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

Ashok Agarwal, Manesh Kumar Panner Selvam, Rafael F Ambar, Ashok Agarwal, Manesh Kumar Panner Selvam, Rafael F Ambar

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.

Keywords: Computer assisted semen analyzer; IVOS CASA; LensHooke® X1 PRO; Semen analysis.

Conflict of interest statement

The authors have nothing to disclose.

Copyright © 2021 Korean Society for Sexual Medicine and Andrology.

Figures

Fig. 1. Comparison of sperm concentration results…
Fig. 1. Comparison of sperm concentration results between manual semen analysis (MSA), X1 PRO analyzer, and HT IVOS CASA. (A–C) Passing–Bablok regression plots comparing sperm concentration as obtained by MSA, X1 PRO, and HT CASA did not show significant deviation from linearity (p>0.05). The solid blue line represents the regression line, the red dashed line represents the diagonal line, and the brown dashed line represents a confidence band (n=101). (D–F) Bland–Altman analysis of the concentration deviation results between the MSA, X1 PRO, and HT CASA. The solid blue line represents the mean of the two methods and the red dashed lines are the 95% confidence ranges. SD: standard deviation.
Fig. 2. Comparison of the sperm total…
Fig. 2. Comparison of the sperm total motility results as measured by manual semen analysis (MSA), X1 PRO analyzer, and HT IVOS CASA. (A–C) Passing–Bablok regression plots comparing sperm total motility as a obtained by MSA, X1 PRO, and HT CASA did not show a significant deviation from linearity (p>0.05). The solid blue line represents the regression line, the red dashed line represents the diagonal line, and the brown dashed line represents a confidence band (n=101). (D–F) Bland–Altman analysis of the total motility deviation results between the MSA, X1 PRO, and HT CASA. The solid blue line represents the mean of the two methods and the red dashed lines are the 95% confidence ranges. SD: standard deviation.
Fig. 3. Comparison of the sperm progressive…
Fig. 3. Comparison of the sperm progressive motility (PR) results as measured by manual semen analysis (MSA), X1 PRO analyzer, and HT IVOS CASA. (A–C) Passing–Bablok regression plots comparing PR as obtained by MSA, X1 PRO, and HT CASA did not show significant deviation from linearity (p>0.05). The solid blue line represents the regression line, the red dashed line represents the diagonal line, and the brown dashed line represents a confidence band (n=101). (D–F) Bland–Altman analysis of the PR motility deviation results between the MSA, X1 PRO, and HT CASA. The solid blue line represents the mean of the two methods and the red dashed lines are the 95% confidence ranges. SD: standard deviation.
Fig. 4. Reliability of LensHooke® X1 PRO…
Fig. 4. Reliability of LensHooke® X1 PRO for the evaluation of normal sperm morphology based on WHO 5th edition strict criteria.

References

    1. Inhorn MC, Patrizio P. Infertility around the globe: new thinking on gender, reproductive technologies and global movements in the 21st century. Hum Reprod Update. 2015;21:411–426.
    1. Rutstein SO, Shah IH. Infecundity, infertility, and childlessness in developing countries. Calverton (MD), Geneva: ORC Macro, World Health Organization; 2004. Sep, Report No.: DHS Comparative Reports No. 9. 56p.
    1. Agarwal A, Parekh N, Panner Selvam MK, Henkel R, Shah R, Homa ST, et al. Male Oxidative Stress Infertility (MOSI): proposed terminology and clinical practice guidelines for management of idiopathic male infertility. World J Mens Health. 2019;37:296–312.
    1. Jarow J, Sigman M, Kolettis PN, Lipshultz LR, McClure RD, Nangia AK, et al. Optimal evaluation of the infertile male: AUA Best Practice Statement [Internet] Linthicum (MD): American Urological Association; c2010. [cited 2020 Dec 16]. Available from: .
    1. World Health Organization. WHO laboratory manual for the examination and processing of human semen. 5th ed. Geneva: World Health Organization; 2010. p. 287.
    1. Baskaran S, Finelli R, Agarwal A, Henkel R. Diagnostic value of routine semen analysis in clinical andrology. Andrologia. 2020 doi: 10.1111/and.13614. [Epub]
    1. Centola GM. Comparison of manual microscopic and computer-assisted methods for analysis of sperm count and motility. Arch Androl. 1996;36:1–7.
    1. Mortimer ST, van der Horst G, Mortimer D. The future of computer-aided sperm analysis. Asian J Androl. 2015;17:545–553.
    1. Lu JC, Huang YF, Lü NQ. Computer-aided sperm analysis: past, present and future. Andrologia. 2014;46:329–338.
    1. Agarwal A, Henkel R, Huang CC, Lee MS. Automation of human semen analysis using a novel artificial intelligence optical microscopic technology. Andrologia. 2019;51:e13440.
    1. Agarwal A, Gupta S, Sharma R. Andrological evaluation of male infertility. Cham: Springer International Publishing; 2016.
    1. Agarwal A, Gupta S, Sharma R. Sperm morphology stain (Diff-Quik®) In: Agarwal A, Gupta S, Sharma R, editors. Andrological evaluation of male infertility. Cham: Springer International Publishing; 2016. pp. 79–82.
    1. Agarwal A, Gupta S, Sharma R. Semen analysis using Hamilton-Thorne computer assisted semen analyzer (CASA) In: Agarwal A, Gupta S, Sharma R, editors. Andrological evaluation of male infertility. Cham: Springer; 2016. pp. 47–58.
    1. Wang C, Swerdloff RS. Limitations of semen analysis as a test of male fertility and anticipated needs from newer tests. Fertil Steril. 2014;102:1502–1507.
    1. Lammers J, Mansour W, Lattes S, Jean M, Barriere P, Freour T. Automated semen analysis…the new gold standard? A comprehensive study comparing manual and automated semen analysis. Fertil Steril. 2012;98(3 Suppl):S150
    1. Agarwal A, Sharma RK. Automation is the key to standardized semen analysis using the automated SQA-V sperm quality analyzer. Fertil Steril. 2007;87:156–162.
    1. Mortimer D, Serres C, Mortimer ST, Jouannet P. Influence of image sampling frequency on the perceived movement characteristics of progressively motile human spermatozoa. Gamete Res. 1988;20:313–327.
    1. Lammers J, Splingart C, Barrière P, Jean M, Fréour T. Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment. J Assist Reprod Genet. 2014;31:35–43.
    1. Yeung CH, Nieschlag E. Performance and comparison of CASA systems equipped with different phase-contrast optics. J Androl. 1993;14:222–228.
    1. Coetzee K, Kruger TF, Lombard CJ. Repeatability and variance analysis on multiple computer-assisted (IVOS) sperm morphology readings. Andrologia. 1999;31:163–168.
    1. Talarczyk-Desole J, Berger A, Taszarek-Hauke G, Hauke J, Pawelczyk L, Jedrzejczak P. Manual vs. computer-assisted sperm analysis: can CASA replace manual assessment of human semen in clinical practice. Ginekol Pol. 2017;88:56–60.
    1. Tomlinson MJ, Pooley K, Simpson T, Newton T, Hopkisson J, Jayaprakasan K, et al. Validation of a novel computer-assisted sperm analysis (CASA) system using multitarget-tracking algorithms. Fertil Steril. 2010;93:1911–1920.
    1. Köse M, Sokmensuer LK, Demir A, Bozdag G, Gunalp S. Manual versus computer-automated semen analysis. Clin Exp Obstet Gynecol. 2014;41:662–664.
    1. Krause W. Computer-assisted semen analysis systems: comparison with routine evaluation and prognostic value in male fertility and assisted reproduction. Hum Reprod. 1995;10 Suppl 1:60–66.
    1. Guidelines on the application of CASA technology in the analysis of spermatozoa. ESHRE Andrology Special Interest Group. European Society for Human Reproduction and Embryology. Hum Reprod. 1998;13:142–145.
    1. Akashi T, Mizuno I, Okumura A, Fuse H. Usefulness of sperm quality analyzer-V (SQA-V) for the assessment of sperm quality in infertile men. Arch Androl. 2005;51:437–442.
    1. Engel KM, Grunewald S, Schiller J, Paasch U. Automated semen analysis by SQA Vision® versus the manual approach-a prospective double-blind study. Andrologia. 2019;51:e13149.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir