5.

Method Evaluation
a. t test – compares the ______ of two groups of data or the __________ of two methods
b. F test – compares the ______ of two groups of data or the __________ of two procedures
c. Linear regression: Independent variable/reference method _________________
Dependent variable/new method _________________
d. Diagnostic Efficiency
1) Diagnostic sensitivity – ability of a test to detect a given disease or condition
2) Diagnostic specificity – ability of a test to detect the absence of a given disease or condition
3) Positive predictive value – probability that a positive test indicates disease
4) Negative predictive value – probability that a negative test indicates absence of disease
Result Disease No Disease Total
Positive TP FP TP + FP PPV (%) = _____________
Negative FN TN TN + FN NPV (%) = _____________
Total TP + FN TN + FP TP + FP + FN + TN
% Sensitivity = ______________ % Specificity = _____________
5) Analytical sensitivity – ability of a method to detect the smallest concentration of an analyte
6) Analytical specificity – ability of a method to detect only the analyte of interest
F. QUALITY MANAGEMENT
 Overall process that encompasses quality assurance, benchmarking, and other aspects that provide for
quality improvement as a means to meet set standards
1. QUALITY ASSURANCE (QA)
a. 3 Phases of QA
1) Pre-analytical – includes test requisition, patient preparation, patient identification, specimen
collection, labeling, specimen transport, handling, and processing
2) Analytical – include reagents, preventive maintenance of equipment, calibration, analysis of
samples, and quality control
3) Post-analytical – include verification of calculations and reference ranges, flagging and notification
of panic/critical values, delta checks, reporting of results
*Delta checks – an algorithm in which a current laboratory result is compared with results obtained
on a previous specimen from the same patient
b. Quality Control
1) Accuracy – closeness of the result to the true or actual value
2) Precision – ability to produce a series of results that agree closely with each other, commonly
expressed in terms of coefficient of variation; also called reproducibility
3) Internal/Intralaboratory QC
 Involves the analysis of at least __ levels of control every _______
 Important for the daily monitoring of accuracy and precision of analytical methods
4) External/Inter-laboratory QC
 Involves testing samples of unknown concentrations of analytes sent periodically by regulatory
agencies to participating laboratories
 SDI > 2.0 is considered significant
c. Analytical Variation
1) Types of Error in Laboratory Testing
a. Random Error
 Present in all measurements due to chance or an unpredictable cause
 Mislabelling, pipetting error, improper mixing of sample and reagent, temperature fluctuation
b. Systematic Error
 Influences observations consistently in one direction
 Deterioration of reagents, unstable reagent blanks, calibration error, changes in the standard
concentration, contaminated control solutions, failing instrumentation
2) Patterns in QC Charts That Indicate Errors
a. Shift – formed by control values that distribute themselves on one side or either side of the mean
for __ consecutive days; usually indicates ________________________________
b. Trend – formed by control values that continue to increase or decrease over a period of __
consecutive days passing through the mean; usually indicates ___________________
c. Outliers – highly deviating control values caused by random or systematic errors