NEW YORK (Reuters Health) – Point-of-care testing (POCT) for neonates exposed to HIV leads to earlier initiation of antiretroviral therapy (ART), according to new findings.
“It performed well compared to the gold-standard laboratory test and it does help get the results back much faster to moms,” Dr. Karl-Gunter Technau of the University of the Witwatersrand in Johannesburg, South Africa, told Reuters Health in a telephone interview. “By getting the results back earlier, it also enables us to start treatment earlier.”
Turnaround times for laboratory-based testing (LABT) range from one day to weeks, and mothers and babies are typically discharged from the hospital before the results are available, Dr. Technau and his team note in their report, online July 12 in The Lancet HIV. Non-negative results thus require tracking down mothers and neonates for follow-up testing and care, and some may be lost to follow-up.
The researchers did a field evaluation of the Cepheid Xpert HIV-1 Qualitative test, comparing results with the Roche COBAS TaqMan HIV-1 Qualitative test, in neonates born to HIV-positive mothers at a Johannesburg hospital.
A total of 3,970 infants had LABT, with 1% testing positive, 99% negative, and fewer than 1% each with an indeterminate or error result. Among the neonates who had LABT, 2,238 also had POCT. POCT identified all 30 neonates with HIV for a sensitivity of 100%; it produced two false-positive results, for a specificity of 99.9%.
Average time between phlebotomy and result return was 2.6 hours with POCT. In days, the median time for result return was one day with POCT and 10 days for LABT. All 30 neonates with HIV started ART, versus 24 of the 27 infants who had LABT only. ART initiation was a median five days earlier with POCT.
The POCT involves placing a sample in a cartridge and takes 90 minutes to run. Using it required additional staff and coverage on weekends, Dr. Technau and his team note.
“Although the actual test doesn’t require a lot of technical know-now, it’s very simple to run, everyone can essentially do it, once you have a larger number of samples you also have to think about quality control,” the researcher said. “If it’s a very busy unit you can’t just expect the standard staff to take that on.”
Also, he noted, POCT must be done seven days a week, with no weekends off. “There’s a whole lot of technical and practical considerations people need to think about,” he said.
“As to how critical the timing is, it’s still something that needs further research,” Dr. Technau added. “We are seeing that it is important to start getting the viral load down as soon as possible, as some of the babies do have quite high viral loads already.”
Dr. Martina Penazzato of the World Health Organization in Geneva co-authored an editorial accompanying the study. In a telephone interview with Reuters Health, she noted that the progress made in preventing mother-to-child transmission has led some to think that pediatric HIV is no longer a problem.
But, she said, “Pediatric HIV is still a problem, and disease progression can happen very quickly.”
“One of the issues with pediatric HIV is that early diagnosis is really critical, to start treatment in a timely manner,” Dr. Penazzato added. “In 2015, only half of the infants that were born to HIV-infected mothers received an HIV test in their first two months of life, and we know that even when that happens the time to get the test results and be able to start treatment is too long to prevent early mortality.”
The new study is the first to combine POCT with HIV testing at birth, Dr. Penazzato noted. “Using these technologies we cannot just test more quickly, but also get the results more rapidly and start treatment more quickly,” she said.
South Africa and Thailand are the only countries that have adopted birth testing at the national level, she added, while more than 10 countries are currently piloting introduction of POCT.
POCT combined with HIV testing at birth may not be a priority for all countries, according to Dr. Penazzato, for example those that are not currently able to immediately link a neonate who tests positive to care and start ART will have limited benefit from these innovations.
“It is feasible and well adopted in South Africa, elsewhere however the tradeoff between the benefits and the investment to be made may be different, therefore pilot testing is required to inform safe and effective introduction,” she said.
The study was funded by the National Institutes of Health. The researchers declared no conflicts of interest.
SOURCE: http://bit.ly/2vBNvio and http://bit.ly/2teIED5
Lancet HIV 2017.
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