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

Abstract

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.

Manual vs. computer-assisted sperm analysis: can CASA replace manual assessment of human semen in clinical practice?

“…Concentrations measured with CASA were significantly higher as compared to the manual control. In contrast, Lammers et al, reported that the overall concentration did not significantly differ between automatic assessment and manual control [11]. However, as in case of our findings, CASA values were higher than these obtained manually, as were the standard deviations.…”

“…We cannot rule out that variability within the CASA system could also influence the obtained results [10]. The technicians who use CASA do not have to specialize in semen analysis but they need to undergo specialist training [11]. However, they should have experience in seminology to perform the analysis properly.…”

Automation of human semen analysis using a novel artificial intelligence optical microscopic technology

“…In addition, the agreement of the methods illustrated by the Bland-Altman plots was poor, with a higher measurement of total motility and MSC in the manual reading revealed by a mean bias >5 (Figures 4b and 5b). Lammers et al (2014) showed that manual reading of total motility was higher than those of two automated systems in a trial of 250 human samples. Recently, a study analysing 100 human ejaculates also showed a proportional difference for total motility measurements with a slope higher than 1.2 between the manual method and a commercially available automated device, SQA-V (Engel, Grunewald, Schiller, & Paasch, 2019).…”

“…Moreover, different CASA systems use different mathematical algorithms to calculate various sperm quality parameters, leading to the greatest disadvantage in the clinical application of CASA, with unreliability of comparative parameters across all devices (Akashi, Mizuno, Okumura, & Fuse, 2005;Amann & Waberski, 2014;Dearing, Kilburn, & Lindsay, 2014;Kanakasabapathy et al, 2017;Lammers, Splingart, Barriere, Jean, & Freour, 2014). Moreover, different CASA systems use different mathematical algorithms to calculate various sperm quality parameters, leading to the greatest disadvantage in the clinical application of CASA, with unreliability of comparative parameters across all devices (Akashi, Mizuno, Okumura, & Fuse, 2005;Amann & Waberski, 2014;Dearing, Kilburn, & Lindsay, 2014;Kanakasabapathy et al, 2017;Lammers, Splingart, Barriere, Jean, & Freour, 2014).…”

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“…Tejerina et al (2008) discussed that sperm motility parameters analysed using CASA system provided a more objective assessment of sperm motility in mammals. CASA technology has several advantages as compared to manual counting, such as, fast analysis; increase consistence when the same setting is used, and high statistical power due to objective analysis of numerous sperm (Schleh and Leoni, 2013;Lammers et al, 2014). Unlike Jing and collaborators' work, we used CASA system for evaluating the sperm motility, contributing with more objective and additional data such as kinetic parameters.…”