How to verify and validate a clinical microbiology test before it can be used in routine diagnostics: a practical guide

Author:

Yusuf Erlangga,Schijffelen Maarten J.,Leeflang Mariska

Publisher

Elsevier BV

Reference31 articles.

1. European Commission. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0746.

2. Evidence-based case review: assessing diagnostic and screening tests: Part 1. Concepts;Gilbert;West J Med,2001

3. Verification and validation of tests used in the clinical microbiology laboratory;Tibbetts;Clin Microbiol Newsl,2015

4. Faster and economical screening for vancomycin-resistant enterococci by sequential use of chromogenic agar and real-time polymerase chain reaction;Tan;J Microbiol Immunol Infect,2017

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