OBJECTIVE: The purpose of this study was to investigate the validity of home pregnancy tests (HPTs) around the time of the missed menses. STUDY DESIGN: Levels of human chorionic gonadotropin (hCG) were determined in urine around the time of the missed menses, and 5th and 95th centiles were calculated. In a blind study evaluating 18 brands of HPTs, each was tested six times with five concentrations of hCG, 0 to 100 mIU/mL. Sensitivity was defined as the concentration at which six of six brands gave positive results, at the suggested reading time or at an extended time. RESULTS: It was estimated that a sensitivity of 12.5 mIU/mL was needed to detect 95% of pregnancies at the time of missing menses. Only 1 of 18 HPTs had this sensitivity. If faintly discernible results considered, 2 of 18 brands gave false-positive or invalid results. Clear positive results were given by only 44% of the brands at 100 mIU/mL hCG. If one accepted faintly discernible and extended reading times, all brands responded at 100 mIU/mL. A test with 100 mIU/mL sensitivity would detect approximately 16% of pregnancies at the time of missed menses. CONCLUSION: The utility of HPTs is questioned. Clinicians need to be aware of the limitations of current HPT brands.
OBJECTIVE: The purpose of this study was to investigate the validity of home pregnancy tests (HPTs) around the time of the missed menses. STUDY DESIGN: Levels of human chorionic gonadotropin (hCG) were determined in urine around the time of the missed menses, and 5th and 95th centiles were calculated. In a blind study evaluating 18 brands of HPTs, each was tested six times with five concentrations of hCG, 0 to 100 mIU/mL. Sensitivity was defined as the concentration at which six of six brands gave positive results, at the suggested reading time or at an extended time. RESULTS: It was estimated that a sensitivity of 12.5 mIU/mL was needed to detect 95% of pregnancies at the time of missing menses. Only 1 of 18 HPTs had this sensitivity. If faintly discernible results considered, 2 of 18 brands gave false-positive or invalid results. Clear positive results were given by only 44% of the brands at 100 mIU/mL hCG. If one accepted faintly discernible and extended reading times, all brands responded at 100 mIU/mL. A test with 100 mIU/mL sensitivity would detect approximately 16% of pregnancies at the time of missed menses. CONCLUSION: The utility of HPTs is questioned. Clinicians need to be aware of the limitations of current HPT brands.
Authors: Germaine M Buck Louis; Enrique F Schisterman; Anne M Sweeney; Timothy C Wilcosky; Robert E Gore-Langton; Courtney D Lynch; Dana Boyd Barr; Steven M Schrader; Sungduk Kim; Zhen Chen; Rajeshwari Sundaram Journal: Paediatr Perinat Epidemiol Date: 2011-06-20 Impact factor: 3.980
Authors: Yu-Hsiang Hsieh; M Terry Hogan; Mathilda Barnes; Mary Jett-Goheen; Jill Huppert; Anne M Rompalo; Charlotte A Gaydos Journal: PLoS One Date: 2010-11-30 Impact factor: 3.240