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Dx Focus: Alere q HIV-1/2 Assay; DiaSorin CMV Test


Alere this week announced the publication of a study demonstrating the viability of accurate and rapid HIV screening of infants at the point of care.

The study, published ahead of print in the Journal of Acquired Immune Deficiency Syndromes, 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, which provides results in less than 60 minutes.

In the study, conducted under the auspices of the Mozambique National Institute of Health, the Clinton Health Access Initiative, and the University Eduardo Mondlane, 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. HIV-exposed infants routinely referred for early infant diagnosis testing were recruited for the study.

Trained nurses conducted Alere q HIV-1/2 Detect testing at the point of care using heel-prick blood samples, and also standard-of-care testing with the Roche cobas AmpliPrep/cobas TaqMan HIV Quantitative Test from dried blood spots obtained through the same heel pricks. Of the 827 samples tested on both the Alere q and Roche assay, 825 concordant results were reported, with 761 negative and 64 positive results detected with both assays. The sensitivity and specificity of the Alere q HIV-1/2 Detect were 98.5 percent and 99.9 percent, respectively.

"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," Landon Myer, associate professor in the School of Public Health, University of Cape Town, South Africa, said in a statement. "If approved, this test will allow us to immediately initiate [anti-retroviral therapy] in HIV-positive infants, and reduce morbidity and mortality in this vulnerable population."

The Alere q HIV-1/2 Detect assay is currently pending World Health Organization pre-qualification, and the company intends to apply for CE IVD marking this month.

DiaSorin this week launched a molecular assay to detect and quantify cytomegalovirus using the DiaSorin Liaison Iam analyzer.

CMV is the most prevalent infectious pathogen in solid organ and bone marrow transplant recipients, and can lead to allograft rejection and other serious complications. The DiaSorin Iam CMV assay is based on DiaSorin's Q-LAMP (quantitative loop-mediated isothermal amplification) technology, and is used to detect and quantify clinically relevant subtypes of CMV in human plasma, urine, and cerebrospinal fluid, enabling physicians to diagnose and monitor CMV infection in transplant recipients and other immunocompromised individuals. In addition the assay can be used on human amniotic fluid samples to diagnose maternal and fetal CMV infection in early pregnancy and to monitor CMV infection in affected babies.

Iam CMV has been standardized against the WHO CMV International Standard as recommended in the updated International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. The assay has demonstrated diagnostic sensitivity of greater than or equal to 97 percent and specificity of 100 percent compared to conventional PCR, but with results in a fraction of the time required by PCR, DiaSorin said.

Iam CMV is the latest addition to an expanding portfolio of infectious disease assays for use on the Liaison Iam analyzer, which the company launched in late 2012. The company said that the instrument's small footprint, ease of use, and scalable design makes it ideal for use in laboratory facilities of all sizes, including those located near patients. The Iam CMV assay is CE marked and available for use outside of the US and Canada only.