Semen analysis is characterized by high levels of intra-and inter-laboratory variability,due to a low level of standardization,high subjectivity of the assessments,and problems with automated procedures.To improve con...Semen analysis is characterized by high levels of intra-and inter-laboratory variability,due to a low level of standardization,high subjectivity of the assessments,and problems with automated procedures.To improve consistency of laboratory results,quality control and training of technicians are important requisites.The goals of this study are to evaluate the results of an external quality control(EQC)program and standardized training by ESHRE Basic Semen Analysis Courses(BSAC)on the variability in manual assessments of semen parameters.We performed retrospective analyses of(1)the interlaboratory variability in the Dutch EQC program and(2)the interobserver variability in BSACs for concentration,motility,and morphology assessments.EQC data showed that the interlaboratory coefficient of variation(CV)for concentration assessment decreased(range from 24.0%–97.5%to 12.7%–20.9%)but not for morphology and motility assessments.Concentration variability was lower if improved Neubauer hemocytometers were used.Morphology assessment showed highest CVs(up to 375.0%),with many outliers in the period of 2007–2014.During BSAC,a significant reduction of interobserver variability could be established for all parameters(P<0.05).The absence of an effect in the EQC program for motility and morphology might be explained by respectively the facts that motility assessment was introduced relatively late in the EQC program(since 2013)and that criteria for morphology assessment changed in time.BSAC results might have been influenced by the pretraining level of participants and the influence of external factors.Both EQC and training show positive effects on reducing variability.Increased willingness by laboratories to change their methods toward standards may lead to further improvements.展开更多
This study explores whether the current external quality assessment(EQA)level and acceptable bias for basic semen analysis in China are clinically useful.We collected data of semen EQA from Andrology laboratories in t...This study explores whether the current external quality assessment(EQA)level and acceptable bias for basic semen analysis in China are clinically useful.We collected data of semen EQA from Andrology laboratories in the Hunan Province(China)in 2022 and searched for data in the published literature from January2000 to December 2023 in China.On the basis of these data,we analyzed the coefficients of variation and acceptable biases of different quality control materials for basic semen analysis through robust statistics.We compared these findings with quality specifications based on biological variation from optimal,desirable,and minimum levels of bias to seek a unified and more suitable semen EQAbias evaluation standard for China's national conditions.Different sources of semen quality control material exhibited considerable variation in acceptable biases among laboratories,ranging from 8.2%to 56.9%.A total of 50.0% of the laboratories met the minimum quality specifications for progressive motility(PR),whereas 100.0%and 75.0%of laboratories met only the minimum quality specifications for sperm concentration and total motility(nonprogressive[NP]+PR),respectively.The Z value for sperm concentration and PR+NP was equivalent to the desirable performance specification,whereas the Z value for PR was equivalent only to the minimum performance specification.This study highlights the feasibility of operating external quality assessment schemes for basic semen analysis using quality specifications based on biological variation.These specifications should be unified among external quality control(EQC)centers based on biological variation.展开更多
基金This study was supported by an unrestricted grant from the Dutch Foundation for Quality Assessment in Medical Laboratories(SKML),Nijmegen,the NetherlandsSKML is a nonprofit organization for external quality control for medical laboratories.
文摘Semen analysis is characterized by high levels of intra-and inter-laboratory variability,due to a low level of standardization,high subjectivity of the assessments,and problems with automated procedures.To improve consistency of laboratory results,quality control and training of technicians are important requisites.The goals of this study are to evaluate the results of an external quality control(EQC)program and standardized training by ESHRE Basic Semen Analysis Courses(BSAC)on the variability in manual assessments of semen parameters.We performed retrospective analyses of(1)the interlaboratory variability in the Dutch EQC program and(2)the interobserver variability in BSACs for concentration,motility,and morphology assessments.EQC data showed that the interlaboratory coefficient of variation(CV)for concentration assessment decreased(range from 24.0%–97.5%to 12.7%–20.9%)but not for morphology and motility assessments.Concentration variability was lower if improved Neubauer hemocytometers were used.Morphology assessment showed highest CVs(up to 375.0%),with many outliers in the period of 2007–2014.During BSAC,a significant reduction of interobserver variability could be established for all parameters(P<0.05).The absence of an effect in the EQC program for motility and morphology might be explained by respectively the facts that motility assessment was introduced relatively late in the EQC program(since 2013)and that criteria for morphology assessment changed in time.BSAC results might have been influenced by the pretraining level of participants and the influence of external factors.Both EQC and training show positive effects on reducing variability.Increased willingness by laboratories to change their methods toward standards may lead to further improvements.
基金supported by the Hunan Province Municipal Natural Science Foundation(2022JJ30018)the Hunan Province Health Commission Science Foundation(B202301037899)to WNL。
文摘This study explores whether the current external quality assessment(EQA)level and acceptable bias for basic semen analysis in China are clinically useful.We collected data of semen EQA from Andrology laboratories in the Hunan Province(China)in 2022 and searched for data in the published literature from January2000 to December 2023 in China.On the basis of these data,we analyzed the coefficients of variation and acceptable biases of different quality control materials for basic semen analysis through robust statistics.We compared these findings with quality specifications based on biological variation from optimal,desirable,and minimum levels of bias to seek a unified and more suitable semen EQAbias evaluation standard for China's national conditions.Different sources of semen quality control material exhibited considerable variation in acceptable biases among laboratories,ranging from 8.2%to 56.9%.A total of 50.0% of the laboratories met the minimum quality specifications for progressive motility(PR),whereas 100.0%and 75.0%of laboratories met only the minimum quality specifications for sperm concentration and total motility(nonprogressive[NP]+PR),respectively.The Z value for sperm concentration and PR+NP was equivalent to the desirable performance specification,whereas the Z value for PR was equivalent only to the minimum performance specification.This study highlights the feasibility of operating external quality assessment schemes for basic semen analysis using quality specifications based on biological variation.These specifications should be unified among external quality control(EQC)centers based on biological variation.
