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

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Catherine G. Sutcliffe ◽  
Jane Mutanga ◽  
Nkumbula Moyo ◽  
Abhishek K. Agarwal ◽  
Jessica L. Schue ◽  
...  

Abstract 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.

2020 ◽  
Vol 84 (1) ◽  
pp. S78-S83
Author(s):  
Kenneth Macneal ◽  
Vincent Tukei ◽  
Emma Sacks ◽  
Mafusi Mokone ◽  
Lehlohonolo Makoti ◽  
...  

2021 ◽  
Vol 9 (1) ◽  
pp. 87-94
Author(s):  
Busari Olusegun

Without access to life-saving drugs, including antiretroviral, about one-third of HIV exposed infants (HEI) will die by age 1 year and 50% by age 2 years. A 75% reduction in disease progression and 76% reduction in HIV mortality in infants has been attributed to early diagnosis of HIV and early commencement on ART. Early Infant Diagnosis (EID) of HIV aids timely commencement on antiretroviral therapy (ART). Several challenges have been identified with the current process. Point of care (POC) technologies are recommended as a veritable means of addressing these challenges and improving EID uptake. With the aim of assessing the standard of care and the acceptability of POC for the provision of EID. A descriptive cross-sectional survey was conducted across eight healthcare facilities in Nigeria. The survey was conducted among 72 healthcare workers using self-administered questionnaire; with a recovery rate of 61(84.7%). Analysis of participants’ responses indicate that 100% of the respondents believes there is a need for EID. Most respondent reported an average turnaround time (TAT) of 3-4 weeks (35.8%) and >6 weeks (34.0%). Most respondents identified distance to the PCR laboratories (45.7%) and long TAT (34.8%) as key issues affecting the conduct of EID. On the benefit of POC for EID; 90.2% of respondent believe it is beneficial; while 81.5% of respondent believe that with the introduction and use of POC for EID there will be an increase in EID uptake. The POC is a viable and acceptable alternative for EID to increase uptake.


BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e043679
Author(s):  
Yasmin Mohamed ◽  
Martha Kupul ◽  
Janet Gare ◽  
Steven G Badman ◽  
Selina Silim ◽  
...  

IntroductionEarly infant diagnosis (EID) of HIV and timely initiation of antiretroviral therapy can significantly reduce morbidity and mortality among HIV-positive infants. Access to EID is limited in many low-income and middle-income settings, particularly those in which standard care involves dried blood spots (DBS) sent to centralised laboratories, such as in Papua New Guinea (PNG). We conducted a qualitative exploration of the feasibility and acceptability of implementing a point-of-care (POC) EID test (Xpert HIV-1 Qualitative assay) among health workers and key stakeholders working within the prevention of mother-to-child transmission of HIV (PMTCT) programme in PNG.MethodsThis qualitative substudy was conducted as part of a pragmatic trial to investigate the effectiveness of the Xpert HIV-1 Qualitative test for EID in PNG and Myanmar. Semistructured interviews were undertaken with 5 health workers and 13 key informants to explore current services, experiences of EID testing, perspectives on the Xpert test and the feasibility of integrating and scaling up POC EID in PNG. Coding was undertaken using inductive and deductive approaches, drawing on existing acceptability and feasibility frameworks.ResultsHealth workers and key informants (N=18) felt EID at POC was feasible to implement and beneficial to HIV-exposed infants and their families, staff and the PMTCT programme more broadly. All study participants highlighted starting HIV-positive infants on treatment immediately as the main advantage of POC EID compared with standard care DBS testing. Health workers identified insufficient resources to follow up infants and caregivers and space constraints in hospitals as barriers to implementation. Participants emphasised the importance of adequate human resources, ongoing training and support, appropriate coordination and a sustainable supply of consumables to ensure effective scale-up of the test throughout PNG.ConclusionsImplementation of POC EID in a low HIV prevalence setting such as PNG is likely to be both feasible and beneficial with careful planning and adequate resources.Trial registration number12616000734460.


2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Francis M. Simmonds ◽  
Jennifer E. Cohn ◽  
Haurovi W. Mafaune ◽  
Tichaona H. Nyamundaya ◽  
Agnes Mahomva ◽  
...  

2019 ◽  
Vol 6 (6) ◽  
pp. e373-e381 ◽  
Author(s):  
Flavia Bianchi ◽  
Jennifer Cohn ◽  
Emma Sacks ◽  
Rebecca Bailey ◽  
Jean-Francois Lemaire ◽  
...  

2021 ◽  
Vol 87 (1) ◽  
pp. S67-S72
Author(s):  
Robert A. Domaoal ◽  
Katrina Sleeman ◽  
Souleymane Sawadogo ◽  
Tafadzwa Dzinamarira ◽  
Ndahafa Frans ◽  
...  

Author(s):  
Paul Lubega ◽  
Stephen Lawoko ◽  
Filbert Akatukunda ◽  
Gloria Seruwagi ◽  
John Bosco Ninsima ◽  
...  

Background: Early infant diagnosis (EID) is an important strategy of the Prevention of Mother-to-child transmission (PMTCT) and when implemented in combination with other strategies could eliminate HIV MTCT. We implemented a series of strategic interventions intended to improve EID at 9 Military facilities in Uganda and evaluated their impact on uptake of EID.Methods: A retrospective cross-sectional design was adopted, following-up HIV Exposed Infants (HEI) at the study sites over a 2 year period, and using a data extraction tool to capture4 indicators of EID namely; number of HIV-positive mothers, number of HEI enrolled, number of PCR and rapid tests performed on HEI, and number of HIV-positive results of HEI. Scatter plots and simple linear regression were applied to demonstrate trends in EID uptake and estimate intervention impact over time. Statistical significance was assumed at p<0.05.Results: We established incremental trends in numbers of first PCR (f [1,6]=2.8; p=0.15),third PCR (f [1,6]=8.4; p<0.05), rapid tests (f [1,6]=16.1; p<0.05) performed on HEI, and a modest decline in HIV-positivity among HEI over the study period. The intervention improved retention in PMTCT cascade to 80%, when contrasted with the national average of 70%.Conclusions: We have demonstrated that interventions invoking pre-booking HIV-positive pregnant mothers during antenatal care, follow up of mother-baby pairs using telephone and mentor mothers and integrating EID in immunization programs can improve uptake of EID in a relatively short period, and with a positive impact on EID indicators.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Anafi Mataka ◽  
Esther A.J. Tumbare ◽  
Tsietso Motsoane ◽  
David Holtzman ◽  
Monkoe Leqheka ◽  
...  

Background: New technologies for rapid point-of-care (POC) diagnostic tests hold great potential for improving the health outcomes of HIV-exposed infants. POC testing for HIV early infant diagnosis (EID) was introduced in Lesotho in late 2016. Here we highlight critical requirements for selecting routine POC EID sites to ensure a sustainable and optimised EID diagnostic network.Intervention: Lesotho introduced POC EID in a phased approach that included assessments of national databases to identify sites with high test volumes, the creation of local networks of sites to potentially increase access to POC EID, and a standardised capacity assessment to determine site readiness. Potential site networks comprising ‘hub’ testing sites and ‘spoke’ specimen referring sites were created.Lessons learnt: After determining optimal placement, a total of 29 testing facilities were selected for placement of POC EID to potentially increase access to 189 facilities through the use of a hub-and-spoke model. Site capacity assessments identified vital human resources and infrastructure capacity gaps that needed to be addressed before introducing POC EID and informed appropriate POC platform selection.Recommendations: POC placement involves more than just purchasing the testing platforms. Considering the relatively small proportion of sites that can be eligible for placement of a POC platform, utilising a hub-and-spoke model can maximise the number of health facilities served by a POC platform while reducing the necessary capacity building and infrastructure investments to fewer sites.


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