BD Biosciences has launched a new easy-to-use CD4 analysis platform for staging and monitoring HIV/AIDS patients in resource-limited settings.
The FACSPresto Near-Patient CD4 Counter system provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples. The system offers an intuitive language-independent graphical touchscreen interface and onboard videos to guide operation. It can be easily transported and will operate off a rechargeable battery, enabling patients even in remote settings to receive critical CD4 testing.
CD4 testing enables HIV/AIDS patients to have access to treatment and monitoring, providing a plan for improved long-term care, and reducing the probability of transmitting the infection to others. According to the World Health Organization (WHO), immediate treatment for infected individuals who meet medical guidelines can dramatically reduce the spread of HIV. This is particularly important as many new cases of HIV/AIDS are transmitted from people who are not aware they are infected.1,2
“The BD FACSPresto system expands the ability to stage and monitor HIV/AIDS patients close to their homes,” said Claude Dartiguelongue, worldwide president of 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 fingerstick 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 FACSPresto system and results are available in less than four minutes. To ensure quality and consistency of testing, onboard reagent and instrument quality control is performed with each result.
Results from clinical studies demonstrate that the 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.3 Bringing this same level of testing precision to resource-limited settings assures operators and patients a high degree of confidence in results.
The system’s cartridge uses dried reagents and offers stability across a wide range of storage conditions. In addition, the system is portable, and weighs only 13.2 lb.
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.
1. Marks G, Crepaz N, and Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS. 2006 Jun 26;20(10):1447–50.
2. Centers for Disease Control and Prevention. HIV Surveillance Report [online]; available at www.cdc.gov/hiv/topics/surveillance/resources/reports.
3. Data on file at BD.