Evaluation of a semi-quantitative pregnancy device for susceptibility to interference caused by hCGβcf

Nerenz, Robert D.; Butch, Anthony W.; Ashby, Lori; Woldemariam, Getachew A.; Gronowski, Ann M.

doi:10.1016/j.clinbiochem.2015.04.015

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“…We have previously reported 3 patients who demonstrated false negative urine hCG results due to excess hCGβcf [1]. Those patients, plus an additional patient from an as yet unpublished report [10], have been plotted on Milhorn and Korpi-Steiner's Figure 2 (which was modified from McChesney) (Fig. 1).…”

Section: Introductionmentioning

confidence: 99%

Assessing the risk of false negative point-of-care urinary human chorionic gonadotropin device results due to beta core fragment

Gronowski

Nerenz

2015

Clinical Biochemistry

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Section: Introductionmentioning

confidence: 99%

Assessing the risk of false negative point-of-care urinary human chorionic gonadotropin device results due to beta core fragment

Gronowski

Nerenz

2015

Clinical Biochemistry

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“…[2][3][4][5] This is due to the "hook effect" in assays for intact or free β-hCG, whereby βcf-hCG saturates β-hCG-specific antibodies, with the paring antibody unable to recognise the bound βcf-hCG, preventing formation of the antibody sandwich.…”

Section: Introductionmentioning

confidence: 99%

Significance of pregnancy test false negative results due to elevated levels of β-core fragment hCG

Johnson¹,

Eapen²,

Smith³

et al. 2017

Journal of Immunoassay and Immunochemistry

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Very high levels of β-core fragment human chorionic gonadotrophin (βcf-hCG) are reported to potentially cause false negative results in point-of-care (POC)/over-the-counter (OTC) pregnancy tests. To investigate this further, women's daily early morning urine samples, collected prior to conception and during pregnancy, were analysed for intact, free β-, and βcf-hCG. The proportion of βcf-hCG was found to be related to that of hCG produced and in circulation. Therefore, best practice for accuracy testing of POC/OTC pregnancy tests would be to test devices against clinical samples containing high levels of βcf-hCG as well as standards spiked with biologically relevant ratios.

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Evaluation of a semi-quantitative pregnancy device for susceptibility to interference caused by hCGβcf

Cited by 2 publications

References 9 publications

Assessing the risk of false negative point-of-care urinary human chorionic gonadotropin device results due to beta core fragment

Assessing the risk of false negative point-of-care urinary human chorionic gonadotropin device results due to beta core fragment

Significance of pregnancy test false negative results due to elevated levels of β-core fragment hCG

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