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The PCR test detects HIV-1 RNA on the NeuMoDx 96/288 Molecular Systems and joins the company's other bloodborne viral tests for hepatitis B and C.
The test will be included in the World Health Organizations list of prequalified in vitro diagnostics and UN agencies will be able to procure it.
While the Lab 2.0 vision is still in its early days, a number of outfits around the country are providing examples of how it might be implemented.
The test is the second infectious disease assay from Bioneer to be CE marked, and the South Korean company has a third test in the pipeline.
Fresenius was alleged to have unnecessarily tested some dialysis patients for hepatitis B surface antigen and billing Medicare for the tests.
The assay is based on the company's AmpiProbe technology, which uses fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA.
Ascend Clinical Laboratory said it replaced its existing Siemens analyzers with the Atellica to manage growth, including during periods of high demand.
The program started in 2014, originally to increase access to HIV diagnostics, and provides special pricing to qualifying organizations in eligible countries.
The two organizations will seek to engage stakeholders worldwide in order to increase demand for and access to HCV diagnostics.
Abbott said that the MDx platform offers a number of initial assays, including tests for HIV-1, HBV, and HCV, among others.