Quality Control in RT-PCR Viral Load Assays: Evaluation of Analytical Performance for HIV, HBV, and HCV.
EJIFCC
; 35(2): 91-99, 2024 Aug.
Article
em En
| MEDLINE
| ID: mdl-39247663
ABSTRACT
Introduction:
Quality Control Management (QCM) in clinical laboratories is crucial for ensuring reliable results in analytical measurements, with biological variation being a key factor. The study focuses on assessing the analytical performance of the Reverse Transcription Polymerase Chain Reaction (RT-PCR) system for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), and Hepatitis C (HCV). Five models proposed between 1999 and 2014 offer different approaches to evaluating analytical quality, with Model 2 based on biological variation and Model 5 considering the current state of the art. The study evaluates the RT-PCR system's analytical performance through Internal Quality Control (IQC) and External Quality Control (EQC). Materials andMethods:
The Laboratório Central de Saúde Pública do Estado do Ceará (LACEN-CE) conducted daily IQC using commercial kits, and EQC was performed through proficiency testing rounds. Random error, systematic error, and total error were determined for each analyte.Results:
Analytical performance, assessed through CV and random error, met specifications, with HIV and HBV classified as "desirable" and "optimal." EQC results indicated low systematic error, contributing to total errors considered clinically insignificant.Conclusion:
The study highlights the challenge of defining analytical specifications without sufficient biological variability data. Model 5 is deemed the most suitable. The analytical performance of the RT-PCR system for HIV, HBV, and HCV at LACEN-CE demonstrated satisfactory, emphasizing the importance of continuous quality control in molecular biology methodologies.
Coefficient of Variation; External Quality Control; HBV (Hepatitis B Virus): HCV (Hepatitis C Virus); HIV (Human Immunodeficiency Virus); Internal Quality Control; Levey-Jennings Chart; RT-PCR (Reverse Transcription Polymerase Chain Reaction); Random Error; Systematic Error; Total Error; Westgard Rules
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
EJIFCC
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Itália