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PubMed

Waived semen analyzers in clinical practice: analytical standards, regulatory categorization, and the limits of automated assessment.

PMID: 42932108 ·

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JournalJournal of assisted reproduction and genetics
Year
PMID42932108

Abstract

The award of Clinical Laboratory Improvement Amendment (CLIA)-waived status to automated semen analyzers, including the LensHooke (Bonraybio) and SQA-iOw (Medical Electronic Systems), has prompted substantive debate regarding analytic adequacy, regulatory classification, and appropriate clinical use. To synthesize academic and industry perspectives on the analytical standards, regulatory categorization, and clinical deployment of waived automated semen analyzers, and to provide practical guidanc

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