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,
{"title":"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。","authors":"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,","doi":"10.1097/qad.0000000000004011","DOIUrl":null,"url":null,"abstract":"OBJECTIVE\r\nEvaluate 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.\r\n\r\nDESIGN\r\nIn 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.\r\n\r\nMETHODS\r\nThe 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.\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). 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]).\r\n\r\nCONCLUSIONS\r\nVL 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.","PeriodicalId":7502,"journal":{"name":"AIDS","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Performance of patient-collected dried blood spot specimens for HIV-1 viral load testing: evidence from the DO ART Study in South Africa.\",\"authors\":\"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,\",\"doi\":\"10.1097/qad.0000000000004011\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"OBJECTIVE\\r\\nEvaluate 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.\\r\\n\\r\\nDESIGN\\r\\nIn 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.\\r\\n\\r\\nMETHODS\\r\\nThe 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.\\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). 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]).\\r\\n\\r\\nCONCLUSIONS\\r\\nVL 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.\",\"PeriodicalId\":7502,\"journal\":{\"name\":\"AIDS\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-09-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"AIDS\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/qad.0000000000004011\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"AIDS","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/qad.0000000000004011","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
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.
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.