China has become one of the fastest growing countries in the global in vitro diagnostic market.

"This is a high-level international seminar that provides us with a valuable opportunity to learn about industry developments." On June 3, well-known in vitro diagnostic companies at home and abroad expressed such feelings after participating in the international seminar on "Research and Development and Quality Control of Protein and Peptide Drugs and Diagnostic Reagents.

In vitro diagnosis, or IVD(In Vitro Diagnosis), refers to products and services, including reagents, instruments, calibrators, etc., that obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.) outside the human body to determine disease or body function. Therefore, it is closely related to public health, and the market demand is huge. According to statistics, in 2013, China's in vitro diagnostic market size has been close to 20 billion yuan. As the hospital market demand accounts for more than 90% of the total demand for in vitro diagnosis, with the increase in the number of patients and per capita examination costs, it is expected that the scale of China's in vitro diagnosis industry will be around 38.4 billion yuan by 2018. China has become one of the countries (regions) with the fastest growth rate in the global in vitro diagnostic market.

In the mid-1980s, China developed the first batch of domestic biochemical diagnostic reagents. At present, there are more than 500 in vitro diagnostic enterprises in China, but the overall scale is small and the industry concentration is not high. In 2015, there were only more than 10 enterprises with profits of more than 100 million yuan, and their total profits were not as much as that of a well-known foreign enterprise. Therefore, how to enhance the core competitiveness and increase the market share is the focus of in vitro diagnostic enterprises in recent years.

With the development of science and technology, laboratory medicine has become an important means of disease diagnosis, efficacy assessment and health status monitoring. The test results are accurate and comparable across time and space, which is the basic need for human disease prevention and treatment and improvement of health. The establishment of traceability of test results is an effective means to ensure that the results of each laboratory are accurate and comparable, and it is also the basis for promoting technical exchanges in the industry, and it is also an important indicator for evaluating the quality of in vitro diagnostic products and clinical laboratories. In the view of Lu Lei, director of the reference system department of Sichuan Mike Biotechnology Co., Ltd. (hereinafter referred to as Sichuan Mike Biological Company), it is urgent to speed up the traceability of products of in vitro diagnosis enterprises, and it is also the key to the core competitiveness of enterprises.

Due to the complexity of laboratory medicine, its traceability has been developed as a relatively independent branch of discipline. In 2003, the International Organization for Standardization issued the standards of laboratory medicine ISO15193 (reference method), ISO15194 (standard substance), ISO15195 (reference laboratory), ISO17511 (quantitative transfer), ISO18153 (enzyme transfer) and other standards, which put forward the theoretical basis for the establishment of reference laboratory. These standards have been transformed into national/industry standards in China, which has laid a theoretical foundation for the traceability of laboratory medicine. In 2002, the International Bureau of Weights and Measures (BIPM) and other three international organizations jointly established the Joint Committee on International Traceability in Laboratory Medicine (JCTLM), which publishes the catalogue of reference methods, standard substances and reference measurement service laboratories every year and organizes the ability verification activities of reference methods, so that the world has a unified traceability related reference.

In my country, the National Clinical Medical Metrology Technical Committee was established in 2007. The secretariat is located in the Chinese Academy of Metrology, which is responsible for the traceability of the national value of measurement, and plays a positive role in promoting the traceability of in vitro diagnostic enterprises and improving product accuracy. The hospital has also vigorously developed laboratory medical reference methods and standard substances. Up to now, reference methods such as uric acid and creatinine have been listed on the JCTLM website. There are dozens of standard substances such as glucose, urea, uric acid, creatinine, calcium, magnesium, phosphorus, etc. The national standard document number facilitates the traceability of in vitro diagnostic enterprises. National measurement benchmarks and national measurement standards are prerequisites for enterprises to establish medical reference laboratories. In the whole process of establishing the reference laboratory, high-precision measurement and measuring equipment is used, and these equipment can only be used after being verified by the measurement department with international metrological benchmarks or measurement standards. Reference laboratories internal calibration thermometers, acidity meters, spectrophotometers, etc. must also purchase corresponding national standard substances.

The National Accreditation Board began accreditation of medical reference laboratories in 2011. As of May 2016, three in vitro diagnostic enterprise reference laboratories have been accredited by CNAS. Sichuan Mike biological company is also obtained the JCTLM recommend global reference measurement service qualification, and is also the enterprise with the most reference measurement service projects in the world. By participating in the assignment of internationally renowned reference materials, it also shows the high-end technology image of Chinese enterprises.

Lu Lei said with deep feeling that the traceability of in vitro diagnostic products has greatly improved the competitiveness of products. After solving the problem of "quasi", the trust of customers has greatly increased, the chance of winning the competition of foreign products is increasing, the share of tertiary hospitals is getting higher and higher, and the popularity and brand value of enterprises are also improved. At the same time, enterprises in the process of quantity traceability, will also be timely to find the original products may exist problems. These defective products will be returned to the R & D department for re-development, thus promoting the continuous improvement of product quality. "In addition, the measurement traceability products can eventually realize the mutual recognition of patients and diagnosis results, realize the consistency of time and space, and technically alleviate the current doctor-patient relationship."

Due to the continuous improvement of traceability, enterprises hide strong market competitiveness, and their economic and social benefits are also improved. According to reports, at present, the three in vitro diagnostic enterprises recognized by CNAS are all dynamic listed enterprises in the whole industry. Annual sales, profits and taxes are significantly higher than the domestic industry average. According to Yu Kang, marketing director of Sichuan Mike Biology Company, the company's operating income has maintained a sustained growth momentum, increasing 14% in 2015 compared with 2014. It is expected that this year will increase by about 41% (including mergers and acquisitions) compared with last year.