Sowder Aleksandra M, Yarbrough Melanie L, Nerenz Robert D, Mitsios John V, Mortensen Rachel, Gronowski Ann M, Grenache David G
Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA.
Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
Clin Chim Acta. 2015 Jun 15;446:165-70. doi: 10.1016/j.cca.2015.04.025. Epub 2015 Apr 25.
The ability to perform quantitative hCG testing in whole blood at the point-of-care is desirable. The purpose of this study was to perform an analytical validation of the Abbott i-STAT Total β-hCG test.
Whole blood, plasma, and serum samples were prepared by the addition of hCG and were used to evaluate precision, linearity, analytical sensitivity, accuracy, the high-dose hook effect, and dilution recovery.
Imprecision was highest with whole blood (CV = 16.0% and 6.7% at 10 and 1184 IU/l, respectively) and lowest in serum (CV = 8.1% and 4.3% at 11 and 1305 IU/l, respectively). The limits-of-quantitation were 8 and <5 IU/l for whole blood and both plasma and serum, respectively. The assay was linear between 5 and 2000 IU/l in all sample types (R(2) ≥ 0.998). i-STAT results agreed most closely with the Architect Total β-hCG assay and with greater differences observed with Beckman DxI Total βhCG and Roche Cobas e601 hCG+β assays (mean differences across all sample types were 9.3% and 12.3%, respectively). A high-dose hook effect was observed at concentrations > 400,000 IU/l. Accuracy was achieved in samples diluted with serum but not saline.
The i-STAT Total β-hCG test demonstrates acceptable performance for quantifying hCG in whole blood, plasma and serum.
能够在床旁对全血进行定量人绒毛膜促性腺激素（hCG）检测是很有必要的。本研究的目的是对雅培i - STAT总β - hCG检测进行分析验证。
通过添加hCG制备全血、血浆和血清样本，并用于评估精密度、线性、分析灵敏度、准确性、高剂量钩效应和稀释回收率。
全血的不精密度最高（在10和1184 IU/L时变异系数分别为16.0%和6.7%），血清的不精密度最低（在11和1305 IU/L时变异系数分别为8.1%和4.3%）。全血、血浆和血清的定量限分别为8和<5 IU/L。在所有样本类型中，该检测在5至2000 IU/L之间呈线性（R²≥0.998）。i - STAT结果与Architect总β - hCG检测最为接近，与贝克曼DxI总βhCG和罗氏Cobas e601 hCG +β检测的差异更大（所有样本类型的平均差异分别为9.3%和12.3%）。在浓度>400,000 IU/L时观察到高剂量钩效应。用血清稀释的样本可实现准确性，但用生理盐水稀释的样本则不行。
i - STAT总β - hCG检测在定量全血、血浆和血清中的hCG方面表现出可接受的性能。
