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目的比较不同梅毒检测方法诊断的准确性,为梅毒筛查和诊断提供依据。方法 23 762例血清标本采用微粒子化学发光免疫分析法(CMIA)和甲苯胺红不加热血清试验(TRUST)联合检测,阳性标本再用梅毒螺旋体明胶颗粒凝集试验(TP-PA)复检,同时对CMIA法检测S/CO值0.50~0.99的阴性血清标本也用TP-PA法复检。CMIA与TP-PA法检测结果不一致的血清标本用免疫印迹法(WB)进行确认。结果 CMIA法联合TRUST法检出1 108例阳性标本(4.66%),其中TRUST法阳性者486例(2.05%),CMIA法阳性者1 074例(4.52%),CMIA法(+)并TRUST法(+)者452例,TP-PA法复检阳性率100%。CMIA法(+)/TRUST法(-)者622例,TP-PA法复检阳性率92.12%;CMIA法(-)/TRUST法(+)者34例,TP-PA法复检阳性率0。CMIA法(-)者的S/CO值0.50~0.99时TP-PA法复检阳性率23.08%,S/CO值1.00~9.99时TP-PA法复检阳性率88.14%,且S/CO值越大,TP-PA法复检阳性率越高,S/CO值≥10.00时TP-PA法复检阳性率100%。WB法对61例CMIA法和TP-PA法不一致标本确证结果显示:CMIA法阳性预测值(PPV)为57.14%,TP-PA法阳性预测值为16.67%,差异有统计学意义(P<0.05)。结论血清梅毒筛查检验方法的敏感性:CMIA法>TP-PA法>TRUST法。CMIA法自动化程度高,结果易保留,为梅毒特异性抗体筛查的首选方法。CMIA法检测阳性的标本需进一步作TRUST及其滴度试验,而CMIA法阴性的标本不必作TRUST试验,以避免TRUST试验假阳性结果误导临床诊疗。CMIA法检测S/CO值处于临界值附近时,临床医生应结合患者临床资料进行综合诊断,对疑似病例进行随访和复检。
Objective To compare the diagnostic accuracy of different syphilis detection methods to provide evidence for screening and diagnosis of syphilis. Methods 23 762 serum samples were detected by microparticle chemiluminescence immunoassay (CMIA) and toluidine red unheated serum assay (TRUST), and the positive samples were retested with TP-PA. CMIA test S / CO value of 0.50 to 0.99 negative serum samples also TP-PA retest. Serum samples with inconsistent CMIA and TP-PA test results were confirmed by Western blotting (WB). Results There were 1 108 positive samples (4.66%) detected by CMIA and TRUST methods. Among them, 486 (2.05%) were TRUST positive, 1 074 (4.52%) were CMIA positive, (+) 452 cases, TP-PA method re-examination of the positive rate of 100%. There were 622 cases with CMIA (+) / TRUST (-), 92.12% with TP-PA and 34 with CMIA (-) / TRUST . The positive rate of TP-PA method was 23.08% when S / CO value of CMIA method (-) was between 0.50 and 0.99, and the positive rate of TP-PA method was 88.14% with S / CO value between 1.00 and 9.99 The greater the positive rate of TP-PA retest, the higher the S / CO value of ≥10.00, the positive rate of TP-PA retest was 100%. WB method inconsistency of 61 cases of CMIA method and TP-PA method confirmed the results of the sample: CMIA positive predictive value (PPV) was 57.14%, TP-PA positive predictive value was 16.67%, the difference was statistically significant (P <0.05 ). Conclusions The sensitivity of the screening test for serum syphilis: CMIA method> TP-PA method> TRUST method. CMIA method of a high degree of automation, the results easily retained, the preferred method of screening for syphilis-specific antibodies. CMIA test positive specimens required further TRUST and its titer test, and CMIA negative specimens do not need TRUST test to avoid TRUST test false positive results of misdiagnosis of clinical diagnosis and treatment. CMIA test S / CO value near the critical value, clinicians should be combined with the clinical data of patients with a comprehensive diagnosis of suspected cases were followed up and re-examination.