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目的总结和分析2011-2014年国内实验室通过中国国际输血感染预防和控制(CITIC)项目参加澳大利亚国立血清参比实验室(NRL)血液筛查核酸检测(NAT)室间质评(EQAS)结果。方法对2011-2014年CITIC项目参加全部10次血液NAT筛查NRL EQAS的参评实验室、检测试剂、不正常结果情况作统计和分析。结果 10次血液NAT筛查EQAS共有33家实验室221次参评,其中78%(172/221)为血液中心实验室、15%(28/221)为中心血站实验室和9%(21/221)为试剂公司实验室。共使用4种试剂检测血清盘234次,分别为Novartis 47%(111/234)、Roche 23%(54/234)、科华12%(27/234)和浩源18%(42/234)。10次EQAS共出现36个不正常结果,包括14个假阴性和22个假阳性。血液中心、中心血站和公司实验室出现不正常结果比例分别为0.27%(23/8 565)、0.22%(3/1 350)和1.06%(10/945),出现不正常结果的实验室比例分别为8.38%(14/167)、11.54%(3/26)和28.57%(6/21)。Novartis、Roche、科华和浩源试剂检测出现不正常结果比例分别为0.20%(13/6 540)、0.74%(9/1215)、0.79%(10/1 260)和0.22%(4/1 845)。阴性样品和阳性样品出现不正常结果频率分别为0.34%(14/4 092)和0.22%(24/11 140)。CITIC参评实验室出现不正常结果实验室比例为10.75%(23/214),低于NRL其他参评实验的27.11%(202/745)。结论 CITIC参评实验室核酸筛查检测整体水平高于参加NRL EQAS的其他参评实验室。实验室通过参加EQAS,可以发现存在的问题,不断改进和提高实验室的检测能力。
Objectives To summarize and analyze the results of the NAT screening of blood tests (NAT) in the National Laboratory Reference Laboratory (NRL) through the China International Blood Transfusion Infection Prevention and Control (CITIC) program in 2011-2014. . Methods Statistics and analysis of the participating laboratories, testing reagents and abnormal results of NTIC EQAS during all 10 blood NAT screening sessions from 2011 to 2014 in CITIC program were conducted. Results 10 blood NAT screening tests included 33 laboratories and 221 evaluations in EQAS, of which 78% (172/221) were blood center laboratories, 15% (28/221) were central blood station laboratories and 9% (21 / 221) for the Reagent Company Laboratory. A total of 234 tests of serum disk were performed using four reagents, which were Novartis 47% (111/234), Roche 23% (54/234), Kehua 12% (27/234) and Haoyuan 18% (42/234) respectively. A total of 36 abnormal results occurred in 10 EQAS, including 14 false negatives and 22 false positives. Undesirable results were 0.27% (23/8 565), 0.22% (3/1 350) and 1.06% (10/945) in the blood center, center blood bank and corporate laboratories, respectively, and laboratories with abnormal results The proportions were 8.38% (14/167), 11.54% (3/26) and 28.57% (6/21), respectively. The rates of abnormal results detected by Novartis, Roche, Kehua and Haoyuan reagents were 0.20% (13/6 540), 0.74% (9/1215), 0.79% (10/1 260) and 0.22% (4/1 845 ). The frequency of abnormal results for negative and positive samples was 0.34% (14/4 092) and 0.22% (24/11 140), respectively. CITIC participating laboratories had an abnormal result laboratory ratio of 10.75% (23/214), which was lower than 27.11% (202/745) of the other NRL evaluation laboratories. Conclusion The overall level of nucleic acid screening test in CITIC participating laboratories is higher than other participating laboratories participating in NRL EQAS. By participating in EQAS, laboratories can identify problems and continually improve and enhance their testing capabilities.