对留样保存标本进行梅毒抗体检测的溯源情况分析  

Traceability of syphilis antibody detection in preserved samples

作　　者：王新梅[1] 傅兆冬 高慧卉[1] 费薇[2] 臧亮[1] WANG Xinmei;FU Zhaodong;GAO Huihui;FEI Wei;ZANG Liang(Clinical Laboratory,Dalian Blood Center,Dalian 116001,China;Zhongshan Hospital Affiliated to Dalian University)

机构地区：[1]大连市血液中心检验科,辽宁大连116001 [2]大连大学附属中山医院

出　　处：《中国输血杂志》2023年第5期416-419,共4页Chinese Journal of Blood Transfusion

摘　　要：目的通过对留样保存标本进行梅毒抗体检测的溯源情况分析来探讨血站目前的留样保存方式是否能全面地满足血液检测结果的溯源要求。方法收集本中心2014—2020年梅毒抗体检测单反应性深孔板留样标本34份、双反应性深孔板留样标本68份和已过保存期可以销毁的非反应性留样血辫和相应的深孔板留样标本263份。采用2种厂家TP-ELISA试剂进行复测,记录结果,并对数据和原始结果进行比对和统计分析。结果梅毒抗体双反应性与单反应性标本与其对应的深孔板留样标本检测结果符合率分别为98.53%(67/68)和67.65%(23/34)(P<0.05);梅毒抗体单反应性标本和其对应的深孔板留样标本检测结果:1)单反应性(试剂A):14份标本中13份原始标本0.65<S/CO<3.5,弱反应性标本占比92.86%(13/14),其中4份对应的深孔板留样标本结果为阴性,分别为2015年2份复检转阴率66.67%(2/3)、2018年和2020年各1份复检转阴率均为50%(1/2)。1份标本对应的深孔板留样标本检测后结果为双反应性。2)单反应性(试剂B):20份标本中18份原始标本0.84<S/CO<5.3,弱反应性标本占比90%(18/20),其中6份对应的深孔板留样标本结果为阴性,分别为2014年5份复检转阴率71.43%(5/7)、2015年1份复检转阴率33.33%(1/3)。有4份标本对应的深孔板留样标本检测后结果为双反应性;梅毒抗体双反应性标本与对应深孔板留样标本检测符合率除2014年为93.75%(15/16),其余年份符合率均为100%(52/52),其中4份深孔板留样标本检测后S/CO值显著增高;梅毒抗体非反应性标本与其对应的血辫和深孔板留样标本的检测结果符合率均为100%(263/263)。结论目前的留样保存方式对于不同的标本类型在检测结果的溯源方面存在比较大的差异,应进一步分析产生差异的原因,并建立一个更完善和先进的留样保存方式,以及更加合理的溯源检测方案,以达到既能满足在司法领域应用的要求,�Objective To investigate whether the current retention methods in blood stations can fully meet the traceability requirements of blood test results by analyzing the traceability of retained samples for syphilis antibody testing.Methods Thirty-four one-assay-positive deep-well plate retention samples,68 double-assay-positive deep-well plate retention samples and 263 negative retention blood braids and corresponding deep-well plate retention samples that expired retention period for syphilis antibody testing from 2014 to 2020 in our center were collected.The TP-ELISA assays of two manufacturers were used for retesting,and the results were recorded and compared with the original results statistically.Results The concordance rate of the double-assay-positive and single-assay-positive samples with their corresponding deep-well plate samples was 98.53%(67/68)and 67.65%(23/34),respectively(P<0.05).Specific results for single-assay-positive syphilis antibody samples and their corresponding deep-well plate retention samples were as follows:1)Single positive(reagent A):13 out of 14 original samples were 0.65<S/CO<3.5,weakly positive samples accounted for 92.86%(13/14),of which 4 corresponding deep-well plate retention samples had negative results,respectively,2 retests in 2015 turned negative at 66.67%(2/3),and 1 retest in 2018 and 2020 each turned negative at 50%(1/2).One sample corresponded to a deep-well plate retention sample with a double-assay-positive result after testing.2)Single positive(Reagent B):18 out of 20 samples were original samples 0.84<S/CO<5.3,with weakly positive samples accounting for 90%(18/20),of which 6 corresponded to deep-well plate retention samples with negative results,respectively,71.43%(5/7)of the 5 retests in 2014 and 33.33%(1/3)of the 1 retest in 2015.Four specimens corresponding to the deep well plate retention samples had double-positive-assay results after testing.The concordance rate between the double-positive-assay syphilis antibody specimens and the corresponding deep-well plate ret

关 键 词：深孔板留样 血辫 梅毒抗体 溯源 

分 类 号：R457.1[医药卫生—治疗学] R377.1[医药卫生—临床医学]