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What is the validation procedure for the Abbott m2000 System?

April 26, 2017abbott m2000 procedure system validation

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What is the validation procedure for the Abbott m2000 System?

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· The IL must perform a validation comparing their current HIV RNA platform against the Abbott m2000 platform using the VQA Secondary Validation Plan. · The IL must validate either the automated or manual extraction methods for the Abbott m2000 assay depending on the extraction method selected by the laboratory. · The IL needs to initiate communication with the VQA ASAP. Please contact the VQA to start the validation process and to get the necessary assistance. · Validation of the Abbott m2000 manual method of sample processing is a component of the VQA secondary validation panel. · Abbott will support the DAIDS VQA secondary validation algorithm at each laboratory and provide up to three (3) Abbott RealTime HIV-1 reagent kits (96 tests/kit, a total of 288 tests) to compare the Abbott RealTime HIV-1 viral load test with the Roche assay used at each site. · The IL needs to have the m2000 System validation results reviewed by both the VQA and the respective Primary Network Laboratory (PN