mentioned by Director CDC at the hearing is actually a common problem when product design and product design upgrades to mass production.Fortunately, these problems have been resolved.However, the 75,000 tests mentioned by Director CDC really have to compare with South Korea's detection, which is really not abundant.
In this regard, the Director of CDC explains that the CDC kit has been distributed to the states, mainly serving public health, and the diagnostic reagent gap required for commercial testing of hospitals or other medical centers must be filled by private manufacturers.In other words, CDC production is limited, and market demand must be solved by the market.This brings out the second question mdash; mdash; regulations and regulatory issues.
Under normal circumstances, medical testing reagents must be listed in the United States or in the medical test laboratory, and they must pass the review by the Food and Drug Administration (FDA).The product should pass the FDA review. The industry has a well -known problem in the industry, and it is time to consume the rigidity.Therefore, even the local producers of the United States, despite the banner of FDA -certified production facilities, and produced in the United States, many companies often only produce products for exports to overseas and avoid the US market.Because it is necessary to allow the product to pass the FDA in a short period of time, and it can meet economic benefits, it is almost impossible to complete.In addition, even if the local qualified medical institution internal development methods are developed, although the regulations will be more flexible, they must pass the FDA regulatory review.
The current is a very different time, and the situation is indeed a bit different.What is happy is that the FDA has made some adjustments at the end of February, allowing those medical testing laboratories that meet the federal requirements to avoid applications, and directly use CDC development methods to test.The premise here is that each testing laboratory must develop its own testing according to the reagent, designated supplier, specified instrument and specified method specified in the CDC method to develop its own testing.
If there is something separated, for example, the existing instrument in the laboratory is not the model specified by the CDC method, or you have to make some additional verification.In addition, there is a hidden problem that allows each laboratory to develop their respective detection arrangements according to the CDC method.That is, the key materials for each testing laboratory can only place an order to the same supplier.Therefore, the supplier's production capacity will become another bottleneck.This way may not be able to fill the existing deficiencies in a short time.
At the hearing, some members asked why they did not use Korean testing reagents directly.In this regard, the answer of Director CDC is that the instruments used are different, but they have skipped the FDA supervision.From a third party perspective, the instrument does not match is never an insurmountable obstacle.The more realistic question is: Do you want to abandon the reagent developed by the CDC itself, and use South Korea's high -throughput technology or the latter to fill the vacancies, do you want to make foreign products enter the country in a special approval, etc.
The latest news is that the FDA has approved the use of Roche's use in the United States based on Emergeency Use Authorization regulations.Because the detection volume provided by the Roche kit is higher than that of the CDC method, I believe it can fill some shortcomings.Next, Roche's production capacity will be a key.
The author is a predecessor technology worker now a consultant
