Rapid, point-of-care HIV test for infants shows promise
New study results suggest that a rapid nucleic acid-based HIV test for early infant diagnosis is feasible at the point of care and could potentially improve access to antiretroviral therapy.
“The ability to provide a definitive HIV test result in less than 60 minutes changes how we relate to our patients and how patients experience the health care system,” Landon Myer, MD, PhD, associate professor at the school of public health, University of Cape Town, South Africa, said in a press release. “If approved, this test will allow us to immediately initiate ART in HIV-positive infants, and reduce morbidity and mortality in this vulnerable population.”
Myer was not involved in the study.
The study, which was published ahead of print in the Journal of Acquired Immune Deficiency Syndromes, included 827 HIV-exposed infants younger than 18 months enrolled in four urban primary care clinics in and around Maputo, Mozambique. Nurses tested blood samples collected through heel pricks using the rapid point-of care test (Alere), the results of which were then compared with standard laboratory-based testing.
According to the researchers, the sensitivity and specificity of the rapid test were 98.5% (95% CI, 91.7-99.9) and 99% (95% CI, 99.3-100), respectively. The overall agreement between both tests was high (Cohen’s kappa=0.981; 95% CI, 0.96-1.00). The conditional probability of both tests producing the same results for both positive (98.5%; 95% CI, 96.3-100) and negative (99.9%; 95% CI, 99.7-100) results was also high, they said.
“This study demonstrates that accurate [point-of-care early infant diagnosis] using a nucleic acid-based test is possible in primary health care settings,” the researchers concluded. “Such technology should be considered in efforts to address critical gaps in access to pediatric ART.”
Disclosure: The researchers report no relevant financial disclosures.