Hepatitis: Orta Mira N

Orta Mira N, Guna Serrano MR, Gimeno Cardona C, Pérez JL. · Programa de Control de Calidad Externo. Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica, Madrid, España. · Enferm Infecc Microbiol Clin. · Pubmed #19195441 links to  free full text

Abstract: The term quality assurance (QA) refers to the quality control activities related to analytical procedures performed in the clinical microbiology laboratory. QA should include both external and internal quality assessment. Application of quality control tools in molecular microbiology assays is crucial to ensure the accuracy of results and appropriate patient management. External quality control is used for laboratory intercomparisons, detection of random and systematic errors, evaluation of the suitability of some reagents or commercial diagnostic kits, and continuing education. The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes quality control procedures for molecular microbiology, as well as specific programs for quantitative determination of the viral load of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV), two highly important molecular markers in clinical settings due to their prognostic value and utility as a treatment guide. Internal quality control allows random and systematic errors to be detected through the inclusion of quality control samples in the assays performed in the laboratory, equipment monitoring, and audit. Evaluation of all molecular microbiology assays before their inclusion in the daily routine work of the laboratory is of utmost importance.

Anonymous00077, Orta Mira N, Guna Serrano Mdel R, Latorre Martínez JC, Ovies MR, Pérez JL, Gimeno Cardona C. · Programa Externo de Control de Calidad SEIMC, España. · Enferm Infecc Microbiol Clin. · Pubmed #19100161 links to  free full text

Abstract: BACKGROUND: Human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) viral load determinations are among the most important tasks performed in the molecular microbiology laboratory, due to their importance in patient follow-up. Quality control tools are crucial in these laboratories to ensure the accuracy of the results. This article presents the analysis of the results obtained in 2007 from the SEIMC External Quality Control Program for HIV-1 and HCV viral loads. METHODS AND RESULTS: In the HIV-1 program, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in a range of 2-5 log(10) copies/mL; to analyze repeatability, two of these standards were identical. The specificity was good for all the methods used by the participants, and only two out of 75 results were considered to be false positive results. A substantial proportion of the laboratories (20% on average) obtained values outside the accepted range (mean +/-0.2 log(10) copies/mL), depending on the standard and on the method used for quantification. A few errors were due to the transcription of the analytical result. Repeatability was also acceptable but approximately 15% of laboratories failed this evaluation. The HCV program consisted of two standards with different viral load contents. Most of the participants (94.6%) obtained results within the accepted range (mean +/-1.96 SD log(10) UI/mL), and interlaboratory variability was <0.5 log units for both standards and all techniques. CONCLUSIONS: Data from this analysis reinforce the utility of proficiency programs to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase in overall quality. Due to wide interlaboratory variability, the use of the same method and the same laboratory for patient follow-up is advisable.