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Clinical gene amplification laboratory construction program

Dec 11, 2018

I. Background and purpose

1. Construction of clinical gene amplification (PCR) test laboratory objectives

In order to standardize the management of clinical gene amplification test laboratories in medical institutions, to ensure the quality of clinical gene amplification test and laboratory biosafety, and to ensure the scientific and rationality of clinical diagnosis and treatment, according to the "Regulations on the Management of Medical Institutions" and "Clinical Experiments in Medical Institutions" Room Management Measures and "Administrative Measures for Clinical Application of Medical Technology", and formulate "Administrative Measures for Clinical Gene Amplification and Testing Laboratories of Medical Institutions" (Wei Ban Medical Administration [2010] No. 194).


2. Clinical gene amplification test laboratory definition:

It refers to a laboratory that conducts disease diagnosis, treatment monitoring, and prognosis determination by amplifying specific DNA or RAN. Medical institutions should be centrally set and managed.


3. The significance of medical institutions to carry out laboratory tests for clinical gene amplification

1 Advantages of PCR detection technology:

Highly sensitive, highly specific, high throughput, fully enclosed automation.

2 Clinical significance of PCR detection technology:

Early diagnosis of disease; differential diagnosis of disease; observation and guidance of antiviral drug efficacy; new drug verification.

3 clinical application of PCR detection technology:

Diagnosis of infectious diseases; control and observation of mother-to-child transmission; diagnosis of genetic diseases; diagnosis of tumors; forensic identification; individualized diagnosis and treatment.

4 Carrying out PCR testing is a higher requirement of the National Clinical Laboratory Project.

Catalogue of Clinical Laboratory Projects for Medical Institutions (2013 Edition)

National Medical Service Price Project Specification (2012 Edition)

The fifth major category is clinical molecular biology and cytogenetic testing.

China's latest specifications and new PCR testing projects have exceeded 60, and continue to grow.

5 Carrying out PCR testing is an important indicator to improve the level of diagnosis and treatment in medical institutions.

In the guidelines for the diagnosis and treatment of infectious diseases by the WHO and the National Health and Family Planning Commission, nucleic acid detection of pathogenic microorganisms is clearly proposed as an important means of diagnosis and diagnosis. For example, in the newly published "Guide to the diagnosis and treatment of hepatitis C" in 2014, HCV-RNA detection is the most important indicator of HCV infection. For antiviral treatment of hepatitis B and AIDS, international standards and national standards clearly indicate the important role of antiviral treatment monitoring of viral load detection of HBV-DNA and HIV-RNA. In addition, it is recommended to promote the use of more sensitive nucleic acid detection reagents, such as: HBV nucleic acid detection, the country recommends the use of sensitivity of less than or equal to 30IU / ml products.

6 Medical institutions that carry out PCR testing in China

Second, the conditions for building a PCR laboratory:

1, hardware configuration

1 main structure:

The main body is color steel plate and aluminum alloy profile.

2 standard three-zone separation and air pressure adjustment:

The PCR laboratory was divided into three separate experimental areas: reagent preparation, specimen preparation, and PCR amplification. There is an overall buffer corridor throughout the area. Each independent experimental zone is provided with a buffer zone, and each zone is regulated by air pressure, so that the reagents and specimens are protected from aerosol contamination during the whole PCR experiment and the pollution of the amplification products to people and the environment is reduced.

As shown in Figure 1, the ideal PCR laboratory partition design pattern.

Figure 1 The ideal PCR laboratory partition design pattern

3 disinfection:

UV lamps are installed in the three experimental areas and on the top of the three buffers and inside the transfer window for disinfection.

A moving ultraviolet lamp is also disposed in the reagent preparation area and the sample preparation area to partially disinfect the experimental table.

4 mechanical chain stainless steel transfer window:

Reagents and specimens are delivered through mechanical interlocking stainless steel (not recommended for electronic interlocking) to ensure that reagents and specimens are not contaminated during transport (personal shunting).

5 ground:

It is recommended to use PVC coiled floor or self-flowing floor for good ground.

6 lighting:

The lamps should be cleaned and sleek, which can be easily cleaned and dust-free.

2, software configuration

1 quality management documents:

The PCR laboratory must establish a strict laboratory management system, establish a standardized operating procedure (SOP), establish a series of quality management documents, etc., to ensure that the daily operation of the laboratory meets the requirements of the Ministry of Health, to ensure accurate test results, to ensure laboratory health and safety, Ensure long-term stable operation of the laboratory;

Our company can provide quality management document models (including quality manuals, procedure documents, SOP documents) that meet the acceptance criteria of the Ministry of Health and are demonstrated by many experts and tested by long-term mature cases;

2 must pass the acceptance and certification of the National Clinical Testing Center;

3 Inspectors must pass the national training center's business training and obtain a certificate of conformity;

The staff in the PCR laboratory must participate in a clinical gene amplification training course organized by the Ministry of Health or the provincial clinical testing center, and be certified to work. The PCR laboratory passes the acceptance test, and at least two or more laboratories in the laboratory shall hold the “Clinical Genetic Testing Certificate”;

4) Reagents: CFDA and GMP certified PCR detection reagents.