“One: physicians, nurses, and other healthcare professionals need to be educated that this is a problem. “There are three important take-home messages here,” said Gronowski. The accuracy of the remaining seven tests was moderately affected by hCG beta core fragment.
Beckman coulter pregnancy test plus#
Two other tests-the Genzyme Diagnostics OSOM hCG Combo test, and the Cen-Med Elite Plus hCG test-were so inhibited by hCG beta core fragment that Gronowski’s team concluded they present an unacceptable risk of false-negative results to patients after 5–7 weeks of pregnancy. Of the 11 tests screened by the researchers, only two-the Beckman Coulter Icon 20 hCG test and the Alere hCG Combo test-were not significantly affected by hCG beta core fragment. The study, “Screening Method to Evaluate Point-of-Care Human Chorionic Gonadotropin (hCG) Devices for Susceptibility to the Hook Effect by hCG? Core Fragment: Evaluation of 11 Devices,” was published online first and in the April 2014 issue of Clinical Chemistry.
The team determined this after developing a screening method that enabled them to evaluate the ability of the tests to detect hCG when high concentrations of hCG beta core fragment are also present. Louis, is the first to discover that this problem affects the majority of common hospital urine pregnancy tests. Gronowski, PhD, of the Washington University School of Medicine, St. In a hospital setting, this failure to detect pregnancy can lead to major consequences such as administration of medications that cause birth defects, fetal radiation exposure, or failure to diagnose ectopic pregnancy, which is the leading cause of first-trimester pregnancy-related maternal death.Įarlier studies have shown that hCG beta core fragment can interfere with pregnancy test accuracy, but a team of researchers led by Ann M.
Around the fifth to seventh week of gestation, however, urine concentrations of an hCG variant known as the hCG beta core fragment rise dramatically, interfering with hCG detection and causing false-negative test results. This is what healthcare providers test for to determine if a woman is pregnant. When a human egg is fertilized, it begins producing the hormone human chorionic gonadotropin (hCG), which can be detected in either urine or blood. In a recent publication, we describe a screening method that can be easily used to examine the effect of hCGβcf and have used this method to test eleven POC hospital urine hCG devices.Although the 11 most popular hospital urine pregnancy tests perform well in the first month after conception, a new study reveals the alarming statistic that nine of the tests become significantly more likely to produce false-negative results after the fifth to seventh week of pregnancy. A standardized method, using defined concentrations of hCG, is needed to evaluate the performance of currently available devices. The problem with this approach is that the relative abundance of hCG, hCGβcf and other hCG variants in the urine that may affect device performance vary between women. The original studies were performed by adding increasing concentrations of purified hCGβcf to a urine sample obtained from a pregnant woman. This hCG variant effect prevents the development of a positive signal and generates a negative result despite the presence of intact hCG in the urine sample being tested.
High concentrations of hCGβcf saturate either one or both of the antibodies used in the test. In previous blog posts we have discussed false negative urine hCG tests due to high concentrations of hCG beta core fragment (hCGβcf), the predominant form of hCG found in urine after six weeks of pregnancy.
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