Good Clinical Laboratory Practice (GCLP) for Molecular Based Tests Used in Diagnostic Laboratories

Abstract

Over the past decade there has been an expansion in molecular based technologies in the diagnostic environment. These molecular based technologies almost always involve Polymerase Chain Reaction of either DNA (PCR) or RNA (RT-PCR), but can also include isothermal amplification and/or sequencing. These molecular tests can be used for rapid qualitative or quantitative analysis for: Detection of infectious disease Viral load monitoring (HIV, HBV, HCV etc...) HIV diagnosis in paediatrics Translocations Mutations Gene rearrangements Forensic medicine Several important steps need to be followed to ensure that a quality service is offered by a molecular laboratory. The quality of the test result is linked to a number of factors. It is reliant on activities that both directly and indirectly impact on the quality of the test ensuring that reliable and accurate results are obtained. There are several benefits to having a quality system in place, it allows for monitoring of the entire system, detects and limits errors, improves consistency among different testing sites and helps to contain costs. Good Laboratory Practice (GLP) is defined in the Organisation for Economic Co-operation and Development (OECD) as “a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported”. The purpose of the Principles of Good Laboratory Practice is to promote the development of quality test data and provide a tool to ensure a sound approach to the management of laboratory studies, including conduct, reporting and archiving. Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected; consistent