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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

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The utility of six over-the-counter (home) pregnancy tests

1Department of Obstetrics and Gynecology, USA hCG Reference Service, University of New Mexico, Albuquerque, NM, USA

Corresponding author: Laurence A. Cole, Department of Obstetrics and Gynecology, USA hCG Reference Service, MSC10-5580, University of New Mexico, Albuquerque, NM 87131, USA Phone: +1-505-272-6137

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 49, Issue 8, Pages 1317–1322, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2011.211, August 2011

Publication History

Received:
2010-10-28
Accepted:
2011-03-13

Abstract

Background: The home pregnancy market is rapidly evolving. It has moved from detection of pregnancy on the day of missed menstrual bleeding, to detection claims 4 days prior. It is moving from all manual tests to digital tests, with a monitor reading the bands and informing women they are pregnant. A thorough study is needed to investigate the validity of claims and evolving usefulness of devices.

Methods: Studies were proposed to examine the sensitivity and specificity of home tests and their abilities to detect pregnancy. Methods examined the abilities of tests to detect human chorionic gonadotropin (hCG), hyperglycosylated hCG, free β-subunit, a mixture of these antigens in 40 individual early pregnancy urines.

Results: Using a mixture of hCG, hyperglycosylated hCG and free β-subunit typical for early pregnancy, the sensitivity of the First Response manual and digital tests was 5.5 mIU/mL, while the sensitivities of the EPT and ClearBlue brand manual and digital tests was 22 mIU/mL. On further evaluation, the First Response manual and digital tests both detected 97% of 120 pregnancies on the day of missed menstrual bleeding. The EPT manual and digital devices detected 54% and 67% of pregnancies, respectively, and the ClearBlue manual and digital devices detected 64% and 54% of pregnancies, respectively.

Conclusions: First Response manual and digital claim >99% detection on the day of missed menses. The results here suggest similar sensitivity for these two tests. The EPT and ClearBlue manual and digital test make similar >99% claims, the data presented here disputes their elevated claim.

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