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Royal Statistical Society Diagnostic Tests Working Group Report

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Royal Statistical Society Diagnostic Tests Working Group Report Royal Statistical Society Diagnostic Tests Working Group Report JUNE 2021 Royal Statistical Society Working Group on Diagnostic Tests Report Abbreviations AIDS Acquired immunodeficiency syndrome ARC Applied Research Collaborative A&E Accident and Emergency BRC Biomedical Research Centre BSE Bovine spongiform encephalopathy CDC Centers for Disease Control and Prevention CE Conformité Européene CI Confidence interval CLIA Chemiluminescent immunoassay CLSI Clinical and Laboratory Standards Institute COVID-19 Coronavirus disease 2019 Ct Cycle threshold CV Coefficient of variation DAA Directly acting antiviral DHSC Department for Health and Social Care DNA Deoxyribonucleic acid ELISA Enzyme-linked immunosorbent assay EU European Union EUA Emergency use approval FDA Food and Drug Administration FIND Foundation for Innovative New Diagnostics FN False negative FP False positive HAART Highly active antiretroviral therapies HAV Hepatitis A virus HBV Hepatitis B virus HCV Hepatitis C virus HCW Healthcare worker HIV Human immunodeficiency virus HMG Her Majesty’s Government IFU Instructions for use Ig Immunoglobulin IGRA Interferon gamma release assays ISO International Organisation for Standards IVD In vitro diagnostic LFT Lateral flow test LoB Limit of blank LoD Limit of detection LoQ Limit of quantification LTBI Latent tuberculosis infection MHRA Medical and Healthcare products Regulatory Agency 1 Royal Statistical Society Working Group on Diagnostic Tests Report MRC Medical Research Council MTB/RIF Mycobacterium tuberculosis and resistance to rifampicin NHS National Health Service NIHR National Institute for Health Research ONS Office of National Statistics NPV Negative predictive value PCR Polymerase chain reaction PHE Public Health England POCT Point of care test PPV Positive predictive value PRISMA-DTA Preferred reporting items for systematic reviews and meta-analyses of diagnostic test accuracy studies QUADAS-2 Quality assessment of diagnostic accuracy studies RCV Reference change value RDT Rapid diagnostic test REACT Real-time assessment of community transmission RNA Ribonucleic acid RSS Royal Statistical Society RT-LAMP Reverse transcription loop-mediated isothermal amplification RT-PCR Reverse transcription polymerase chain reaction SAGE Scientific Advisory Group for Emergencies SARS Severe acute respiratory syndrome SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 SD Standard deviation STARD Standards for reporting diagnostic accuracy TB Tuberculosis TN True negative TP True positive TPP Target product profile TST Tuberculin skin test UAT Unlinked anonymous testing UK United Kingdom USA United States of America vCJD Variant Creutzfeldt–Jakob disease VTM Viral transport media WHO World Health Organisation 2 Royal Statistical Society Working Group on Diagnostic Tests Report Table of Contents Abbreviations ........................................................................................................................................................ 1 Executive Summary ............................................................................................................................................... 7 Context ............................................................................................................................................................. 7 Terms of reference ........................................................................................................................................... 7 Recommendations: Study-design matters ....................................................................................................... 8 Recommendations: Regulation matters ........................................................................................................... 9 Recommendations: Transparency matters .................................................................................................... 10 Section 1: Understanding infectious diseases .................................................................................................... 11 1.1 Immune response ..................................................................................................................................... 11 1.2 Stages of infectious diseases .................................................................................................................... 12 Section 2: Diagnostic tests .................................................................................................................................. 14 2.1 Types of in vitro diagnostic tests for infectious diseases .......................................................................... 14 2.2 Setting of testing ....................................................................................................................................... 16 2.3 Challenges in testing for infectious diseases ............................................................................................ 16 2.4 General principles ..................................................................................................................................... 16 Section 3: Statistical parameters required for reporting .................................................................................... 17 3.1 Analytical performance ............................................................................................................................ 17 3.1.1 Imprecision ........................................................................................................................................ 18 3.1.2 Bias .................................................................................................................................................... 18 3.1.3 Analytical sensitivity .......................................................................................................................... 19 3.1.4 Analytical specificity .......................................................................................................................... 19 3.1.5 Sample size requirements for analytical performance studies ......................................................... 20 3.2 Clinical performance ................................................................................................................................. 20 3.2.1 Clinical studies ................................................................................................................................... 20 3.2.2 Diagnostic or clinical sensitivity and specificity ................................................................................. 21 3.2.3. Predictive values ............................................................................................................................... 21 3.2.4 Indeterminate results and test failures ............................................................................................. 21 3.2.5 Other aspects of test performance ................................................................................................... 21 Section 4: Study design for clinical performance studies ................................................................................... 22 4.1 Specifying the intended use or purpose ................................................................................................... 22 4.2 Study design considerations ..................................................................................................................... 22 4.2.1 Target population .............................................................................................................................. 23 4.2.2 Prospective recruitment of a representative sample of participants ............................................... 23 3 Royal Statistical Society Working Group on Diagnostic Tests Report 4.2.3 Timing of the tests ............................................................................................................................. 23 4.2.4 Delivery of tests ................................................................................................................................. 24 4.2.5 Comparisons of tests ......................................................................................................................... 24 4.3 Variations in study design – impact on validity (internal and external) ................................................... 24 4.3.1 Could the selection of patients have introduced bias? ..................................................................... 24 4.3.2 Could the conduct or interpretation of the index test have introduced bias? ................................. 25 4.3.3 Could the conduct or interpretation of the reference standard have introduced bias? .................. 25 4.3.4 Flow and timing – Could the patient flow have introduced bias? ..................................................... 25 4.4 Sample size issues and incorporating or evaluating uncertainty ............................................................. 26 4.5 Study designs for other relevant clinical studies of diagnostic tests ........................................................ 26 4.5.1 Studies of the natural history of disease ........................................................................................... 27 4.5.2 Studies of the impact of tests and testing strategies ........................................................................ 27 4.6 Surveillance studies .................................................................................................................................
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