Clinical analysis and methodological evaluation of syphilis infection in patients in a first-class tertiary hospital in Suzhou, China.

IF 1.4 Q4 IMMUNOLOGY American journal of clinical and experimental immunology Pub Date : 2023-10-15 eCollection Date: 2023-01-01
Sheng Zhang, Chen Ling, Zhongping Qian, Jingping Yin, Qingqin Tang, Ximeng Zhang, Yinjuan Shi, Bin Feng, Jie Ding, Qian Yang
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Abstract

Objective: To explore the distribution and epidemiological characteristics of patients with syphilis in a first-class tertiary hospital and to evaluate the coincidence rate between chemiluminescence immunoassay (CLIA) and Treponema pallidum particle agglutination assay (TPPA).

Methods: The medical records of 247,501 outpatients and inpatients were retrospectively analyzed. TPPA was used to verify positive and suspected cases, and the coincidence rate between CLIA and TPPA was evaluated. Receiver operating characteristic (ROC) curve was used to determine optimal diagnostic thresholds.

Results: Of the 247,501 serum samples, 5,173 were detected positive for syphilis using CLIA, with a detection rate of 2.09% and a men-to-women ratio of 1.39. The chi-square test showed that sex and age were both factors that affected the detection rate (χ2=229.51, P < 0.0001). In addition, urology, orthopedics, cardiology, general surgery, gastroenterology, and gynecology represented the top six departments with the highest numbers of positive cases. Comparative analysis showed that the overall coincidence rate between CLIA and TPPA was 80.24%. Analysis of the ROC curve showed that the area under the curve (AUC) was 0.936 (95% confidence interval [CI]: 0.929-0.942, P < 0.0001) using sample/cut-off value (S/CO) as a diagnostic indicator. The results showed that an S/CO value of 3.945 was the best diagnostic value for the CLIA method, with a diagnostic specificity of 93.64% and a sensitivity of 81.90%.

Conclusions: Syphilis is widely distributed in various hospital departments and primarily affects middle-aged and older individuals. For cases that have been initially screened as positive or suspicious, TPPA and other tests should be used for verification to avoid misdiagnosis and missed diagnosis.

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苏州市某三甲医院梅毒患者感染的临床分析与方法学评价
目的:了解某三甲医院梅毒患者的分布及流行病学特征,评价化学发光免疫分析法(CLIA)与梅毒螺旋体颗粒凝集试验(TPPA)的符合率。方法:对247501例门诊和住院患者的病历资料进行回顾性分析。采用TPPA对阳性和疑似病例进行验证,并评估CLIA与TPPA的符合率。采用受试者工作特征(ROC)曲线确定最佳诊断阈值。结果:247501份血清标本中,CLIA检测梅毒阳性5173份,检出率为2.09%,男女比为1.39。卡方检验显示,性别和年龄均是影响检出率的因素(χ2=229.51, P < 0.0001)。此外,泌尿外科、骨科、心脏科、普外科、消化内科和妇科是阳性病例最多的前6个科室。对比分析显示,CLIA与TPPA的总体符合率为80.24%。ROC曲线分析显示,以样本/截断值(S/CO)作为诊断指标,曲线下面积(AUC)为0.936(95%置信区间[CI]: 0.929-0.942, P < 0.0001)。结果表明,S/CO值为3.945是CLIA方法的最佳诊断值,诊断特异性为93.64%,敏感性为81.90%。结论:梅毒在医院各科室分布广泛,以中老年人群为主。对于初步筛查为阳性或可疑病例,应采用TPPA等检测进行验证,避免误诊和漏诊。
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