ABSTRACT
The study presents a historical analysis of the problems of standardization of methods for determining ESR. The modern approaches to the automation of ESR research are presented. It is shown that the solution to the problems of standardization of methods for determining ESR lies in the plane of regular intra-laboratory quality control. In accordance with the principles of evidence-based medicine, recommendations are given on the use of methods for determining ESR in clinical practice.
Subject(s)
Blood Sedimentation , Humans , Quality Control , Reference StandardsABSTRACT
Se formulan recomendaciones de un grupo de consenso de expertos sobre los criterios para evaluar el desempeño diagnóstico (tamaño y selección de muestras para sensibilidad y especificidad analíticas, criterios para establecer límites de detección, criterios para establecer el estándar de oro para las serologías) que deberían ser tenidos en cuenta al evaluar y validar las pruebas diagnósticas para SARS CoV-2. Con el propósito de asegurar la calidad de las pruebas serológicas a utilizar en el país, se recomienda la participación en un programa de control de calidad externo, que garantice la idoneidad y desempeño en la realización de las pruebas diagnósticas serológicas y moleculares durante esta pandemia, ya que su uso tiene profundas implicaciones para las medidas de intervención clínicas individuales y de seguimiento y control en salud pública.
We formulate recommendations from a consensus working group on the criteria to evaluate the diagnostic performance (size and criteria of selection of samples to determine sensitivity, analytical specificity, criteria for limit of detection, criteria for gold standard to evaluate serological assays) that should be taken into account during the evaluation and validation/verification of diagnostic tests for SARS CoV-2 infection. A national external quality control program should be established to guarantee the suitability and performance of these diagnostic serological and molecular tests during this pandemic, that will have deep implications for decisions on clinical and public health.
Subject(s)
Humans , Male , Female , Quality Control , Pandemics , Consensus , Diagnostic Tests, Routine , Laboratory Test , COVID-19 Testing , SARS-CoV-2 , InfectionsABSTRACT
The purpose - evaluated the quality of the implementation of hematology studies using sigmametry. Studies were perfomed at the Federal state budgetary establishment "Federal center cardiovascular surgery". The data were collected in the period for 2017 y. The following hematology parameters were monitored daily: white cells, red blood cell, platelet, hemoglobin. For conducting laboratory quality control we used certified three-level (Level 1 (low) , Level 2 (normal)and Level 3 (High)) control material "CBC-XE Hematology control" ("R and D Systems", USA). The study of blood hematology parameters was carried out on an automatic hematology analyzer "Sysmex XT- 2000i" and "Sysmex XT- 1800i" ("Sysmex Corporation", Japan). Sigmametry values were calculated the CV (coefficient of variation), the systematic error (Bias) and the total allowable analytical error (TE max). On the analyzer «Sysmex XT- 2000i¼ sigma values for platelet were between 3 and 4. For white blood cells, red blood cells, hemoglobin the value of the sigma was greater than 4. On the analyzer «Sysmex XT- 1800i¼ for platelet, white blood cells, red blood cells, hemoglobin the value of the sigma was greater than 4. Based on the results obtained, we drew conclusions on the choice of control material and the frequency of the internal laboratory quality control. The introduction of sigmametry in the daily activities of clinic laboratory will improve the quality of the determination of platelet, which requires further observation.
Subject(s)
Hematology/instrumentation , Hematology/standards , Erythrocyte Count , Humans , Japan , Leukocyte Count , Platelet Count , Reproducibility of ResultsABSTRACT
OBJECTIVE:To provide a way to evaluate test capability for biological sample analysis laboratory,so as to im-prove this test quality. METHODS:By analyzing the use of measurement uncertainty in China and detailing the steps of biological sample analysis laboratory measurement uncertainty,the effects of measurement uncertainty on biological sample analysis laborato-ry are illustrated from two aspects of inner and outer quality control. RESULTS & CONCLUSIONS:National laboratories mainly examine the source of uncertainty through establishing mathematical model,and then uncertainty is evaluated. Uncertainty evalua-tion is a continuous process. Uncertainty assessment and assurance is the overall situation in a biological sample analysis laboratory quality control. Thus,biological sample analysis laboratory can find a method of self-testing capabilities by uncertainty evaluation, find the maximum uncertainty and eliminate or reduce it gradually,ultimately improve laboratory testing quality.
