BD Biosciences, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the launch of the BD FACSPresto Near Patient CD4 Counter system that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to stage and monitor HIV/AIDS patients. With an intuitive language-independent graphical touchscreen interface and on-board videos to guide operation, the BD FACSPresto system can be easily transported and operate off a rechargeable battery, enabling patients even in remote settings to receive critical CD4 testing.
CD4 testing allows HIV/AIDS patients to have access to treatment and monitoring, reducing the probability of transmitting the infection to others and providing a plan for improved long-term care. Immediate treatment for infected individuals who meet medical guidelines can dramatically quell the spread of HIV according to the World Health Organization (WHO). This is particularly important as many new cases of HIV/AIDS are transmitted from people who are not aware they are infected.
“The BD FACSPresto system expands the ability to stage and monitor HIV/AIDS patients close to their homes,” said Claude Dartiguelongue, Worldwide President, BD Biosciences. “We have taken great care to ensure that the system meets the needs of resource-limited settings, such as featuring intuitive operation, without compromising our standards of precision and high-quality results.”
The workflow begins with blood collection from a finger-stick or venipuncture and is transferred to a single-use disposable cartridge. To increase the number of tests that can be conducted per day, the cartridge is incubated outside the instrument for 18 minutes. After incubation, the cartridge is inserted into the BD FACSPresto system and results are available in less than four minutes. To ensure quality and consistency of testing, on-board reagent and instrument quality control is performed with each result.
Results from clinical studies demonstrate that the BD FACSPresto system performs comparably with traditional analyzers, including the BD FACSCalibur cell analysis system, in terms of accuracy, precision and linearity across a wide measuring range. Bringing this same level of testing precision to resource-limited settings assures operators and patients a high degree of confidence in results.
The cartridge uses dried reagents and offers stability across a wide range of storage conditions. In addition, the system is portable and weighs only 6 kg (13.2 lbs.).
The BD FACSPresto system is CE-IVD marked and available now. The system is priced competitively compared to existing CD4 systems currently on the market. Pricing for both the system and reagents will align with expectations of the Clinton Health Access Initiative (CHAI), President’s Emergency Plan for AIDS Relief (PEPFAR), The Global Fund, Partnership for Supply Chain Management (PFSCM), and UNICEF.