Assay Identifies T-Lymphocytes in Whole Blood

A new assay is designed to identify and quantify absolute counts of CD4+ T-lymphocytes in EDTA (ethylenediaminetetraacetic acid) whole blood.

The EZCD4 system, developed by Guava Technologies, Inc. (Hayward, CA, USA), includes the procoagulant activity (PCA) instrument and the CytoSoft v2.3 software, which incorporates three modules: EZCD 4, Guava Check and Clean, and Shutdown. The system has been cleared by the U.S. Food and Drug Administration (FDA).

The EZCD4 system can be used with Guava's microcapillary cytometry technology for the ongoing monitoring of patients with documented diagnosis of an immunodeficiency disease. Absolute counts of CD4+ T-cells can be useful in characterizing, monitoring, and evaluating the effectiveness of treatment for autoimmune and immunodeficiency diseases. Determining the number of CD4+ T-cells is very useful in monitoring HIV patients.

The Guava EZCD4 assay is a two-color, direct immunofluorescence reagent kit intended for use with a Guava PCA system. The kit includes a monoclonal anti-human CD3 antibody that uniquely identifies T-cells and a monoclonal anti-human CD4 antibody that allows the identification of human helper/inducer CD4+ T-cells.

Guava Technologies notes that the system requires far less reagent per sample, dramatically lowering the overall costs of performing the assay. Testing requires only 10 ml of whole blood per patient. The microcapillary technology does not require the use of sheath fluid, large amounts of which are typically needed for conventional flow cytometers.

"In addition to the very necessary diagnostic application of monitoring immuno-compromised patients, we believe the Guava system provides an ideal approach for combining powerful cell analysis with healthcare systems struggling to conserve resources in personnel and equipment.”



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Guava Technologies