Abstract
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.
Keywords
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Article info
Publication history
Accepted:
August 27,
2003
Received in revised form:
August 7,
2003
Received:
May 12,
2003
Footnotes
☆Supported in part by National Institutes of Health grant No. HD35654.
Identification
Copyright
© 2004 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
