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False-Negative Urine Human Chorionic Gonadotropin Testing in the Clinical Laboratory
Adrianna Z Herskovits1, Yigu Chen1, Niloofar Latifi2
1Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Laboratory Medicine
|June 28, 2019
Summary
False-negative human chorionic gonadotropin (hCG) urine tests are rare but can occur. Early gestational age and hook effects are common causes, necessitating strategies to minimize patient risk.
Area of Science:
- Clinical Chemistry
- Immunoassays
- Point-of-Care Testing
Background:
- Urine human chorionic gonadotropin (hCG) assays are vital for pregnancy detection and patient triage.
- False-negative results from urine hCG tests can lead to significant patient management issues.
Purpose of the Study:
- To determine the frequency of factors causing false-negative urine hCG test results.
- To identify specific reasons for inaccurate pregnancy test outcomes at the institutional level.
Main Methods:
- Retrospective review of clinical data over a one-year period.
- Analysis of patients with initially negative urine hCG tests followed by positive or equivocal serum hCG results.
Main Results:
- Eleven cases of potential missed diagnoses were identified from 9447 negative urine hCG results.
- The primary causes for false-negative results were early gestational age and beta-core (β-core) hook effects.
Conclusions:
- False-negative urine hCG test results are infrequent but clinically significant.
- Understanding common causes like early gestation and hook effects aids in developing risk-mitigation strategies.
- Clinical centers can improve patient safety by addressing these testing inaccuracies.
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