New Alere™ q Point-of-Care Early Infant Diagnosis Test Prototype Accurately
Detects HIV in Infants with High Sensitivity and Specificity in Primary Health
Clinics in Mozambique
Results Published Ahead of Print in the Journal of Acquired Immune Deficiency
WALTHAM, Mass., July 14, 2014
WALTHAM, Mass., July 14, 2014 /PRNewswire/ -- Alere Inc. (NYSE: ALR) today
announced the publication of a study demonstrating the viability of accurate
and rapid HIV screening among infants at the point of care (POC). The study
was conducted in five clinics in Maputo, Mozambique, with the prototype of
Alere's new POC nucleic acid test, the Alere™ q HIV-1/2 Detect assay. Results
of the study have been published ahead of print in the Journal of Acquired
Immune Deficiency Syndromes (JAIDS).
In the study, conducted under the auspices of the National Institute of Health
together with the Clinton Health Access Initiative and the University Eduardo
Mondlane (all Maputo, Mozambique), nurses in five clinics in Maputo tested
infants with the Alere q HIV-1/2 Detect assay, which provides results in less
than 60 minutes. Samples were also reference tested as per standard of care
(SOC) with a laboratory-based nucleic acid test. Results showed that the new
Alere q HIV-1/2 Detect assay administered at the POC had rates of sensitivity
and specificity comparable with the reference method with high overall test
agreement between the two platforms of 98.5% for positive results and 99.9%
for negative results.
Commenting on the study results, Landon Myer, M.D., Ph.D., Associate Professor
School of Public Health, University of Cape Town in South Africa, said, "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
healthcare system. If approved, this test will allow us to immediately
initiate ART in HIV-positive infants, and reduce morbidity and mortality in
this vulnerable population."
According to UNAIDS, almost 90% of HIV-infected children currently live in
sub-Saharan Africa, and an estimated 90% of infections in children are
acquired through mother-to-child transmission (MTCT) of HIV. It is estimated
that more than half of HIV-positive infants who are not diagnosed and who do
not receive anti-retroviral treatment (ART) within the first three months of
life will die before their second birthday. The World Health Organization
(WHO) recommends that all HIV-exposed infants have a molecular HIV test at 4
to 6 weeks of age or at the earliest opportunity thereafter, and that
antiretroviral therapy be initiated as early as possible in infants diagnosed
"In Mozambique and other resource-limited settings, far too few infants are
screened for HIV infection, and clinicians often cannot initiate therapy in
those who test positive because they are lost to follow-up before results can
be obtained," said Willem Pretorius, Global Product Manager - HIV Care, Alere.
"Results of this study suggest that point-of-care early infant diagnosis is
clinically feasible when administered by non-laboratory personnel, can improve
access to screening and treatment, and can help keep people who initiate
therapy retained in care."
About the Study
In the blinded, cross-sectional study, 827 HIV-exposed infants between one and
18 months of age were enrolled in four public primary health clinics in and
around Maputo and Maputo Central Hospital, between February and September
2012. The majority of infants were between the ages of 1-2 months (60%) and
2-3 months (14.9%), with a median age at testing of 1.4 months.
HIV-exposed infants routinely referred for early infant diagnosis (EID)
testing were recruited for the study. Trained nurses conducted Alere q HIV-1/2
Detect testing at the POC using blood samples collected through heel pricks,
and also collected samples through the same heel pricks for SOC testing with a
laboratory-based nucleic acid test (Roche COBAS^® AmpliPrep/COBAS^® TaqMan^®
HIV Quantitative Test) from dried blood spots. Of the 827 samples tested on
both the Alere q and the laboratory platform, 825 concordant results were
reported, with 761 negative and 64 positive results detected with both assays.
The sensitivity and specificity of POC EID with the Alere q HIV-1/2 Detect
were 98.5% (95% confidence interval [CI]: 91.7-99.9) and 99.9% (95% CI:
99.3-99.9), respectively. Overall agreement between the two methods was high
(Cohen Kappa = 0.981, 95% CI: 0.96-1.00).
The Alere q HIV-1/2 Detect assay is currently pending WHO pre-qualification,
and application for CE IVD marking will be made in July 2014.
By developing new capabilities in near-patient diagnosis, monitoring and
health information technology, Alere enables individuals to take charge of
improving their health and quality of life at home. Alere's global leading
products and services, as well as its new product development efforts, focus
on infectious disease, toxicology, cardiology and diabetes. Alere is
headquartered in Waltham, Massachusetts. For more information regarding Alere,
please visit www.alere.com.
Director, Corporate Communications
SOURCE Alere Inc.
Press spacebar to pause and continue. Press esc to stop.