EQC - Introduction
The “External Quality Control (EQC) Program for Molecular Biology”, set up by bcs Biotech srl in collaboration with the University Foundation “G. D’Annunzio” of Chieti and the Chair of Medical Genetics of the University of Cagliari, has the purpose to verify the variables that are encountered in the most commonly applied molecular laboratory technique.
Large scale development of new diagnostic methodologies based on molecular biology techniques has led to a growing need for standardization of procedures and control of the results. The peculiarity and complexity of molecular biology procedures, combined with the limited possibilities currently available for their automation, makes it necessary to adapt a method of verification that accounts for the variables encountered in the most commonly used molecular biology techniques, particularly in the phases of extraction of the nucleic acid from different biological matrices and amplification of gene targets.
The “External Quality Control (EQC) Program” has been designed to evaluate both the basic molecular biology methodologies (Level 1) and the different diagnostic methods used in the single laboratories (Level 2). Level 2 makes it possible to evaluate the methods in terms of specificity (ability to correctly detect the target sequence – Phase 2A) and in terms of sensitivity (detection limits with respect to known dilutions of the clone – Phase 2B).
Participation to the EQC makes it possible to:
a) use control samples that do not represent a biohazard, produced in one single batch
b) evaluate the efficacy of the extraction method starting from the biological matrix
c) evaluate carry-over phenomena during the different phases of the process
d) evaluate the efficacy of the reagents used
e) evaluate the specificity and sensitivity of the single diagnostic methods
obtain a “performance score” for the laboratory with respect to the other laboratories participating to the EQC Program.
