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Article(id=1321170617391493756, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1321170520196895605, articleNumber=null, orderNo=null, doi=10.11847/zgggws1141416, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1691164800000, receivedDateStr=2023-08-05, revisedDate=1701964800000, revisedDateStr=2023-12-08, acceptedDate=1739203200000, acceptedDateStr=2025-02-11, onlineDate=1792921221349, onlineDateStr=2026-10-25, pubDate=1741536000000, pubDateStr=2025-03-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792921221349, onlineIssueDateStr=2026-10-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792921221349, creator=13701087609, updateTime=1792921221349, updator=13701087609, issue=Issue{id=1321170520196895605, tenantId=1146029695717560320, journalId=1319373219989389464, year='2025', volume='41', issue='3', pageStart='257', pageEnd='384', issueExtLink='null', onlineDate='null', pubDate='1741536000000', pubDateStr='2025-03-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792921198175, creator='13701087609', updateTime=1792921198175, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=372, endPage=375, ext={EN=ArticleExt(id=1321170617789952637, articleId=1321170617391493756, tenantId=1146029695717560320, journalId=1319373219989389464, language=EN, title=Immunological characteristics before and after laboratory testing and treatment of HIV "indeterminate-positive" individuals in Pudong New Area, Shanghai, from 2014 to 2019, columnId=1320427686514770171, journalTitle=Chinese Journal of Public Health, columnName=Survey and Report, runingTitle=null, highlight=null, articleAbstract=
Objective

To differentiate between "indeterminate" early and late HIV infection samples to ensure timely follow-up.

Methods

A retrospective analysis was conducted on all "indeterminate" HIV infection samples from the Pudong New Area confirmatory laboratory between 2014 and 2019. Samples were grouped based on epidemiological data and follow-up results: 58 "early positive-indeterminate"and 31 "late positive-indeterminate"samples. Fourth-generation rapid diagnostic tests (RDTs) and third-generation enzyme-linked immunosorbent assays (ELISAs) were performed on both groups. The characteristics of the screening results and confirmatory bands were analyzed, and the differences in CD4+T cell levels before and after 3 years of treatment were compared between the two groups.

Results

Both the fourth-generation RDT and third-generation ELISA antibody tests were 100% positive in both the "early positive-indeterminate" and "late positive-indeterminate" groups. However, the S/CO values from the third-generation ELISA showed a statistically significant difference between the two groups (t=31.65, P<0.001). The proportions of different band patterns in the antibody confirmatory test that transitioned to "early positive" and "late positive" were also statistically significant (χ2=65.10, P<0.001). The overall distribution of changes in CD4+T cell counts before and after 3 years of treatment differed significantly between the "early positive-indeterminate" and "late positive-indeterminate"groups (U=415.5, P<0.001).

Conclusions

Combining screening results and confirmatory band characteristics can effectively distinguish different stages of infection in "indeterminate" HIV antibody results and provide corresponding follow-up recommendations. Furthermore, changes in CD4+T cell counts before and after treatment can be used to assess immune reconstitution following treatment.

, authors=Yan TANG1, Zhi TIAN2, Guancong DENG1, Qianqian LIU1, Yingzhi JIN1, authorsList=Yan TANG, Zhi TIAN, Guancong DENG, Qianqian LIU, Yingzhi JIN, authorCompany=null, correspAuthors=Yingzhi JIN, authorNote=null, correspAuthorsNote=
JIN Yingzhi, E-mail:
, copyrightStatement=Copyright © 2025 Chinese Journal of Public Health. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1321170620952457863, articleId=1321170617391493756, tenantId=1146029695717560320, journalId=1319373219989389464, language=CN, title=2014—2019年上海市浦东新区HIV“不确定–阳性”实验室检测及治疗前后免疫学特征分析, columnId=1320427686770622717, journalTitle=中国公共卫生, columnName=调查报告与分析, runingTitle=null, highlight=null, articleAbstract=
目的

鉴别“不确定”HIV早期和晚期感染样本，确保其按时随访。

方法

回顾性分析2014—2019年浦东新区确证实验室所有“不确定”感染样本，按照流行病学资料及随访后结果进行分组：58例“早期阳性–不确定”和31例“晚期阳性–不确定”。对2组样本进行4代RDT及3代ELISA实验，联合分析其筛查结果特征及确证条带特征，并分析2组感染者治疗3年前后CD4+T细胞水平的差异性特征。

结果

“早期阳性–不确定”组和“晚期阳性–不确定”组的4代RDT及3代ELISA抗体均100%呈阳性反应；此外，3代ELISA的S/CO值结果显示2组间差异具有统计学意义（t=31.65，P<0.001）。抗体确证试验不同的带型转归为“早期阳性”与“晚期阳性”之间的比例差异具有统计学意义（χ2=65.10，P<0.001）。“早期阳性–不确定”组与“晚期阳性–不确定”组服药3年前后之间CD4+T细胞变化值的总体分布差异具有统计学意义（U=415.5，P<0.001）。

结论

通过联合筛查结果和确证条带特征，可以有效识别HIV抗体“不确定”结果的不同感染阶段，并为提供后续相应随访建议；同时根据服药前后的CD4+T值变化来评估患者治疗后的免疫重建功能。

, authors=汤琰1, 田智2, 邓冠聪1, 刘乾乾1, 金樱枝1, *, *, authorsList=汤琰, 田智, 邓冠聪, 刘乾乾, 金樱枝, authorCompany=null, correspAuthors=金樱枝, authorNote=

汤琰（ 1969—） ，副主任技师，硕士，研究方向：艾滋病性病咨询、流调及实验室检测

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金樱枝，E-mail：
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S/CO values of third-generation ELISA in "early positive-indeterminate" and "late positive-indeterminate" groups

, figureFileSmall=null, figureFileBig=null, tableContent=
年份早期阳性–不确定晚期阳性–不确定
例数S/CO最小值S/CO最大值 $\bar x \pm s$例数S/CO最小值S/CO最大值 $\bar x \pm s$
2014 10 1.0913.396.26±3.841026.95230.7628.11±1.36
2015 10 1.7811.026.36±2.90821.23631.7326.88±2.92
20166 1.8813.216.77±3.97526.85132.1929.19±2.27
20178 2.01814.997.32±3.77324.96232.6228.52±3.86
2018 11 1.4512.817.32±3.77322.33629.5626.48±3.73
20199 2.2713.576.34±3.54223.34926.9725.16±2.56
合计54 a 1.0914.996.91±3.403121.23621.23627.64±2.58
), ArticleFig(id=1321170901064864361, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321170617391493756, language=CN, label=表1, caption=

“早期阳性–不确定”和“晚期阳性–不确定”3代ELISA的S/CO值

, figureFileSmall=null, figureFileBig=null, tableContent=
年份早期阳性–不确定晚期阳性–不确定
例数S/CO最小值S/CO最大值 $\bar x \pm s$例数S/CO最小值S/CO最大值 $\bar x \pm s$
2014 10 1.0913.396.26±3.841026.95230.7628.11±1.36
2015 10 1.7811.026.36±2.90821.23631.7326.88±2.92
20166 1.8813.216.77±3.97526.85132.1929.19±2.27
20178 2.01814.997.32±3.77324.96232.6228.52±3.86
2018 11 1.4512.817.32±3.77322.33629.5626.48±3.73
20199 2.2713.576.34±3.54223.34926.9725.16±2.56
合计54 a 1.0914.996.91±3.403121.23621.23627.64±2.58
), ArticleFig(id=1321170901408797290, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321170617391493756, language=EN, label=Tab.2, caption=

Proportion of each type of WB confirmation band in “uncertain-positive” samples (%)

, figureFileSmall=null, figureFileBig=null, tableContent=
WB确证条带例数早期阳性–不确定晚期阳性–不确定
例数占比/%例数占比/%
gp1609 666.67333.33
gp160+p24 37 3710000
gp160+p24+p17 10 1010000
gp160+gp120 12 216.671083.33
gp160+gp120+gp41 14 0014100
其他b5 360240
合计87 a 5866.72933.3
), ArticleFig(id=1321170901773701739, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321170617391493756, language=CN, label=表2, caption=

“不确定–阳性”样本的WB确证条带各类型分布情况/%

, figureFileSmall=null, figureFileBig=null, tableContent=
WB确证条带例数早期阳性–不确定晚期阳性–不确定
例数占比/%例数占比/%
gp1609 666.67333.33
gp160+p24 37 3710000
gp160+p24+p17 10 1010000
gp160+gp120 12 216.671083.33
gp160+gp120+gp41 14 0014100
其他b5 360240
合计87 a 5866.72933.3
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CD4+T cell counts (cell/μL) and their changes before and after 3 years of medication in "early positive-indeterminate" and "late positive-indeterminate"groups

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年份“早期阳性–不确定”服药3年前后CD4+T值及变化（$\bar x \pm s$）“晚期阳性–不确定”服药3年前后CD4+T值及变化（$\bar x \pm s$）
例数服药前服药后ΔCD4+T例数服药前服药后ΔCD4+T
20148 344.88±82.99683.88±127.05339.00± 142.05729.14±15.49266.29±73.02237.14±58.21
2015 11 318.09±146.24660.64±239.36342.00±220.48829.38±15.59262.00±62.23232.63±46.79
20167 399.71±77.02547.43±162.4147.71± 132.67639.17±16.1291.50±70.63252.33±56.31
20179 389.44±156.42614.44±75.58225.00±89.94344.67±31.77322.00±121.13277.33±91.06
2018 10 359.40±127.54640.00±116.3280.60±90.33110.00342.00332.00
20199 396.67±136.7729.67±170.63333.00±230.414.00253.00249.00
合计54 a 365.28±125.88649.39±162.41298.96±207.982631.62±18.57279.62±71.54248.00±56.77
), ArticleFig(id=1321170903354954353, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321170617391493756, language=CN, label=表3, caption=

“早期阳性–不确定”与“晚期阳性–不确定”服药3年前后CD4+T数值及其变化（cell/μL）

, figureFileSmall=null, figureFileBig=null, tableContent=
年份“早期阳性–不确定”服药3年前后CD4+T值及变化（$\bar x \pm s$）“晚期阳性–不确定”服药3年前后CD4+T值及变化（$\bar x \pm s$）
例数服药前服药后ΔCD4+T例数服药前服药后ΔCD4+T
20148 344.88±82.99683.88±127.05339.00± 142.05729.14±15.49266.29±73.02237.14±58.21
2015 11 318.09±146.24660.64±239.36342.00±220.48829.38±15.59262.00±62.23232.63±46.79
20167 399.71±77.02547.43±162.4147.71± 132.67639.17±16.1291.50±70.63252.33±56.31
20179 389.44±156.42614.44±75.58225.00±89.94344.67±31.77322.00±121.13277.33±91.06
2018 10 359.40±127.54640.00±116.3280.60±90.33110.00342.00332.00
20199 396.67±136.7729.67±170.63333.00±230.414.00253.00249.00
合计54 a 365.28±125.88649.39±162.41298.96±207.982631.62±18.57279.62±71.54248.00±56.77
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2014—2019年上海市浦东新区HIV“不确定–阳性”实验室检测及治疗前后免疫学特征分析
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汤琰 1 , 田智 2 , 邓冠聪 1 , 刘乾乾 1 , 金樱枝 1, *, *
中国公共卫生 | 调查报告与分析 2025,41(3): 372-375
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中国公共卫生 |调查报告与分析 2025 , 41 (3) : 372 -375
2014—2019年上海市浦东新区HIV“不确定–阳性”实验室检测及治疗前后免疫学特征分析
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汤琰1, 田智2, 邓冠聪1, 刘乾乾1, 金樱枝1, *, *
作者信息
  • 1上海市浦东新区疾病预防控制中心（上海市浦东新区卫生健康监督所），上海 200136
  • 2东部战区疾病预防控制中心，南京 210000
通讯作者:
金樱枝，E-mail：
作者简介:

汤琰（ 1969—） ，副主任技师，硕士，研究方向：艾滋病性病咨询、流调及实验室检测

Immunological characteristics before and after laboratory testing and treatment of HIV "indeterminate-positive" individuals in Pudong New Area, Shanghai, from 2014 to 2019
Yan TANG1, Zhi TIAN2, Guancong DENG1, Qianqian LIU1, Yingzhi JIN1
Affiliations
  • 1hanghai Pudong New Area Center for Disease Control and Prevention (Shanghai Pudong New Area Health Supervision Institute), Zhangyang Road 3039, Shanghai, 200136, China
  • 2Centre for Diseases Prevention and Control of Eastern Theater, Nanjing 210000, China
    • Corresponding Author:
    JIN Yingzhi, E-mail:
出版时间: 2025-03-10 doi: 10.11847/zgggws1141416
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摘要
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目的

鉴别“不确定”HIV早期和晚期感染样本，确保其按时随访。

方法

回顾性分析2014—2019年浦东新区确证实验室所有“不确定”感染样本，按照流行病学资料及随访后结果进行分组：58例“早期阳性–不确定”和31例“晚期阳性–不确定”。对2组样本进行4代RDT及3代ELISA实验，联合分析其筛查结果特征及确证条带特征，并分析2组感染者治疗3年前后CD4+T细胞水平的差异性特征。

结果

“早期阳性–不确定”组和“晚期阳性–不确定”组的4代RDT及3代ELISA抗体均100%呈阳性反应；此外，3代ELISA的S/CO值结果显示2组间差异具有统计学意义（t=31.65，P<0.001）。抗体确证试验不同的带型转归为“早期阳性”与“晚期阳性”之间的比例差异具有统计学意义（χ2=65.10，P<0.001）。“早期阳性–不确定”组与“晚期阳性–不确定”组服药3年前后之间CD4+T细胞变化值的总体分布差异具有统计学意义（U=415.5，P<0.001）。

结论

通过联合筛查结果和确证条带特征，可以有效识别HIV抗体“不确定”结果的不同感染阶段，并为提供后续相应随访建议；同时根据服药前后的CD4+T值变化来评估患者治疗后的免疫重建功能。

HIV“不确定”结果  /  3代酶联免疫吸附试验（ELISA）  /  4代快速诊断检测（RDT）  /  蛋白质免疫印迹（WB）试验  /  CD4+T细胞  /  免疫重建  /  随访管理
Objective

To differentiate between "indeterminate" early and late HIV infection samples to ensure timely follow-up.

Methods

A retrospective analysis was conducted on all "indeterminate" HIV infection samples from the Pudong New Area confirmatory laboratory between 2014 and 2019. Samples were grouped based on epidemiological data and follow-up results: 58 "early positive-indeterminate"and 31 "late positive-indeterminate"samples. Fourth-generation rapid diagnostic tests (RDTs) and third-generation enzyme-linked immunosorbent assays (ELISAs) were performed on both groups. The characteristics of the screening results and confirmatory bands were analyzed, and the differences in CD4+T cell levels before and after 3 years of treatment were compared between the two groups.

Results

Both the fourth-generation RDT and third-generation ELISA antibody tests were 100% positive in both the "early positive-indeterminate" and "late positive-indeterminate" groups. However, the S/CO values from the third-generation ELISA showed a statistically significant difference between the two groups (t=31.65, P<0.001). The proportions of different band patterns in the antibody confirmatory test that transitioned to "early positive" and "late positive" were also statistically significant (χ2=65.10, P<0.001). The overall distribution of changes in CD4+T cell counts before and after 3 years of treatment differed significantly between the "early positive-indeterminate" and "late positive-indeterminate"groups (U=415.5, P<0.001).

Conclusions

Combining screening results and confirmatory band characteristics can effectively distinguish different stages of infection in "indeterminate" HIV antibody results and provide corresponding follow-up recommendations. Furthermore, changes in CD4+T cell counts before and after treatment can be used to assess immune reconstitution following treatment.

HIV "indeterminate"results  /  third-generation enzyme-linked immunosorbent assay (ELISA)  /  fourth-generation rapid diagnostic test (RDT)  /  western blot (WB) assay  /  CD4+T cells  /  immune reconstitution  /  follow-up management
汤琰, 田智, 邓冠聪, 刘乾乾, 金樱枝. 2014—2019年上海市浦东新区HIV“不确定–阳性”实验室检测及治疗前后免疫学特征分析. 中国公共卫生, 2025 , 41 (3) : 372 -375 . DOI: 10.11847/zgggws1141416
Yan TANG, Zhi TIAN, Guancong DENG, Qianqian LIU, Yingzhi JIN. Immunological characteristics before and after laboratory testing and treatment of HIV "indeterminate-positive" individuals in Pudong New Area, Shanghai, from 2014 to 2019[J]. Chinese Journal of Public Health, 2025 , 41 (3) : 372 -375 . DOI: 10.11847/zgggws1141416
正文
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研究显示，HIV筛查检测结果会有一定比例的假阳性[1–5]。目前国内医院普遍使用第4代化学发光（chemiluminescence Immunoassay assay, CLIA）检测方法，其检测出的HIV假阳性样本如进行蛋白质免疫印迹（Western blot， WB）确证试验有可能导致非特异性条带的出现而呈现“不确定”结果[6–8]。早期感染HIV在阳转之初抗体浓度较低以及感染晚期由于抗体逐渐衰竭导致浓度较低，均有可能呈现“不确定”结果，很难与未感染的“不确定”结果清晰分开。虽然按照2009年版及2015年版《全国艾滋病检测技术规范》[9–10]，对“不确定”结果进行随访，但很难进行针对性督导以及区分早期感染与晚期感染存在困难，导致部分早期感染者存在侥幸心理不愿随访及晚期感染者因未能及时进行核酸随访检测而最终因机会性感染而死亡。因此，本研究收集了2014—2019年上海市浦东新区确证实验室89例WB确证试验结果为“不确定”的样本，在原有4代化学发光筛查检测基础上进一步延伸3代酶联免疫吸附试验（ELISA ） 和4代快速诊断检测（rapid diagnostic test, RDT）筛查实验，分析其联合筛查结果特征和确证条带特征，从而可以有理有据地督导其分类随访。
1　材料与方法
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1.1　样本来源
89例样本均为2014—2019年上海市浦东新区二、三级医疗机构经4代化学发光法筛查呈阳性反应后送至浦东新区确证实验室待确证的样本，其首次WB确证为“不确定”经随访后转为“阳性”，其中包括58例“早期阳性–不确定”和31例“晚期阳性–不确定”。
1.2　实验试剂
3代ELISA试剂（北京万泰生物药业有限公司）；4代RDT试剂（日本雅培有限公司）；WB确证试剂HIV Blot2.2（新加坡生物医学亚太有限公司）。所有试剂均经国家药品监督管理局注册，每批次均有符合生物制品的签发证书，并在有效期内使用。第4代RDT的HIV抗原和抗体结果分别显示。
1.3　方法
1.3.1　相关定义
（1）早期感染[11]：3～6个月内有流行病学史和/或有急性 HIV 感染综合征和/或有持续性全身性淋巴结病（persistent generalized lymphadenopathy PGL）。（2）晚期感染[11]：CD4+T<200 cell/μL，同时具有至少1项艾滋病期临床症状。（3）不确定–阳性[9–10]：WB确证试验的首次“不确定”结果通过2～4周后WB试验随访“阳性”或随后的核酸随访“阳性”。（4）早期阳性–不确定：首次WB确证“不确定”，WB随访阳性且具有早期感染临床特征。（5）晚期阳性–不确定：首次WB试验“不确定”，核酸随访阳性且具有晚期感染临床特征。
1.3.2　“不确定”样本分组方法及分析指标
按照随访结果及临床流行病学资料分为： “早期阳性–不确定”和“晚期阳性–不确定”组，随后对2组样本进行4代RDT和3代ELISA延伸筛查实验。分析指标包括：（1）2组“不确定”样本4代RDT检测结果特征及3代ELISA吸光度值/临界值（sample/cutoff，S/CO）特征；（2）2组“不确定”样本WB确证结果的条带特征；（3）CD4+T值：2组患者随访转阳后的CD4+T值基线入组后，每年随访1次服药治疗后的CD4+T情况，随访3年，随访截止时间为2022年12月31日。
1.4　统计分析
采用SPSS 28.0软件进行。计数资料以例数（占比）表示，两组间的比较采用χ2检验。对于计量资料，首先进行Shapiro-Wilk正态性检验，根据正态性检验及方差齐性检验结果，分别选择两独立样本的t检验、Mann-Whitney U检验或两相关样本的Wilcoxon秩和检验。所有检验均为双侧检验，显著性水平设定为α<0.05。
2　结　果
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2.1　“阳性–不确定”早期和晚期的筛查特征（表1）
在54例“早期阳性–不确定”样本和31例“晚期阳性–不确定”样本中，4代RDT与3代ELISA检测结果均同时显示阳性反应。其中“早期阳性–不确定”和“晚期阳性–不确定”组的4代RDT抗体均100%呈阳性反应，同时4代RDT抗原和抗体同时均呈阳性反应的比例分别为16.67%（9/54）和12.90%（4/31），2组差异无统计学意义（χ2=0.22，P=0.63）。此外，3代ELISA检测均呈阳性，其S/CO值结果显示，2组间的S/CO值差异具有统计学意义（t=31.65, P<0.001），其中“早期阳性–不确定”组的S/CO值低于“晚期阳性–不确定”组。
2.2　“阳性–不确定”样本WB确证条带及转归特征（表2）
“不确定–阳性”占比前五的带型分别为gp160+p24、gp160+gp120+gp41、gp160+gp120、gp160+p24+p17及gp160，分别占比42.53%（37/87）、16.09%（14/87）、13.79%（12/87）、11.49%（10/87）、10.34%（9/87）。带型gp160+p24、gp160+p24+p17均为早期感染带型；带型gp160+gp120+gp41均为晚期感染带型。不同的带型转归为“早期阳性”与“晚期阳性”之间的比例差异具有统计学意义（χ2=65.10，P<0.001）。
2.3　“早期阳性–不确定”与“晚期阳性–不确定”基线及治疗3年后CD4+T情况（表3）
根据正态性检验及方差齐性检验结果，分别采用两独立样本Mann-Whitney U检验或两相关样本Wilcoxon秩和检验，结果表明：“早期阳性–不确定”组服药前和服药3年后CD4+T值总体分布差异具有统计学意义（W=1 485，P<0.001），“晚期阳性–不确定”组服药前和服药3年后CD4+T值总体分布差异具有统计学意义（W=351，P<0.001）；“早期阳性–不确定”服药前后之间变化值与“晚期阳性–不确定”服药3年前后之间变化值的总体分布差异具有统计学意义（U=415.50，P<0.001），早期组变化要大于晚期组。
3　讨　论
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本研究结果显示，“不确定–阳性”样本在筛查时，3代ELISA、4代RDT抗体均呈阳性反应。然而，由于4代化学发光法筛查阳性结果与WB确证结果符合率较低，即使高荧光值样本也屡屡出现筛查假阳性现象[12–15],仅凭确证条带结果联合化学发光值对“不确定”结果进行评估并不现实。相比之下，RDT和ELISA筛查检测结果与WB结果阳性符合率较高/阳性预测值均较高[8、16-18]。本研究采用延伸4代RDT和3代ELISA筛查检测，不仅显著提高了评估效率，还通过3代ELISA的S/CO值区分了早期感染和晚期感染。若两类筛查结果均为阳性，则需要督导按时随访。尽管这并不一定表明处于窗口期感染，但感染概率相对较高，尤其是4代RDT抗原和抗体同时呈阳性的情况下，感染概率会更高[19–21]。
“不确定–阳性”究竟是早期还是晚期感染，对于治疗非常关键。晚期“不确定–阳性”，由于抗体的衰减，确证条带会越来越少或浅，导致2～4周后的随访仍为不确定结果。因此，可以从以下两方面初步判断感染阶段：一方面，可以根据联合筛查结果的3代ELISA的吸光度值具有差异性特征，判断感染所处阶段；另一方面，结合带型特征作出初步判断。研究显示，带型gp160+gp120+gp41通常提示晚期感染，此时应通知患者立即就医并进行核酸随访检测；而带型gp160+p24则更符合早期感染特征，这与黎俊宏[22]、赖专华[23]等学者的研究结果基本吻合。针对早期感染，应按照《全国艾滋病检测技术规范》，督导患者2～4周后按时至医疗机构随访[9–10]，有条件者建议进行核酸检测。对于带型gp160+gp120或带型单独gp160的情况，因其难以明确区分到底是早期或晚期感染，可结合延伸的3代ELISA和4代RDT检测结果，必要时辅以流行病学资料来大致评估感染阶段。在评估前，一定要了解患者是否已经服药或是否具有患有影响免疫力的疾病，这些因素均有可能影响评估结果[24]，应避免误判。本研究中，带型gp160+gp120+p31与带型gp160+gp120+p66均被定义为晚期“不确定”带型，其他实验室鲜有报道。本实验室多年来也仅各发现1例，因此在今后的工作中，需要进一步总结其有可能发生的各种转归情况。此外，在随访转归为阳性的样本中，带型p24与gp160+p17均表现为早期不确定条带，但这些条带并非一定会转归为阳性，也有可能转归为阴性。
本研究通过比较“早期阳性–不确定”与“晚期阳性–不确定”病例治疗后的CD4+T值随访结果，发现2组间差异具有统计学意义，早期治疗病例的免疫重建功能显著高于晚期发现病例，这一结果与现有文献高度一致[25–27]。然而，也有部分早期发现的患者因未按时服药导致耐药，或因合并其他感染性疾病导致免疫功能重建不良[28–30]。还有部分早期感染者的基数CD4+T<200 cell/μL，这可能是一过性下降，随着免疫功能逐步恢复，即使不服药，CD4+T值也会慢慢上升[31]。

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doi: 10.11847/zgggws1141416
  • 接收时间：2023-08-05
  • 首发时间：2026-10-25
  • 出版时间：2025-03-10
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  • 收稿日期：2023-08-05
  • 修回日期：2023-12-08
  • 录用日期：2025-02-11
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    1上海市浦东新区疾病预防控制中心（上海市浦东新区卫生健康监督所），上海 200136
    2东部战区疾病预防控制中心，南京 210000

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Number of
species		 占总种数比例
Percentage of
total species (%)		 属
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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