Sensitivity of over-the | 合法醫療器材資訊網

Objective: To determine the sensitivity of seven over-the-counter pregnancy tests (OTC-PTs) using urine containing a mixture of human chorionic gonadotropin (hCG)-related molecules as found on the first day of missed menstrual period.

Design: Blinded in vitro sensitivity analysis.

Setting: Medical school laboratory.

Participants: None.

Interventions: Urine was tested with OTC-PT devices at titers of 100, 50, 25, 12.5, 6.3, and 0 mIU/mL hCG immunoreactivity, and laboratory workers rated their confidence in the test result based on whether the test result was a clear, sharp, and unquestionable band in the test window.

Main outcome measures: Analytical sensitivity, defined as the urine concentration at which all OTC-PTs tested gave a positive result regardless of operator confidence score; clinical sensitivity of OTC-PTs, defined as th...