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. 2019 Feb 1;68(4):615-622.
doi: 10.1093/cid/ciy538.

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

Issa Sabi  1 , Hellen Mahiga  1 , Jimson Mgaya  1 , Otto Geisenberger  2   3 , Sabine Kastner  2   3 , Willyhelmina Olomi  1 , Elmar Saathoff  2   3 , Lilian Njovu  1 , Cornelia Lueer  1   2 , John France  4 , Leonard Maboko  1 , Nyanda Elias Ntinginya  1 , Michael Hoelscher  2   3 , Arne Kroidl  2   3
Affiliations

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

Issa Sabi et al. Clin Infect Dis. .

Abstract

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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Figures

Figure 1.
Figure 1.
Study flow. Abbreviation: HIV, human immunodeficiency virus.
See this image and copyright information in PMC

References

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