HIV核酸定量检测在“艾滋病一站式诊疗服务”模式中的应用和效果

Application and effectiveness of HIV nucleic acid quantitative detection in the one-stop service for AIDS diagnosis and treatment model

目的 探讨HIV核酸定量检测在“艾滋病一站式诊疗服务”模式中的应用效果和可行性,为HIV/AIDS患者早期诊断、早期治疗和科学管理提供参考依据。方法 在普定县人民医院开展“艾滋病一站式诊疗服务”模式探索,对HIV初筛有反应血液进行院内核酸定量试验,并将HIV初筛有反应血液送至贵州省疾病预防控制中心进行抗体确证试验,将院内检测结果与复核结果进行比较,以验证核酸定量检测的可行性;同时对“艾滋病一站式诊疗服务”开展前后抗体初筛有反应到抗体确证或核酸定量试验结果的时间间隔、抗体初筛有反应到接受cART时间间隔、30天内接受cART比例进行对比分析。结果 对新检测发现的HIV抗体初筛有反应就诊者血液进行核酸定量检测,结果>5 000拷贝/mL占比为94.97%(189/199),≤5 000拷贝/mL占比为4.02%(8/199),≤5 000拷贝/mL后期经随访均为阳性,未检出占比为1.01%(2/199);将HIV初筛有反应血液送至贵州省疾病预防控制中心进行复核,结果阳性197份,阴性2份;院内检测结果与复核结果的一致性较好(Kappa=1,P<0.001),总符合率为100.00%(199/199);核酸定量检测的灵敏度较好,为95.94%(189/197),特异度为100.00%(2/2);“艾滋病一站式诊疗服务”开展前后新报告病例抗体初筛有反应到抗体确证或核酸定量试验结果中位时间由8天缩短至1天、抗体初筛有反应到接受cART中位时间由16天缩短至1天,差异有统计学意义(P <0.001);开展前后新报告病例30天内接受cART比例由68.00%提升至99.49%(196/197),差异有统计学意义(P<0.001)。结论 通过HIV核酸定量检测在“艾滋病一站式诊疗服务”模式中的应用,HIV核酸定量检测用于HIV感染诊断的可行性得到了有效验证,可以显著缩短HIV/AIDS患者从检测到治疗的时间,及时接受抗病毒治疗。

Objective The study explores the effectiveness and feasibility of HIV nucleic acid quantitative detection in the one-stop service for AIDS diagnosis and treatment model.The aim is to provide evidence for early diagnosis,early treatment,and improved management of HIV/AIDS patients.Methods The one-stop service for AIDS diagnosis and treatment model was implemented at Puding County People's Hospital.For patients with positive blood initial HIV antibody screening results,nucleic acid quantitative detection was performed in-hospital alongside referral of blood samples to the Guizhou Provincial Center for Disease Control and Prevention for confirmatory antibody assays.Inhospital test results were compared with verification results to assess the feasibility of the on-site testing.Additionally,researchers compared the time intervals between positive initial antibody screening results and receiving antibody confirmatory antibody results or HIV nucleic acid detection results,positive initial antibody screening results and receiving combined antiretroviral therapy(cART)regimens,and the proportion of patients receiving cART regimens within 30 days before and after implementing the one-stop service model.Results Among newly diagnosed patients with positive HIV antibody screening results,in-hospital HIV nucleic acid detection revealed that 94.97%(189/199)of blood samples had viral loads exceeding 5000 copies/mL.The remaining 4.02%(8/199)of samples with viral loads≤5000 copies/mL were later confirmed positive and ultimately became undetectable.Notably,1.01%(2/199)of samples displaced undetectable viral loads.Verification at the Guizhou Provincial Center for Disease Control and Prevention confirmed positive results for 197 patients and negative results for two patients,demonstrating excellent consistency with in-hospital test results(Kappa=1,P<0.001)and 100.00%(199/199)overall agreement rate.The sensitivity of the in-hospital nucleic acid quantitative test was high(95.94%,189/197),and the specificity was perfect(100.00%,2/2).Following the implementation of the one-stop service model,the median time from positive initial antibody screening results to receiving confirmatory antibody results or nucleic acid quantitative detection results significantly decreased from 8 days to 1 day(P<0.001).Similarly,the median time to receive cART after a positive initial screening dropped significantly from 16 days to 1 day(P<0.001).The proportion of newly reported cases receiving cART within 30 days also saw a significant increase(P<0.001)from 68.00%to 99.49%(196/197)after adopting the one-stop service model.Conclusions This study effectively demonstrates the feasibility of HIV nucleic acid quantitative detection for HIV diagnosis.This approach significantly reduces the time from testing to treatment,allowing HIV/AIDS patients to receive cART therapy promptly.