Overview of Analytic Phase

It is a truism that accurate pipettes, proper air circulation, and pure chemicals and active enzymes assure success in any analytic procedure. Molecular diagnosis is no exception to this. In addition, because molecular diagnosis often requires exponential target amplification before detection of a sequence of interest, sequestration of amplified materials (post-PCR) from incoming patient samples and preparation 

Samples should be accessioned into a computerized database, consistent with federal regulations (21CFR). Most rules concerning a compliant database have to do with whether the structure provides for an audit trail, so that anyone who has viewed or written to the database can be traced. Handwritten accessioning procedures are strongly encouraged as well. 

The specimen will be the basis for the analytic analysis. Is it RNA or DNA What is the origin of the tissue Amniocentesis Was it a spontaneous product of conception Were anatomic pathology slides or tissue blocks prepared Are cell lines involved Are these primary or immortalized Was a chorionic villus sampling procedure done Is the sample properly collected peripheral blood The answers to each of these questions should be noted, and considered part of the validation of a useful nucleic acid extraction method. A molecular diagnostics laboratory should adhere to the highest standards in providing services, and prior validation of applicable nucleic acid extraction procedures is a must to ensure high-quality service. 

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