Study on performance specifications of 34 routine chemistry analytes in China / 中华检验医学杂志

Objective:The allowable total error ( TEa),allowable imprecision ( CV)and allowable bias( Bias)were recommended for 34 routine chemistry analytes in China. Methods:According to the performance specification setting mode newly determined at the Milan conference in Italy,the performance specification was derived based on components biological variation (BV)and current state of the art mode. The data(including EQA data and IQC data)of laboratories participating in the routine chemistry and lipids and lipoproteins EQA activities of the national center for clinical laboratories from 2019 to 2021 was collected through clinet-EQA. For the analytes with biological variation(BV)data,compared the'percentage difference′ of EQA data and the'in-control coefficient of variation of the month′ of IQC data of each research analyte with the three levels evaluation criteria derived based on BV,and calculated the percentage difference passing rate and CV passing rate of all batches in each year. When the passing rate reaches 80%,the performance specifications of this level met the requirements of the recommended performance specifications of the analyte. For the analytes without BV data or analytes whose performance specifications at three levels derived based on BV could not be used as recommended standards,the recommended performance specifications are derived based on the current state of the art. After obtaining the recommended TEa and allowable CV for each analyte,used the formula | Bias|≤ TEa-z? CV to derive the recommended allowable bias. Results:The results of TEa ( CV)% recommended by 34 analytes are as follows:K4.7(2),Na4(1.5),Cl4(1.4),Ca5(2),P9.6(3.9),Glu6.4(2.5),Urea8(3),UA12(4.1),Cre11(3.3),TP5(2),Alb5.2(2.4),TC8.6(2.7),TG13.5(5),HDL-C16.5(4.3),LDL-C20.5(6.2),ApoAⅠ16(5.3),ApoB 17.1(5.5),Lp(a) 24.1(10.4),TBil 12.4(5),DBil 20(7.3),ALT16(5),AST13.5(4.8),ALP17.5(4.8),AMY13.1(3.3),CK11.3(3.8),LDH11(3.9),CHE13.4(5.3),LIP20(6.9),Fe13.3(5.2),Mg14(4.5),Cu17.9(6.8),Zn15.1(6.4),γ-GGT10(3.3),α-HBDH18(5.8).The formula | Bias|≤ TEa-z? CV is used to derive the allowable bias of 34 analytes. Conclusions:For 34 clinical routine chemistry quantitative analytes,the allowable total error,allowable imprecision and allowable bias that meet the current state of the art of Chinese laboratories are recommended.

Establishing allowable total error for serum total folate in external quality assessment / 中华检验医学杂志

Objective:To establish the allowable total error (TEa) of the national external quality assessment (EQA) program in line with the current quality level of serum folate measurement in China.Methods:The data of serum total folate test in the clinical laboratory of a hospital in Beijing in 2016 were collected, and the Stata SE 15 software was used for Monte Carlo simulation to obtain the false-negative rate under different bias and inaccuracy conditions. The Origin Pro 9.1 software was used to make the contour figure. The TEa of serum total folate test is derived based on the acceptable false-negative rate. National EQA data of serum total folate in 2020 were collected to calculate the pass rate of participating laboratories and the laboratory pass rate of quality control products at each level under the five TEa derived from the analysis performance on clinical outcomes, biological variation, and the evaluation criterion of national EQA.Results:Based on the influence of analytical performance on clinical outcomes, the TEa was 10%. Under this TEa, the pass rate of the first EQA program of serum total folate in 2020 was more than 80%, and the pass rate of the second time was 73.1%. Under the minimum (46.57%) and appropriate level of TEa (15.52%) derived from biological variation and national EQA evaluation criterion, the pass rate of serum total folate in the two EQA programs in 2020 exceeded 85%.Conclusion:The analytical performance of serum total folate in China cannot meet the requirements of TEa derived based on the effect of analytical performance on clinical outcomes. An appropriate level of TEa derived based on biological variation (15.52%) is suggested as the recommended criterion for the TEa of serum total folate test.

Application of total error concept in the analytical method validation for the assay of essential amino acids by precolumn derivatization

A pre-Ultraperformance Liquid Chromatography (UPLC) column derivatization procedure was developed for thesimultaneous quantification of essential amino acids (EAAs) in the solid oral dosage pharmaceutical formulation.This analytical procedure has been validated with the help of the concept of total error. The total error approach (thecombination of systematic and random error) is a decision-making tool for ensuring the performance of the method.Fluorenylmethyloxycarbonyl chloride was used as a derivatization reagent. The amino acid derivatives were separatedon a C18 column (internal diameter 2.1 × 100 mm, 1.6 µm) by gradient elution with 0.1% trifluoroacetic acid andacetonitrile:water (90:10, v/v), respectively, as mobile phase A and B. About 10 EAAs could be detected at 265 nm in35 minutes with a flow rate of 0.25 ml/min. The linearity range of each amino acid was between 0.1 and 1.0 mg/ml.The accuracy and risk profiles were considered acceptable across the range. The precolumn derivatization procedureand the concept of the validation of total error could be used as an appropriate strategy to demonstrate the suitabilityof the analytical procedure for the separation and evaluation of EAA in solid oral dosage formulations.

Evaluación de la calidad de los procesos analíticos en un laboratorio clínico mediante el cálculo del error total y la métrica seis sigma / Evaluation of the analytic processes quality in a clinical laboratory by means of the calculation of the total error and the sigma six metrics

Se realizó una investigación experimental, retrospectiva y longitudinal en el Laboratorio Clínico del Hospital Oncológico Docente Provincial Conrado Benítez García de Santiago de Cuba, con vistas a evaluar la calidad de los procesos analíticos por medio del cálculo del error total y la métrica seis sigma, para lo cual se tomaron los parámetros de glucemia, colesterol, gammaglutamil transferasa y alanina aminotransferasa, registrados en el control de calidad interno mensual durante el año 2017. La evaluación de cada medición química se había efectuado con dos controladores: Elitrol 1 y Elitrol 2. En más de 90 % de los meses fue aceptable la competencia en la determinación de los analitos controlados, excepto en la glucemia 1; así mismo existió un desempeño aceptable en las mediciones de la gammaglutamil transferasa y la alanina aminotransferasa, mientras que la glucemia y el colesterol mostraron el nivel inferior. Se concluyó que el cálculo del error total y la métrica seis sigma fortalecen el control de la calidad interno, garantizan la calidad de los resultados través del laboratorio clínico y, con ello, la calidad de la asistencia médica a los pacientes.

An experimental, retrospective and longitudinal investigation was carried out in the Clinical Laboratory of Conrado Benítez García Teaching Provincial Oncological Hospital in Santiago de Cuba, with the aim of evaluating the quality of the analytic processes by means of the total error calculation and the sigma six metrics, for which the glycemia, cholesterol, gammaglutamyl transferase and alanina aminotransferase parameters were used, registered in the monthly internal quality control during the year 2017. The evaluation of each chemical measurement had been carried out with two controllers: Elitrol 1 and Elitrol 2. In more than 90 % of the months, the competence in the determination of the controlled analyte was acceptable, except in the glycemia 1; also an acceptable performance existed in the mensurements of the gammaglutamyl transferase and the alanina aminotransferase, while the glycemia and the cholesterol showed the lower level. It was concluded that the calculation of the total error and the sigma six metrics strengthen the control of the inner quality, they guarantee the quality of the results through the clinical laboratory and, thus, the quality of the medical care to the patients.

Especificaciones de calidad en base a error total: ¿Cuál es la mejor elección? / Quality specifications based on total error: What's the best choice? / Especificações de qualidade com base em erro total: Qual é a melhor escolha?

El objetivo del trabajo fue evaluar el desempeño anual de los métodos, en términos de error total (ET), las distintas especificaciones de calidad disponibles y el modelo Seis Sigma para calificar desempeño. Se evaluaron analitos con variabilidad biológica (VB), muy baja, baja, media y alta. Se calculó el ET (ETc) y el sigma (s) mensual a dos niveles de control; el ET permitido (ETp) para cada analito se obtuvo de 8 fuentes (metas biológicas y regulatorias). Se consideró desempeño aceptable cuando ETc

The aim of this work was to evaluate the annual performance of the methods in terms of total error (TE), the different quality specifications available, and the Six Sigma model to qualify performance. Analytes with very low, low, medium and high biological variability (BV) were evaluated. TE (TEc) and sigma (s) were calculated monthly at two levels of control; allowable TE (TEa) for each analyte was obtained from 8 sources (biological and regulatory goals). Acceptable performance was considered when TEc

O objetivo do trabalho foi avaliar o desempenho anual dos métodos em termos de erro total (ET), as diferentes especificações de qualidade disponíveis e o modelo Seis Sigma para qualificar desempenho. Foram avaliados analitos com variabilidade biológica (VB) muito baixa, baixa, média e alta. Calculou-se ET (ETc) e o sigma (s) mensal a dois níveis de controle; o ET permitido (ETp) para cada analito foi obtido de 8 fontes (metas biológicas e regulatórias). Levou-se em consideração o desempenho aceitável quando ETc < ETp e s≥3. Foi observada a estabilidade analítica durante o período de avaliação. Não foram alcançadas as metas biológicas para analitos com VB muito baixa, algo semelhante aconteceu para analitos com VB baixa e média; com VB alta alcançaram todas as especificações. O desempenho s e a regra de controle de Westgard dependeram do ETp escolhido; para magnésio, com CLIA (ETp=25%) se obteve s >10 (World Class) e simples regra (13s), com VB mínima s <3 e multirregra. Conclui-se que a aceitação do desemperno do método e as regras de controle dependeram do ETp escolhido, sem disporem nesse meio de metas mínimas a alcançar. O monitoramento mensal do ETc mostrou a estabilidade analítica com variabilidade típica de cada método.

Evaluación de los límites analíticos de desempeño del laboratorio del HIGA O. Alende de Mar del Plata / Evaluation of analytical limits of performance in the laboratory of HIGA O. Alende of Mar del Plata / Avaliação dos limites analíticos de desempeno do laboratório do HIGA O. Alende de Mar del Plata

Los límites analíticos de desempeño (LAD) forman parte del diseño del programa de control de calidad analítico. Los objetivos de este trabajo fueron determinar imprecisión (CV), error sistemático (ES) y error total (ET) de 14 analitos de Química Clínica en los sectores de planta y de guardia del laboratorio del HIGA O. Alende de Mar del Plata, evaluar su desempeño analítico según variabilidad biológica y comparar los datos obtenidos. Se realizó un estudio retrospectivo con el registro de controles de calidad y se utilizaron los LAD derivados de VB para obtener las especificaciones de calidad para CV, ES y ET. Respecto del CV, cumple con los criterios el 79% en el sector planta y el 64% en el de guardia. Y en cuanto al ET, cumple el 90% y el 75%, respectivamente. En conclusión, aunque la mayoría de los analitos evaluados cumplen al menos con los criterios mínimos establecidos, los resultados ponen de manifiesto la necesidad de mejorar el desempeño analítico. Detectar los tipos de errores presentes en el proceso de laboratorio es el primer paso para instaurar controles de procedimiento y análisis, soluciones que permitirán mejorar la calidad analítica, uno de los pilares que optimizan la seguridad del paciente.

The analytical limits of performance (ALP) are part of the programme design of analytical quality control. The goals of this study were to determine imprecision (VC), systematic error (SE) and total error (TE) of 14 clinical chemistry analytes in the routine and emergency laboratory of HIGA O. Alende of Mar del Plata, to evaluate their analytical performance in accordance with biological variability, and compare the data obtained. A retrospective study was performed using the record of quality controls. The ALP were obtained from BV to get the quality specifications for VC, SE and TE. Regarding VC, 78% of the analytes meet the criteria in the routine laboratory and 64% in the emergency. Regarding TE, in the routine laboratory, 90% meet the TE criteria, and 75% in the emergency. It can be concluded that, although most of the evaluated analytes meet at least the minimum established criteria, the results highlight the need to improve the analytical performance. Detecting the types of errors in the laboratory process is the first step to establish procedural and analysis controls. These are solutions that will improve the analytical quality, one of the pillars to optimize patient safety.

Os limites analíticos de desmpeño (LAD) são parte do desenho do programa de controle de qualidade analítico. Os objetivos deste estudo foram determinar a imprecisão (CV), o erro sistemático (ES) e o erro total (ET) de 14 analitos de Química Clínica nas áreas de planta e de plantão do laboratório HIGA O. Alende de Mar del Plata, avaliar seu desempenho analítico de acordo com a variabilidade biológica e comparar os dados obtidos. Um estudo retrospectivo foi realizado com o registro de controles de qualidade utilizando os LAD derivados de VB para obter as especificações de qualidade para CV, ES e ET. Quanto ao CV, 79% cumpre com os critérios no setor da planta e 64% no setor de plantão. E, quanto ao ET, cumpre 90% e 75% respectivamente. Em conclusão, embora a maioria dos analitos testados cumpra pelo menos com os critérios mínimos estabelecidos, os resultados destacam a necessidade de melhorar o desempenho analítico. Detectar os tipos de erros encontrados no processo de laboratório é o primeiro passo para estabelecer controles de procedimento e análise, soluções que permitirão melhorar a qualidade analítica, um dos pilares que otimizam a segurança do paciente.

The evaluation of clinical performance for blood gas analyzer: MB-3100 / 中国医学装备

Objective:To estimate the precision and accuracy performance of blood gas analyzer(MB-3100) for three measuring indicators: pH, pCO2 and pO2.Methods: The evaluation of precision was achieved by testing quality controls of BIO-RAD, and the mean, SD and CV of the results were calculated according to protocol EP5 of Clinical and LaboratoryStandards Institute(CLSI). The evaluation of accuracy was achieved by comparing MB-3100 and Rapidlab 1265 according to the EP9-A2 of CLSI, and the consistency check of the two detection systems were analyzed by using paired t- test and equation of linear regression. All of these results were analyzed by using SPSS19.0.Results: The results of the research showed that the precision performances of analyzer MB-3100 in various detection level were acceptable. And there was no statistically significant difference for the accuracy performances between the two systems on pH, pCO2 and pO2, respectively (t=0.042,t=1.489,t=-1.6,P>0.05). Moreover, both of the system errors of the two systems at different medical decision level were less than the corresponding total error allowances (TEa), respectively.Conclusion: Both of the precision and accuracy performances of MB-3100 blood gas analyzer are acceptable, and it can provide reliable reports for clinical practice.

Further Understanding of Measurement Uncertainty in Clinical Laboratory Medicine / 现代检验医学杂志

In clinical laboratory medicine,measurement uncertainty (MU) is a fixed property of testing results in the measuring system.As an important part of ISO 15189,it is necessary for clinical laboratories to determine MU during the period of validation and verification for each measurement procedure and to review MU over time.Now,testing reports provided by clinical laboratories usually do not offer MU,but some clinical laboratories have already estimated MU in their routine work.Estimation andmonitoring of MU can help clinical laboratories offering more accurate results and provide objective tools for clinicians used in result intcrpretatinn.Generally,result interpretation can be achieved by the result comparison with three main comparators,including a previous result from the same patient,a population reference interval and a clinical decision point.The means of true value and the components contributing to the estimation of MU are both different when the com parison is conducted between testing results and different comparators,so the optimum estimation method of MU is accordingly different,which will subsequently affect the MU value and the determination of clinical decisions.Obviously,depending on the actual clinical uses,laboratories can choose appropriate comparators to the result interpretation and the determination of optimum estimation method of MU.For different clinical uses (diagnosis or monitoring) of the same mearurands,the adoption of different estimation methods should be used to acq uire reasonable MU.By interpreting the concept,characteristics,estimation,and uses of MU,as well as explaining how three main comparison methods of results exploit their own traceable chain to get MU,this paper intends to help clinical laboratories get further understanding of the importancc of MU and provide guidance for the MU estimation in routine work.

Requerimientos de calidad en hemostasia: Variabilidad biológica versus estado actual de la metodología / Quality requirements in hemostasis: Biological variability versus the state of art / Requisitos de qualidade em hemostasia: Variabilidade Biológica versus o Estado atual da metodología

El objetivo del trabajo fue comparar los requerimientos de calidad (RC) de Variabilidad Biológica (VB) con el Estado Actual de la Metodología (EA) en ocho analitos de hemostasia. Se determinó el EA calculando el Coeficiente de Variación promedio ponderado (CVpp) de al menos 6 evaluaciones externas: RIQAS (ET1) y CAP (ET2). Los datos de Error Total aceptable (ETa) por VB mínimo (VBm) y deseable (VBd) se calcularon a partir de los CV intra e inter individuos reportados en www.westgard.com. Los datos obtenidos: Tiempo de Protrombina (TP segundos): ETVBm 7,9%, ETVBd 5,3%, ET1 19%, ET2 13%; Tiempo parcial de tromboplastina activada: (APTT segundos): ETVBm 6,7%, ETVBd 4,5%, ET1 23%, ET2 11%. INR: ETVBm 7,9%, ETVBd 5,3%, ET1 20%, ET2 16%; Fibrinógeno: ETVBm 20,4%, ETVBd13,6%, ET 10%, ET2 16%, FVIII: ETVBm13,3%, ETVBd 8,9%, ET1 30%, ET2 45%, FVII ETVBm16,1%, ETVBd 10,7%, ET1 31%, ET2 42%, Proteína C cromogénica (PCc) ETVBm 28%, ETVBd 18,7%, ET1 36%, ET2 25%; Proteína S libre (PSl ): ETVBm 31,1%, ETVBd 20,7%, ET1 18%, ET2 28%; Antitrombina cromogénica (ATc): ETVBm 12,5%, ETVBd 8,9%, ET1 18%, ET2 28%. Los únicos analitos que cumplen con el requerimiento de calidad de VBm o VBd son: fibrinógeno, PC y PS. Si bien cada laboratorio puede decidir las especificaciones de calidad que desea aplicar, la cuestión a debatir es: "cuál es el requerimiento de calidad deseable para la utilidad clínica de estos ensayos".

The aim of this work was to compare the quality requirements of biological variability (BV) with the state of the art (SA) in eight hemostasis analytes. SA was determined by calculating the weighted average coefficient of vari ation (CVwa) of at least 6 external evaluations: RIQAS (ET1) and CAP (ET2). Data acceptable total error (TEa) for minimum and desirable biological variability (VBm y VBd) was calculated from the coefficient of variation (CV) within-subject and between subject www.westgard.com reported. The following was the data : Prothrombin time ( PT second): ETVBm 7.9%, ETVBd 5.3%, ET1 19%, ET2 13%; Activated partial thromboplastin time (second APTT): ETVBm 6.7%, ETVBd 4.5%, ET1 23%, ET2 11%; INR: ETVBm 7.9%, ETVBd 5.3%, ET1 20%, ET2 16%; Fibrinogen: ETVBm 20.4% ETVBd 13.6% ET1 20%, ET2 16%, FVIII: ETVBm 13.3%, ETVBd 8.9%, ET1 30%, ET2 45% ; FVII: ETVBm 16.1%, ETVBd 10.7%, ET1 31%, ET2 42%; chromogenic Protein C (PCc): ETVBm 28%, ETVBd 18.7%, ET1 36%, ET2 25%; free Protein S (PSf ): ETVBm 31.1% ETVBd 20.7%, ET1 18%, ET2 28%; chromogenic Antithrombin (ATc): ETVBm 12.5%, ETVBd8.9%, ET1 18%, ET2 28%.The only analytes that meet the VBm or VBd quality requirement are fibrinogen, PC and PS. While each laboratory can decide the quality specifications it wants to apply, the issue to be discussed is: "what is the desirable quality requirement for clinical usefulness of these tests?"

O objetivo do trabalho foi comparar os requisitos de qualidade (RQ) de variabilidade biológica (VB) com o estado atual da metodologia (EA) em oito analitos de hemostasia. Foi determinada a EA através do cálculo do coeficiente de variação médio ponderado (CVmp) de pelo menos 6 avaliações externas: RIQAS (ET1) e CAP (ET2). Os dados de erro total admissível (ETa) para VB mínimo desejável (VBm) e (VBd) foram calculados a partir do CV intra e inter indivíduos reportados em www.westgard.com. Os dados obtidos: Tempo de Protrombina (TP segundos) ETVBm 7,9%, ETVBd 5,3%, ET1 19%, ET2 13% ; Tempo parcial de tromboplastina ativada (APTT segundos): ETVBm 6,7%, ETVBd 4,5%, ET1 23%, ET2 11%; INR: ETVBm 7,9%, ETVBd 5,3%, ET1 20%, ET2 16%; Fibrinogênio: ETVBm 20.4%, ETVBd 13,6%, ET1 20%, ET2 16%; FVIII: ETVBm 13,3%, ETVBd 8,9%, ET1 30%, ET2 45%; FVII: ETVBm 16,1%, ETVBd 10,7%, ET1 31%, ET2 42%; Proteína C cromogênica (PCc): ETVBm 28% ETVBd 18,7%, ET1: 36%, ET2: 25%; Proteína S livre (PSl ): ETVBm: 31,1%, ETVBd 20,7%, ET1: 18%, ET2: 28%; Antitrombina cromogênica (ATc): ETVBm12,5%, ETVBd 8.9%, ET1 18%, ET2 28%. Os únicos analitos que atendem o requisito de qualidade de VBm ou VBd são: fibrinogênio, PC e PS. Embora cada laboratório possa decidir as especificações de qualidade que deseja aplicar, a questão a ser discutida é "qual é o requisito de qualidade desejável para a utilidade clínica destes testes?".

Total Error and Measurement Uncertainty in Clinical Laboratory Medicine / 现代检验医学杂志

In the clinical laboratory medicine,the measurement uncertainty (MU)is a relatively new concept.Over the years, experts of clinical laboratory medicine from all over the world made a great number of further researches and promote the development of MU,which led clinical laboratories to pay more and more attention to the meanings and functions of MU at the same time.However,because of the habitual using of the total error (TE)in clinical laboratories and similarities between concepts of MU and TE which easily resulted in confusion,a lot of laboratories still cannot completely accept MU.By explai-ning concepts of TE and MU and analyzing the pros and cons of models of TE and MU as well as their functions,the obj ec-tive of this paper is to help clinical laboratories make further comprehensions of TE and MU and understand how to properly use them in practice.

Application Comparison of Two Source of Allowable Total Errors inσMetrics Assessing the Analytical Quality and Selecting Quality Control Procedures for Automated Clinical Chemistry / 现代检验医学杂志

Objective To evaluate the difference of two sources of allowable total errors provided by National Health Industry Standard (WS/T 403-2012,analytical quality specification for routine analytes in clinical biochemistry)and National Stand-ard (GB/T 20470-2006,requirements of external quality assessment for clinical laboratories)in assessing the analytical qual-ity byσmetrics,and selecting quality control procedures using operational process specifications graphs.Methods Selected one of the laboratories participating in the internal quality control activity of routine chemistry of February,2014 and the first time external quality assessment activity of routine chemistry in 2014 organized by National Center for Clinical Labora-tories for its coefficient of variation and the bias of nineteen clinical chemistry tests.With the CV% and Bia%,σmetrics of controls at two analyte concentrations were calculated using two different allowable total errors targets (National Health In-dustry Standard (WS/T 403-2012)and National Standard (GB/T 20470-2006).Could obtain a operational process specifica-tions graph by which Could select quality control procedures using the Quality control computer simulat software developed by National Center for Clinical Laboratories and the company zhongchuangyida.Results The σ metrics under National Health Industry Standard (WS/T 403-2012)were from 0 to 7.Most of the values (86% and 76.2%)under National Stand-ard (GB/T 20470-2006)were from 3 to 15.On the normalized method decision chart,the assay quality using the allowable total errors targets of National Standard (GB/T 20470-2006)was at least one hierarchy more than one using National Health Industry Standard (WS/T 403-2012).The quality control rules under National Health Industry Standard (WS/T 403-2012)were obviously more strict than that under National Standard (GB/T 20470-2006).Among the control procedures using National Health Industry Standard (WS/T 403-2012),multirule (n=4):ALB,ALP,Ca,Cl,TC,Crea,Glu,LDH,K, Na,TP,TG and Urea;13s (n=4):Mg;12.5s (n=2):CK,AMY ang Fe;13s (n=2):TBIL;13.5s (n=2):ALT,AST and UA.Conclusion The allowable total errors provided by National Health Industry Standard (WS/T 403-2012)are more stringent than that from National Standard (GB/T 20470-2006).So Laboratories need to improve the analytical quality of their tests furthermore.

Comparison Research Between Total Error and Uncertainty in Nine Humoral Immune Items / 现代检验医学杂志

Objective To evaluate the performance of humoral immune items by the statistical method of total error (TE)and uncertainty.Methods The data of internal quality control were collected by Bio-Rad quality controll software from January to October 2013,and the accumulation means (x-),accumulation standard deviations (s)and accumulation coefficients of var-iation (CV)were computed.According to the external quality assessment plans from Chinese National Center for Clinical Laboratories[2 reports(201311~201315,201321~201325)].The relative bias(bias%)and relative average bias (bias%)of humoral immune item results and target values were calculated.TE was calculated with the accumulation coefficients of vari-ation and the relative bias.By Nordtest method,the uncertainties of humoral immune items were calculated according to the external quality assessment data and internal quality control accumulation CV.Results The maximum TEs with every 2 in-ternal quality control levels of immunoglobulin G (IgG),immunoglobulin A (IgA),immunoglobulin M (IgM),complement 3 (C3 ),complement 4 (C4 ),antistreptolysin“O”(ASO),rheumatoid factor (RF),C-reactive protein (CRP),immunoglobulin E (IgE)were 13.07,14.05,13.99,15.68,14.84,14.,16.55,14.19 ,10.05.The uncertainties of those items were 15.44, 15.82,16.23,17.67,16.73,19.96,19.01,16.25,10.86.In the constituent ratio of the uncertainties,imprecision play major roles in items of C4,CRP,IgE while bias play major roles in items of ASO,RF.The two elements approach parity in items of IgG,IgA,IgM,C3.Conclusion Both TE and uncertainty have good consistency,and they can be the important reference for the analysis and improvement of laboratory quality.But uncertainty can provide more informations for reference.

The Usefulness of Internal Quality Control Procedure Using External Quality Control Materials / 임상검사와정도관리

BACKGROUND: It is very important to keep the quality of the process of clinical tests and for that internal & extenal quality control procedures are performed in many clinical laboratorys. With the simultaneous use of external quality control materials for internal and external quality control procedures, not only precision but also bias presumed to be systematic error can be assessed. Also the control limits for internal quality control procedure can be obtained. It is the aim of this study to investigate the useful aspects of the integration of internal and extenal quality control procedures. METHODS: The Korean Association of Quality Assurance for Clinical Laboratory 2006-CC-01 quality control materials for external quality control survey were tested on 19 general chemistry items with Hitachi 7180 (Hitachi, Tokyo, Japan) autoanlyzer once a day for 20 days. Current means and standard deviations(sd) were obtained from internal quality control results for 20 days and were used to calculate the biases with target means from external quality control survey results. Bias, sigma(TEa/sd), method sigma(TEa-|bias|/sd) and total error(TE) of each the 19 items were calculated and the calculated total errors of 19 items were compared with the CLIA'88 allowable total errors(TEa). Contol limits for internal quality control procedures were established according to the method sigma levels and probability for false rejection(Pfr), probability for error detection(Ped), average run length for false rejection(ARLfr) and average run length for error detection(ARLed) according to the control limit levels were estimated. RESULTS: Out of total 19 items, 8 items such as albumin, glucose, triglyceride, total cholesterol, uric acid, total bilirubin, GGT and LDH satisfied the CLIA'88 TEa criteria and 11 items such as total protein, total calcium, inorganic phosphorus, BUN, creatinine, AST, ALT, ALP, sodium, potassium and chloride didn't satisfied. In the 11 items not satisfying CLIA'88 TEa criteria, 6 items such as BUN, creatinine, AST, ALT, sodium and chloride had the method sigma below 1.65 and control limits for internal quality control procedure could not be established. Control limits of the other 13 items were established according to the method sigma leves. In case of 6 method sigma level, Pfr were estimated to be 0.000007 and Ped to be 1.0000 and ARLfr to be 146910 and ARLed to be 1.00. CONCLUSION: The integrated data from both the internal and external quality control results were very useful in assessment of the quality status of the tests and in designing and planning the internal quality control procedures such as control limits.

Seohan Computerized Hue Test(2): Total Error Scores According to the Age in Normal Subjects and Total Error Scores and Central Cap in Color Defectives

PURPOSE: To evaluate the clinical usefulness and its own characteristic of Seohan computerized 85-hue test(SCHT-85) which was developed by authors. METHODS: SCHT-85 was performed in 89 normal subjects and 41 subjects with color defects diagnosed by Hardy-Rand-Rittler test(HRR test) and Farnsworth Munsell 100-hue test(FM 100-hue test) and total error scores(TES) according to the age in normal subjects and TES and central cap in subjects with color defects were determined. RESULTS: In normal subjects, TES of SCHT-85 according to the age were slightly higher than those of FM 100-hue test and highly correlated with those of FM 100-hue test. TES of SCHT-85 were increased according to the degree of abnormality in the HRR test in subjects with color defects. TES of SCHT-85 were lower than those of FM 100-hue test in normal subjects and higher than those of FM 100-hue test in subjects with color defects. In subjects with color defects, the central cap of SCHT-80 showed the tendency to yellowgreen-purple axis in protan and green-bluepurple axis in deutan compared to that of FM 100-hue test. CONCLUSIONS: SCHT-85 is highly correlated with FM 100-hue test and seems to be more useful to differentiate normal subjects and subjects with color defects than FM 100-hue test.

Seohan Computerized Hue Test 1: The Development of Computerized Color Vision Test and Pilot Study

Several tests have been used for assessing color vision but most of them are nonspecific, expensive, complicated or too time consuming to perform. We have developed a new computerized color vision test named Seohan computerized 85-hue test[SCHT/85]that has many advantages compared to Farnsworth Munsell[FM]100-hue test.SCHT/85 has 85 color caps which can be displayed based on a model of FM 100-hue test using Multimedia toolbook 4.0.Selected color caps in the lower random area can be moved and inserted to the upper result area by a mouse.At the end of the test, error scores and ring graph can be displayed in monitor and can be also printed out. Total 15 subjects performed with SCHT/85 and FM 100-hue test twice who have been showed 10 normal and 5 abnormal color vision reported with other color vision tests and the results of two tests were analysed to compare the total error scores[TES]and reproducibility. All ten normal subjects showed lower TES in SCHT/85 than FM 100-hue test and the mean TES were 31.5 and 43.6 with SCHT/85 and FM 100-hue test.The coefficients of variation [CV]were 4.3%and 22.7%with SCHT/85 and FM 100-hue test.The two tests were highly correlated[r=0.92].Five abnormal subjects showed higher TES in SCHT/85 than FM 100-hue test and the mean TES were 169.8 and 157.3 with SCHT/85 and FM 100-hue test.The coefficients of variation were 9.1%and 21.2%with SCHT/85 and FM 100-hue test.These two tests were also highly correlated[r=0.965]. In conclusion, SCHT/85 which was newly developed by authors is a highly useful test for color vision.