Milhorn Denise, Korpi-Steiner Nichole
Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, NC, USA.
Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, NC, USA.
Clin Biochem. 2015 Feb;48(3):99-104. doi: 10.1016/j.clinbiochem.2014.11.004. Epub 2014 Nov 14.
It is unclear if the point-of-care (POC) Clinitest hCG device is subject to high-dose hook interference from physiological concentrations of intact human chorionic gonadotropin (hCG), β-core fragment of hCG (hCGβcf), and hCG free β-subunit (hCGβ) found in urine during pregnancy. We used a simulation model to address this question and related our findings to our institution's pregnant population in order to assess risk for potential false-negative hCG results.
The expected distribution of days relative to ovulation during routine POC hCG testing was estimated from 182 patients. Clinitest-Clinitek Status hCG device susceptibility to high-dose hook interference from hCG variants and potential risk of false-negative results as it relates to this population were evaluated by testing increasing concentrations of hCG, hCGβcf, hCGβ as well as urine simulating physiological hCG, hCGβcf and hCGβ concentrations expected during early pregnancy (≤44 days post-ovulation).
The Clinitest-Clinitek Status hCG device exhibited high-dose hook interference from hCGβcf alone, but not from hCG, hCGβ, or simulated physiological urinary concentrations of combined hCG, hCGβcf and hCGβ expected during early pregnancy. The majority of our patient population had urinary hCG testing conducted during early pregnancy.
The Clinitest-Clinitek Status hCG device is unlikely to exhibit false-negative urinary hCG results due to high-dose hook interference for women in early healthy pregnancy, although additional studies are necessary to determine potential risk in other patient populations. Visual interpretation of POC urinary hCG device results is an important failure mode to consider in risk analyses for erroneous urinary hCG device results.
尚不清楚即时检验（POC）的Clinitest hCG检测设备是否会受到孕期尿液中生理浓度的完整人绒毛膜促性腺激素（hCG）、hCG的β核心片段（hCGβcf）以及游离β亚基hCG（hCGβ）的高剂量钩状效应干扰。我们使用了一个模拟模型来解决这个问题，并将我们的研究结果与我们机构的孕妇群体相关联，以评估潜在假阴性hCG结果的风险。
从182名患者中估计了常规POC hCG检测期间相对于排卵日的预期分布。通过检测不断增加浓度的hCG、hCGβcf、hCGβ以及模拟早孕期（排卵后≤44天）预期的生理hCG、hCGβcf和hCGβ浓度的尿液，评估了Clinitest-Clinitek Status hCG检测设备对hCG变体高剂量钩状效应的敏感性以及与该群体相关的假阴性结果的潜在风险。
Clinitest-Clinitek Status hCG检测设备仅表现出受hCGβcf的高剂量钩状效应干扰，而不受hCG、hCGβ或早孕期预期的hCG、hCGβcf和hCGβ组合的模拟生理尿液浓度的干扰。我们的大多数患者群体在早孕期进行了尿液hCG检测。
对于早期健康妊娠的女性，Clinitest-Clinitek Status hCG检测设备不太可能因高剂量钩状效应干扰而出现尿液hCG假阴性结果，尽管需要进一步研究以确定其他患者群体中的潜在风险。POC尿液hCG检测设备结果的视觉判读是错误尿液hCG检测设备结果风险分析中要考虑的一个重要失败模式。
