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

Accurate Results in the Clinical Laboratory......Page 1
Introduction......Page 264
Copyright......Page 7
List of contributors......Page 2
Foreword......Page 4
Introduction......Page 365
Reference......Page 6
8 -
Biotin interference in clinical laboratory tests: sporadic problem or a serious clinical issue?......Page 8
Heterophilic antibody interferences......Page 77
Introduction......Page 9
Quality improvement in clinical laboratory......Page 12
References......Page 15
24 -
Sources of pre-analytical, analytical and post-analytical errors in the microbiology laboratory......Page 16
A......Page 209
Issues with variable active ingredients and poor manufacturing practice of herbal supplements......Page 17
Whole blood......Page 18
Specimen composition......Page 20
Stoppers and stopper lubricants......Page 21
Serum separator gel tubes (SST)......Page 22
Anticoagulants......Page 23
Order of draw of various blood collection tubes......Page 24
Skin puncture......Page 26
Hemolysis......Page 27
Suprapubic aspiration......Page 28
References......Page 29
Transportation......Page 32
B......Page 357
Test selection......Page 242
Effects of temperature......Page 35
Effects of specimen handling and turbulence......Page 36
Macro-complexes......Page 37
Elderly......Page 51
Effect of centrifugation on test results......Page 38
Effect of storage conditions on laboratory results......Page 41
Turnaround time......Page 56
Detection and correction of heterophilic antibody interferences......Page 81
Conclusions......Page 45
β2 microglobulin......Page 199
Pre-analytical issues......Page 49
Introduction......Page 226
Adulthood......Page 50
Gender related changes on clinical laboratory values......Page 52
Special diet-related changes on clinical laboratory values......Page 53
Fasting/starvation-related changes on clinical laboratory values......Page 54
Nutraceutical-related changes on clinical laboratory values......Page 55
Difference in laboratory test results among populations......Page 58
References......Page 59
ERRORS IN TRANSFUSION......Page 399
Introduction......Page 61
Effect of hemolysis on laboratory tests......Page 62
In vivo hemolysis......Page 63
In vitro hemolysis......Page 64
Case report......Page 66
Sources of analytical interferences in TDM......Page 211
Opiates screening assays......Page 230
Icterus......Page 68
Herbal supplements and abnormal liver function tests......Page 69
31 -
Special concern: sources of inaccuracy in breath alcohol analysis......Page 72
Immunoassay reagents......Page 74
Specimen types for immunoassays......Page 75
References......Page 76
Mechanism of heterophilic antibody interference......Page 78
How problematic is heterophilic antibody interference?......Page 79
Interference from human anti-animal antibodies (HAAA)......Page 80
Removal of interfering substances......Page 82
Sources of errors in breath alcohol measurement......Page 434
References......Page 83
BIOTIN INTERFERENCE IN IMMUNOASSAYS......Page 85
RhD typing......Page 86
BIOTIN REQUIREMENT AND PHYSIOLOGICAL FUNCTIONS......Page 87
Pennyroyal......Page 89
Pseudothrombocytopenia......Page 368
HISTORY OF BIOTIN INTERFERENCE......Page 90
Lactate dehydrogenase analysis......Page 91
Mass spectrometers and library searching......Page 93
CONCLUSION......Page 94
Clinical summary and initial testing......Page 404
Acknowledgments......Page 95
30 -
Methodological issues in point of care testing devices......Page 100
Creatinine analysis......Page 101
Limitations of the MDRD equation......Page 104
Metabolites......Page 105
Case reports......Page 106
Enzymatic creatinine assays......Page 107
Urea analysis......Page 108
Urea assay methods......Page 109
Challenges in anticoagulants and lupus anticoagulant tests......Page 374
Pre-analytical factors......Page 110
Case report......Page 111
Glucose analysis......Page 112
Pre-analytical considerations for glucose measurement......Page 113
Post-transfusion purpura......Page 114
Interferences in phenytoin measurement......Page 115
Physiologic pre-analytical issues......Page 118
Specimen issues......Page 121
Case report......Page 122
Adjustment for plasma water with indirect methods......Page 123
Phosphate Assays......Page 126
Pre-analytical issues......Page 127
Analytical issues......Page 128
Analytical issues......Page 130
Pre-analytical issues......Page 131
Analytical issues......Page 132
Lipid profiles analysis......Page 133
Combined CEA and CA 19-9......Page 198
Case report......Page 134
References......Page 135
Index......Page 316
Analytical issues and interferences......Page 140
Urinary albumin measurements to detect microalbuminuria......Page 141
Molecular methods......Page 142
Specimen processing......Page 144
Methodology......Page 145
NPS in various biological matrix......Page 257
Amylase and lipase analysis......Page 146
Host factors influencing response to infectious disease......Page 147
Creatine kinase analysis......Page 149
Cardiac troponin analysis......Page 150
B-type natriuretic peptide analysis......Page 153
Iron studies......Page 155
Emerging markers in iron metabolism......Page 158
References......Page 159
Errors in hemoglobin measurement and RBC count......Page 332
INTRODUCTION......Page 412
Preanalytical challenges......Page 163
ADVERSE EFFECTS OF TRANSFUSION......Page 164
Human anti-mouse antibodies, rheumatoid factor and heterophile antibodies......Page 165
Biotin ingestion-associated interference......Page 166
Growth hormone......Page 168
Oxycodone screening......Page 231
Guidelines for using POCT devices......Page 425
Prolactin......Page 171
Challenges in measuring human chorionic gonadotropin......Page 172
Thyroglobulin......Page 173
Cortisol......Page 174
Aldosterone & renin......Page 175
Parathyroid hormone......Page 176
Gonadal and reproductive medicine......Page 177
Testing for insulin like growth factor-I......Page 178
Prenatal testing......Page 179
References......Page 180
Diagnosis of cancer......Page 188
Abuse of NPS......Page 250
Detecting relapses......Page 189
Elevated PSA in prostate cancer and other conditions......Page 190
Serum free and bound PSA......Page 191
False positive and unexpected PSA results......Page 192
Cancer antigen 125 (CA-125)......Page 193
Emerging biomarkers in diagnosis of ovarian cancer......Page 194
Alpha-fetoprotein (AFP)......Page 195
Serum CEA concentration and colorectal carcinoma......Page 196
False positive CEA......Page 197
Causes and evaluation of persistent low levels of human chorionic gonadotropin......Page 200
False positive human chorionic gonadotropin......Page 201
Markers of breast cancer......Page 202
References......Page 223
Less frequently monitored tumor markers......Page 204
References......Page 205
Mechanisms of analytical interferences in TDM......Page 213
Chromatography and mass spectrometry......Page 214
Vital signs......Page 215
DLIF (Digoxin like immunoreactive factors)......Page 216
Herbal medicines......Page 217
Interference from over the counter and prescription medication......Page 218
Urine......Page 219
Flow cytometry analysis of fluids......Page 220
Analytical variables......Page 221
Analytical variables......Page 222
Amphetamine isomers/medications containing or metabolizing to amphetamines......Page 227
Opioids......Page 229
Benzodiazepines......Page 232
Cannabinoids......Page 233
Limitations of NPS immunoassays......Page 234
26 -
Sources of errors in coagulation testing......Page 236
Testing process for drug confirmation......Page 237
References......Page 397
Case studies......Page 241
Spurious leukocytosis......Page 290
Methadone......Page 243
Compensation......Page 389
Confirmation of marijuana metabolite......Page 244
Confirmation of benzodiazepines......Page 245
Specimen validity testing......Page 246
References......Page 247
Rise of synthetic cannabinoids, cathinones and fentanyl analogues abuse......Page 251
Analytical challenges......Page 252
Assay sensitivity......Page 255
Glucuronidation, hydrolysis, and metabolites......Page 256
Blood......Page 258
Oral fluid......Page 259
Confirmation of NPS......Page 260
References......Page 262
Pharmacodynamics of ethanol......Page 265
Pharmacokinetics of ethanol......Page 266
Alcohol measurement methods......Page 268
Testing methodologies: alcohol dehydrogenase (ADH)......Page 269
Conclusions......Page 270
Shortcomings of existing automated testing methods......Page 271
Shortcomings of existing automated testing methods: cross reactivity with other alcohols......Page 272
Shortcomings of existing automated testing methods: elevated lactate and LDH......Page 273
Eliminating interferences in alcohol assays......Page 274
Pre-analytical considerations......Page 275
Platelet aggregates......Page 276
Markers of ethanol ingestion......Page 277
Markers of ethanol ingestion: osmole gap......Page 278
Weak or absent reactivity of expected antigen......Page 279
Toxic alcohols......Page 280
References......Page 282
INTRODUCTION......Page 285
FDA warnings to toxic herbs......Page 286
Methodological issues of POC devices......Page 318
Germander......Page 289
Herbal supplements associated with kidney damage......Page 291
Herbal supplements and hypoglycemia......Page 293
Adulteration of herbal supplements with oral hypoglycemic agents......Page 294
Kelp and abnormal thyroid function tests......Page 295
Interaction of St. John's wort with various drugs......Page 296
Interactions of warfarin with herbal supplements......Page 300
Other drug-herb interactions......Page 301
Herbs adulterated with Western drugs......Page 302
Grapefruit juice-drug interactions......Page 303
Conclusions......Page 304
References......Page 305
Challenges in hemoglobinopathy detection......Page 309
Hemoglobinopathy diagnosis errors......Page 310
Challenges in HIV testing......Page 312
Hepatitis testing......Page 313
Serology for hepatitis C......Page 314
References......Page 315
Free light chain (FLC) immunoassay......Page 317
References......Page 319
21 -
Sources of error in molecular diagnostic analyses......Page 321
Cold agglutinins......Page 367
Specimen assessment......Page 322
Hybridization methods......Page 323
Amplification inhibitors......Page 324
Transfusion-associated graft versus host disease......Page 416
Commonly encountered inhibitors and their sources......Page 325
Next-generation sequencing (NGS)......Page 326
Case report: false negative result of PCR testing for Neisseria meningitidis......Page 327
Unexpected antibody reactivity......Page 328
Acknowledgments......Page 329
Multi-variant panels......Page 333
Sequencing......Page 334
KRAS......Page 336
BCR/ABL......Page 338
KIT......Page 339
HLA-B∗15:02......Page 340
CYP2D6......Page 341
Hemostasis (CYP2C19, CYP2C9, VKORC1)......Page 342
Precision medicine and pediatrics......Page 343
References......Page 344
23 -
Challenges and sources of inaccuracy in biochemical genetics testing......Page 347
Cell viability......Page 377
Acute hemolytic transfusion reaction......Page 348
D......Page 350
Organic acid disorders......Page 351
Allergic transfusion reaction......Page 354
Lysosomal storage disorders......Page 355
Acknowledgments......Page 356
Specimen collection......Page 358
Case study......Page 359
Reporting......Page 360
Results archiving and specimen storage......Page 361
Quality improvement......Page 362
References......Page 363
Sample transit times......Page 380
Errors related to sample collection, transport and storage......Page 369
References......Page 370
Errors in thrombin time measurement......Page 372
Fibrinolysis products and rheumatoid factor......Page 373
Conclusions......Page 375
References......Page 376
Drugs of abuse......Page 422
Cell doublets......Page 383
Paraproteins and flow analysis......Page 384
Mab therapies......Page 386
Spillover beyond compensation......Page 390
Tandem dyes......Page 392
The strange case of calcium oxalate and CSF......Page 394
Case scenario 1......Page 395
Autocontrol and direct anti-human globulin test......Page 400
INTERFERENCES IN BASIC BLOOD BANK TESTING......Page 401
Unexpected RBC antigen-like reactivity......Page 402
Clinical summary and initial testing......Page 403
Initial interpretation and further testing......Page 405
Final interpretation......Page 406
Clinical summary and initial testing......Page 407
Clinical summary and initial testing......Page 408
Initial interpretation and further testing......Page 409
References......Page 410
Febrile nonhemolytic transfusion reaction......Page 414
Septic transfusion reaction......Page 415
Iron overload......Page 417
CONCLUSIONS......Page 418
References......Page 419
Design of POC devices......Page 421
Infectious disease (ID)......Page 424
References......Page 426
Alcohol analysis using breath analyzers: legal issues......Page 429
Technical aspect of breath alcohol measurement......Page 430
Issues with partition ratio......Page 432
Alcohol measurement in breath: cooperative versus noncooperative person......Page 433
Case report......Page 435
Interferences of volatiles in breath alcohol analysis......Page 436
J......Page 437
References......Page 438
C......Page 443
E......Page 446
F......Page 447
H......Page 448
I......Page 450
L......Page 451
M......Page 452
N......Page 453
P......Page 454
S......Page 456
T......Page 457
W......Page 459
Z......Page 460