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Comprehensive and Detailed Explanation:

Waived urine pregnancy tests detect human chorionic gonadotropin (hCG). Testing too soon after a missed period can yield false negatives because hCG levels may not yet be high enough for detection. The concentration varies by individual and gestational age. Other contributors to inaccurate results include expired or improperly stored kits, diluted urine (e.g., excessive fluid intake), and not following instructions. QC must still be performed regularly, even for waived tests, to confirm kit reliability. Specimen integrity and adherence to manufacturer guidelines are critical. ASCP training emphasizes patient education about timing and the importance of follow-up confirmatory testing when clinical suspicion is high despite negative results. Thus, while waived tests are simple, accuracy depends on correct usage, proper storage, and awareness of biological factors such as timing of collection.