检验医学
檢驗醫學
검험의학
Laboratory Medicine
2015年
9期
926-930
,共5页
蔡玉婵%赵旭鸿%韩平%陈昌明%李智
蔡玉嬋%趙旭鴻%韓平%陳昌明%李智
채옥선%조욱홍%한평%진창명%리지
血小板聚集%血小板分析仪%连续血小板计数%性能评价
血小闆聚集%血小闆分析儀%連續血小闆計數%性能評價
혈소판취집%혈소판분석의%련속혈소판계수%성능평개
Platelet aggregation%Platelet analyzer%Continuous platelet count%Performance evaluation
目的：探讨PL-11血小板分析仪在检测血小板数量及聚集功能方面的性能。方法按照美国临床实验室标准化协会（ CLSI）制定的仪器性能验证标准及我国卫生行业标准 WS／T 406-2012《临床血液学检验常规项目分析质量要求》对PL-11血小板分析仪进行血小板计数及聚集功能的性能评价。采用PL-11血小板分析仪、LBY-NJ4血小板聚集仪及TEG-5000血栓弹力图仪检测健康人群血小板聚集率，分析各仪器检测结果间的相关性。结果 PL-11血小板分析仪的批内及日间精密度均＜1／3总误差（7％）；携带污染率为0．32％；在（4．12～1380．4）×109／L线性范围内回归方程斜率为1．03，R2＝0．993；血小板计数结果与血小板参考方法的结果符合率为84％，均符合行业标准要求。分别采用PL-11血小板分析仪、LBY-NJ4血小板聚集仪及TEG-5000血栓弹力图仪检测79例2型糖尿病患者单服用氯匹格雷前、后血小板聚集率，3种仪器之间差异均无统计学意义（ P＞0．05），患者服药前、后血小板聚集率差异有统计学意义（P＜0．01）。结论 PL-11血小板分析仪可为临床提供准确、可靠的血小板计数及聚集功能的检测结果。
目的：探討PL-11血小闆分析儀在檢測血小闆數量及聚集功能方麵的性能。方法按照美國臨床實驗室標準化協會（ CLSI）製定的儀器性能驗證標準及我國衛生行業標準 WS／T 406-2012《臨床血液學檢驗常規項目分析質量要求》對PL-11血小闆分析儀進行血小闆計數及聚集功能的性能評價。採用PL-11血小闆分析儀、LBY-NJ4血小闆聚集儀及TEG-5000血栓彈力圖儀檢測健康人群血小闆聚集率，分析各儀器檢測結果間的相關性。結果 PL-11血小闆分析儀的批內及日間精密度均＜1／3總誤差（7％）；攜帶汙染率為0．32％；在（4．12～1380．4）×109／L線性範圍內迴歸方程斜率為1．03，R2＝0．993；血小闆計數結果與血小闆參攷方法的結果符閤率為84％，均符閤行業標準要求。分彆採用PL-11血小闆分析儀、LBY-NJ4血小闆聚集儀及TEG-5000血栓彈力圖儀檢測79例2型糖尿病患者單服用氯匹格雷前、後血小闆聚集率，3種儀器之間差異均無統計學意義（ P＞0．05），患者服藥前、後血小闆聚集率差異有統計學意義（P＜0．01）。結論 PL-11血小闆分析儀可為臨床提供準確、可靠的血小闆計數及聚集功能的檢測結果。
목적：탐토PL-11혈소판분석의재검측혈소판수량급취집공능방면적성능。방법안조미국림상실험실표준화협회（ CLSI）제정적의기성능험증표준급아국위생행업표준 WS／T 406-2012《림상혈액학검험상규항목분석질량요구》대PL-11혈소판분석의진행혈소판계수급취집공능적성능평개。채용PL-11혈소판분석의、LBY-NJ4혈소판취집의급TEG-5000혈전탄력도의검측건강인군혈소판취집솔，분석각의기검측결과간적상관성。결과 PL-11혈소판분석의적비내급일간정밀도균＜1／3총오차（7％）；휴대오염솔위0．32％；재（4．12～1380．4）×109／L선성범위내회귀방정사솔위1．03，R2＝0．993；혈소판계수결과여혈소판삼고방법적결과부합솔위84％，균부합행업표준요구。분별채용PL-11혈소판분석의、LBY-NJ4혈소판취집의급TEG-5000혈전탄력도의검측79례2형당뇨병환자단복용록필격뢰전、후혈소판취집솔，3충의기지간차이균무통계학의의（ P＞0．05），환자복약전、후혈소판취집솔차이유통계학의의（P＜0．01）。결론 PL-11혈소판분석의가위림상제공준학、가고적혈소판계수급취집공능적검측결과。
Objective To investigate the performance of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation.Methods According to the instrument performance verification standards in the Clinical and Laboratory Standards Institute ( CLSI) and the Health Industry Standard of the People′s Republic of China, WS/T 406-2012:the Quality Standard of Routine Tests in Clinical Hematology, the performance of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation were evaluated.Platelet aggregation rate in healthy subjects was compared for correlation, which was detected by PL-11 platelet analyzer, LBY-NJ4 platelet tester and TEG-5000 thromboelastogram.Results The within-run and inter-day precisions of PL-11 platelet analyzer were<1/3 of total error (7%), and the carry-over rate was 0.32%.In (4.12-1 380.4) ×109/L linear range, the regression equation slope was 1.03 (R2 =0.993).The coincidence rate for platelet count by PL-11 platelet analyzer with reference method was 84%.There was no statistical significance of platelet aggregation rate among PL-11 platelet analyzer, LBY-NJ4 platelet tester and TEG-5000 thromboelastogram in 79 patients with type 2 diabetes mellitus (P>0.05).However, there was statistical significance in platelet aggregation rates before and after taking clopidogrel hydrogen(P<0.01).Conclusions PL-11 platelet analyzer can provide accurate and reliable results for platelet count and aggregation.
