Development of working reference materials for clinical virology.

Area of Science:

• Clinical diagnostics
• Molecular biology
• Virology

Background:

• Nucleic acid amplification technique (NAT)-based assays are increasingly used in clinical laboratories, replacing traditional methods.
• A lack of standardized reference materials hinders the implementation and control of in-house developed NAT assays.
• Variability in assay performance affects the reliability of diagnostic results.

Purpose of the Study:

• To develop and evaluate working standards, termed 'run controls,' for diagnostic NAT-based assays, particularly real-time PCR.
• To enable continuous monitoring of diagnostic NAT assay performance on a run-by-run basis.
• To facilitate inter-laboratory comparisons and improve the consistency of results in clinical microbiology.

Main Methods:

• Collaboration between the Clinical Virology Network (CVN), NIBSC, and HPA to develop run controls.
• Candidate run controls representing clinically relevant viral targets were prepared.
• Evaluation of run controls by CVN laboratories in routine diagnostic assays.

Main Results:

• Eight candidate run controls for viral targets have been prepared for evaluation.
• Preliminary data show significant variability in intra- and inter-assay detection of targets.
• The need for standardization in molecular diagnostics is highlighted by the results.

Conclusions:

• Development of standardized run controls is crucial for reliable NAT-based diagnostics.
• Continuous monitoring and inter-laboratory comparisons are essential for assay validation.
• Standardization efforts are necessary to improve the consistency and accuracy of molecular diagnostic results.