Laboratory Test Verification and Validation Toolkit

Details

• Corporate Authors:
  Association of Public Health Laboratories (U.S.) ; National Center for Zoonotic, Vector-borne, and Enteric Diseases (U.S.) ; Centers for Disease Control and Prevention (U.S.)
• Description:
  Clinical laboratory testing should be accurate and reliable to ensure correct diagnosis and treatment. Laboratories that perform testing on human specimens for the purpose of diagnosis, treatment or mitigation of a disease or
  
  disease state must demonstrate that new instruments and tests have acceptable performance prior to implementation. Studies that demonstrate the performance characteristics of the instrument or assay must be documented
  
  and accessible for external inspections and assessments. This process is known as verification or validation.
  
  This publication was supported by Cooperative Agreements #NU60OE000104, 100% funded by the US Centers for Disease Control and Prevention (CDC). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC or the US Department of Health and Human Services.
  
  QSA-VV-Toolkit.pdf
  
  
• Subjects:
  Clinical Laboratory Techniques/standards Reproducibility Of Results Validation Studies As Topic
• Document Type:
  Pamphlet (or booklet)
• Funding:
  Cooperative Agreements #NU60OE000104
• Pages in Document:
  37 numbered pages
• Collection(s):
  Stephen B. Thacker CDC Library
• Main Document Checksum:
  urn:sha256:efed46ea1d7527f284b9db6c4814482cd21b2657abb13b268b080b1c084589f1
• Download URL:
  https://stacks.cdc.gov/view/cdc/153395/cdc_153395_DS1.pdf
• File Type:
  [PDF - 985.48 KB ]