Wei-Medical Fa [1998] No. 9
Provinces, autonomous regions, municipalities directly under the Central Health Department (Bureau):
Gene amplification technology is one of the advanced means of modern molecular biology testing. To carry out PCR testing technology in medical institutions to build laboratories have hundreds of, and is rapidly expanding, some even in township health centers. However, there are currently hundreds of PCR reagent kit production units, so far there has not been a formal approval of the production number. The quality of reagents is uneven, coupled with the laboratory setup is not standardized, the lack of basic training of personnel, resulting in confusion of clinical test results, increasing the burden on patients and a serious waste of resources.
The study decided that the medical institutions shall not use the reagents not formally approved to carry out clinical PCR testing program and issue clinical testing and diagnostic reports. At this stage, genetic diagnostic testing can only be used for scientific research, and shall not be charged to patients in any form.
Please local health administrative departments will be the spirit of this notice forwarded to the medical institutions in a timely manner, and asked to seriously comply with the implementation.
Ministry of Health
April 15, 1998