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

Department of Obstetrics and Gynecology, USA hCG Reference Service, University of New Mexico, Albuquerque, NM 87131, USA.
Clinical Chemistry and Laboratory Medicine (Impact Factor: 2.71). 08/2011; 49(8):1317-22. DOI: 10.1515/CCLM.2011.211
Source: PubMed


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.
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.
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.
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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    • "Home pregnancy tests (HPTs), which are commercially available antibody-based assays, have been shown to be misread by 1 in 4 women; this translates into a 25% disagreement/75% agreement rate among independent readers [14]. While most of these HPTs claim " over 99% accuracy " or a similar statement on their packaging or insert [15], their actual accuracy rates can range from 8.3% to 97% [14] [16]. The high false negative rates for these tests may be caused by many factors, including the length of time after a missed menstrual period at the point the test is conducted, late implantation, an ectopic or heterotopic pregnancy, heterophilic antibodies, spontaneous abortion, or non-compliance with the HPT instructions [17] [18]. "
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    ABSTRACT: This review examines human chorionic gonadotropin (hCG) or pregnancy tests from multiple perspectives. It first investigates the molecule hCG and shows that the term represents five independent molecules differing in carbohydrate and meric structure that share a common amino acid sequence. The review goes on to show that multiple degradation produces also the need to be tested for an hCG or pregnancy test to be optimally efficient. The review then carefully examines the literature showing the sensitivity and specificity of automated laboratory tests. Point-of-care pregnancy tests are then investigated along with over-the-counter pregnancy tests. Appropriate detection of hyperglycosylated hCG, nicked hCG, nicked hCG missing the β-subunit C-terminal peptide and nicked hyperglycosylated hCG is a limitation on all pregnancy tests. In the opinion of the author, just one automated laboratory test, the Siemen’s Immulite, one point-of-care test, the Beckman-Coulter Icon 25, and one brand of over-the-counter device, First Response, are suitable for early pregnancy detection and possibly other applications.
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