False-Negative Results from Point-of-Care Qualitative Human Chorionic Gonadotropin (hCG) Devices Caused by Excess hCGβ Core Fragment Vary with Device Lot Number

Falsely Decreased Human Chorionic Gonadotropin (hCG) Results Due to Increased Concentrations of the Free β Subunit and the β Core Fragment in Quantitative hCG Assays

“…This effect was predicted in 2000 by Madersbacher and Berger (15 ) and highlights the need for appropriate selection of antibodies and assay design (17 ). In 2009 Gronowski et al demonstrated that this phenomenon occurred with some qualitative hCG devices (9,10 ). One limitation of this study was that measurements were made in singleton and not in duplicate, due to the expense of the purified materials.…”

“…Some qualitative point-of-care hCG devices have been reported to demonstrate false-negative results in the presence of increased concentrations of hCG␤cf, hCG␤, nicked hCG␤, and nicked hCG (9,10 ). In light of these findings, we hypothesized that the same would be true for quantitative hCG assays.…”

Screening Method to Evaluate Point-of-Care Human Chorionic Gonadotropin (hCG) Devices for Susceptibility to the Hook Effect by hCG β Core Fragment: Evaluation of 11 Devices

“…Here we sought to develop an easy-to-use, affordable screening method that could be used by device users to select devices and select specific device lots (since interferences have been shown to vary with both device and lot number (12 )) and also be used by manufacturers to develop better hCG devices and potentially modify existing devices.…”

Using a simulation model to assess risk of false negative point-of-care urinary human chorionic gonadotropin device results due to high-dose hook interference

“…Recent studies have alerted the medical community of risk for potential false-negative POC urinary hCG results likely attributed to high-dose hook interference from hCGβcf [8][9][10]. Estimation of risk involves analyses of both the probability of occurrence of harm and the severity of harm [15].…”

“…Case studies of falsenegative POC urinary hCG results have been reported and investigations highlight high-dose hook interference from hCGβcf as a potential cause [8][9][10]. Initial investigations of high-dose hook interference from hCGβcf in the qualitative detection of hCG using select POC and OTC hCG devices were performed through the addition of increasing concentrations of hCGβcf into hCG-positive patient urine samples; however, high-dose hook interference findings may have been confounded given the hCG molecular heterogeneity in patient urine specimens [8][9][10]. Nerenz and Gronowski further evaluated qualitative hCG device susceptibility to high-dose hook interference from hCGβcf utilizing defined concentrations of intact hCG and hCGβcf in hCG-negative urine matrix.…”