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ABSTRACT
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.
Conflict of interest
This study was conducted by SPD Development Co. Ltd., the manufacturer of Clearblue home pregnancy and fertility tests. S. Johnson, S. Eapen, P. Smith and G. Warren are employees of SPD Development Co., Ltd. (Bedford UK), who funded this study. M. Zinaman has received consultancy from SPD Development Co., Ltd., not relating to this study.
Acknowledgments
Dr. Debra Scates, supported by integrated medhealth communication (imc), provided medical writing assistance in the development of this manuscript, supported by SPD Development Co. This study was funded and conducted by SPD Development Co. Ltd., the manufacturer of Clearblue home pregnancy and fertility tests. Data from this manuscript have been presented at the American College of Obstetricians and Gynecologists (ACOG) meeting, May 2–6, 2015, held in San Francisco and the Royal College of Obstetricians and Gynaecologists (RCOG) meeting, June 20‒22, 2016, held in Birmingham, UK.
Funding
This study was conducted by SPD Development Co. Ltd., the manufacturer of Clearblue home pregnancy and fertility tests.