Accuracy of home pregnancy tests at the time of missed menses

Am J Obstet Gynecol. 2004 Jan;190(1):100-5. doi: 10.1016/j.ajog.2003.08.043.


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.

Publication types

  • Research Support, U.S. Gov't, P.H.S.
  • Validation Study

MeSH terms

  • Chorionic Gonadotropin / urine
  • False Positive Reactions
  • Female
  • Humans
  • Menstruation
  • Pregnancy
  • Pregnancy Tests / standards*
  • Self Administration
  • Sensitivity and Specificity


  • Chorionic Gonadotropin