Point-of-care p24 antigen detection for early infant diagnosis of HIV infection: cross-sectional and longitudinal studies in Zambia

Autor: Nkumbula Moyo, Robert Elghanian, Kara M. Palamountain, Philip E. Thuma, Abhishek K. Agarwal, William J. Moss, Jane N. Mutanga, Jessica L. Schue, Mark James Fisher, Mutinta Hamahuwa, Catherine G. Sutcliffe
Rok vydání: 2021
Předmět:
Male
Rural Population
0301 basic medicine
Pediatrics
Longitudinal study
HIV Core Protein p24
Human immunodeficiency virus (HIV)
HIV Infections
medicine.disease_cause
0302 clinical medicine
Pregnancy
Longitudinal Studies
030212 general & internal medicine
Pregnancy Complications
Infectious
Diagnostics
Sub-Saharan Africa
P24 antigen
Test (assessment)
Infectious Diseases
Point-of-Care Testing
Female
Research Article
medicine.medical_specialty
Anti-HIV Agents
Point-of-Care Systems
Zambia
Immunologic Tests
Sensitivity and Specificity
lcsh:Infectious and parasitic diseases
03 medical and health sciences
Neonatal Screening
medicine
Humans
lcsh:RC109-216
Implementation Science
Point of care
Pediatric HIV
Diagnostic Tests
Routine
business.industry
Infant
Newborn
Infant
medicine.disease
030112 virology
Antiretroviral therapy
Infectious Disease Transmission
Vertical
Cross-Sectional Studies
Early Diagnosis
Point-of-care
Feasibility Studies
Rural area
business
Zdroj: BMC Infectious Diseases
BMC Infectious Diseases, Vol 21, Iss 1, Pp 1-11 (2021)
ISSN: 1471-2334
DOI: 10.1186/s12879-021-05808-2
Popis: Background Early infant diagnosis of HIV infection is challenging in sub-Saharan Africa, particularly in rural areas, leading to delays in diagnosis and treatment. Use of a point-of-care test would overcome many challenges. This study evaluated the validity of a novel point-of-care p24 antigen detection test (LYNX) in rural and urban settings in southern Zambia. Methods Two studies were conducted: a cross-sectional study from 2014 to 2015 at Macha Hospital (LYNX Hospital study) and a longitudinal study from 2016 to 2018 at 12 health facilities in Southern Province, Zambia (NSEBA study). In both studies, children attending the facilities for early infant diagnosis were enrolled and a blood sample was collected for routine testing at the central lab and immediate on-site testing with the LYNX test. The performance of the LYNX test was measured in comparison to nucleic acid-based testing at the central lab. Results In the LYNX Hospital study, 210 tests were performed at a median age of 23.5 weeks (IQR: 8.9, 29.0). The sensitivity and specificity of the test were 70.0 and 100.0%, respectively. In the NSEBA study, 2608 tests were performed, including 1305 at birth and 1222 on children ≥4 weeks of age. For samples tested at birth, sensitivity was 13.6% (95% CI: 2.9, 34.9) and specificity was 99.6% (95% CI: 99.1, 99.9). While specificity was high for all ages, sensitivity increased with age and was higher for participants tested at ≥4 weeks of age (80.6%; 95% CI: 67.4, 93.7). Children with positive nucleic acid tests were more likely to be negative by the LYNX test if their mother received antiretroviral therapy during pregnancy (60.7% vs. 24.2%; p = 004). Conclusions Considering the high specificity and moderate sensitivity that increased with age, the LYNX test could be of value for early infant diagnosis for infants ≥4 weeks of age, particularly in rural areas where centralized testing leads to long delays. Point-of-care tests with moderate sensitivity and high specificity that are affordable, easy-to-use, and easily implemented and maintained should be developed to expand access to testing and deliver same-day results to infants in areas where it is not feasible to implement nucleic acid-based point-of-care assays.
Databáze: OpenAIRE
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