Basic Method Validation and Verfication

For 50 years, Dr. James O. Westgard has championed standard of quality and best practices for method validation. In this, the fourth edition of Basic Method Validation, Dr. Westgard and colleagues provide important updates on regulatory requirements, evolving standards of practice, and the latest guidelines from CLSI, FDA, CMS, and ISO: New coverage of the validation and verification of qualitative and semi-quantitative testing, a topic critically important in the age of SARS-COV-2; Update of CLIA regulations and accreditation requirements' Discussion of Laboratory-Developed Tests (LDTs); Full coverage of the different studies necessary for validation and verification; Detailing of strengths of different regression techniques for comparison of methods Book jacket.