Search results for: amr wgs testing

NAHLN UNIVERSITY OF NEBRASKA CLIN: 0003.10 ITEM: AMR WGS TESTING CONTRACT #12639522D0006 Solicitation ID/Procurement Identifier: 12639522D0006 Ultimate Completion Date: Mon Nov 30 18:00:00 GMT 2026

CLIN 0003.10 AMR WGS TESTING Solicitation ID/Procurement Identifier: AG6395C160159 Ultimate Completion Date: Thu Jun 16 17:00:00 GMT 2022

CLIN 0003.10 AMR WGS TESTING Solicitation ID/Procurement Identifier: AG6395C160182 Ultimate Completion Date: Thu Jun 16 17:00:00 GMT 2022

Every time a new piece of instrumentation enters the laboratory all precautions are made to provide the necessary training on the analyzers to prevent delay in testing and operator errors that could lead to erroneous results. New instrumentation and new vendors increase the odds of errors mostly due to learning the new system.

For any Analyte Specific Reagent (ASR) testing or Research Use Only (RUO) testing the platform must provide flexibility, to include PCR applications using multiple probe design technologies. 11. Assays that have had FDA cleared testing methodologies assigned to them by the FDA must utilize the FDA cleared technology for the assay. For example, the following assays may or may not be FDA cleared.

Analytical Measurement Range (AMR) Validation shall be performed on proposed instruments for each analyte to validate the reportable range.  The material must have values, which are near the low, mid and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. Precision study using normal and abnormal control material. 

Many testing systems within P&LMS also require validation of the Analytical Measurement Range (AMR) for an analyte both initially and at least every six months thereafter. This can be accomplished through purchase of linearity material that is both matrix specific and spans the range of the AMR for each analyte, when required. This is addressed in 42 CFR 493.1255 (b) and the College of American Pathologists (CAP) standard CHM.13600.

Many testing systems within P&LMS also require validation of the Analytical Measurement Range (AMR) for an analyte both initially and at least every six months thereafter. This can be accomplished through purchase of linearity material that is both matrix specific and spans the range of the AMR for each analyte, when required. This is addressed in 42 CFR 493.1255 (b) and the College of American Pathologists (CAP) standard CHM.13600.

The DXI800 is the instrument that is used in Chemistry for Immunoassay testing. This test is needed to help diagnose and manage Congestive heart failure in the VA patient population at the CMC VAMC. Only reagents made strictly for the Beckman Coulter DXI800 analyzer is acceptable. B. DEFINITIONS BNP = brain natriuretic peptide C.