Ten years' experience with an external quality control program for semen analysis

Mallidis, Con; Cooper, Trevor G.; Hellenkemper, Barbara; Lablans, Martin; Ückert, Frank; Nieschlag, Eberhard

doi:10.1016/j.fertnstert.2012.05.006

Cited by 60 publications

(37 citation statements)

References 13 publications

(15 reference statements)

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“…A wide inter-lab variation in concentration and percent normal morphology was found in the reports. However, it is possible to achieve good interlaboratory agreement in semen analysis, provided the technicians undergo regular training and participate in an ongoing program of external quality and internal quality control [5,6]. Recently, the World Health Organization published the 5th edition manual for sperm analysis (WHO 5th Edition) [7].…”

Section: Introductionmentioning

confidence: 99%

Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment

Lammers¹,

Splingart

Barrière

et al. 2013

J Assist Reprod Genet

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Purpose Despite controversy regarding its clinical value, male fertility investigation mainly relies on semen analysis. Even though reference guidelines are available, manual sperm analysis still suffers from analytical variability, thus questioning the interest of automated sperm analysis systems. The aim of this study is to compared automated computerized semen analysis systems (SQA-V GOLD and CASA CEROS) to the conventional manual method in terms of accuracy and precision. Methods We included 250 men in this double-blind prospective study. The SQA-V GOLD (Medical Electronic Systems) and CEROS, CASA system (Hamilton Thorne) were compared to the standard manual assessment based on the WHO 5th Edition. The main outcome measures were sperm concentration, total sperm number, total motility, progressive motility, non-progressive motility, morphology, motile sperm concentration (MSC) and progressively motile sperm concentration (PMSC) with the three methods. Results Statistical analysis of the test results from the automated systems and the manual method demonstrated no significant differences for most of the semen parameters. The Spearman coefficients of rank correlation (rho) for CASA and the SQA-V GOLD automated systems vs. the manual method were: Sperm concentration (0.95 and 0.95), total sperm number (0.95 and 0.95), MSC (0.94 and 0.96) and PMSC (0.94 and 0.93) correspondingly. Concerning sperm morphology, both automated systems demonstrated high specificity (Sp) and negative predictive values (NPV), despite significantly different medians (CASA: 83.7 % for Sp and 95.2 % for NPV, SQA-V: 97.9 % for Sp and 92.5 %). The highest precision (lowest 95 % confidence interval for duplicate tests) for all semen variables was found in the SQA-V GOLD. Conclusions The advantages of using automated semen analysers are: Standardization, speed (lower turnaround time), precision, reduced potential for human error, automated data recording and less need for highly skilled professionals to run the systems. The disadvantages of using automated systems are: notably the problem with testing some atypical samples and the inability to perform an assessment of morphology abnormalities. Based on the results of this study, the SQA-V Gold demonstrated better agreement vs. the manual method. In conclusion, automated semen analyzers can be used for routine semen analysis providing rapid clinically acceptable results with higher precision, and positively impacting laboratory standardization.

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Section: Introductionmentioning

confidence: 99%

Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment

Lammers¹,

Splingart

Barrière

et al. 2013

J Assist Reprod Genet

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“…9 Even today more than 30 years after the publication of World Health Organization (WHO) guidelines, different laboratories continue to use different techniques; a survey of laboratories participating in the German Quality Assurance Scheme found that ,8% of laboratories fully followed WHO guidelines and only 55% used the recommended Neubauer chamber to determine sperm concentration. 10 In a sample of 118 Chinese seminology laboratories, 49.2% relied on manual semen analysis, of which 60.2% used the recommended haemocytometer and 33.9% of laboratories used computer assisted semen analysis (CASA), with machines coming from a variety of sources. 11 A review concluded that there was large variation in the conduct and reporting of the test among American laboratories.…”

Section: Lack Of Consistencymentioning

confidence: 99%

Ignorance but not bliss: too little is known about the determinants of semen quality

Ford

2013

Asian J Androl

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riticisms of the data that have been presented to demonstrate a decline in sperm counts over time reveal problems with semen analysis methods and a lack of understanding of the genetic and environmental factors that determine a man's sperm count. Potential sources of error in the WHO semen analysis protocol and some areas of ignorance about the biological and environmental factors which can influence sperm counts are briefly discussed. I conclude that there is a need to include semen analyses in a large cohort study to fill the gaps in our knowledge.The paper by Carlsen et al. 1 that is being marked in this issue of Asian Journal of Andrology stimulated widespread concern and considerable research effort. Together with other supportive studies, e.g. Auger et al., 2 strong evidence that testicular cancer was not only becoming more prevalent but was developing at lower ages 3,4 and observations that other disorders of male development, e.g. cryptorchidism and hypospadias, were being more frequently reported, although this might be due to changes in clinical practice (see Thonneau et al. 5 ), have raised serious concerns that something was going amiss with the human male. The proposition that oestrogen exposure in utero might be responsible by an effect on Sertoli cell development gave rise to the 'testicular dysgenesis' hypothesis to explain these effects, 6 although the role of oestrogen has been questioned recently. As most andrologists, I have followed developments in this area with keen interest but other contributors to this issue are far more knowledgeable than me, so I intend to say nothing about the testicular dysgenesis hypothesis or the latest consensus on whether sperm counts have indeed declined. Instead I will review some of the reasons why assessing trends in semen quality over time is difficult, and how these problems reveal gaps, or perhaps chasms, in our knowledge about the biology of human semen.First, although there is no better alternative, the standard semen analysis is inherently imprecise and is prone to many errors. The equipment used has changed over time and with it the nature of the error, making historical comparisons difficult. The errors introduced could be random, leading to imprecision and greater difficulty in demonstrating statistical significance but without effect on the nature of the trend, or systematic, leading to bias in the results. In theory systematic error could be corrected by direct comparison of former and current techniques. However, as discussed below results can potentially be affected by technical errors whose effects are difficult to predict. These can only be detected and eliminated by good quality control systems that have only been in place for at most two decades. Therefore doubt about older data will always remain. Secondly, the environmental factors that might influence a man's sperm count have changed over time and movements of populations have changed the genetic mix in many places. Moreover, social changes might affect the characteristics of the men rec...

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“…12 Although the WHO manuals have been available for more than 30 years, there are still reports revealing a lack of standardization of the methods used in andrology laboratories and wide variation in the results obtained among laboratory technicians in many countries. 8,10,[13][14][15][16] The selection and implementation of methods for semen analysis which are accepted, standardized and validated worldwide should be the basis of good practice in every seminological laboratory. With this aim in mind, the present is a survey of employees of laboratories offering semen analysis in Poland, to ascertain their compliance with WHO recommendations and to determine the variation in the methods used.…”

Section: Introductionmentioning

confidence: 99%

Semen analysis standardization: is there any problem in Polish laboratories?

Walczak-Jędrzejowska¹,

Marchlewska²,

Oszukowska³

et al. 2013

Asian J Androl

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The aim of the study was to determine the degree of compliance of Polish laboratories with World Health Organization (WHO) recommendations, with regard to semen analysis methodology. A survey requesting information about methods of semen analysis was distributed to employees of 55 laboratories. Respondents who had participated in external seminological workshops (31%) were termed certified respondents (CR), the remaining (69%)-non-certified respondents (NCR). Only one laboratory (6%) in the CR group and none in the NCR were compliant with WHO guidelines for methods and equipment used to evaluate seminal volume, sperm motility, concentration, vitality and morphology. Most problems were of volume measurement (weighing method was reported by 17% of CR and 10% of NCR) and staining method for sperm morphology (Papanicolau or Diff-Quik were found in 33% of CR and 23% of NCR). A three-or four-point grading of sperm motility was used by the majority of respondents; however, 17% of CR and 37% of NCR did not use a laboratory counter to tally spermatozoa. Although a haemocytometer method was used by 80% of laboratories in each group, the improved Neubauer chamber was used only by 42% of CR and 19% of NCR. In each group, 24% of laboratories did not perform a vitality test. Procedural errors and the interchangeable utilization of two or even three methods to analyse a given parameter was observed in both groups. The results indicate a need for standardisation of the methods and continuous, unified training in semen analysis in Polish laboratories.

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Ten years' experience with an external quality control program for semen analysis

Cited by 60 publications

References 13 publications

Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment

Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment

Ignorance but not bliss: too little is known about the determinants of semen quality

Semen analysis standardization: is there any problem in Polish laboratories?

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