Omega’s VISITECT CD4 Advanced Disease test is a semi-quantitative lateral flow assay that estimates CD4 protein on the surface of CD4+ T cells in human whole blood. Credit: DarkoStojanovic / Pixabay.

Omega Diagnostics has received the World Health Organisation (WHO) Prequalification for VISITECT CD4 Advanced Disease test.

The test is a rapid, semi-quantitative lateral flow assay that estimates CD4 protein on the surface of CD4+ T cells in human whole blood.

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It is said to be the only currently available handheld lateral flow point-of-care test for identifying the risk of potentially life-threatening opportunistic infections in patients with advanced HIV.

The test can be used in decentralised settings at the point-of-care or primary healthcare level.

As part of the WHO Prequalification, the VISITECT CD4 Advanced Disease test will now be included in the organisation’s list of prequalified in vitro diagnostics (IVD). It is now eligible to participate in the procurement processes of UN agencies.

WHO member states use the WHO list of prequalified IVDs for their respective procurement decisions.

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Omega CEO Colin King said: “We are extremely pleased to receive WHO Prequalification on our VISITECT CD4 Advanced Disease test, which has allowed PEPFAR and UN agencies to get the test incorporated into their budgets for 2021, meaning the test can reach more people in those countries most in need.

“This has been an extensive process, and I am proud of the team delivering on such an important milestone for the group in such challenging economic conditions.”

Omega recently secured a supply agreement with Clinton Health Access Initiative to scale up the access of the test to low-income, lower-middle income and upper-middle income countries.

In April, Omega signed a memorandum of understanding (MoU) with three other UK companies to jointly develop and manufacture a Covid-19 point-of-care antibody test.