BACKGROUND Point-of-care (POC) hemoglobin testing has the potential to revolutionize massive transfusion strategies. No prior studies have compared POC and central laboratory testing of hemoglobin in patients undergoing massive transfusions. METHODS We retrospectively compared the results of our point-of-care hemoglobin test (EPOC®) to our core laboratory complete blood count (CBC) hemoglobin test (Sysmex XE-5000™) in patients undergoing massive transfusion protocols (MTP) for hemorrhage. One hundred seventy paired samples from 90 patients for whom MTP was activated were collected at a single, tertiary care hospital between 10/2011 and 10/2017. Patients had both an EPOC® and CBC hemoglobin performed within 30 min of each other during the MTP. We assessed the accuracy of EPOC® hemoglobin testing using two variables: interchangeability and clinically significant differences from the CBC. The Clinical Laboratory Improvement Amendments (CLIA) proficiency testing criteria defined interchangeability for measurements. Clinically significant differences between the tests were defined by an expert panel. We examined whether these relationships changed as a function of the hemoglobin measured by the EPOC® and specific patient characteristics. RESULTS Fifty one percent (86 of 170) of paired samples' hemoglobin results had an absolute difference of ≤7 and 73% (124 of 170) fell within ±1 g/dL of each other. The mean difference between EPOC® and CBC hemoglobin had a bias of - 0.268 g/dL (p = 0.002). When the EPOC® hemoglobin was < 7 g/dL, 30% of the hemoglobin values were within ±7, and 57% were within ±1 g/dL. When the measured EPOC® hemoglobin was ≥7 g/dL, 55% of the EPOC® and CBC hemoglobin values were within ±7, and 76% were within ±1 g/dL. EPOC® and CBC hemoglobin values that were within ±1 g/dL varied by patient population: 77% for cardiac surgery, 58% for general surgery, and 72% for non-surgical patients. CONCLUSIONS The EPOC® device had minor negative bias, was not interchangeable with the CBC hemoglobin, and was less reliable when the EPOC® value was < 7 g/dL. Clinicians must consider speed versus accuracy, and should check a CBC within 30 min as confirmation when the EPOC® hemoglobin is < 7 g/dL until further prospective trials are performed in this population.

中文翻译：

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大量输血期间对血红蛋白的即时护理与集中测试。

背景技术即时护理（POC）血红蛋白测试具有彻底改变大规模输血策略的潜力。以前没有研究比较过大量输血患者的血红蛋白的POC和中心实验室测试。方法我们回顾性地比较了接受大规模输血方案（MTP）出血的患者的即时护理血红蛋白测试（EPOC®）与核心实验室全血细胞计数（CBC）血红蛋白测试（Sysmex XE-5000™）的结果。在2011年10月10日至2017年10月10日之间，从一家三级护理医院收集了90例激活了MTP的患者的一百七十对配对样本。在MTP期间，患者在彼此之间的30分钟内均表现出EPOC®和CBC血红蛋白。我们使用两个变量评估了EPOC®血红蛋白测试的准确性：与CBC的互换性和临床上的显着差异。临床实验室改进修正案（CLIA）能力测试标准定义了测量的互换性。测试之间的临床显着差异由专家小组定义。我们检查了这些关系是否随着血红蛋白和特定患者特征的变化而改变。结果配对样品的血红蛋白结果中有51％（170个中的86个）的绝对差值≤7，而73％（170个中的124个）的绝对值相差在±1 g / dL之内。和CBC血红蛋白之间的平均差为-0.268 g / dL（p = 0.002）。当血红蛋白<7 g / dL时，30％的血红蛋白值在±7以内，57％的血红蛋白值在±1 g / dL以内。当测得的EPOC®血红蛋白≥7 g / dL时，和CBC血红蛋白值的55％在±7以内，而76％在±1 g / dL以内。EPOC®和CBC血红蛋白值在±1 g / dL以内的患者人群而异：心脏手术的77％，普通手术的58％和非手术患者的72％。结论EPOC®装置具有较小的负偏压，不能与CBC血红蛋白互换，并且当EPOC®值<7 g / dL时可靠性较低。临床医生必须考虑速度与准确性，并应在30分钟内检查CBC，以确认EPOC®血红蛋白<7 g / dL，直到对该人群进行进一步的前瞻性试验。非手术患者占72％。结论EPOC®装置具有较小的负偏压，不能与CBC血红蛋白互换，并且当EPOC®值<7 g / dL时可靠性较低。临床医生必须考虑速度与准确性，并应在30分钟内检查CBC，以确认EPOC®血红蛋白<7 g / dL，直到对该人群进行进一步的前瞻性试验。非手术患者占72％。结论EPOC®装置具有较小的负偏压，不能与CBC血红蛋白互换，并且当EPOC®值<7 g / dL时可靠性较低。临床医生必须考虑速度与准确性，并应在30分钟内检查CBC，以确认EPOC®血红蛋白<7 g / dL，直到对该人群进行进一步的前瞻性试验。