Alere Point-Of-Care CD4 Test Prequalified by WHO
16 Dec 2011

Alere has announced that its Alere Pima™ CD4 Test has been prequalified by the World Health Organization (WHO) in an effort to increase access to HIV/AIDS monitoring tools. The point-of-care test from Alere is the first of its kind to make it onto the WHO list of prequalified products which was released on November 25, 2011.

CD4 is a co-receptor that assists the T cell receptor (TCR) with an antigen-presenting cell. HIV infection leads to a progressive reduction in the number of T cells expressing CD4 and the CD4 count has become an essential part of monitoring the course of immunosuppression.

The Alere Pima™ Analyser and an Alere Pima™ CD4 cartridge, enables CD4 T-cell analysis at point-of-care from a fingerstick or venous whole-blood sample in only 20 minutes providing an effective and affordable tool in the management of HIV patients. The system has been specifically designed to serve the needs of the healthcare professional in the field, the laboratory or the office.

The WHO’s evaluation consists of an in-depth product assessment, an inspection of the manufacturing facility, and independent multi-site performance studies to ensure the highest of standards of quality and reliability are met. The Alere Pima™ CD4 Test was accepted for the WHO’s list of prequalified diagnostics on the basis of this evaluation and in advance of multi-site performance studies. This is due to the significant public health impact this product, unique for its innovative point-of-care technology, could have.

“We believe that this is an important move on the part of the World Health Organization, which has conditionally prequalified the Alere Pima™ Test,” said Avi Pelossof, Vice President of the Infectious Disease Business Unit at Alere Inc. “It is a testimony to the ability of this point-of-care system to provide rapid, accurate CD4 counts to those affected most by the HIV/AIDS epidemic.”

Alere believes that its newly obtained WHO prequalification status provides further evidence that the Alere Pima™ CD4 Test meets the needs of those looking to deploy a point-of-care CD4 solution. The system has been designed to operate in the most challenging of environments to give more patients access to a CD4 result. This reduces both the number of patients lost to follow-up, and the time taken to initiate antiretroviral therapy.

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Sonia Nicholas
Clinical Diagnostics Editor