Adopting Traditional Quality Control Protocols to Monitor Molecular Diagnostic Tests

Abstract

Quality Control (QC) for molecular diagnostic tests encounters many challenges. The traditional QC practice of using homogeneous (consistent lot to lot) QC materials could be useful for molecular diagnostics but current QC practices for genetic tests are limited in their ability to detect and prevent errors. To address the QC gaps in molecular diagnostic quality assurance, protocols can be adopted from routine clinical chemistry laboratories. The objective of our study was emerged to find out the effectiveness of adopting the routine and homogeneous control samples to be monitored and statistically analyzed for shifts and trends to detect potential test performance problems before failure occurs and even before the establishments of actual mean and standard deviation. We used 10 curves of different Molecular Diagnostic Tests comparing the failure occurred before and after establishments of actual mean and standard deviation as an example of adoption. The result was highly insignificant (p> 0.05) comparing the number of finding before and after establishments of actual mean and standard deviation as an example of adoption. We concluded that adoption of Molecular Diagnostic Tests quality control charts could be an available and good solution to overcome the challenges facing current QC practices for genetic tests.