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Point-of-care testing can achieve same-day diagnosis for infants and rapid ART initiation: results from government
Caroline E Boeke1, Jessica Joseph1, Melody Wang1
1Clinton Health Access Initiative, Boston, MA, USA.
Insights
Point-of-care (POC) early infant diagnosis (EID) testing dramatically reduces turnaround times for HIV results and ART initiation in infants. Same-day diagnosis via POC EID significantly increases the rate of early treatment initiation, improving outcomes.
Area of Science:
- Public Health
- Infectious Diseases
- Diagnostics
Background:
- Centralized laboratory testing for early infant diagnosis (EID) of HIV involves significant delays in result delivery and Antiretroviral Therapy (ART) initiation.
- Point-of-care (POC) EID technologies offer a potential solution to expedite diagnosis and treatment for HIV-exposed infants in resource-limited settings.
Purpose of the Study:
- To evaluate the feasibility and effectiveness of POC EID testing within national programs in sub-Saharan Africa.
- To assess the impact of same-day result delivery on the timeliness of ART initiation for HIV-positive infants.
Main Methods:
- A pre-/post-evaluation design comparing centralized laboratory-based EID testing with POC EID testing across 52 facilities in six African countries.
- Retrospective data collection from routine health facility records for infants under two years of age.
- Statistical analysis using hazard ratios, confidence intervals, and Kaplan-Meier curves to compare time-to-event outcomes.
Main Results:
- POC EID testing significantly reduced the median time from sample collection to caregiver result receipt (0 days vs. 35 days) and to ART initiation (1 day vs. 39 days).
- 72% of infants received POC EID results on the same day as sample collection.
- HIV-positive infants diagnosed on the same day had a six-fold higher rate of ART initiation compared to those diagnosed later (HR: 6.39).
Conclusions:
- Same-day diagnosis and ART initiation for infants are achievable with POC EID in public sector healthcare facilities in resource-limited settings.
- POC EID facilitates rapid ART initiation, aligning with WHO recommendations and potentially reducing mortality in infants with HIV.
- Implementation of POC EID in national programs can significantly improve early treatment access and outcomes for HIV-positive infants.
Introduction:
Point-of-care (POC) early infant diagnosis (EID) testing has been shown to dramatically decrease turnaround times from sample collection to caregiver result receipt and time to ART initiation for HIV-positive infants compared to centralized laboratory testing. As governments in sub-Saharan Africa implement POC EID technologies, we report on the feasibility and effectiveness of POC EID testing and the impact of same-day result delivery on rapid ART initiation within national programmes across six countries.
Methods:
This pre-/post-evaluation compared centralized laboratory-based (pre) with POC (post) EID testing in 52 facilities across Cameroon, Democratic Republic of Congo, Ethiopia, Kenya, Senegal and Zimbabwe between April 2017 and October 2019 (country-dependent). Data were collected retrospectively from routine records at health facilities for all infants tested under two years of age. Hazard ratios and 95% confidence intervals were calculated to compare time-to-event outcomes, visualized with Kaplan-Meier curves, and the Somers' D test was used to compare continuous outcomes.
Results:
Data were collected for 2892 EID tests conducted on centralized laboratory-based platforms and 4610 EID tests on POC devices with 127 (4%) and 192 (4%) HIV-positive infants identified, respectively. POC EID significantly reduced the time from sample collection to caregiver result receipt (POC median: 0 days, IQR: 0 to 0 vs. centralized: 35 days, IQR: 26 to 56) and time from sample collection to ART initiation for HIV-positive infants (POC median: 1 day, IQR: 0 to 7 vs. centralized: 39 days, IQR: 26 to 57). With POC testing, 72% of infants received results on the same day as sample collection; HIV-positive infants with a same-day diagnosis had six times the rate of ART initiation compared to those diagnosed one or more days after sample collection (HR: 6.39; 95% CI: 3.44 to 11.85).
Conclusions:
Same-day diagnosis and treatment initiation for infants is possible with POC EID within routine government-led and -supported public sector healthcare facilities in resource-limited settings. Given that POC EID allows for rapid ART initiation, aligning to the World Health Organization's recommendation of ART initiation within seven days, its use in public sector programmes has the potential to reduce overall mortality for infants with HIV through early treatment initiation.
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