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Guava Auto CD4/CD4% System

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This Global Health Medical Device is designed for or implemented within resource-limited settings - Browse the devices - Add a device


Guava automated.jpg
Health Topic HIV/AIDS
Classification Diagnosis
Scope Commercialized
Location Africa, Asia, South America

Problem being addressed[edit]

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[edit]

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[edit]

  • 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[edit]

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[edit]

Peer-reviewed publication[edit]

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[edit]

Company and product information for Millipore found here.

Comany product data sheet for Millipore found here.

Externally generated reports[edit]

Mergia, A., Elad, K., Sharp, M., Fishwild, D., O’Connell, B., Bredt, B., & Tyagarajan, K. (February, 2005). 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, Boston, Massachusetts USA.