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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 and Methods: 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.
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Resumen La mayor accesibilidad a los tratamientos de reproducción asistida (RA) y los avances de la criobiología produjeron cambios en los laboratorios de andrología. El objetivo de este trabajo fue analizar la demanda y evolución de las variables seminales en las últimas dos décadas, caracterizar el laboratorio andrológico actual, evaluar el impacto de la incorporación del aseguramiento de la calidad y la inclusión de los sistemas computarizados (CASA). Se utilizaron datos de las medias mensuales del control de calidad interno (n=22 528) y encuestas a profesionales de laboratorios andrológicos (n=65) y a médicos especialistas en fertilidad (n=33). La demanda global se redujo significativamente con el aumento de las solicitudes de primera vez. El volumen y recuento, variables dependientes de andrógenos, disminuyeron con los años. El criterio estricto en morfología disminuyó el porcentaje de normales; la mitad de los médicos encuestados recibieron resultados entre 0 y 10% y el 40% consideró que ponía en riesgo el valor clínico de la variable. El sistema CASA permitió objetivar la cinética espermática e incrementar el porcentaje de progresivos rápidos, pero pocos laboratorios lo incorporaron. El 66% de los médicos resuelven el factor andrológico severo por tratamientos clínicos y el 95% utiliza técnicas de RA. El análisis de semen es ejecutado fundamentalmente por bioquímicos especializados, con baja adhesión a la automatización y acreditación del laboratorio, pero con participación en programas de evaluación externa de calidad. La demanda disminuyó como consecuencia del aumento del tratamiento por RA. La reducción del porcentaje de formas normales compromete su utilidad clínica.
Abstract Increasing availability to assisted reproduction (AR) treatments in Argentina and advances in cryobiology resulted in changes in andrology laboratories. The aim of this study was to evaluate the demand and evolution of seminal variables in the last two decades, characterise the current andrology laboratory, evaluate the impact of the incorporation of quality assurance and the introduction of computer assisted semen analysis (CASA). Data were taken from internal quality control (IQC) monthly means (n=22 528) and professionals in charge of laboratories (n=65) and fertility physicians' (n=33) surveys. Overall demand decreased significantly while first-time orders increased. Sperm volume and sperm count -androgen dependent parameters- decreased over the years. Strict morphology criteria reduced the percentage of normal results; half of the physicians received results between 0 and 10% and 40% considered that it compromised the clinical value of the variable. The CASA system made it possible to objectify sperm kinetic, increasing the percentage of fast progressives, but few laboratories have incorporated it. Sixty-six percent of physicians resolve severe andrological factor by clinical treatments and 95% use AR techniques in those cases. Semen analysis is mainly performed by specialised biochemists, with low adherence to laboratory automatisation and accreditation, but with participation in external quality assessment programmes. The demand decreased because of the increase in AR treatment. The lower percentage of normal forms compromises their clinical utility.
Resumo O aumento do acesso aos tratamentos de reprodução assistida (RA) e os avanços na criobiologia levaram a mudanças nos laboratórios de andrologia. O objetivo deste trabalho foi analisar a demanda e a evolução das variáveis de sêmen nas últimas duas décadas, caracterizar o laboratório de andrologia atual, avaliar o impacto da incorporação da garantia da qualidade e a inclusão dos sistemas computadorizados (CASA). Foram utilizados dados das médias mensais do controle de qualidade interno (n= 22 528) e pesquisas a profissionais de laboratórios andrológicos e a médicos especialistas em fertilidade (n=33). A demanda geral diminuiu significativamente com o aumento das solicitações de primeira vez. O volume e a contagem de esperma, parâmetros dependentes de andrógenos, diminuíram ao longo dos anos. O critério morfológico rigoroso diminuiu a porcentagem de normais; metade dos médicos entrevistados recebeu resultados entre 0 e 10% e 40% considerou que isso comprometía o valor clínico do parâmetro. O sistema CASA, permitiu objetivar a cinética espermática e aumentar o percentual de progressões rápidas, mas poucos laboratórios o incorporaram. 66% dos médicos resolvem o fator andrológico grave por tratamentos clínicos e 95% utilizam técnicas de RA nesses casos. A análise do sêmen é realizada principalmente por bioquímicos especializados, com baixa aderência à automação e acreditação laboratorial, mas com participação em programas de avalação externa de qualidade. A demanda diminuiu como consequência do aumento do tratamento por RA. A diminuição em percentagem de formas normais compromete sua utilidade clínica.
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INTRODUCTION: Quality control for the detection of infectious markers in blood banks is a necessary activity to ensure the accuracy of donor screening results. Considering that in Mexico blood safety is one of the goals of the National Action Programs, it is essential to evaluate banks through an External Quality Control Program. OBJECTIVE: To analyze one of the evaluations that showed the greatest participation (2014-2/lot46) of banks in the Mexican Republic in the detection of transfusion-transmitted diseases. MATERIALS AND METHODS: A randomized panel of infectious markers of HIV, HCV, HBV, Treponema pallidum and Trypanosoma cruzi was manufactured under high quality standards. The evaluation criteria for each infectious marker were the identification of false positives and false negative results. Additionally, technologies used to detect infectious markers were requested for each bank. RESULTS: Of the 503 banks, only 374 participated in the evaluation. Technologies based on chemiluminescence, immunofluorescence and immunocolorimetry were used to detect viral markers. Even rapid tests for T. pallidum continue to be the methods of choice with 42%. Trypanosoma cruzi was 20% with fast techniques versus 80% with automated tests. Highest incidence of false positives was identified for T. pallidum and HBV, followed by T. cruzi, HIV and HCV. Fourteen (3.74%) false negatives results were identified for T. cruzi, followed by T. pallidum (nâ¯=â¯5/1.33%), HCV (nâ¯=â¯4/1.06) and HVB/HIV (nâ¯=â¯2/0.53%). CONCLUSION: False positive results identified for each infectious marker was considered high. This evidence will allow us to focus on areas of opportunity during serologic screening with greater emphasis on good laboratory practices.
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Armazenamento de Sangue/métodos , Bancos de Sangue/normas , Segurança do Sangue/métodos , Segurança do Sangue/normas , Infecções/sangue , Infecções/diagnóstico , Biomarcadores/sangue , Feminino , Humanos , Masculino , México , Controle de QualidadeRESUMO
Quality control procedures are indispensable to ensure the reliability of the results provided by laboratories responsible for serological screening in blood banks. International recommendations on systems of quality management classify as a top component the inclusion of two types of control: (a) internal quality control (IQC) and (b) external quality control (EQC). In EQC it is essential to have, at least, a monthly frequency of laboratory assessment. On the other hand, IQC involves the daily use of low-reactivity control sera, which should be systematically added in all run, carried out in the laboratory for each parameter. Through the IQC analysis some variations in the criteria of run acceptance and rejection may be revealed, but it is of paramount importance to ensure the previous definition of these criteria and even more importantly, the adherence to them; and that corresponds to the validation of analytical runs of each test. Since 2010 this has been, for instance, the experience of the PNCQ*, developing external quality control programmes on serology for blood banks. These programmes use samples of lyophilized sera well-characterized for the reactivity related to the parameters used for the serological screening of blood donors. The programmes have used blind panels of six samples for monthly assessments. In the last 50 assessments, which involved 68 blood banks in Brazil, a significant number of instances of non-compliance were observed in all monthly assessments. These results provide strong support to the recommendation of systematic monthly assessments. (*) National Quality Control Programme (PNCQ).
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En diciembre de 2005 se inició el Programa de Evaluación Externa de la Calidad (PEEC) para Laboratorios Andrológicos, organizado por la Facultad de Farmacia y Bioquimica, UBA y la Fundación Bioquímica Argentina. El objetivo del presente trabajo es informar la respuesta obtenida a la convocatoria de participar en el PEEC, dar a conocer los resultados de las primeras encuestas y compararlos con los relatados por otros programas extranjeros. Los parámetros evaluados fueron movilidad (video), morfología (fotografías digitales en CD) y recuento espermático (RE) (suspensiones de espermatozoides). Se solicitó utilizar la estandarización OMS 1999. Participaron 60 laboratorios. Los valores de Error de Medida Permitidos (EMP) fueron de 60%, 50%, 15% y 30% para morfología, movilidad progresiva rápida (MPR), movilidad progresiva (MP) y RE, respectivamente. Los resultados hallados fueron similares a los publicados por el Programa de Control de Calidad Externo del ASEBIR-España para el "nivel óptimo" de las especificaciones de calidad del "estado del arte". Cuando el requerimiento de calidad fue "variabilidad biológica", los EMP disminuyeron significativamente para morfología y MPR: 28,2% y 29,3% no así para MP y RE. La alta aceptación de la convocatoria pone de manifiesto la necesidad de un PEEC-Andrología. El elevado Error de Medida obtenido para morfología y movilidad progresiva rápida denota la necesidad de estandarizar los procedimientos y criterios para lograr el requerimiento de calidad de variabilidad biológica.
In December 2005 began the first External Quality Assessment Scheme (EQAS) for Andrology Laboratories organized by the School of Pharmacy and Biochemistry (University of Buenos Aires) and the Fundación Bioquímica Argentina. The aim of this study was to inform the response obtained after the enrollment to participate in the first Argentine EQAS, to discuss the results obtained in the first surveys and to compare them with the ones reported by other foreign programs. The evaluated parameters were sperm motility (videotapes), morphology (digital photography) and concentration (SC) (suspensions of spermatozoa). Participants were asked to follow WHO 1999. Nearly 60 laboratories throughout Argentine participated. The Total Allowable Error was 60%, 50%, 15% and 30% for morphology, progressive rapid motility (PRM), progressive motility (PM) and SC, respectively. The results found were similar to those published by the External Quality Program of the ASEBIR-Spain for the "optimum quality specification" on the "State of the art". When the established requirement of quality was "Biological Variability", the Total Allowable Error decreased significantly for morphology and PRM: 28.2% and 29.3% but not for PM and SC. The present data confirms the need for a Scheme. The high Total Error obtained for morphology and progressive rapid motility demamds to standardizing the procedures and establishing analytical goals based on Biological Variability.