Draft:Sperm Quality Analyzer

Sperm Quality Analyzer
TypeMedical device (laboratory analyzer)
ManufacturerMedical Electronic Systems
AvailableYes

Sperm Quality Analyzer (SQA), also rendered Semen Quality Analyzer, is a family of automated semen analysis instruments manufactured by Medical Electronic Systems (MES) of Israel and Los Angeles, California.[1][2][3] Introduced in the 1990s and revised across several generations, the instruments are used in clinical and andrology laboratories, in vitro fertilisation centres and sperm banks, and have been adapted for veterinary breeding programmes.[4][5][6]

Unlike image-based computer-assisted sperm analysis (CASA) systems, which track individual cells across video frames, SQA instruments measure an electro-optical signal generated as spermatozoa pass through a light beam in a narrow capillary, and derive semen parameters from that signal using proprietary algorithms.[7][8][9] The devices have been the subject of independent validation studies since the 1990s, with reported agreement against manual semen analysis varying substantially by generation and by parameter; morphology has consistently shown the weakest agreement.[1][9][10]

Technology

A semen sample is drawn into a disposable capillary and inserted into the analyzer. Fluctuations in optical density are registered by a photometric cell, and the frequency of the resulting analog signal is converted to a digital output from which sperm parameters are derived. Because the device registers only motile particles, interference from debris is reduced relative to some other methods.[8][7] A standard automated analysis takes approximately 75 seconds.[10]

Early SQA and SQA-II models reported derived composite indices, notably the sperm motility index (SMI) and a total functional sperm concentration, rather than direct values for each parameter.[4][8] The SQA-V added a visualisation system and sperm velocity assessment.[11] Later models report sperm concentration, motile and progressively motile sperm concentration, normal morphology and calculated total and progressive motility against World Health Organization reference values.[3][12]

Each instrument performs an electronic self-test on startup in which simulated signals are passed through the algorithms used for patient samples, and external quality control is carried out using assayed latex bead preparations.[13]

Models

The original SQA and the SQA-II series, comprising the SQA-II, SQA-IIB and SQA-IIC, appear in the literature from the mid-1990s onward.[14][1][8]

The SQA-V, which added a visualisation system, received FDA 510(k) clearance in September 2002 under number K021746.[3][11] A later revision, the SQA-V Gold, was in use in published comparative studies by 2014.[5][10]

The SQA-Vision was released worldwide in 2015 as a higher-tier system, adding a touchscreen interface, barcode scanning, laboratory information system connectivity and click-to-mark counters for vitality and differential morphology.[15][16] The manufacturer states that it is classified as moderate complexity under the Clinical Laboratory Improvement Amendments.[17]

The SQA-iO, a compact instrument aimed at lower-volume laboratories, was cleared by the FDA in August 2023 under number K220828, using the SQA-V as its predicate device on the basis of substantial equivalence in intended use, sample type, measured parameters and in vitro use.[3]

MES also produces the consumer YO Home Sperm Test, which has been validated against SQA laboratory analyzers.[18]

Evaluation

Early models

An evaluation of the SQA-IIB by Makler and colleagues, published in Fertility and Sterility, analysed samples from 26 volunteers and reported that values deviated significantly from the standard WHO method across all three main sperm indices, with disagreement exceeding twofold in 53% of cases. Specimens with very low or absent motility were returned as zero concentration and zero motility. The authors concluded that indirect algorithmic evaluation was inadequate for the purpose and that the device could not be recommended for clinics, sperm banks or andrology research.[1]

Other contemporaneous assessments were more favourable to specific applications. Mahmoud and colleagues examined the performance of the SQA in predicting the outcome of assisted reproduction,[19] and Martinez and colleagues found the sperm motility index useful for ruling out oligozoospermia and asthenozoospermia, with sensitivity of 96% and specificity of 84% against progressively motile sperm concentration, while reporting that the device was not a valid method for assessing morphology.[4] Suzuki and colleagues compared SQA-IIC variables with CASA estimates.[8]

SQA-V and SQA-V Gold

Hirano and colleagues assessed whether sperm velocity measurements introduced with the SQA-V correlated with CASA estimates.[11] Akashi and colleagues compared the SQA-V against CASA and manual analysis in 105 fresh semen samples, reporting significant correlations for sperm concentration, motility and normal morphology, while noting that the device did not correlate with certain kinematic parameters measured by CASA.[20]

A double-blind prospective study at the Cleveland Clinic using samples from 50 donors reported good agreement between SQA-V and manual sperm concentration results, sensitivity of 89.9% for identifying percent normal morphology, and higher precision than manual assessment. The authors concluded that the SQA-V could be used interchangeably with manual methods for concentration and motility.[2]

Lammers and colleagues at the University Hospital of Nantes compared the SQA-V Gold and a CASA system against manual assessment in 250 men, concluding that automated analyzers could be used for routine semen analysis with clinically acceptable results and higher precision.[5]

A 2025 study of 326 participants evaluated three automated systems against manual analysis as the reference standard. For the SQA-V Gold, the authors reported moderate agreement for sperm concentration (intraclass correlation coefficient 0.631) and poor agreement for total motility (0.451) and morphology (0.261), with limited agreement in classifying asthenozoospermia and teratozoospermia. They concluded that none of the systems tested could replace manual semen analysis at present and that automated results should be interpreted with caution.[10]

SQA-Vision

Engel and colleagues at Leipzig compared the SQA-Vision with manual analysis in a prospective double-blind study, assessing agreement using Bland–Altman plots and Passing–Bablok regression.[12]

A double-blind prospective study of 102 men at Nantes compared a CASA analyzer and the SQA-Vision against manual analysis performed strictly according to WHO guidelines. The authors found no significant difference between either automated method and manual assessment for any parameter except morphology, where the electro-optical system returned higher values and performed slightly worse than CASA, and concluded that both types of system could be implemented for routine analysis.[7]

A retrospective study of 1,130 cases at a laboratory in Montpellier reported no significant difference between SQA-Vision and manual assessment across sperm parameters, with correlation coefficients ranging from 0.81 to 0.98 depending on the parameter.[21]

Reviews

A 2021 systematic review of computer-aided semen analyzers published in Translational Andrology and Urology assessed the validity and reliability of these systems and noted that very low or very high sperm concentrations increase the variability of automated results.[9] Reviews of automated semen analysis generally note that instrument results should be confirmed by trained operators and that automated analysis does not constitute a complete clinical evaluation of male fertility.[9][3]

Veterinary use

SQA instruments have been evaluated for veterinary applications, principally in dogs and cattle. Iguer-Ouada and Verstegen assessed the SQA for canine semen, reporting coefficients of variability below 10% across the concentrations tested.[22] Rijsselaere and colleagues at Ghent University tested the SQA II-C on dog semen, reporting good repeatability for medium- and high-quality samples but a high coefficient of variance for one dog with inferior semen quality.[23] Prinosilova and colleagues used the SQA IIc to evaluate fresh and cryopreserved dog ejaculates,[24] and Hoflack and colleagues validated the SQA II-C for bull semen analysis.[6]

See also

References

  1. ^ a b c d Makler, Amnon; Shiran, Eynath; Geva, Hana; Mashiah, Tania (1999). "Evaluation of the SQA IIB: a new version of a sperm quality analyzer". Fertility and Sterility. 71 (4): 761–764. doi:10.1016/S0015-0282(98)00532-9. PMID 10202894.
  2. ^ a b Agarwal, Ashok; Sharma, Rakesh K. (2007). "Automation is the key to standardized semen analysis using the automated SQA-V sperm quality analyzer". Fertility and Sterility. 87 (1): 156–162. doi:10.1016/j.fertnstert.2006.05.083. PMID 17081526.
  3. ^ a b c d e "510(k) Summary K220828: SQA-iO Sperm Quality Analyzer" (PDF). U.S. Food and Drug Administration. 7 August 2023. Retrieved 24 July 2026.
  4. ^ a b c Martinez, C.; Mar, C.; Azcarate, M.; Pascual, P.; Aritzeta, J. M.; Lopez-Urrutia, A. (2000). "Sperm motility index: a quick screening parameter from sperm quality analyser-IIB to rule out oligo- and asthenozoospermia in male fertility study". Human Reproduction. 15 (8): 1727–1733. doi:10.1093/humrep/15.8.1727. PMID 10920094.
  5. ^ a b c Lammers, J.; Splingart, C.; Barrière, P.; Jean, M.; Fréour, T. (2014). "Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment". Journal of Assisted Reproduction and Genetics. 31 (1): 35–43. doi:10.1007/s10815-013-0139-2. PMC 3909144. PMID 24242989.
  6. ^ a b Hoflack, G.; Rijsselaere, T.; Maes, D.; Dewulf, J.; Opsomer, G.; de Kruif, A.; Van Soom, A. (2005). "Validation and usefulness of the Sperm Quality Analyzer (SQA II-C) for bull semen analysis". Reproduction in Domestic Animals. 40 (3): 237–244. doi:10.1111/j.1439-0531.2005.00584.x. PMID 15943698.
  7. ^ a b c Lammers, Jenna; Chtourou, Sana; Reignier, Arnaud; Loubersac, Sophie; Barrière, Paul; Fréour, Thomas (2021). "Comparison of two automated sperm analyzers using 2 different detection methods versus manual semen assessment". Journal of Gynecology Obstetrics and Human Reproduction. 50 (3) 102084. doi:10.1016/j.jogoh.2021.102084. PMID 33545411.
  8. ^ a b c d e Suzuki, T.; et al. (2002). "Comparison of the Sperm Quality Analyzer IIC variables with the computer-aided sperm analysis estimates". International Journal of Andrology. 25 (1): 49–54. doi:10.1046/j.1365-2605.2002.00324.x. PMID 11869377.
  9. ^ a b c d Finelli, R.; Leisegang, K.; Tumallapalli, S.; Henkel, R.; Agarwal, A. (2021). "The validity and reliability of computer-aided semen analyzers in performing semen analysis: a systematic review". Translational Andrology and Urology. 10 (7): 3069–3079. doi:10.21037/tau-21-276. PMC 8350227. PMID 34430409.
  10. ^ a b c d Xu, Murong; Zhao, Mingpeng; Yang, Huixia; Liu, Minqi; Chan, Carol Pui Shan; Fung, Ka Kei; Chung, Jacqueline Pui Wah; Fok, Ellis Kin Lam; Chan, David Yiu Leung (2025). "ICSI/IVF treatments allocation using CASAs compared to manual semen analyses". Medicine. 104 (6) e41501. doi:10.1097/MD.0000000000041501. PMC 11813069. PMID 39928763.
  11. ^ a b c Hirano, Yuki; Shibahara, Hiroaki; Shimada, Kazuhiko; Yamanaka, Seiji; Suzuki, Tatsuya; Takamizawa, Satoru; Motoyama, Mitsuhiro; Suzuki, Mitsuaki (2004). "Accuracy of sperm velocity assessment using the Sperm Quality Analyzer V". Reproductive Medicine and Biology. 2 (4): 151–157. doi:10.1111/j.1447-0578.2003.00039.x. PMC 5907002. PMID 29699178.
  12. ^ a b Engel, K. M.; Grunewald, S.; Schiller, J.; Paasch, U. (2019). "Automated semen analysis by SQA Vision versus the manual approach: a prospective double-blind study". Andrologia. 51 (1) e13149. doi:10.1111/and.13149. PMID 30255510.
  13. ^ "Technical Release Bulletin: SQA-V/Vision and QwikCheck Gold Sperm Analyzer Quality Controls". Medical Electronic Systems. 14 December 2017. Retrieved 24 July 2026.
  14. ^ Johnston, R. C.; Clarke, G. N.; Liu, D. Y.; Baker, H. W. G. (1995). "Assessment of the sperm quality analyzer". Fertility and Sterility. 63 (5): 1071–1076. doi:10.1016/S0015-0282(16)57550-5. PMID 7720920.
  15. ^ "Sperm quality analyzer". CAP Today. College of American Pathologists. September 2015. Retrieved 24 July 2026.
  16. ^ "Medical Electronic Systems Announces the Release of the New SQA-Vision Automated Sperm Quality Analyzer" (Press release). Medical Electronic Systems. July 2015. Retrieved 24 July 2026 – via Newswise.
  17. ^ "SQA-Vision Automated Semen Analyzer". Medical Electronic Systems. 29 August 2023. Retrieved 24 July 2026.
  18. ^ Kobori, Y. (2019). "Home testing for male factor infertility: a review of current options". Fertility and Sterility. 111 (5): 864–870. doi:10.1016/j.fertnstert.2019.01.032. PMID 30922654.
  19. ^ Mahmoud, A. M. A.; Gordts, S.; Vereecken, A.; Serneels, A.; Campo, R.; Rombauts, L.; Comhaire, F. H. (1998). "Performance of the sperm quality analyser in predicting the outcome of assisted reproduction". International Journal of Andrology. 21 (1): 41–46. doi:10.1046/j.1365-2605.1998.00090.x. PMID 9639151.
  20. ^ Akashi, T.; Mizuno, I.; Okumura, A.; Fuse, H. (2005). "Usefulness of sperm quality analyzer-V (SQA-V) for the assessment of sperm quality in infertile men". Archives of Andrology. 51 (6): 437–442. doi:10.1080/014850190959081. PMID 16214729.
  21. ^ Ilardo, Claudio; Defort, Naomi; Gala, Anna; Ostengo, Violaine; Regnier Vigouroux, Gilles; Quere, Guillaume; Sanguinet, Pierre (2024). "Retrospective study investigating the performance of the SQA-Vision analyser compared with manual semen analysis". Scandinavian Journal of Clinical and Laboratory Investigation. 84 (5): 373–378. doi:10.1080/00365513.2024.2392245. PMID 39146445.
  22. ^ Iguer-Ouada, M.; Verstegen, J. P. (2001). "Validation of the sperm quality analyzer (SQA) for dog sperm analysis". Theriogenology. 55 (5): 1143–1158. doi:10.1016/S0093-691X(01)00473-3. PMID 11322241.
  23. ^ Rijsselaere, T.; Van Soom, A.; Maes, D.; de Kruif, A. (2002). "Use of the Sperm Quality Analyzer (SQA II-C) for the assessment of dog sperm quality". Reproduction in Domestic Animals. 37 (3): 158–163. doi:10.1046/j.1439-0531.2002.00356.x. PMID 12071890.
  24. ^ Přinosilová, P.; Vežník, Z.; Zajícová, A.; Švecová, D. (2005). "Using the Sperm Quality Analyzer (SQA IIc) to evaluate dog ejaculates". Veterinární Medicína. 50 (5): 195–204. doi:10.17221/5615-VETMED.


Category:Medical equipment Category:Andrology Category:Fertility Category:Laboratory equipment

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