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Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus–exposed Neonates in Tanzania

BACKGROUND: Point-of-care (PoC) systems for early infant diagnosis (EID) may improve timely infant human immunodeficiency virus (HIV) management. Experiences within African public health settings are limited. METHODS: We evaluated the accuracy and operational feasibility of the Xpert HIV-1 Qual for...

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Autores principales: Sabi, Issa, Mahiga, Hellen, Mgaya, Jimson, Geisenberger, Otto, Kastner, Sabine, Olomi, Willyhelmina, Saathoff, Elmar, Njovu, Lilian, Lueer, Cornelia, France, John, Maboko, Leonard, Ntinginya, Nyanda Elias, Hoelscher, Michael, Kroidl, Arne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355822/
https://www.ncbi.nlm.nih.gov/pubmed/29961841
http://dx.doi.org/10.1093/cid/ciy538
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author Sabi, Issa
Mahiga, Hellen
Mgaya, Jimson
Geisenberger, Otto
Kastner, Sabine
Olomi, Willyhelmina
Saathoff, Elmar
Njovu, Lilian
Lueer, Cornelia
France, John
Maboko, Leonard
Ntinginya, Nyanda Elias
Hoelscher, Michael
Kroidl, Arne
author_facet Sabi, Issa
Mahiga, Hellen
Mgaya, Jimson
Geisenberger, Otto
Kastner, Sabine
Olomi, Willyhelmina
Saathoff, Elmar
Njovu, Lilian
Lueer, Cornelia
France, John
Maboko, Leonard
Ntinginya, Nyanda Elias
Hoelscher, Michael
Kroidl, Arne
author_sort Sabi, Issa
collection PubMed
description BACKGROUND: Point-of-care (PoC) systems for early infant diagnosis (EID) may improve timely infant human immunodeficiency virus (HIV) management. Experiences within African public health settings are limited. METHODS: We evaluated the accuracy and operational feasibility of the Xpert HIV-1 Qual for PoC-EID testing, using fresh blood and dried blood spots (DBS) samples at obstetric health facilities in Tanzania at birth and at postpartum weeks 1, 2, 3, and 6 in HIV-exposed infants. Test results were confirmed using TaqMan DBS HIV-deoxyribonucleic acid and/or plasma HIV-ribonucleic acid (RNA) testing. RESULTS: At week 6, 15 (2.5%) out of 614 infants were diagnosed with HIV; 10 (66.7%) of them at birth (median HIV-RNA 4570 copies/mL). At birth, the Xpert-PoC and Xpert-DBS were 100% sensitive (95% confidence intervals: PoC, 69.2–100%; DBS, 66.4–100%) and 100% specific (PoC, 92.1–100%; DBS, 88.4–100%). By week 3, 5 infants with intra/postpartum HIV-infection (median HIV-RNA 1 160 000 copies/mL) were all correctly diagnosed by Xpert. In 2 cases, Xpert-PoC testing correctly identified HIV-infection when DBS tests (Xpert and TaqMan) were negative, suggesting a greater sensitivity. In 2 infants with confirmed HIV at birth, all tests were negative at week 6, possibly because of viral suppression under nevirapine prophylaxis. Problems were reported in 183/2736 (6.7%) of Xpert-PoC tests, mostly related to power cuts (57.9%). CONCLUSIONS: We demonstrated excellent Xpert HIV-1 Qual performance and good operational feasibility for PoC-EID testing at obstetric health facilities. Week 6 sensitivity issues were possibly related to nevirapine prophylaxis, supporting additional birth PoC-EID testing to avoid underdiagnosis. CLINICAL TRIALS REGISTRATION: NCT02545296
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spelling pubmed-63558222019-02-08 Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus–exposed Neonates in Tanzania Sabi, Issa Mahiga, Hellen Mgaya, Jimson Geisenberger, Otto Kastner, Sabine Olomi, Willyhelmina Saathoff, Elmar Njovu, Lilian Lueer, Cornelia France, John Maboko, Leonard Ntinginya, Nyanda Elias Hoelscher, Michael Kroidl, Arne Clin Infect Dis Articles and Commentaries BACKGROUND: Point-of-care (PoC) systems for early infant diagnosis (EID) may improve timely infant human immunodeficiency virus (HIV) management. Experiences within African public health settings are limited. METHODS: We evaluated the accuracy and operational feasibility of the Xpert HIV-1 Qual for PoC-EID testing, using fresh blood and dried blood spots (DBS) samples at obstetric health facilities in Tanzania at birth and at postpartum weeks 1, 2, 3, and 6 in HIV-exposed infants. Test results were confirmed using TaqMan DBS HIV-deoxyribonucleic acid and/or plasma HIV-ribonucleic acid (RNA) testing. RESULTS: At week 6, 15 (2.5%) out of 614 infants were diagnosed with HIV; 10 (66.7%) of them at birth (median HIV-RNA 4570 copies/mL). At birth, the Xpert-PoC and Xpert-DBS were 100% sensitive (95% confidence intervals: PoC, 69.2–100%; DBS, 66.4–100%) and 100% specific (PoC, 92.1–100%; DBS, 88.4–100%). By week 3, 5 infants with intra/postpartum HIV-infection (median HIV-RNA 1 160 000 copies/mL) were all correctly diagnosed by Xpert. In 2 cases, Xpert-PoC testing correctly identified HIV-infection when DBS tests (Xpert and TaqMan) were negative, suggesting a greater sensitivity. In 2 infants with confirmed HIV at birth, all tests were negative at week 6, possibly because of viral suppression under nevirapine prophylaxis. Problems were reported in 183/2736 (6.7%) of Xpert-PoC tests, mostly related to power cuts (57.9%). CONCLUSIONS: We demonstrated excellent Xpert HIV-1 Qual performance and good operational feasibility for PoC-EID testing at obstetric health facilities. Week 6 sensitivity issues were possibly related to nevirapine prophylaxis, supporting additional birth PoC-EID testing to avoid underdiagnosis. CLINICAL TRIALS REGISTRATION: NCT02545296 Oxford University Press 2019-02-15 2018-06-29 /pmc/articles/PMC6355822/ /pubmed/29961841 http://dx.doi.org/10.1093/cid/ciy538 Text en © The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Articles and Commentaries
Sabi, Issa
Mahiga, Hellen
Mgaya, Jimson
Geisenberger, Otto
Kastner, Sabine
Olomi, Willyhelmina
Saathoff, Elmar
Njovu, Lilian
Lueer, Cornelia
France, John
Maboko, Leonard
Ntinginya, Nyanda Elias
Hoelscher, Michael
Kroidl, Arne
Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus–exposed Neonates in Tanzania
title Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus–exposed Neonates in Tanzania
title_full Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus–exposed Neonates in Tanzania
title_fullStr Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus–exposed Neonates in Tanzania
title_full_unstemmed Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus–exposed Neonates in Tanzania
title_short Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus–exposed Neonates in Tanzania
title_sort accuracy and operational characteristics of xpert human immunodeficiency virus point-of-care testing at birth and until week 6 in human immunodeficiency virus–exposed neonates in tanzania
topic Articles and Commentaries
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355822/
https://www.ncbi.nlm.nih.gov/pubmed/29961841
http://dx.doi.org/10.1093/cid/ciy538
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