山西医药杂志
山西醫藥雜誌
산서의약잡지
SHANXI MEDICAL JOURNAL
2015年
15期
1747-1749
,共3页
梅毒血清诊断%酶联免疫吸附测定%Kappa一致性分析
梅毒血清診斷%酶聯免疫吸附測定%Kappa一緻性分析
매독혈청진단%매련면역흡부측정%Kappa일치성분석
Syhilis serodiagnosis%Enzyme-linked immunosorbent assay%Kappa consistency analysis
目的：通过对2种梅毒螺旋体酶联免疫吸附试验（TP‐ELISA）检测方法一致性的研究，为选择最佳的血液筛查方法提供了理论基础，以确保输血安全。方法利用科美生物免疫化学试剂盒检测2014年1月至9月我院所有门诊和住院患者的梅毒待检标本；其中可疑和阳性标本利用科华 T P‐ELISA和M urex T P‐ELISA分别进行双孔复检；利用SAS 9．2软件对可疑和阳性复检结果进行Kappa一致性分析，并对可疑和阳性结果分别进行Kappa一致性分析，并对Kappa系数进行了U检验。结果科美生物免疫化学试剂盒检测所有标本中共754份可疑和阳性结果，其中171份为可疑结果，583份为阳性结果；科华T P‐ELISA检测754份标本，阴性、可疑和阳性结果分别为85（11％）、19（3％）和650（86％），Murex TP‐ELISA 结果为173（23％）、29（4％）和552（73％）。2种方法针对可疑及阳性标本、阳性标本和可疑标本的Kappa系数分别为Kappa＝0.4800，95％ CI ＝（0.4096，0.5505）；Kappa＝0.3795，95％ CI ：（0.2312，0.5279）；Kappa＝0.0108；95％ CI ＝（－0.0787，0.1004）。结论2种方法针对可疑阳性标本和阳性标本有较好的一致性，而仅针对可疑标本时2种方法的一致性可能是由机器造成的。针对可疑标本应采用其他更敏感特异的实验进行验证。
目的：通過對2種梅毒螺鏇體酶聯免疫吸附試驗（TP‐ELISA）檢測方法一緻性的研究，為選擇最佳的血液篩查方法提供瞭理論基礎，以確保輸血安全。方法利用科美生物免疫化學試劑盒檢測2014年1月至9月我院所有門診和住院患者的梅毒待檢標本；其中可疑和暘性標本利用科華 T P‐ELISA和M urex T P‐ELISA分彆進行雙孔複檢；利用SAS 9．2軟件對可疑和暘性複檢結果進行Kappa一緻性分析，併對可疑和暘性結果分彆進行Kappa一緻性分析，併對Kappa繫數進行瞭U檢驗。結果科美生物免疫化學試劑盒檢測所有標本中共754份可疑和暘性結果，其中171份為可疑結果，583份為暘性結果；科華T P‐ELISA檢測754份標本，陰性、可疑和暘性結果分彆為85（11％）、19（3％）和650（86％），Murex TP‐ELISA 結果為173（23％）、29（4％）和552（73％）。2種方法針對可疑及暘性標本、暘性標本和可疑標本的Kappa繫數分彆為Kappa＝0.4800，95％ CI ＝（0.4096，0.5505）；Kappa＝0.3795，95％ CI ：（0.2312，0.5279）；Kappa＝0.0108；95％ CI ＝（－0.0787，0.1004）。結論2種方法針對可疑暘性標本和暘性標本有較好的一緻性，而僅針對可疑標本時2種方法的一緻性可能是由機器造成的。針對可疑標本應採用其他更敏感特異的實驗進行驗證。
목적：통과대2충매독라선체매련면역흡부시험（TP‐ELISA）검측방법일치성적연구，위선택최가적혈액사사방법제공료이론기출，이학보수혈안전。방법이용과미생물면역화학시제합검측2014년1월지9월아원소유문진화주원환자적매독대검표본；기중가의화양성표본이용과화 T P‐ELISA화M urex T P‐ELISA분별진행쌍공복검；이용SAS 9．2연건대가의화양성복검결과진행Kappa일치성분석，병대가의화양성결과분별진행Kappa일치성분석，병대Kappa계수진행료U검험。결과과미생물면역화학시제합검측소유표본중공754빈가의화양성결과，기중171빈위가의결과，583빈위양성결과；과화T P‐ELISA검측754빈표본，음성、가의화양성결과분별위85（11％）、19（3％）화650（86％），Murex TP‐ELISA 결과위173（23％）、29（4％）화552（73％）。2충방법침대가의급양성표본、양성표본화가의표본적Kappa계수분별위Kappa＝0.4800，95％ CI ＝（0.4096，0.5505）；Kappa＝0.3795，95％ CI ：（0.2312，0.5279）；Kappa＝0.0108；95％ CI ＝（－0.0787，0.1004）。결론2충방법침대가의양성표본화양성표본유교호적일치성，이부침대가의표본시2충방법적일치성가능시유궤기조성적。침대가의표본응채용기타경민감특이적실험진행험증。
Objective To provide scientific materials for selecting the best method of blood screening and to ensure the safety of blood transfusion in our country by performing kappa consistency analysis of 2 type TP‐ELISA methods . Methods All the syphilis inspected samples which were collected from the outpatients and inpatients in the Military Gen‐eral Hospital of Beijing from January to September 2014 ,were detected by Kemei Immunohistochemistry kits .Among them ,the suspicious and positive specimens were re‐inspected by Kehua TP‐ELISA and Murex TP‐ELISA .Kappa con‐sistency analysis of the re‐inspected results of suspicious and positive samples was carried out on SAS 9 .2 software and u test of Kappa coefficient was performed .Results Among all the samples ,754 suspicious and positive specimens were de‐tected by Kemei Immunohistochemistry kits ,which included 171 suspicious and 583 positive specimens .Of 754 specimens re‐inspected by Kehua TP‐ELISA showed negative ,suspicious ,positive specimens were 85 (11% ) ,19 (3% ) and 650 (86% ) ,respectively .The re‐inspected results by Murex TP‐ELISA was 173 (23% )negative ,29(4% ) suspicious and 552(73% ) positive .Kappa coefficient of suspicious‐positive specimens ,suspicious specimens and positive specimens by two TP‐ELISA methods were 0.480 0 ,95% CI :(0.409 6 ,0.550 5);0.379 5 ,95% CI :(0.231 2 ,0.527 9);0.010 8 , 95% CI :(-0.078 7 ,0.100 4) ,respectively .Conclusion There is a good consistency of suspicious‐positive and positive specimens by two TP‐ELISA methods .Consistency of the two methods for suspicious specimens was caused by opportu‐nity .Suspicious specimens should be confirmed by other more sensitive and specific methods ,such as PCR ,WB and rab‐bit infectivity testing and so on .
