重组结核杆菌融合蛋白皮肤试验筛查HIV/AIDS病例结核分枝杆菌潜伏感染的效果分析

Effectiveness of recombinant Mycobacterium tuberculosis fusion protein skin test in screening for latent tuberculosis infection among HIV/AIDS patients

目的 评价重组结核杆菌融合蛋白皮肤试验(EC-ST)筛查艾滋病病毒感染者和艾滋病患者(HIV/AIDS)结核分枝杆菌潜伏感染(LTBI)的效果,为EC-ST筛查HIV/AIDS病例LTBI的适用性提供依据。方法 于2023年4—6月,选择江苏省扬州市在管在治的HIV/AIDS病例为研究对象,通过问卷调查收集基本资料,分别采用EC-ST和γ-干扰素释放试验(IGRA)筛查LTBI。以IGRA结果为诊断标准,分析EC-ST筛查阳性率、灵敏度、特异度和一致率,以及CD4^(+)T淋巴细胞(CD4)计数对EC-ST筛查效果的影响。结果 纳入HIV/AIDS病例523例,其中男性458例,占87.57%;女性65例,占12.43%;年龄M (QR)为48.00 (21.00)岁。EC-ST阳性率为7.27%,IGRA阳性率为7.46%,差异无统计学意义(P>0.05)。两种方法的一致率为94.84%,Kappa值为0.621 (95%CI:0.489~0.752,P<0.05);EC-ST的灵敏度为64.10%,特异度为97.31%。CD4计数<500和≥500个/μL组比较,两种方法的一致率分别为95.32%和94.44%,Kappa值分别为0.568和0.650 (均P<0.05),EC-ST阳性率、灵敏度和特异度差异无统计学意义(均P>0.05);CD4计数<200和≥200个/μL组比较,两种方法的一致率分别为96.55%和94.62%,Kappa值分别为0.648和0.619(均P<0.05),EC-ST阳性率、灵敏度和特异度差异无统计学意义(均P>0.05)。结论 EC-ST筛查HIV/AIDS病例LTBI的效果与IGRA存在一致性,且不受CD4计数水平的影响。

Objective To evaluate the effectiveness of recombinant Mycobacterium tuberculosis fusion protein skin test(EC-ST)in screening for latent tuberculosis infection(LTBI)among HIV/AIDS patients,so as to provide insights into the applicability of EC-ST in LTBI screening among HIV/AIDS patients.Methods From April to June 2023,HIV/AIDS patients under management and treatment in Yangzhou City,Jiangsu Province,were selected as study subjects.Basic information was collected through questionnaire surveys.LTBI was screened by EC-ST and interferon-gamma release assay(IGRA).Taking IGRA results as the diagnostic standard,the positive rate,sensitivity,specificity and consistency rate of EC-ST,and the impact of CD4^(+)T lymphocyte(CD4)counts on the screening effect of EC-ST were analyzed.Results A total of 523 HIV/AIDS patients were screened,including 458 males(87.57%)and 65 females(12.43%).The median age was 48.00(interquartile range,21.00)years.The positive rate of EC-ST was 7.27%and the positive rate of IGRA was 7.46%,with no statistically significant difference(P>0.05).The consistency rate of the two methods was 94.84%,and the Kappa value of 0.621(95%CI:0.489-0.752,P<0.05).The sensitivity of EC-ST was 64.10%and the specificity was 97.31%.Comparing the groups with CD4 counts<500 and≥500 cells/μL,the consistency rates of the two methods were 95.32%and 94.44%,and the Kappa values were 0.568 and 0.650,respectively(both P<0.05).There were no statistically significant differences in the positive rates,sensitivity,and specificity of EC-ST(all P>0.05).Comparing the groups with CD4 counts<200 and≥200 cells/μL,the consistency rates of the two methods were 96.55%and 94.62%,and the Kappa values were 0.648 and 0.619,respectively(both P<0.05).There were no statistically significant differences in the positive rates,sensitivity,and specificity of EC-ST(all P>0.05).Conclusion The effectiveness of EC-ST in screening for LTBI among HIV/AIDS patients is consistent with that of IGRA and is not affected by CD4 counts.