Validation of the Sperm Class Analyser CASA System for Sperm Count in a Diagnostic Semen Analysis Laboratory

Sperm counts have been linked to several fertility outcomes making it an essential parameter of semen analysis. It has become increasingly recognised that Computer Assisted Semen Analysis provides improved precision over manual methods but systems are seldom robustly validated for use. The objective of this work was to gather the evidence to validate or reject the Sperm Class Analyser as a tool for routine sperm counting in a busy laboratory setting. The criteria examined were comparison with the Improved Neubauer and Leja 20μm chambers, within and between field precision, linearity from a stock diluted in both semen and media, accuracy against internal and external quality material, an assessment of uneven flow effects and a ROC analysis to predict fertility in comparison with the Neubauer method. The technology is not a stand alone “black box” but rather a tool for well trained staff that allow rapid, high number sperm counting providing errors are identified and corrected. The system will produce rapid, accurate, linear, precise results with less analytical variance than manual methods that correlate well against the Improved Neubauer chamber. The system provides superior predictive potential for diagnosing fertility problems.