This BD Device Could Help the Fight against AIDSThis BD Device Could Help the Fight against AIDS

BD's FACSPresto system could enable better monitoring of HIV/AIDS around the world.

Nancy Crotti

FDA has provided 510(k) clearance for a significant platform addition for an AIDS patient diagnostic device made by Becton, Dickinson & Co.

An automated, multicolor fluorescent imaging cytometer and absorbance spectrometer, the newly cleared FACSPresto system provides absolute and percentage results for CD4 T lymphocytes (T cells) and hemoglobin concentration in whole blood samples.

T cell counts help indicate the presence or progression of HIV/AIDs in a patient. About 2 million people around the world contracted the HIV virus in 2014, the latest year available, according to the United Nations.

FACSPresto works with as little as a few drops of whole blood and delivers results in less than 4 minutes, the company said in a news release. The previous FACSCalibur that FACSPresto was build off of requires at least 1 ?l of blood.

"We believe our BD FACSPresto system provides superior ability to accurately monitor patients living with HIV/AIDS in a variety of health care settings at a reasonable cost, which ultimately may help control the spread of the disease," Claude Dartiguelongue, worldwide president for biosciences at Franklin Lakes, NJ-based BD, said in a news release.

BD designed the system to be an intuitive and easy-to-use instrument. It weighs only 6 kg (13.23 lb), and it uses a proprietary dried reagents cartridge that also has received 510(k) clearance. The cartridge offers increased stability across a wide range of storage conditions.

The new system can process up to 80 tests per day, according to BD.

After finger stick or venipuncture blood collection, the device user can simply transfer and incubate the sample on the single-use disposable cartridge, obtaining results within 4 minutes.

It includes a touchscreen and its user interface works regardless of language.

BD makes medical supplies, devices, laboratory equipment and diagnostic products. Its product lineup includes disposable needles, syringes and intravenous catheters. It completed a $12 billion merger with CareFusion in March 2015.

Nancy Crotti is a contributor to Qmed and MPMN.

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