A-383 Assessment of commercially available home pregnancy tests

Background Home use urine pregnancy point of care testing (POCT) devices are widely used and are commercially available. Although they afford high degree of utility and ease of use, however, there have been concern over their claim for their sensitivity and detection of early pregnancy. This study compared sensitivity of a number of commercially available POCT pregnancy tests. Methods Several commercially available urine pregnancy testing devices were obtained namely; G-care (Hubei MEIBAO Biotechnology Co. Ltd), JusChek (ACRO BIOTECH, Inc. USA), SMARTCHECK (Nantong Egens Biotechnology Co.Ltd, China), Equate Advanced Early Result Pregnancy Test (Distributed by Walmart, USA), Equate One Step Pregnancy test (Distributed by Walmart. USA), FIRST STEP (Beijing Jinhuake Biological Technology Co., Ltd. China), and SAFECARE Bio-tech (SAfecare Biotech Co, Ltd . China). Using standard human chorionic gonadotropin (HCG) (Millipore Corporation, USA), hCG concentrations ranging from 318 mIU/mL to 19 mIU/mL were prepared in phosphate buffered saline containing 0.1% bovine serum albumin. 3-5 drops of the prepared hCG solutions were applied to the POCT pregnancy devices according to the manufactures’ instructions. Results All tested POCT devices with the exception of one (G-care) produced acceptable positive hCG response where all were positive at 318 mIU/L. All devices except one (G-care) were positive at 159 mIU/mL, and only 4 devices (JuCheck, Equte, FIRSTSTEP, and SAFECARE Bio-tech) produced a faint positive response at 19 mIU/mL. One of those (Equate One Step) was immediately positive, whereas the remaining 3 showed faint positive line at > 20 minutes. Overall, with the exception one POCT device, all tested devices provided acceptable positive response. Conclusion Home based urine pregnancy tests are widely available and essay to operate. However, the intensity of their response is variable. Only one of the tested devices met the claim for early pregnancy detection.