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Analytical versus clinical sensitivity and specificity in pregnancy testing.

K Emancipator1, E M Cadoff, M D Burke

  • 1Department of Pathology, State University of New York, Stony Brook.

American Journal of Obstetrics and Gynecology
|March 1, 1988
PubMed
Summary

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The Tandem Icon urine pregnancy test accurately detects human chorionic gonadotropin (hCG). This reliable urine test is sufficient for routine pregnancy screening and ruling out ectopic pregnancy concerns.

Area of Science:

  • Clinical Chemistry
  • Reproductive Endocrinology

Background:

  • Human chorionic gonadotropin (hCG) is a key biomarker for pregnancy.
  • Accurate and timely pregnancy testing is crucial for clinical management, including early detection of pregnancy and potential complications like ectopic pregnancy.

Purpose of the Study:

  • To evaluate the diagnostic accuracy of the Tandem Icon enzyme-linked immunoassay (ELISA) urine pregnancy test.
  • To compare the performance of the urine test with a qualitative serum radioimmunoassay for hCG.

Main Methods:

  • Simultaneous analysis of 871 urine and serum specimens using Tandem Icon urine ELISA and serum radioimmunoassay for hCG.
  • Serum radioimmunoassay was performed with a positive cutoff set at 30 IU/L.
  • Clinical follow-up was used to confirm pregnancy status in cases with borderline hCG levels.
Keywords:
BiologyData AnalysisEndocrine SystemEvaluationExaminations And DiagnosesFamily PlanningGonadotropinsGonadotropins, Chorionic--analysisHormonesLaboratory Examinations And DiagnosesLaboratory ProceduresPhysiologyPregnancy ComplicationsPregnancy TestsPregnancy, EctopicReproductive Control AgentsResearch Methodology

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Main Results:

  • High concordance (99.5%) was observed between the urine ELISA and serum radioimmunoassay methods.
  • Serum radioimmunoassay detected hCG as low as 10 IU/L, but levels between 10-30 IU/L often did not correlate with clinical pregnancy.
  • Only one of nine patients with negative urine tests and serum hCG between 10-30 IU/L was clinically pregnant.

Conclusions:

  • The Tandem Icon urine hCG test is a reliable and sufficient method for routine pregnancy testing.
  • The urine test effectively rules out the need for immediate intervention in suspected ectopic pregnancy cases.
  • Serum hCG levels between 10-30 IU/L require careful clinical correlation due to a low likelihood of pregnancy.