Contemporary Practice in Clinical Chemistry.
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| Other Authors: | |
| Format: | eBook |
| Language: | English |
| Published: |
San Diego :
Elsevier Science & Technology,
2020.
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| Edition: | 4th ed. |
| Subjects: | |
| Online Access: | View fulltext via EzAccess |
Table of Contents:
- Front Cover
- Contemporary Practice in Clinical Chemistry
- Copyright Page
- Contents
- List of contributors
- Preface
- 1 Preanalytical variation
- Order entry
- Patient preparation
- Specimen collection
- Tube type and order of draw
- Needle size, tourniquet use, and line collection
- Processing and transportation
- Detecting preanalytical errors
- Summary
- References
- Self-assessment questions
- Answers
- 2 Statistical methods in laboratory medicine
- Introduction
- Basic descriptive statistical analysis
- Central tendency and dispersion
- Mean
- Median
- Standard deviation, interquartile range, and quantiles
- Quantiles and the interquartile range
- Is my data normally distributed?
- Make a histogram
- Prepare a normal QQ plot
- Calculate the skewness and kurtosis
- Statistical tests for normality
- The Shapiro-Wilk test
- The Shapiro-Francia test
- The Lilliefors test
- The Anderson-Darling test
- Detecting outliers
- The Grubbs test
- Dixon test
- Tukey's fences
- Chauvenet's criterion
- Common inferential statistics
- The two-sample t-test
- Examples
- The paired t-test
- Wilcoxon rank-sum test (Mann-Whitney U-test)
- Wilcoxon signed-rank test
- The chi-square test
- Application to proportions
- General application to contingency tables
- Methods of regression
- Ordinary least squares
- Weighted ordinary least squares
- Deming regression
- Passing-Bablok regression
- Evaluation of diagnostic test performance
- Sensitivity
- Specificity
- Positive predictive value
- Negative predictive value
- Likelihood ratios
- Example calculation
- Receiver operating characteristic curves
- Interpreting a receiver operating characteristic curve
- Preparing a receiver operating characteristic curve
- Suggested additional topics for study
- References
- Self-assessment questions
- Answers.
- 3 Reference intervals: theory and practice
- Introduction
- Concept of reference intervals and importance to laboratory medicine
- Reference intervals versus clinical decision limits
- Current gaps and recent initiatives in reference interval establishment
- Methodological approaches to establishment of reference intervals
- Population-based reference intervals
- Selection of reference individuals
- Direct versus indirect sampling
- A priori versus a posteriori sampling
- Preanalytical and analytical variables
- Outlier exclusion
- Partitioning and minimum sample size
- Statistical determination of reference intervals
- Nonparametric analysis
- Robust analysis
- Parametric analysis
- Covariates that affect reference interval determination
- Age-dependent reference curves
- Pediatric and geriatric reference intervals: challenges and recent advances
- Pediatric reference intervals
- Geriatric reference intervals
- Reference interval transference and verification
- Methodological approach to transference
- Limitations of the transference method
- Transference initiatives
- Verification of transferred reference intervals
- Toward reference interval harmonization
- Limitations of population-based reference intervals
- Concluding remarks
- References
- Self-assessment questions
- Answers
- 4 Method validation
- Introduction
- Regulations
- Analytical goals and method selection
- Helpful tips and tools prior to performing validation
- Method validation basics
- Precision and accuracy
- Reportable range
- Method comparison
- Validation of laboratory developed tests
- Carryover validation
- Stability validation
- Selectivity/specificity and interference validation
- Matrix effects validation
- Recovery validation
- Sensitivity validation
- Dilution validation
- Reference standards.
- The role of the medical laboratory director
- References
- Self-assessment questions
- Answers
- 5 Quality control
- Introduction
- Implementing statistical process control
- Selection of quality control materials
- Limitations of quality control materials
- Frequency to assay quality control samples
- Establishing quality control target values and acceptance ranges that represent a stable measurement operating condition
- Establishing acceptance criteria to evaluate quality control results
- Corrective action when a quality control result indicates a measurement problem
- Verifying quality control evaluation parameters following a reagent lot change
- Verifying method performance following use of a new lot of calibrator
- Calibration issues in quality control
- Development of a quality control plan based on risk management
- Reviewing the quality control plan
- Using patient data in quality control procedures
- Delta check with a previous result for a patient
- Verify consistency between more than one instrument or method
- Using patient data for statistical process control
- Proficiency testing
- Noncommutability of proficiency testing/external quality assessment materials and peer group grading
- Reporting proficiency testing/external quality assessment results when one method is adjusted to agree with another method
- Interpretation of proficiency testing/external quality assessment results
- Accuracy-based proficiency testing/external quality assessment programs
- References
- Further reading
- Self-assessment questions
- Answers
- 6 Laboratory calculations
- Analytical calculations
- Dimensional analysis
- Centrifugation
- Concentration
- Dilutions
- Equilibrium calculations and pH
- Buffer calculations
- Ionic strength
- Photometry calculations
- Electrophoresis
- Electrochemistry
- Enzyme kinetics.
- Chromatography
- Clinical calculations
- Electrolytes
- Osmolality and osmolal gap
- Renal function calculations
- Iron calculations
- Lipid calculations
- Statistics
- Mean
- Median
- Standard deviation
- Coefficient of variation
- Variance
- Standard error of the mean
- Method evaluation
- Accuracy: regression analysis of method comparison data
- Accuracy: recovery studies
- Precision: repeatability and within-lab precision studies
- Total error
- Detection limits
- Clinical performance of laboratory tests: predictive value theory
- Laboratory management
- Budget justification
- Full-time equivalent
- Cost per reportable result
- Capital equipment justification
- References
- 7 Spectrophotometry
- Principles of light absorption and emission
- Principles of spectrophotometric measurement
- Configuration of spectrophotometers
- Critical operating parameters: accuracy
- Bandpass
- Stray light
- Wavelength accuracy
- Absorbance accuracy
- Chromogen limitations
- Calibration of spectrophotometric measurements
- Molar absorptivity
- Calibration relationship
- Critical operating parameters: precision
- Interferences
- Bichromatic and polychromatic measurements
- Other applications of spectrophotometric or light emission measurements
- Cooximetry
- Reflectance spectrophotometry
- Densitometry
- Turbidimetry and nephelometry
- Atomic absorption
- Atomic emission
- Fluorescence
- Fluorescence lifetime
- Fluorescence polarization (depolarization)
- Chemiluminescence
- References
- Suggested reading
- Self-assessment questions
- Answers
- 8 Chromatography and electrophoresis
- Introduction to chromatography
- General terms and concepts
- Theory of chromatography
- Evaluating and optimizing chromatographic separations
- Gas chromatography
- General terms and concepts.
- Gas chromatography mobile phases and elution methods
- Gas chromatography supports and stationary phases
- Gas chromatography detectors
- Methods for sample injection and pretreatment in gas chromatography
- Liquid chromatography
- General terms and concepts
- Liquid chromatography mobile phases and elution methods
- Types of liquid chromatography
- Adsorption chromatography
- Partition chromatography
- Ion-exchange chromatography
- Size-exclusion chromatography
- Affinity chromatography
- Liquid chromatography detectors
- Introduction to electrophoresis
- General terms and concepts
- Theory of electrophoresis
- Gel electrophoresis
- General terms and concepts
- Supports and sample application in gel electrophoresis
- Detection in gel electrophoresis
- Special types of gel electrophoresis
- Capillary electrophoresis
- General terms and concepts
- Supports and sample application in capillary electrophoresis
- Detection in capillary electrophoresis
- Special types of capillary electrophoresis
- References
- Self-assessment questions
- Answers
- 9 Electrochemistry
- Introduction
- Potentiometric methods in clinical chemistry
- Redox electrodes
- Ion-selective electrodes
- Glass membrane electrodes
- Polymer membrane electrodes
- Gas-sensing electrodes
- Ion-selective electrodes-units of measure and reporting for clinical application
- Amperometric methods in clinical chemistry
- Conductometric methods in clinical chemistry
- Coulometric methods in clinical chemistry
- Interferences for potentiometric and amperometric sensors
- Biosensors based on electrochemical methods
- Enzyme-based biosensors with amperometric and potentiometric detection
- Affinity biosensors with electrochemical detection
- References
- Self-assessment questions
- Answers
- 10 Mass spectrometry
- Basic mass spectrometry concepts.
- Sample introduction.