Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment.
OBJECTIVE
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.
Service de Médecine et Biologie de la Reproduction, University Hospital of Nantes, 44093, Nantes Cedex, France.
J
J
Lammers
C
C
Splingart
P
P
Barrière
M
M
Jean
T
T
Fréour
D000328:Adult; D057205:Automation, Laboratory / Q000592:standards; D004311:Double-Blind Method; D006801:Humans; D007248:Infertility, Male / Q000175:diagnosis; D008297:Male; D015203:Reproducibility of Results; D055101:Semen Analysis / Q000295:instrumentation* / Q000379:methods* / Q000592:standards; D012680:Sensitivity and Specificity; D013076:Sperm Count; D013081:Sperm Motility