Accurate Results in the Clinical Laboratory: A Guide to Error Detection and Correction

Description

Accurate Results in the Clinical Laboratory: A Guide to Error Detection and Correction, Second Edition, provides a comprehensive review of the factors leading to errors in all areas of clinical laboratory testing. This trusted guide addresses interference issues in all laboratory tests, including patient epigenetics, processes of specimen collection, enzymes and biomarkers. Clinicians and laboratory scientists will both benefit from this reference that applies discussions to both accurate specimen analysis and optimal patient care. Hence, this is the perfect reference for clinical laboratorians, from trainees, to experienced pathologists and directors. Key Features Provides comprehensive coverage across endocrine, oncology, hematology, immunohistochemistry, immunology, serology, microbiology, and molecular testing Includes new case studies that highlight clinical relevance and errors to avoid Highlights the best titles published within a variety of medical specialties Reviewed by medical librarians and content specialists, with key selections compiled in their annual list Readership Pathologists, clinical chemists, and toxicologists; practicing clinicians, fellows and residents in pathology, internal medicine, emergency medicine and family practice COVER......Page 1 Accurate Results in the Clinical Laboratory......Page 2 List of contributors......Page 3 Copyright......Page 8 Foreword (from the first edition)......Page 5 Reference......Page 7 Preface......Page 9 Errors in clinical laboratory......Page 10 Quality improvement in clinical laboratory......Page 13 References......Page 16 Introduction......Page 17 Whole blood, plasma, and serum specimens for clinical laboratory analysis......Page 18 Whole blood......Page 19 Specimen composition......Page 21 Stoppers and stopper lubricants......Page 22 Serum separator gel tubes (SST)......Page 23 Anticoagulants......Page 24 Order of draw of various blood collection tubes......Page 25 Skin puncture......Page 27 Hemolysis......Page 28 Suprapubic aspiration......Page 29 References......Page 30 Transportation time......Page 33 Effects of temperature......Page 36 Effects of specimen handling and turbulence......Page 37 Special case: blood gases and ionized calcium......Page 38 Effect of centrifugation on test results......Page 39 Effect of storage conditions on laboratory results......Page 42 Specimen misidentification......Page 43 References......Page 46 Effect of age related changes on clinical laboratory test results......Page 50 Adulthood......Page 51 Elderly......Page 52 Gender related changes on clinical laboratory values......Page 53 Special diet-related changes on clinical laboratory values......Page 54 Fasting/starvation-related changes on clinical laboratory values......Page 55 Nutraceutical-related changes on clinical laboratory values......Page 56 Exercise related changes on clinical laboratory values......Page 57 Difference in laboratory test results among populations......Page 59 References......Page 60 Introduction......Page 62 Effect of hemolysis on laboratory tests......Page 63 In vivo hemolysis......Page 64 In vitro hemolysis......Page 65 Case report......Page 67 Lipemia......Page 68 Icterus......Page 69 References......Page 70 Immunoassay methods and assay principle......Page 73 Immunoassay reagents......Page 75 Specimen types for immunoassays......Page 76 References......Page 77 Heterophilic antibody interferences......Page 78 Mechanism of heterophilic antibody interference......Page 79 How problematic is heterophilic antibody interference?......Page 80 Interference from human anti-animal antibodies (HAAA)......Page 81 Detection and correction of heterophilic antibody interferences......Page 82 Removal of interfering substances......Page 83 References......Page 84 BIOTIN INTERFERENCE IN IMMUNOASSAYS......Page 86 The convergence of susceptible methods and supra-physiological biotin intake......Page 87 BIOTIN REQUIREMENT AND PHYSIOLOGICAL FUNCTIONS......Page 88 High dose biotin therapy beyond metabolic disease......Page 90 HISTORY OF BIOTIN INTERFERENCE......Page 91 Assessing the risk of adverse events......Page 92 Surveillance......Page 94 CONCLUSION......Page 95 References......Page 96 Introduction......Page 101 Creatinine analysis......Page 102 Limitations of the MDRD equation......Page 105 Jaffe-based methods......Page 106 Case reports......Page 107 Enzymatic creatinine assays......Page 108 Urea analysis......Page 109 Urea assay methods......Page 110 Pre-analytical factors......Page 111 Case report......Page 112 Glucose analysis......Page 113 Pre-analytical considerations for glucose measurement......Page 114 Hexokinase......Page 115 Analysis of electrolytes......Page 116 Physiologic pre-analytical issues......Page 119 Specimen issues......Page 122 Case report......Page 123 Adjustment for plasma water with indirect methods......Page 124 Phosphate Assays......Page 127 Pre-analytical issues......Page 128 Analytical issues......Page 129 Analytical issues......Page 131 Pre-analytical issues......Page 132 Analytical issues......Page 133 Fasting versus nonfasting lipid profiles......Page 134 Case report......Page 135 References......Page 136 Analytical issues and interferences......Page 141 Urinary albumin measurements to detect microalbuminuria......Page 142 Alanine and aspartate aminotransferases analysis......Page 143 Specimen processing......Page 145 γ-Glutamyl transferase and alkaline phosphatase analysis......Page 146 Amylase and lipase analysis......Page 147 Analytical issues......Page 148 Lactate dehydrogenase analysis......Page 149 Creatine kinase analysis......Page 150 Cardiac troponin analysis......Page 151 B-type natriuretic peptide analysis......Page 154 Iron studies......Page 156 Emerging markers in iron metabolism......Page 159 References......Page 160 Sample collection and processing......Page 164 High-dose hook effect......Page 165 Human anti-mouse antibodies, rheumatoid factor and heterophile antibodies......Page 166 Biotin ingestion-associated interference......Page 167 Growth hormone......Page 169 Adrenocorticotropic hormone......Page 170 Thyroid stimulating hormone......Page 171 Prolactin......Page 172 Challenges in measuring human chorionic gonadotropin......Page 173 Thyroglobulin......Page 174 Cortisol......Page 175 Aldosterone & renin......Page 176 Parathyroid hormone......Page 177 Gonadal and reproductive medicine......Page 178 Testing for insulin like growth factor-I......Page 179 Prenatal testing......Page 180 References......Page 181 Diagnosis of cancer......Page 189 Detecting relapses......Page 190 Elevated PSA in prostate cancer and other conditions......Page 191 Serum free and bound PSA......Page 192 False positive and unexpected PSA results......Page 193 Cancer antigen 125 (CA-125)......Page 194 Emerging biomarkers in diagnosis of ovarian cancer......Page 195 Alpha-fetoprotein (AFP)......Page 196 Serum CEA concentration and colorectal carcinoma......Page 197 False positive CEA......Page 198 Combined CEA and CA 19-9......Page 199 β2 microglobulin......Page 200 Causes and evaluation of persistent low levels of human chorionic gonadotropin......Page 201 False positive human chorionic gonadotropin......Page 202 Markers of breast cancer......Page 203 Hetrophilic antibody interference in tumor markers testing......Page 204 Less frequently monitored tumor markers......Page 205 References......Page 206 Sources of pre-analytical factors affecting drug levels......Page 210 Sources of analytical interferences in TDM......Page 212 Mechanisms of analytical interferences in TDM......Page 214 Chromatography and mass spectrometry......Page 215 Digoxin metabolites......Page 216 DLIF (Digoxin like immunoreactive factors)......Page 217 Herbal medicines......Page 218 Interferences in phenytoin measurement......Page 219 Interferences in measurement of immunosuppressants......Page 220 Drug metabolites......Page 221 Analytical variables......Page 222 Analytical variables......Page 223 References......Page 224 Introduction......Page 227 Amphetamine isomers/medications containing or metabolizing to amphetamines......Page 228 Opioids......Page 230 Opiates screening assays......Page 231 Oxycodone screening......Page 232 Benzodiazepines......Page 233 Cannabinoids......Page 234 References......Page 235 Purpose of drug testing......Page 237 Testing process for drug confirmation......Page 238 Confirmation of amphetamines......Page 240 Confirmation of opioids......Page 242 Codeine......Page 243 Interpretation of opioid results......Page 244 Confirmation of marijuana metabolite......Page 245 Confirmation of benzodiazepines......Page 246 Specimen validity testing......Page 247 References......Page 248 Abuse of NPS......Page 251 Rise of synthetic cannabinoids, cathinones and fentanyl analogues abuse......Page 252 Analytical challenges......Page 253 Reference standards for the appropriate analytical target......Page 255 Assay sensitivity......Page 256 Glucuronidation, hydrolysis, and metabolites......Page 257 Urine......Page 258 Blood......Page 259 Limitations of NPS immunoassays......Page 260 Confirmation of NPS......Page 261 Mass spectrometers and library searching......Page 262 References......Page 263 Introduction......Page 265 Pharmacodynamics of ethanol......Page 266 Pharmacokinetics of ethanol......Page 267 Alcohol measurement methods......Page 269 Testing methodologies: alcohol dehydrogenase (ADH)......Page 270 Performance evaluation of enzymatic alcohol assays......Page 271 Shortcomings of existing automated testing methods......Page 272 Shortcomings of existing automated testing methods: cross reactivity with other alcohols......Page 273 Shortcomings of existing automated testing methods: elevated lactate and LDH......Page 274 Eliminating interferences in alcohol assays......Page 275 Pre-analytical considerations......Page 276 Post-analytical considerations......Page 277 Markers of ethanol ingestion......Page 278 Markers of ethanol ingestion: osmole gap......Page 279 Markers of ethanol ingestion: ethyl glucuronide, ethyl sulfate, phosphatidylethanol (PEth) and fatty acid ethyl esters (FAEEs)......Page 280 Toxic alcohols......Page 281 References......Page 283 Introduction......Page 286 FDA warnings to toxic herbs......Page 287 Herbal supplements and abnormal liver function tests......Page 288 Kava......Page 289 Germander......Page 290 Other supplements associated with liver damage......Page 291 Herbal supplements associated with kidney damage......Page 292 Herbal supplements and hypoglycemia......Page 294 Adulteration of herbal supplements with oral hypoglycemic agents......Page 295 Kelp and abnormal thyroid function tests......Page 296 Interaction of St. John's wort with various drugs......Page 297 Interactions of warfarin with herbal supplements......Page 301 Other drug-herb interactions......Page 302 Herbs adulterated with Western drugs......Page 303 Grapefruit juice-drug interactions......Page 304 Conclusions......Page 305 References......Page 306 Challenges in hemoglobinopathy detection......Page 310 Hemoglobinopathy diagnosis errors......Page 311 Challenges in HIV testing......Page 313 Hepatitis testing......Page 314 Serology for hepatitis C......Page 315 References......Page 316 Detection of monoclonal proteins......Page 317 Free light chain (FLC) immunoassay......Page 318 Antinuclear antibodies......Page 319 References......Page 320 Specimen collection......Page 322 Specimen assessment......Page 323 Hybridization methods......Page 324 Amplification inhibitors......Page 325 Commonly encountered inhibitors and their sources......Page 326 Next-generation sequencing (NGS)......Page 327 Case report: false negative result of PCR testing for Neisseria meningitidis......Page 328 Quality control......Page 329 References......Page 330 Targeted single variant detection......Page 333 Multi-variant panels......Page 334 Sequencing......Page 335 KRAS......Page 337 BCR/ABL......Page 339 KIT......Page 340 HLA-B∗15:02......Page 341 CYP2D6......Page 342 Hemostasis (CYP2C19, CYP2C9, VKORC1)......Page 343 Precision medicine and pediatrics......Page 344 References......Page 345 Preanalytical challenges......Page 348 Method evaluation, quality control and quality assurance......Page 349 Amino acids disorders......Page 351 Organic acid disorders......Page 352 Fatty acid oxidation defects......Page 355 Lysosomal storage disorders......Page 356 References......Page 357 Test selection......Page 358 Specimen collection......Page 359 Case study......Page 360 Reporting......Page 361 Results archiving and specimen storage......Page 362 Quality improvement......Page 363 References......Page 364 Introduction......Page 366 Errors in WBC counts and WBC differential count......Page 367 Cold agglutinins......Page 368 Pseudothrombocytopenia......Page 369 Errors related to sample collection, transport and storage......Page 370 References......Page 371 Errors in thrombin time measurement......Page 373 Fibrinolysis products and rheumatoid factor......Page 374 Challenges in anticoagulants and lupus anticoagulant tests......Page 375 Conclusions......Page 376 References......Page 377 Cell viability......Page 378 Sample transit times......Page 381 Clotting, cell clumping and laminar flow......Page 383 Cell doublets......Page 384 Paraproteins and flow analysis......Page 385 Mab therapies......Page 387 Compensation......Page 390 Spillover beyond compensation......Page 391 Tandem dyes......Page 393 The strange case of calcium oxalate and CSF......Page 395 Case scenario 1......Page 396 References......Page 398 ABO TYPING......Page 400 Autocontrol and direct anti-human globulin test......Page 401 INTERFERENCES IN BASIC BLOOD BANK TESTING......Page 402 Unexpected RBC antigen-like reactivity......Page 403 Clinical summary and initial testing......Page 404 Clinical summary and initial testing......Page 405 Initial interpretation and further testing......Page 406 Final interpretation......Page 407 Clinical summary and initial testing......Page 408 Clinical summary and initial testing......Page 409 Initial interpretation and further testing......Page 410 References......Page 411 ERRORS IN TRANSFUSION......Page 413 Acute hemolytic transfusion reaction......Page 414 Febrile nonhemolytic transfusion reaction......Page 415 Septic transfusion reaction......Page 416 Transfusion-associated graft versus host disease......Page 417 Iron overload......Page 418 CONCLUSIONS......Page 419 References......Page 420 Design of POC devices......Page 422 Drugs of abuse......Page 423 Infectious disease (ID)......Page 425 Guidelines for using POCT devices......Page 426 References......Page 427 Alcohol analysis using breath analyzers: legal issues......Page 430 Technical aspect of breath alcohol measurement......Page 431 Issues with partition ratio......Page 433 Alcohol measurement in breath: cooperative versus noncooperative person......Page 434 Sources of errors in breath alcohol measurement......Page 435 Case report......Page 436 Interferences of volatiles in breath alcohol analysis......Page 437 Conclusions......Page 438 References......Page 439 A......Page 441 B......Page 443 C......Page 444 D......Page 446 E......Page 447 F......Page 448 H......Page 449 I......Page 451 L......Page 452 M......Page 453 N......Page 454 P......Page 455 S......Page 457 T......Page 458 W......Page 460 Z......Page 461