Sensitivity of over-the-counter pregnancy tests: comparison of utility and marketing messages

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 the proportion of pregnancies likely to be detected on the first day of a missed period and calculated from the analytical sensitivity and a recently published regression curve for total urine hCG immunoreactivity in 25 urine samples from this period of gestation; percentage of tested devices showing a band in the test window at a specific hCG concentration measured devices positive; percentage faulty devices, defined as the proportion of tested devices failing to yield a band in the control window; and confidence score, determined from operator ratings for each device at each concentration of hCG. Results: First Response Early Result had an analytical sensitivity of 6.3 mIU/mL, which was estimated to detect greater than 95% of pregnancies on the day of missed period. The sensitivity of Clearblue Easy Earliest Results was 25 mIU/mL, which indicated detection of 80% of pregnancies. The sensitivity of the five other products was 100 mIU/mL or greater, indicating detection of 16% or less of pregnancies. Three of these last products included faulty devices. Conclusion: Universal claims for OTC-PTs of more than 99% laboratory accuracy and use as early as the first day of missed period, while cleared for use by the U.S. Food and Drug Administration, are ambiguous and inappropriate for many products, according to these data. The majority of products tested were found to detect only a small percentage of pregnancies on the first day of a missed menstrual period. Until more data become available on the actual clinical sensitivity of these products, pharmacists should advise consumers to be cautious in interpreting test results.