دورية أكاديمية
Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care.
العنوان: | Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care. |
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المؤلفون: | Agutu CA; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya., Ngetsa CJ; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya., Price MA; International AIDS Vaccine Initiative (IAVI), Department of Medical Affairs, New York, New York, United States of America., Rinke de Wit TF; Department of Global Health, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands., Omosa-Manyonyi G; School of Medicine, College of Health Sciences, University of Nairobi, Nairobi, Kenya., Sanders EJ; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.; Department of Global Health, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom., Graham SM; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.; Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington, United States of America. |
المصدر: | PloS one [PLoS One] 2019 Jun 27; Vol. 14 (6), pp. e0218369. Date of Electronic Publication: 2019 Jun 27 (Print Publication: 2019). |
نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't; Systematic Review |
اللغة: | English |
بيانات الدورية: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: San Francisco, CA : Public Library of Science |
مواضيع طبية MeSH: | Point-of-Care Testing*/standards , RNA, Viral*, HIV Infections/*diagnosis , HIV Infections/*virology , HIV-1/*genetics, Age Factors ; HIV Infections/drug therapy ; HIV-1/classification ; Humans ; Point-of-Care Systems/standards ; Polymerase Chain Reaction ; Reproducibility of Results ; Sensitivity and Specificity ; Viral Load/methods |
مستخلص: | Background: Point of-care (POC) HIV-1 RNA tests which are accurate and easy to use with limited infrastructure are needed in resource-limited settings (RLS). We systematically reviewed evidence of POC test performance compared to laboratory-based HIV-1 RNA assays and the potential utility of these tests for diagnosis and care in RLS. Methods: Studies published up to July 2018 were identified by a search of PUBMED, EMBASE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials. Studies evaluating the use of POC HIV-1 RNA testing for early infant diagnosis (EID), acute HIV infection (AHI) diagnosis, or viral load monitoring (VL), compared to centralized testing, were included. Separate search strategies were used for each testing objective. Results: 197 abstracts were screened and 34 full-text articles were assessed, of which 32 met inclusion criteria. Thirty studies evaluated performance and diagnostic accuracy of POC tests compared to standard reference tests. Two of the thirty and two additional studies with no comparative testing reported on clinical utility of POC results. Five different POC tests (Cepheid GeneXpert HIV-1 Quantitative and Qualitative assays, Alere q HIV-1/2 Detect, SAMBA, Liat HIV Quant and Aptima HIV-1 Quant) were used in 21 studies of VL, 11 of EID and 2 of AHI. POC tests were easy to use, had rapid turnaround times, and comparable accuracy and precision to reference technologies. Sensitivity and specificity were high for EID and AHI but lower for VL. For VL, lower sensitivity was reported for whole blood and dried blood spots compared to plasma samples. Reported error rates for Cepheid GeneXpert Qual (2.0%-5.0%), GeneXpert Quant (2.5%-17.0%) and Alere q HIV-1/2 Detect (3.1%-11.0%) were higher than in WHO prequalification reports. Most errors resolved with retesting; however, inadequate sample volumes often precluded repeat testing. Only two studies used POC results for clinical management, one for EID and another for VL. POC EID resulted in shorter time-to-result, rapid ART initiation, and better retention in care compared to centralised testing. Conclusions: Performance of POC HIV-1 RNA tests is comparable to reference assays, and have potential to improve patient outcomes. Additional studies on implementation in limited-resources settings are needed. Competing Interests: The authors have declared that no competing interests exist. |
References: | J Clin Microbiol. 2018 Mar 26;56(4):. (PMID: 29386266) J Int AIDS Soc. 2014 Jun 11;17:18914. (PMID: 24925044) J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):521-6. (PMID: 27007866) J Acquir Immune Defic Syndr. 2016 Jun 1;72(2):e45-8. (PMID: 26959192) J Acquir Immune Defic Syndr. 2017 Mar 1;74(3):e86-e88. (PMID: 27828879) AIDS. 2014 Jun 1;28(9):1365-7. (PMID: 24959964) J Infect Dis. 2010 Apr 15;201 Suppl 1:S73-7. (PMID: 20225951) PLoS One. 2016 Mar 31;11(3):e0152672. (PMID: 27032094) PLoS One. 2018 Jun 18;13(6):e0198344. (PMID: 29912987) Bull World Health Organ. 2012 Dec 1;90(12):914-20. (PMID: 23284197) Clin Infect Dis. 2016 Apr 15;62(8):1043-8. (PMID: 26743094) J Clin Microbiol. 2015 Nov;53(11):3458-65. (PMID: 26292298) Lancet HIV. 2017 Oct;4(10):e442-e448. (PMID: 28711526) J Int AIDS Soc. 2017 Nov;20 Suppl 7:. (PMID: 29130601) Annu Rev Med. 2015;66:387-405. (PMID: 25423597) Trends Biotechnol. 2011 May;29(5):240-50. (PMID: 21377748) AIDS. 2018 Jul 17;32(11):1453-1463. (PMID: 29746301) J Acquir Immune Defic Syndr. 2017 Oct 1;76(2):e52-e57. (PMID: 28902680) J Clin Virol. 2018 Apr;101:7-10. (PMID: 29414189) PLoS One. 2018 Mar 2;13(3):e0193577. (PMID: 29499042) J Med Microbiol. 2017 Oct;66(10):1379-1382. (PMID: 28901908) PLoS One. 2016 Dec 16;11(12):e0168244. (PMID: 27992495) J Clin Microbiol. 2016 Dec;54(12):3050-3055. (PMID: 27733636) Clin Chem Lab Med. 2016 Mar;54(3):493-9. (PMID: 26351942) J Virol Methods. 2017 Jun;244:39-45. (PMID: 28274744) J Clin Virol. 2017 Aug;93:15-19. (PMID: 28564629) PLoS One. 2017 Dec 20;12(12):e0189226. (PMID: 29261707) J Infect Dis. 2012 Feb 15;205(4):528-34. (PMID: 22207651) AIDS Res Hum Retroviruses. 2017 Mar;33(3):203-210. (PMID: 27758117) Nat Med. 1996 Jun;2(6):625-9. (PMID: 8640545) J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):e1-4. (PMID: 24933096) J Virol Methods. 2016 Mar;229:35-9. (PMID: 26709099) J Virol Methods. 2016 Nov;237:143-149. (PMID: 27568275) Lancet Glob Health. 2017 Aug;5(8):e754-e755. (PMID: 28716346) J Acquir Immune Defic Syndr. 2017 May 1;75 Suppl 1:S51-S58. (PMID: 28398997) BMJ. 2003 Jan 4;326(7379):41-4. (PMID: 12511463) AIDS. 2015 Dec;29 Suppl 3:S221-30. (PMID: 26562811) J Clin Microbiol. 2016 Aug;54(8):2104-8. (PMID: 27252459) J Clin Virol. 2016 Mar;76:1-3. (PMID: 26761545) J Clin Virol. 2016 Jul;80:27-32. (PMID: 27135387) J Clin Virol. 2017 Jul;92:14-19. (PMID: 28505569) BMC Med. 2014 Sep 08;12:173. (PMID: 25197773) J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):e128-e131. (PMID: 28350554) PLoS One. 2014 Feb 18;9(2):e85869. (PMID: 24558359) J Clin Microbiol. 2014 Sep;52(9):3377-83. (PMID: 25031444) J Clin Microbiol. 2015 Apr;53(4):1080-6. (PMID: 25428162) J Clin Microbiol. 2017 Nov;55(11):3227-3235. (PMID: 28855305) Int J Epidemiol. 2011 Apr;40(2):385-96. (PMID: 21247884) J Int AIDS Soc. 2017 Jun 28;20(1):21579. (PMID: 28691435) J Clin Microbiol. 2015 May;53(5):1616-21. (PMID: 25740777) AIDS. 2015 Nov 28;29(18):2465-71. (PMID: 26558545) J Clin Virol. 2015 Aug;69:56-62. (PMID: 26209380) |
معلومات مُعتمدة: | 107752/Z/15/Z United Kingdom WT_ Wellcome Trust; R01 AI124968 United States AI NIAID NIH HHS; United Kingdom WT_ Wellcome Trust; R25 MH064712 United States MH NIMH NIH HHS; R25 MH123256 United States MH NIMH NIH HHS |
المشرفين على المادة: | 0 (RNA, Viral) |
تواريخ الأحداث: | Date Created: 20190628 Date Completed: 20200219 Latest Revision: 20240717 |
رمز التحديث: | 20240717 |
مُعرف محوري في PubMed: | PMC6597060 |
DOI: | 10.1371/journal.pone.0218369 |
PMID: | 31246963 |
قاعدة البيانات: | MEDLINE |
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