Korpi-Steiner Nichole L, Walz J Matthias, Schanzer Andres, Rao Lokinendi V
Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, NC.
Department of Anesthesiology, UMass Memorial Medical Center, Worcester, MA.
J Appl Lab Med. 2017 Nov 1;2(3):356-366. doi: 10.1373/jalm.2017.024414.
This study is a comparative analysis of measured activated clotting time (ACT) values by use of 5 different point-of-care (POC) ACT methods spanning the range detected during different clinical procedures at our institution.
We determined the correlation, imprecision, and differences in measured ACT values with use of 4 POC ACT methods compared with a reference ACT method in 41 venous whole blood samples collected from 25 adult patients undergoing interventional procedures. The POC ACT methods evaluated included the i-STAT with kaolin activator in prewarm mode, i-STAT with Celite activator in prewarm and nonprewarm modes, ACTPlus, and HMSPlus, which was designated the reference method. Each venous whole blood patient sample was tested in duplicate on each POC ACT test system (total n = 410 ACT measurements). Analyses of imprecision and differences in measured ACT values were stratified by moderate (100-299 s) and high (≥300 s) ACT ranges.
In this study population, measured ACT values ranged from 100-835 s with use of the HMSPlus. All methods demonstrated good correlation (r ≥ 0.95) in ACT values compared to the reference method. Imprecision varied by method with ranges of 1.7%-2.7% CV in the moderate ACT range and 2.5%-4.8% CV in the high ACT range. ACTPlus and i-STAT-Celite-prewarm methods exhibited proportional differences in measured ACT values whereas the i-STAT-Celite-nonprewarm and i-STAT-kaolin-prewarm demonstrated constant differences in measured ACT values compared to HMSPlus.
ACT values correlate well between POC methods. Imprecision and difference profiles vary by method; notably, imprecision exceeds systematic differences in the high ACT range and contributes to intermethod differences that are limitations worthy of consideration when contemplating a change in ACT methods.
本研究是一项对比分析,使用5种不同的即时检测(POC)活化凝血时间(ACT)方法,这些方法涵盖了在我们机构不同临床操作中检测到的范围。
我们在从25名接受介入操作的成年患者采集的41份静脉全血样本中,使用4种POC ACT方法与一种参考ACT方法,确定了测量的ACT值之间的相关性、不精密度和差异。评估的POC ACT方法包括预热模式下使用高岭土激活剂的i-STAT、预热和非预热模式下使用硅藻土激活剂的i-STAT、ACTPlus以及被指定为参考方法的HMSPlus。每个静脉全血患者样本在每个POC ACT检测系统上重复检测(ACT测量总数n = 410)。测量的ACT值的不精密度和差异分析按ACT的中度范围(100 - 299秒)和高度范围(≥300秒)分层。
在该研究人群中,使用HMSPlus时测量的ACT值范围为100 - 835秒。与参考方法相比,所有方法在ACT值上均显示出良好的相关性(r≥0.95)。不精密度因方法而异,在中度ACT范围内变异系数(CV)为1.7% - 2.7%,在高度ACT范围内为2.5% - 4.8%。ACTPlus和i-STAT - 硅藻土 - 预热方法在测量的ACT值上表现出比例差异,而i-STAT - 硅藻土 - 非预热和i-STAT - 高岭土 - 预热与HMSPlus相比,在测量的ACT值上表现出恒定差异。
POC方法之间的ACT值相关性良好。不精密度和差异情况因方法而异;值得注意的是,在高度ACT范围内,不精密度超过系统差异,并导致方法间差异,这是在考虑改变ACT方法时值得考虑的局限性。