Quality assurance and quality control in the laboratory andrology

We summarise and comment on the topics discussed by the contributors to this Special Issue. As an introduction, Ann Jequier's [1] generally positive assessment of the new-look manual was tempered with her reservations about reference values, on which other chapters dwelt at length. Aspects of laboratory technique were discussed by Charlene Brazil [2], whose offering gives a rare insight into the actual workings of andrology laboratories and highlights the need for greater involvement of laboratory directors (often clinicians) in assessing the quality of data provided. Experience with the German external quality control programme for semen analysis confirms that some laboratories treat the quality control (QC) samples differently (using a Neubauer chamber, for instance) from routine samples (a Makler chamber) so that the exercise may be undermined and fail to provide proper control of the lab's quality of work. It is one thing to have QC accepted in principle but the essential job of "policing" semen analysis QC falls in no-one's court. Allan Pacey's [3] contribution supports wholeheartedly quality assurance (QA) in andrology but also zeros in on a potential quantitative problem in the precision of normal sperm morphology assessment, when such values are low.Rune Eliasson's [4] characteristically blunt contribution lambasts the whole process of scientific consensus, the mainstay of world health organization (WHO) committees' recommendations. He considers that the perspective of the handbook are too narrow; its recommendations on assessing sperm morphology are inadequate; there to be insufficient emphasis on interpretation of results (cumulative importance of laboratory findings, interpretation of reference limits) or on manipulation of data (e.g. dividing total sperm numbers by days of abstinence and the testicular volume) and finds no mention of how to measure testicular volume. He laces this with invective against the lack of scientific method of those working in ART and reserves particular venom for the morphology method espoused in WHO3 [5] and WHO4 [6] that is given even more prominence in WHO5 [7].Once our hackles are down again, though, his view contain some prickly wisdom. First, if only normal forms are examined, the analysis could provide little indication of testicular dysfunction (other than the reduced output of normal forms) that may be indicated by production of particular abnormal forms. Second, as the normative reference values are so low, it can provide little scope for diagnosis, making it a meaningless end-point.Eliasson's [4] suggestion is that different criteria for categorising spermatozoa as morphologically normal (borderline forms considered normal, as in earlier editions of the WHO manual) should be implemented. These should provide higher percentages of normal forms and thus increase the possibility of distinguishing men with lower perentages of such forms. Thus far more workable and informative reference limits around 40%-60% would be provided by using less restrictive assessment. Howe...

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confidence: 71%

Afterword to Semen Analysis in 21st Century Medicine special issue in Asian Journal of Andrology

Crowther¹,

Handelsman²,

Trevor³

et al. 2010

“…This poor practice is of course not limited to the UK and has been highlighted by a number of authors. 10,11 Secondly, training methods exist-but are they used/useful? A plethora of data shows that there are robust training methods available for assessment of basic semen analysis.…”

Section: Where Is Semen Analysis Now and Where Is It Going?mentioning

confidence: 99%

“…11,14,15 An example is the assumption that semen assessments are currently performed in an adequate manner. This is wrong.…”

Section: Where Is Semen Analysis Now and Where Is It Going?mentioning

confidence: 99%

Diagnostic tools in male infertility—the question of sperm dysfunction

Barratt¹,

Mansell²,

Beaton³

et al. 2010

Sperm dysfunction is the single most common cause of infertility, yet what is remarkable is that, there is no drug a man can take or add to his spermatozoa in vitro to improve fertility. One reason for the lack of progress in this area is that our understanding of the cellular and molecular workings of the mature spermatazoon is limited. However, over the last few years there has been considerable progress in our knowledge base and in addressing new methods to diagnose sperm dysfunction. We review the current state of the field and provide insights for further development. We conclude that: (i) there is little to be gained from more studies identifying/categorizing various populations of men using a basic semen assessment, where an effort is required in making sure the analysis is performed in an appropriate high quality way; (ii) technological development is likely to bring the reality of sperm function testing closer to implementation into the clinical pathways. In doing this, these assays must be robust, cheap (or more appropriately termed cost effective), easy to use and clinically useful; and (iii) clinical necessity, e.g., the need to identify the highest quality spermatozoon for injection is driving basic research forward. This is an exciting time to be an andrologist and, likely, a fruitful one. Keywords: gamete biomarker; male fertility; sperm biomarker; sperm dysfunction INTRODUCTION Infertility is a significant global problem affecting approximately 80 million (1:7) couples worldwide. 1 In a landmark study by Mike Hull and colleagues, in which a representative British population was studied, sperm dysfunction (lacking 'normal' function) was identified as the single most common cause of infertility. 2 Subsequent studies have confirmed these observations 3 and highlighted dysfunctional cells in men with 'normal' semen parameters and conversely normal sperm function in oligozoospermic men. 4 What is remarkable is that, for this group, there is no drug a man can take or add to his spermatozoa in vitro to improve fertility. The only option is assisted reproductive technology (ART) which usually consists of a graduation of treatment depending on severity, i.e., intrauterine insemination for mild, in vitro fertilisation (IVF) for moderate and intracytoplasmic sperm injection (ICSI) for men with severe sperm dysfunction. One reason for the lack of progress in this area is that our understanding of the cellular and molecular workings of the mature spermatazoon is limited. However, over the last few years there has been considerable progress in our knowledge base and in addressing new methods to diagnose sperm dysfunction. The purpose of this paper is to review the current state of the field and provide insights for further development. The initial focus is on the value of semen analysis as a clinical tool with the discussion progressing to examining sperm dysfunction in detail.

“…13 This methodological inadequacy, as well as the use of multiple methods for the evaluation of a single parameter, may result from the lack of top-down directives from the supervisory authorities or a lack of internal and external quality control in laboratories. 14,19,24 It is alarming that of the 55 respondents representing different laboratories in Poland, only in one case were the methods used to evaluate the principal semen parameters compliant with the guidelines presented in both of the last editions of the WHO manual.…”

Section: Variations In Methods Of Semen Analysis In Poland R Walczak-mentioning

confidence: 99%

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

Walczak-Jędrzejowska¹,

Marchlewska²,

Oszukowska³

et al. 2013

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.