患者采集的干血斑标本用于 HIV-1 病毒载量检测的性能:南非 DO ART 研究的证据。

IF 3.4 2区 医学 Q3 IMMUNOLOGY AIDS Pub Date : 2024-09-12 DOI:10.1097/qad.0000000000004011
Maitreyi Sahu,Torin Schaafsma,Adam A Szpiro,Heidi Van Rooyen,Stephen Asiimwe,Maryam Shahmanesh,Meighan L Krows,Nsika Sithole,Alastair Van Heerden,Ruanne V Barnabas,
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From October 2017 to November 2019, we collected 996 pairs of plasma/DBS specimens from 760 participants and 315 pairs of staff-/participant-collected DBS cards from 261 participants. We assessed DBS test sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using the WHO failure threshold of 1000 copies/mL. Log-transformed VL was compared using concordance correlation coefficients (CCC) and mean differences from linear mixed models.\r\n\r\nRESULTS\r\nIn a population with 13% detectable VL, DBS VL compared with plasma VL had 91% (95% CI: 86-95) sensitivity, 99% (98-100) specificity, 94% (90-98) PPV, and 99% (98-99) NPV. We observed high agreement between staff-collected DBS VL and plasma VL (CCC: 0.94), and between participant-collected DBS VL and plasma VL (CCC: 0.92). 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引用次数: 0

摘要

目的 评估患者采集的干血斑(DBS)与医护人员采集的干血斑和血浆相比,在监测抗逆转录病毒疗法(ART)中测量 HIV-1 病毒载量(VL)的临床实用性。设计在南非开展的一项以社区为基础提供抗逆转录病毒疗法的随机试验中,我们评估了:(1) DBS 标本与血浆相比的性能;(2) 参与者收集的 DBS 标本与工作人员收集的 DBS 标本相比,在测量 HIV-1 VL 方面的性能。方法使用生物梅里埃 NucliSENS EasyQ HIV-1 v2.0 检测仪测量 VL。从 2017 年 10 月到 2019 年 11 月,我们收集了 760 名参与者的 996 对血浆/DBS 标本和 261 名参与者的 315 对工作人员/参与者收集的 DBS 卡。我们使用 1000 拷贝/毫升的世卫组织失败阈值评估了 DBS 检测的灵敏度、特异性、阳性预测值 (PPV) 和阴性预测值 (NPV)。结果 在可检测到 13% VL 的人群中,与血浆 VL 相比,DBS VL 的灵敏度为 91% (95% CI: 86-95),特异性为 99% (98-100),PPV 为 94% (90-98),NPV 为 99% (98-99)。我们观察到,工作人员采集的 DBS VL 与血浆 VL(CCC:0.94)以及参与者采集的 DBS VL 与血浆 VL(CCC:0.92)之间的一致性很高。参与者和工作人员采集的 DBS 之间的相关性非常高(CCC:结论 参与者自采 DBS 的 VL 结果与临床工作人员和使用血浆采集的结果具有临床可比性。自采 DBS 有可能用于诊所外的抗逆转录病毒疗法监测。
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Performance of patient-collected dried blood spot specimens for HIV-1 viral load testing: evidence from the DO ART Study in South Africa.
OBJECTIVE Evaluate the clinical utility of patient-collected dried blood spots (DBS) in measuring HIV-1 viral load (VL) for monitoring antiretroviral therapy (ART) compared to provider-collected DBS and blood plasma. DESIGN In a randomized trial of community-based delivery of ART in South Africa, we assessed performance of: (1) DBS specimens compared to plasma, and (2) participant-collected versus staff-collected DBS specimens, to measure HIV-1 VL. METHODS The bioMérieux NucliSENS EasyQ HIV-1 v2.0 assay was used for VL measurement. From October 2017 to November 2019, we collected 996 pairs of plasma/DBS specimens from 760 participants and 315 pairs of staff-/participant-collected DBS cards from 261 participants. We assessed DBS test sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using the WHO failure threshold of 1000 copies/mL. Log-transformed VL was compared using concordance correlation coefficients (CCC) and mean differences from linear mixed models. RESULTS In a population with 13% detectable VL, DBS VL compared with plasma VL had 91% (95% CI: 86-95) sensitivity, 99% (98-100) specificity, 94% (90-98) PPV, and 99% (98-99) NPV. We observed high agreement between staff-collected DBS VL and plasma VL (CCC: 0.94), and between participant-collected DBS VL and plasma VL (CCC: 0.92). Correlation between participant- and staff-collected DBS was very high (CCC: 0.97; mean difference for those with a detectable result: -0.10 log10 copies/mL [-0.21-0.02]). CONCLUSIONS VL results from participant-collected DBS are clinically comparable with those collected by clinical staff and using blood plasma. Self-collected DBS has potential for use for ART monitoring outside the clinic.
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来源期刊
AIDS
AIDS 医学-病毒学
CiteScore
5.90
自引率
5.30%
发文量
478
审稿时长
3 months
期刊介绍: ​​​​​​​​​​​​​​​​​Publishing the very latest ground breaking research on HIV and AIDS. Read by all the top clinicians and researchers, AIDS has the highest impact of all AIDS-related journals. With 18 issues per year, AIDS guarantees the authoritative presentation of significant advances. The Editors, themselves noted international experts who know the demands of your work, are committed to making AIDS the most distinguished and innovative journal in the field. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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