The World Health Organisation (WHO) has prequalified the Alere Pima CD4 Test as part of an effort to increase access to rapid and accurate HIV/AIDS monitoring tools. The product is said to be the first and only point-of-care diagnostic designed for the measurement of absolute CD4 counts to receive such recognition from the WHO.
The WHO’s evaluation consists of an in-depth product assessment, an inspection of the manufacturing facility, and independent multisite performance studies to ensure the highest standards of quality and reliability are met. The test was accepted for the WHO’s list of prequalified diagnostics on the basis of this evaluation and in advance of multisite performance studies due to the significant public health impact this product could have.
In addition to the independent performance data that is currently available, the product’s prequalification status provides further evidence that it meets the needs of those looking to deploy a point-of-care CD4 solution. Designed specifically to operate in the most challenging environments, this rapid point-of-care analyser gives healthcare providers the ability to obtain absolute CD4 counts in under 20 min, enables more patients to access a CD4 result and reduces both the number of patients lost to follow-up and the time to initiate antiretroviral therapy.
As part of the company’s ongoing commitment to provide products that support the screening and monitoring of people living with HIV/AIDS, Alere manufactures the Alere Determine HIV 1/2 Test, which is designed for HIV screening at the point of care and also appears on the WHO’s list of qualified diagnostics. To date, 37 HIV rapid tests have been submitted to the WHO for prequalification, and the Determine Test is claimed to have been one of the first HIV rapid assays to complete the process.
