Analysis of the clinical use of IVD reagents and problems in China

In 2015, the Medical Laboratory Industry Branch of the National Health Industry Enterprise Management Association was commissioned to conduct a serious and in-depth survey on the use of in vitro diagnostic reagents in 51 medical institutions (24 Grade 3A hospitals, 15 Grade 2A hospitals, and 11 Grade 1 hospitals) and one third-party medical laboratory in eight provinces and cities in Beijing, Shanghai, Shandong, Guangdong, Jiangsu, Zhejiang, Jiangxi, and Fujian, through which the survey truly Through the survey, the use of in vitro diagnostic reagents in China was really mapped out.

Section I. Basic situation of clinical use of in vitro diagnostic reagents

I The situation of laboratories carrying out clinical testing in medical institutions

At present, only the Laboratory Department of first-level hospitals in China carries out clinical testing. Level II hospitals are laboratory departments and pathology departments. Tertiary hospitals usually have a variety of small laboratories attached to clinical departments to carry out clinical testing, in addition to the Department of Laboratory Medicine and Department of Pathology. These laboratories include nuclear medicine, haematology laboratories, rheumatology and immunology laboratories, allergy and immunology laboratories, nephrology laboratories, reproduction centres, and so on.

II Types of in vitro diagnostic reagents in active use in medical institutions

There are about 1,000 types of in vitro diagnostic reagents in active use in large medical institutions. About 500 kinds of in vitro diagnostic reagents are routinely used in the laboratory of comprehensive tertiary hospitals, 250~300 kinds in the pathology department, 250 kinds of flow cytometry supporting reagents, and dozens of special reagents in each department. Some mega hospitals, such as a hospital using a total of nearly 2,000 kinds of in vitro diagnostic reagents, the hospital's Laboratory Department has more than 600 kinds, more than 620 kinds of Pathology, more than 480 kinds of haematology laboratories, a variety of specialist laboratories more than 170 kinds.

Level II hospitals generally carry out dozens of tests such as biochemistry, two-to-half, three major routines, coagulation, and so on. Level I hospitals carry out very limited testing items, usually biochemical and three major routine tests.

III in vitro diagnostic reagents imported and domestic situation

At present, about 75% of the reagents used in the laboratory of large tertiary hospitals in China are imported products, especially the luminescent tumour markers, sex hormones, thyroid hormones, blood coagulation, blood cells and other reagents are almost all imported. At present, only biochemical reagents have a high proportion of domestic production. Almost all of the biochemical reagents of the first and second level hospitals are made in China, and the third level hospitals also have a high proportion of domestic reagents. Enzymatic infection reagents (such as preoperative eight) and other reagents are also all domestic reagents.

The two most important reasons that lead to such a high proportion of imported reagents in large hospitals are: large-scale testing equipment is mainly imported, and domestic equipment has not yet become mainstream. In addition to biochemical tests, luminescent instruments are all "closed system", that is, the bar code method of locking reagents, resulting in incompatibility with other companies' reagents. And part of the industry experts to promote the "proprietary closed reagents better quality" concept, which promotes the imported manufacturers with the instrument to take up space to control the supply of consumables. In addition, large hospitals have high requirements for reagents and instruments, and most large hospitals choose imported reagents because they believe that the quality of domestic reagents is not as good as that of imported ones. Domestic reagents and instruments in the level of research and development and product quality also need more experts trust and time to accumulate.

IV In vitro diagnostic reagents procurement and logistics situation

Many first-level hospitals are unified procurement by the government procurement platform, the procurement channel is relatively single, the management is also relatively simple, and only products with registration certificates are procured. For level II hospitals, part of the procurement is unified and supplied by the government procurement platform, and part of it is procured independently.

Large tertiary hospitals purchase 1000~2000 kinds of products and have many suppliers. Some hospitals have adopted electronic software systems for procurement and supplier management. Supply information is more complete and management is more organised. However, the management of registration certificate archives in many hospitals is worrying, and expired or incomplete registration certificates are common.

At present, no matter whether it is a tertiary hospital or a first- or second-level hospital, it does not pay enough attention to the logistics of diagnostic reagents, such as cold chain delivery. For example, there are deliveries in simple plastic bags by underground, without ice and basic foam box protection measures. Causes of neglect of cold chain transport is also a variety of reasons. The relevant laboratory personnel believe that "experience shows" a short city transport without cold chain does not affect the quality of reagents. In addition, the use of in vitro diagnostic reagents hospital ordering frequency is high, the single shipment is small, the cold chain truck transport is not realistic, which is also generally reflected in the problem. In the hospital to receive this link, most of the procurement department personnel are only concerned about the variety and quantity of goods, simply check the appearance of the reception, for whether there is a cold chain transport and so on, generally do not care.

V Use of in vitro diagnostic reagents by third-party testing organisations

China's third-party testing organisations have now become an important medical service provider in the field of clinical testing. According to preliminary research, third-party testing organisations also have a large number of unregistered products, which are mainly concentrated in the hospitals are not willing to carry out, or hospitals want to avoid the risk and clinical need of testing projects, commissioned outside the third-party testing organisations for testing. The main types are now booming molecular testing and sequencing and other areas, but also includes pathology, FISH, flow cytometry and other tests.