Statistics for Method Verification of Qualitative Assays in Clinical Microbiology

Despite improvement over the last decade, inadequate method verification strategies and documentation are still common laboratory inspection deficiencies. Some of the gaps occur because microbiologists may not use scientific experiment concepts, such as experimental design, data validation, biostatistics, and electronic documentation, that can improve their verification strategies for new test methods. Other gaps occur because laboratory resources are often limited. Clinical laboratories face tough choices when they consider implementing a new test method, and this review summarizes the basic statistical concepts that microbiologists need to critically plan and review qualitative method verification with the aim of determining whether a new diagnostic test is fit for patient testing.