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Validation Study Design: What the SpermScope vs Makler Study at Spermatology 2026 Gets Right Methodologically

The study presented by Dr Bryan Woodward of X&Y Fertility at the XVth International Symposium on Spermatology (University of Birmingham, 29 July to 2 August 2026) is worth examining on its methodological merits.

The reference samples came from UKNEQAS RS (Manchester University NHS Foundation Trust, UKAS-accredited against ISO/IEC 17043:2023), with pre-established target concentration values. That avoids the circular reference problem common in instrument validation - both instruments were tested against an independent, externally verified standard rather than against each other as mutual ground truth.

Results summary

SpermScope R squared vs UKNEQAS targets: 0.77
Makler R squared vs UKNEQAS targets: 0.68
Direct comparison between chambers: no significant difference (p greater than 0.05)
Both differed significantly from UKNEQAS targets (p less than 0.05)

Conclusion

The SpermScope could be used instead of the Makler, with a slightly higher correlation to externally validated target values in this study.

Full coverage including methodology and clinical implications: Cryolab study article

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