Problem being addressed
CD4 T cell counts are necessary for the monitoring and diagnosis of HIV/AIDS. These tests are often difficult and expensive. A low-cost, easy to use option is needed for use in resource-limited settings.
Detailed description of the solution
The Guava Auto CD4/CD4% System is a unique bench-top instrument equiped with acquisition software that health providers can use to easily monitor patients' T-lymphocytes. The Guava Auto CD4/CD4% System provides reliable results with minimum technical expertise to operate. The system provides absolute CD4 counts, CD4% of total lymphocytes, and total lymphocyte count.
Designed by
- Designed by: Guava Technologies, Inc., but Millipore acquired Guava in 2009.
- Manufacturing: Headquarters located in Billerica, Massachusetts, USA.
When and where it was tested/implemented
Testing of the device has been done in the United States. Performance has been evaluated in multiple laboratories against several well-accepted methods for determining absolute CD4 counts and CD4% values. Studies were performed on both adult and pediatric HIV samples as well as normal samples. Auto CD4/CD4% Assay test results were compared to results from other well established methods for CD4 analysis, showing consistently comparable results.
References
Peer-reviewed publication
The 2009 WHO "Review of CD4 Technologies" stated that there have been no peer-reviewed independent performance evaluation data for the Guava Auto CD4. PDF cited here.
Other internally generated reports
Company and product information for Millipore found here.
Externally generated reports
Mergia, A., Elad, K., Sharp, M., Fishwild, D., O’Connell, B., Bredt, B., & Tyagarajan, K. Performance of Aged, TransFix-Treated Blood in the Guava EasyCD4 and EasyCD8 Assays. Guava Technologies. Presented at the 12th Conference on Retroviruses and Opportunistic Infections, February 22-25, 2005, Boston, Massachusetts USA.