The cellular molecular genetics and the molecular pathology departments (originally called molecular biology department) are among Shanghai centre for clinical laboratory’s main technical departments. Among others, it has a standard clinical gene amplification laboratory, a cell culture room, a molecular diagnostic research room, etc. The department covers nearly 300m2 and is equipped with an automatic nucleic acid extraction and amplification analyzer (La Roche Ltd), a La Roche Ltd and ABI fluorescence quantitative PCR analyzer, a chip analyzer, a sequencer, a micro-drop digital PCR device, as well as other advanced equipments. Over the years, the department has been involved, and achieved great results, in various quality evaluation activities organized by the National health research commission for clinical laboratory and the American association of pathologists. The department’s main focus is the technology of the molecular diagnostic assessment, laboratory quality evaluation projects and the PCR technicians induction training. The department had previously issued the "Shanghai medical institutions clinical gene amplification testing and molecular diagnosis audit methods in related technologies", as well as the “Prenatal screening of fetal DNA in pregnant women developed in Shanghai and diagnostic testing of technical specifications”. Up until now, the department has carried out almost 30 quality assessment projects regarding infectious diseases, molecular pathologies, molecular genetics, prenatal screening and other. Lastly, thanks to the efforts of the department’s members, around 3,000 people have received specific training in PCR induction.
In 2017, it was granted the title of “outstanding team” by the Shanghai medical association laboratory physicians, and counts numerous awards for “special contribution”. The department has rich experience in the field of research and development of molecular diagnostic quality controls, as well as in the writing of reference materials. It has successfully conducted a number of infectious diseases tests and metabolism drugs controls in the appropriate laboratories. Moreover, it has developed HBV DNA, HCV RNA secondary national standard references for which it received a grading certificate from the National bureau of quality inspection. Thanks to the team’s work ethic, the department of scientific research has been making considerable progress and has been involved in a range of fields, such as the municipal natural fund. It has not only published over 30 papers in SCI and other important magazines but has also actively participated in their three editions.
The department’s specific responsibilities include:
1. To be responsible for the quality supervision of the molecular diagnostic laboratories in the medical institutions in Shanghai, as well as their technical specifications;
2. To be responsible for the use and the technical assessments of the molecular diagnostic laboratories in Shanghai;
3. To conduct quality evaluations in the molecular diagnostic laboratories in Shanghai;
4. To carry out quality controls and provide related services, to promote the standardization of molecular diagnostic testing items and the operating procedures;
5. To be responsible for the clinical gene amplification testing and train the stuff in the field of molecular diagnosis technology;
6. To carry out continuing medical education projects, and to promote new theories, technologies and methods in the field of molecular diagnosis, as well as its standardized applications;
7. To plan quality evaluations with double-checking of their correctness, to development quality control devices and write national standards references.
8. To carry out molecular diagnosis of in vitro diagnostic medical equipment and reagents quality assessments;
9. To carry out molecular testing of clinical samples.