Requirements for the construction of molecular pathology laboratories

(1) Design principles of clinical gene amplification laboratory

    The standardized setting of clinical gene amplification laboratories can be found in the Interim Measures for the Management of Clinical Gene Amplification Laboratories and ISO015189/CNAS9

(2) Basic requirements for the venue:

    ① It shall not affect the quality of work, quality control procedures, or personnel safety.

    ② Beneficial for the normal operation of infrastructure (energy, lighting, ventilation, water supply, waste disposal, and environmental conditions, etc.)

(3) Regional division requirements:

    ① In principle, clinical gene amplification laboratories (specimen pre-treatment area, reagent storage and preparation area, specimen preparation area, amplification area, amplification product analysis area) should have independent ventilation systems and buffer rooms.

    ② According to the function of the instrument used, the regions can be appropriately merged, for example, using a real-time fluorescence PCR instrument, the amplification area and amplification product analysis area can be merged; By using an automated analyzer that integrates sample processing, nucleic acid extraction, and amplification detection, the sample preparation area, amplification area, and amplification product analysis area can be merged.

(4) Air flow direction requirements:

    ① There should be a certain ventilation pressure difference between each experimental area and buffer room to ensure reasonable air flow and prevent pollution.

    ② The air flow direction in the laboratory can be arranged according to the reagent storage and preparation area, specimen preparation area, amplification area, and amplification product analysis area to prevent amplification products from entering the pre amplification area through air flow.

(5) Equipment requirements:

    Divided by laboratory work area:

    ① Reagent storage and preparation area: It should include a refrigerator, mixer, micro sampler (covering 0.2-1000 μ L), fixed UV lamp and movable UV lamp (near the workbench), consumables, specialized work clothes, work shoes (covers), and specialized office supplies below 2-8 ℃ and -20 ℃.

    ② Specimen preparation area: should include a 2-8 ℃ refrigerator, a -20 ℃ or -80 ℃ refrigerator, a low-temperature high-speed centrifuge, a mixer, a water bath or heating module, a micro sampler, a movable UV lamp (near the workbench), a secondary biosafety cabinet, a UV spectrophotometer, consumables, specialized work clothes and shoes (sets), and specialized office supplies.

    ③ Amplification area: should include various nucleic acid amplification instruments, micro samplers, and movable ultraviolet lamps (near the workbench); Consumables, specialized work clothes and shoes, and specialized office supplies.

   ④ Product analysis area: It shall include equipment consistent with the test items, micro sampler, electrophoresis instrument equipment, gel imaging system, movable UV lamp (near the workbench), consumables, special work clothes, work shoes and special office supplies.