Validation of LensHooke® X1 PRO and Computer-Assisted Semen Analyzer Compared with Laboratory-Based Manual Semen Analysis

Abstract

Purpose To compare two automated semen quality analysis systems (LensHooke® X1 PRO [X1 PRO]) and IVOS CASA) for accuracy, precision and agreement with laboratory-based manual semen analysis (MSA). Materials and Methods Semen samples (n=31) were obtained from normozoospermic healthy male volunteers and infertile men with a minimum abstinence period between 2–3 days. After complete liquefaction, 101 seminal aliquots were prepared and tested according to WHO 5th Edition (2010) guidelines. The results obtained by X1 PRO and IVOS CASA were compared with that of MSA. Additionally, 10 samples were used to evaluate the intra- and inter-rater agreement for X1 PRO and MSA. Results The semen parameters (sperm concentration, total, and progressive motility) showed strong correlation and agreement for both automated semen analyzers and MSA (Spearman's rank correlation ≥0.92, p<0.0001). X1 PRO and IVOS CASA were able to differentiate samples with abnormal concentration with a positive predictive value (PPV) of 100%. Furthermore, the PPV for X1 PRO (86.5%) was higher than that for IVOS CASA (71.7%) in differentiating samples with abnormal motility. The X1 PRO device showed a high PPV (97.7%) in identifying normal sperm forms compared to MSA. Semen parameters evaluated showed a high inter-rater (kappa >0.91) and intra-rater (kappa >0.92) agreement for X1 PRO compared with MSA. Conclusions Both automated semen analyzers demonstrated a high level of concordance and their performance was comparable with MSA analysis. Furthermore, high-levels of inter-and intra-rater reliability for semen analysis indicate that the new X1 PRO can be used in a clinical laboratory to offer accurate and quick test results.

The validity and reliability of computer-aided semen analyzers in performing semen analysis: a systematic review

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Accurate Quantitative Histomorphometric-Mathematical Image Analysis Methodology of Rodent Testicular Tissue and Its Possible Future Research Perspectives in Andrology and Reproductive Medicine

“…The computer-based identification of testicular tissue structures and cell types with the application of artificial intelligence and deep machine learning techniques under strict human supervision can be implemented in analogy with the abovementioned examples and Computer-Assisted or -Aided Sperm Analysis (CASA) [73]. Various automated semen quality analysis systems exist and demonstrate highly concordant results, which can be compared to manual analyzing methods [74].…”

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“…In a recent study, the AI‐equipped LensHooke® X1 PRO system was shown to be able to detect sperm concentrations over a very wide range (0.1–300 × 10 6 /mL). Moreover, it showed greater sensitivity and specificity (>90%) in identifying samples of oligospermia and asthenospermia compared with the IVOS II system 7 . The continuous improvement in the performance of AI‐based CASA systems may be the development direction of semen analysis automation in the future.…”