中华实验和临床病毒学杂志
中華實驗和臨床病毒學雜誌
중화실험화림상병독학잡지
CHINESE JOURNAL OF EXPERIMENTAL AND CLINICAL VIROLOGY
2013年
6期
477-479
,共3页
杨俊梅%李进香%郭振欣%赵鼎
楊俊梅%李進香%郭振訢%趙鼎
양준매%리진향%곽진흔%조정
巨细胞病毒%免疫球蛋白G%试剂盒,诊断%评价研究
巨細胞病毒%免疫毬蛋白G%試劑盒,診斷%評價研究
거세포병독%면역구단백G%시제합,진단%평개연구
Cytomegalovirus%Immunoglobulin G%Reagnent kits,diagnostic%Evaluation studies
目的 对国内两种巨细胞病毒IgG抗体ELISA诊断试剂进行评价.方法 用两种试剂对BBI公司的质控盘QTC711,血清转化盘PTC901,BIOMEX公司血清转化盘SCP-CMV-001(RP-003)、SCP-CMV-002(RP-019),儿童、孕妇和门诊患者2163份标本进行检测,对不一致的样本用Diasorin ELISA试剂盒和Mikrogen重组免疫印迹试剂盒进行复测,比较两种试剂的灵敏度、特异性和对不同人群的检测差异.结果 A试剂对3个血清转化盘的检出时间均早于B试剂,平均提前25 d,与Abbott Imx CMV IgG检测灵敏度一致.两种试剂检测孕妇样本607份,8份不一致,总符合率98.68％;门诊样本512份,7份不一致,总符合率98.63％;儿童样本1044份,74份不一致,总符合率92.91％,两试剂对儿童人群的符合率低于孕妇和门诊人群.两试剂对三个人群检测均为阴性的161份样本,和A试剂检测为阳性B试剂检测为阴性的89份样本,用意大利Diasorin公司CMV-IgGELISA试剂复测,A试剂与Diasorin的阳性符合率为100％,阴性符合率为93.06％,总符合率为95.22％;B试剂与Diasorin的阴性符合率为100％,78份阳性未检出,总符合率为68.92％.选择A试剂与Diasorin结果不一致的样本12份,一致的样本6份,用重组免疫印迹复测,其中14份阳性,4份阴性.结论 国内A试剂对血清转化盘的检测窗口期较B试剂显著提前.两试剂对孕妇和门诊人群的符合率高于儿童人群.两试剂不符合的样本用进口试剂盒复测,A试剂与进口试剂盒的符合率高于B试剂,显示了较高的灵敏度.
目的 對國內兩種巨細胞病毒IgG抗體ELISA診斷試劑進行評價.方法 用兩種試劑對BBI公司的質控盤QTC711,血清轉化盤PTC901,BIOMEX公司血清轉化盤SCP-CMV-001(RP-003)、SCP-CMV-002(RP-019),兒童、孕婦和門診患者2163份標本進行檢測,對不一緻的樣本用Diasorin ELISA試劑盒和Mikrogen重組免疫印跡試劑盒進行複測,比較兩種試劑的靈敏度、特異性和對不同人群的檢測差異.結果 A試劑對3箇血清轉化盤的檢齣時間均早于B試劑,平均提前25 d,與Abbott Imx CMV IgG檢測靈敏度一緻.兩種試劑檢測孕婦樣本607份,8份不一緻,總符閤率98.68％;門診樣本512份,7份不一緻,總符閤率98.63％;兒童樣本1044份,74份不一緻,總符閤率92.91％,兩試劑對兒童人群的符閤率低于孕婦和門診人群.兩試劑對三箇人群檢測均為陰性的161份樣本,和A試劑檢測為暘性B試劑檢測為陰性的89份樣本,用意大利Diasorin公司CMV-IgGELISA試劑複測,A試劑與Diasorin的暘性符閤率為100％,陰性符閤率為93.06％,總符閤率為95.22％;B試劑與Diasorin的陰性符閤率為100％,78份暘性未檢齣,總符閤率為68.92％.選擇A試劑與Diasorin結果不一緻的樣本12份,一緻的樣本6份,用重組免疫印跡複測,其中14份暘性,4份陰性.結論 國內A試劑對血清轉化盤的檢測窗口期較B試劑顯著提前.兩試劑對孕婦和門診人群的符閤率高于兒童人群.兩試劑不符閤的樣本用進口試劑盒複測,A試劑與進口試劑盒的符閤率高于B試劑,顯示瞭較高的靈敏度.
목적 대국내량충거세포병독IgG항체ELISA진단시제진행평개.방법 용량충시제대BBI공사적질공반QTC711,혈청전화반PTC901,BIOMEX공사혈청전화반SCP-CMV-001(RP-003)、SCP-CMV-002(RP-019),인동、잉부화문진환자2163빈표본진행검측,대불일치적양본용Diasorin ELISA시제합화Mikrogen중조면역인적시제합진행복측,비교량충시제적령민도、특이성화대불동인군적검측차이.결과 A시제대3개혈청전화반적검출시간균조우B시제,평균제전25 d,여Abbott Imx CMV IgG검측령민도일치.량충시제검측잉부양본607빈,8빈불일치,총부합솔98.68％;문진양본512빈,7빈불일치,총부합솔98.63％;인동양본1044빈,74빈불일치,총부합솔92.91％,량시제대인동인군적부합솔저우잉부화문진인군.량시제대삼개인군검측균위음성적161빈양본,화A시제검측위양성B시제검측위음성적89빈양본,용의대리Diasorin공사CMV-IgGELISA시제복측,A시제여Diasorin적양성부합솔위100％,음성부합솔위93.06％,총부합솔위95.22％;B시제여Diasorin적음성부합솔위100％,78빈양성미검출,총부합솔위68.92％.선택A시제여Diasorin결과불일치적양본12빈,일치적양본6빈,용중조면역인적복측,기중14빈양성,4빈음성.결론 국내A시제대혈청전화반적검측창구기교B시제현저제전.량시제대잉부화문진인군적부합솔고우인동인군.량시제불부합적양본용진구시제합복측,A시제여진구시제합적부합솔고우B시제,현시료교고적령민도.
Objective To evaluate the two commercial cytomegalovirus IgG ELISA diagnostic kits.Methods Anti-CMV quality control panel QTC711 and seroconversion Panel PTC901 from BBI,seroconversion panel SCP-CMV-001 (RP-003) and SCP-CMV-002 (RP-019) from BIOMEX,and 2163 samples from three population groups were detect by the two kits.The inconsistent sample were retest by Diasorin CMV-IgG ELISA kit and Mikrogen recomblot CMV-IgG kit.Results Three seroconversion panel result show that the average detected positive time of A kit is 25 days earlier than B kit,the sensitivity of A kit is same as Abbott Imx CMV.The two kits detect 607 pregnant woman samples,8 were inconsistent,the coincidence rate is 98.68％; 512 outpatients samples,7 were inconsistent,the coincidence rate is 98.63％ ; 1044 Pediatric population samples,74 were inconsistent,the coincidence rate is 92.91％ ; the coincidence rate of Pediatric group is lower than other two groups.161 negative samples detect by A and B kits,and 89 samples positive by A kit but negative by B kit,were retest by Diasorin CMV-IgG ELISA kit,the positive coincidence rate of A and Diasorin kit is 100％,negative coincidence rate is 93.64％,total coincidence is 95.62％ ; the negative coincidence rate of B and Diasorin kit is 100％,total coincidence is 68.92％,78 samples were negative by B kit.12 A and Diasorin kit detect inconsistent samples and 6 consistent samples were retest by recomblot CMV-IgG,14 results were positive,4 results were negative.Conclusion The detection window period of A kit is shoter than B kit.The coincidence rate of A and B kit for pregnant women and outpatient population is higher than pediatrie population.The inconsistent samples were retest by imported kits,A kit show high consistent with imported kit than B kit.
