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Performance and sensitivity of modern home pregnancy tests
1Department of Obstetrics and Gynecology, University of California, Irvine, Orange.
International Journal of Fertility
|May 1, 1988
Summary
This study evaluated three home pregnancy tests, finding they can detect pregnancy early. The Advance test showed the highest positive results at menses onset, with a sensitivity of 200 mIU/mL.
Area of Science:
- Reproductive endocrinology and diagnostics
- Biotechnology and immunoassay development
Background:
- Home pregnancy tests (HPTs) are widely used for early pregnancy detection.
- Assessing the performance of commercially available HPTs is crucial for accurate results.
Purpose of the Study:
- To evaluate the performance of three distinct home pregnancy tests: Advance, Daisy 2, and FACT.
- To compare the sensitivity and detection window of these tests against radioimmunoassay beta-human chorionic gonadotropin (beta-hCG) levels.
Main Methods:
- Monoclonal antibody-based enzyme immunoassay (Advance) and hemagglutination inhibition assay (Daisy 2, FACT) were used.
- Urine specimens were collected daily for 16 days from 35 pregnant patients undergoing assisted reproductive technologies.
- Tests were performed on each specimen, with results correlated to urinary beta-hCG concentrations measured by radioimmunoassay.
Main Results:
- All tested HPTs could detect pregnancy as early as 9-10 days post-conception.
- Positive results at the expected onset of menses were achieved in 70% (Daisy 2), 95% (Advance), and 88% (FACT) of cases.
- The sensitivity for all HPTs was determined to be approximately 200 mIU/mL of urine.
Conclusions:
- The Advance, Daisy 2, and FACT home pregnancy tests demonstrate reliable early pregnancy detection capabilities.
- The Advance test exhibited the highest detection rate at the time of expected menses.
- These HPTs offer a sensitivity threshold of around 200 mIU/mL, comparable to established diagnostic standards.