Commentary and definitions
C1.9.1Laboratories undertaking nucleic acid amplification should be configured to minimise the risk of contamination of samples and reagents by other samples in the laboratory or by amplified material.
C1.9.2Laboratories undertaking nucleic acid detection from eukaryotic cells are viewed as being at significantly lower risk of contamination than those laboratories undertaking nucleic acid detection of microorganisms. In microbiology laboratories, microorganisms are present in samples in large numbers or are cultured at high concentrations. There is also greater potential for aerosol contamination because of the small size of microorganisms compared to eukaryotic cells.
C1.9.3The wording of the following sections is intended to allow flexibility of laboratory layout without compromising the guiding principle that laboratories undertaking nucleic acid amplification should be configured to minimise the risk of contamination of samples and reagents by amplified material or other samples in the laboratory.
C1.9.4The term ‘separate areas’ is used in the following sections to mean laboratory spaces that are used for nucleic acid based testing and are separated from other laboratory spaces by walls, distance or strict laboratory practice, or by performance of the test within the working space of an instrument, as dictated by the methods and technology available in the laboratory. The term ‘contained area’ means a laboratory space that can be isolated from the rest of the laboratory either by walls and doors or within the working space of an instrument.
Minimum standards for a nucleic acid amplification facility
C1.9.5The standards listed below are the minimum standards for a PCR laboratory using exclusively eukaryotic cells, tissues or isolated DNA.
S1.9.1Three physically separate areas are required in order to reduce the risk of cross-contamination or carry-over contamination.
S1.9.2The three areas required in each nucleic acid amplification laboratory are:
a) a separate area for the extraction of nucleic acids from samples and for the addition of sample DNA to tubes containing master mix before PCR amplification
b) a dedicated clean area for the preparation of reagents (including dispensing of the master mix)
c) a dedicated, contained area for amplification and product detection.