诊断实验室的标准化和血小板透射电子显微镜的验证。,Platelets

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诊断实验室的标准化和血小板透射电子显微镜的验证。
Platelets ( IF 2.5 ) Pub Date : 2018-06-05 , DOI: 10.1080/09537104.2018.1476682
Dong Chen ₁ , Cindy B Uhl ₂ , Sandra C Bryant ₃ , Marcy Krumwiede ₄ , Ryan L Barness ₂ , Mary C Olson ₂ , Susan C Gossman ₂ , Sibel Erdogan Damgard ₂ , Scott I Gamb ₂ , Lisa A Cummins ₂ , Jon E Charlesworth ₂ , Christina M Wood-Wentz ₃ , Jeffrey L Salisbury ₂ , Elizabeth A Plumhoff ₁ , Elizabeth M Van Cott ₅ , Rong He ₁ , Deepti M Warad ₁ , Rajiv K Pruthi ₁ , John A Heit ₁ , William L Nichols ₁ , James G White ₄

Affiliation

血小板透射电子显微镜（PTEM）被认为是评估遗传性血小板疾病（IPD）中不同的超微结构异常的金标准测试。尽管如此，由于缺乏标准化的程序，经过验证的致密颗粒（DG）计数参考范围和标准化的图像解释标准，PTEM仍然主要是一种研究工具。这项研究的目的是标准化和验证PTEM作为临床实验室测试。基于以前建立的方法，我们优化和标准化了整个安装（WM）和薄截面（TS）PTEM的分析前，分析和分析后程序。DG /血小板的平均数（plt），不含DG的蛋白的百分比，血小板计数（PC），平均血小板体积（MPV），未成熟的血小板分数（IPF），对113位健康捐献者的血液样本进行了plt和光透射凝集分析。使用分位数回归来估计DG / plt的参考范围，并使用线性回归来评估DG / plt与其他plt测量的关联。所有PTEM程序均使用市售材料和试剂进行了标准化。DG的解释标准是根据以前的出版物和专家共识建立的，从而改善了操作员的协议。血液样本采集后，平均DG / plt稳定2天。患者体内平均DG / plt变异系数的中位数为22.2％；DG / plt参考平均值范围（95％中）为1.2-4.0。平均DG / plt与IPF相关（p = .01，R2 = 0.06），但与年龄，性别，PC，MPV或plt最大聚集或聚集的主要斜率无关（p> .17，R2 <0.02）。建立了TS-PTEM的基线超微结构特征。使用先前已确诊为IPD的患者的样本对PTEM进行了验证。PTEM程序和解释的标准化和验证，以及正常平均DG / plt参考范围和PTEM基线超微结构特征的建立，将有助于PTEM作为评估IPD超微结构异常的有效临床实验室测试的实施。

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Diagnostic laboratory standardization and validation of platelet transmission electron microscopy.

Platelet transmission electron microscopy (PTEM) is considered the gold standard test for assessing distinct ultrastructural abnormalities in inherited platelet disorders (IPDs). Nevertheless, PTEM remains mainly a research tool due to the lack of standardized procedures, a validated dense granule (DG) count reference range, and standardized image interpretation criteria. The aim of this study was to standardize and validate PTEM as a clinical laboratory test. Based on previously established methods, we optimized and standardized preanalytical, analytical, and postanalytical procedures for both whole mount (WM) and thin section (TS) PTEM. Mean number of DG/platelet (plt), percentage of plts without DG, platelet count (PC), mean platelet volume (MPV), immature platelet fraction (IPF), and plt light transmission aggregometry analyses were measured on blood samples from 113 healthy donors. Quantile regression was used to estimate the reference range for DG/plt, and linear regression was used to assess the association of DG/plt with other plt measurements. All PTEM procedures were standardized using commercially available materials and reagents. DG interpretation criteria were established based on previous publications and expert consensus, and resulted in improved operator agreement. Mean DG/plt was stable for 2 days after blood sample collection. The median within patient coefficient of variation for mean DG/plt was 22.2%; the mean DG/plt reference range (mid-95th %) was 1.2-4.0. Mean DG/plt was associated with IPF (p = .01, R2 = 0.06) but not age, sex, PC, MPV, or plt maximum aggregation or primary slope of aggregation (p > .17, R2 < 0.02). Baseline ultrastructural features were established for TS-PTEM. PTEM was validated using samples from patients with previously established diagnoses of IPDs. Standardization and validation of PTEM procedures and interpretation, and establishment of the normal mean DG/plt reference range and PTEM baseline ultrastructural features, will facilitate implementation of PTEM as a valid clinical laboratory test for evaluating ultrastructural abnormalities in IPDs.

更新日期：2019-11-01

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