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Abstract Presented at the 2011 AACC Meeting in Atlanta, GA.         DOWNLOAD STUDY HERE

Semen analysis is one of the clinical laboratory tests which has significantly benefited from automation. Manual counting methods, motility and morphology testing often resulted in prolonged turn-around-times and left our Laboratory faced with challenges of maintaining consistency in result reporting among Technologists. The projected shortage of laboratorians also weighed in our decision to automate, since finding skilled help might be a problem in the future. We decided to automate semen analysis testing with Medical Electronics SQA-V Semen Analyzer. This decision was the result of our laboratory’s use of LEAN practices which identified what we needed in order to streamline testing while providing clinicians with accurate and consistent results. Our main goals at this time were decreasing turn- around times and cost savings.

The SQA-V Semen Analyzer is a bench top device that determines the total sperm count, motility and morphology of a specimen in less than 2 minutes. The SQA-V technology is based on the principle of electro-optical signal processing in conjunction with algorithms built into the software. A disposable testing capillary is filled with a liquefied, well mixed sample inserted into the analyzer for testing. We are currently running fresh specimens on the analyzer. QwikCheck beads at two known concentrations are run as the quality control material.

37 patient samples were used to validate the automated system. This included a representation of both normal and abnormal specimens. The manual testing was performed by all members of the staff trained in manual semen analysis using WHO 3rd classification. Training the staff on the automated system was completed in 5 days and after implementation we were immediately able to meet our new turn-around-time goal consistently. Previously, with manual semen analysis, the average TAT was 3 days due to delays involved in manual processing, such as transport for staining and microscopic examination. Automating the process has decreased the turn-around-time for the majority of our specimens to under 3 hours. (See Figure 1).



Through automation, we were able to reduce our average turn-around-time per case from 82 hours to 3 hours. Annualized, this freed up 0.5 FTE. We performed 161 cases in 2010. Overall, labor costs for semen analysis were reduced by $14,560.00.

Automating semen analysis has enabled our Laboratory to offer testing on demand while eliminating many of the delays involved in manual processing. It has enabled us to maximize our resources, so that now our laboratorians are no longer spending hours working on a single specimen and are free to perform other tasks. Our physicians can now rely on having accurate test results consistently available in less than 3 hours. Our staff oriented quickly, with minimal training and automating the process has proven to be a major boost to staff morale. Maintaining competency will continue to remain a challenge since we will still need to perform manual testing on short samples. But most importantly, process improvement through automation brings us one step closer to achieving our vision; to be a premier laboratory, implementing advances in laboratory medicine, while providing exceptional service to exceed the needs and expectations of the people we serve.

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Comparison of manual sperm analysis (WHO 5th) with two automated systems (DOWNLOAD HERE)

Lammers J, Mansour W, Jean M, Barriere P, Freour T
ART laboratory, University Hospital of Nantes, France

Introduction
Semen analysis is the first diagnostic tool to evaluate the male factor in an infertile couple. Conventional manual semen analysis is the routine method in most Assisted Reproductive Technology laboratories, but this method suffers from subjectivity and lack of standardization. Even though the recently published WHO 5th edition manual recommendations (2010) should improve the analytical performance of manual semen analysis, existing high performance automated analysis systems can provide an accurate technical alternative.

Objective
The aim of this study was to compare conventional manual sperm analysis performed according to WHO 5th edition manual (2010), Computer-Assisted Sperm Analysis (CASA, CEROS Sperm Analyzer, Hamilton Thorne) and a fully automated sperm analyzer based on electro-optical and computer algorithm technology (SQA-V Sperm Quality Analyzer, Medical Electronic Systems) in terms of standardization, accuracy and precision.
Materials and methods

All infertile men who received routine fertility evaluations at the andrology laboratory between February and April 2011 were prospectively included in the trial based on the following criteria: semen sample volume >2.5 ml (in order to allow assessments by all three methods).
Sperm concentration, total sperm number, motility, progressive motility, motile sperm concentration (MSC), progressively motile sperm concentration (PMSC) and normal morphology (WHO 5th Kruger strict criteria, 4% threshold) were first assessed simultaneously and independently by two operators. Secondly sperm analysis was performed in duplicates by both automated systems (see workflow below).
Statistical evaluation was then performed (MedCalc software) to analyze mean values, coefficients of variation, correlation, mountain plot distribution and ROC curve parameters: specificity (Sp) and negative predictive values (NPV) for all three methods.

Results
A total of 250 patient samples were included in the study. 246 of 250 samples were compared for Sperm Concentration, Total Sperm Number and MSC. Four samples were excluded due to a testing problem. 224 of 250 samples were compared for other semen parameters. 26 samples were excluded from comparison for these parameters because of methodological difficulties due to azoospermia or severe oligospermia. Correlation coefficients of both automated systems with manual analysis were very high for sperm concentration, total sperm number, MSC, and PMSC (r>=0.93 for all parameters). The best precision was obtained with the SQA-V for all semen variables (CV<10%). All three methods showed good agreement, except for CASA MSC and PMSC that were systematically higher than reported by the other two methods. Distribution of automated systems differences versus manual assessment was analyzed by mountain plots. The SQA-V and CASA plots were comparable for concentration, but CASA plots for motility-related parameters tended to be slightly wider, compared with SQA-V. Concerning morphology, Sp and NPV of SQA-V and CASA versus manual assessment were: SpSQA – 98%, NPVSQA – 93% and SpCASA – 84%, NPVCASA – 96% respectively.

Conclusions
Both CASA and SQA-V were easy to integrate into the laboratory routine and demonstrated an acceptable agreement versus manual semen analysis performed according to WHO 5th ed. manual. The best precision among all three methods was shown by the SQA-V system. Both automated systems, and particularly SQA-V, gave accurate morphology results. Automated sperm analysis systems can be considered accurate tools for routine sperm analysis, providing high quality results and allowing better standardization than manual analysis.

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