ANALYTICAL METHOD SELECTION, COMPARISON, AND EVALUATION IN THE

CONTEXT OF A MEDICAL LABORATORY, WITH APPROPRIATE EXAMPLES

AND INCLUDING STATISTICAL MEASURES THAT MUST BE PERFORMED
1.0 INTRODUCTION
Clinical laboratories are constantly changing to meet customers' needs, operate on a financially
sound basis, successfully pass proficiency programs and comply with the mandates of regulatory
agencies. Several aspects of meeting customers' needs from a laboratorys perspective are
producing information which is accurate, precise and available in a timely manner. Laboratory
information which is both accurate and precise Elements of the law cover: allows members of
health care delivery team to make the best possible decisions concerning the care and treatment
of the patient.
Federal and state governmental bodies as well as accreditation organizations now require clinical
laboratories to demonstrate and document the performance of the assays in use and to evaluate
all non-exempt new assays being introduced in the laboratory. The Clinical Laboratory
Improvement Act of 1988 (CLIA 88) published testing performance standards for individual
analytes.
If a new test is being considered for introduction by the laboratory, a need assessment should be
done to determine the expected number of analyses which will be performed daily by the
laboratory and when, during the day, specimens will be received and what the expected
turnaround time is for the test. The information gathered from the need assessment is essential in
equipment and method selection as well as cost analysis.
After a needs assessment has defined the expected workload and turn around time, the laboratory
administration should establish a working group to carry out the method selection, evaluation,
comparison, user training and implementation. The group should make an objective search of
vendors who supply equipment and/or reagents and quality control materials for the new test.
The process of implementing a new test requires a considerable amount of time, energy and cost,
hence the administration must be prepared to make an investment in the project. Depending on
the regulations which govern clinical testing in a particular state and the test complexity, the

laboratory will be required to establish the performance characteristics of the assay and may be
required to successfully pass one or more rounds of proficiency testing prior to patient testing.
After acquiring the equipment, associated reagents and supplies, the working group should
become familiar with the use, calibration of the assay and any special procedures (ex. dilutions)
or data reduction required.

2.0 SELECTION
2.1 METHOD SELECTION (Medical Need and Quality Goals)
Optimal method selection involves consideration of medical need, analytical performance, and
practical criteria. The selection of appropriate methods for clinical laboratory assays is a vital
part of rendering optimal patient care, and advances in patient care are frequently based on the
use of new or improved laboratory tests. With established analytes, a common scenario is the
replacement of an older, labor-intensive method with a new, automated assay that is more
economical in daily use.

2.2 ANALYTICAL PERFORMANCE CRITERIA

The following factors are of utmost importance in evaluating the characteristics of a method:
1. precision
2. accuracy
3. analytical range
4. detection limit
5. analytical specificity

Various instrumental parameters require evaluation are needed when a new clinical analyzer is
included in the overall evaluation process which are as follows:
1. pipetting
2. specimen-to-specimen carryover
3. reagent lot-to-lot variation

4. detector imprecision
5. time to first reportable result
6. onboard reagent
7. stability
8. overall throughput
9. mean time between instrument failures
10. mean time to repair

2.3 OTHER CRITERIA

Contrary to new methods which require in house development, commercial kit methods are
ready for implementation in the laboratory, often in a closed analytical system on a dedicated
instrument.
When potential methods are studied, the following should be considered:
1. Detailed protocol for performing the test
2. Stability of reagents and reference materials
3. Technologist time and required skills
4. Type, quantity, and disposal of waste generated
5. Specimen requirements (type of anticoagulants, transportation, collection conditions)
6. Cost-effectiveness
7. Availability of technical support, supplies, and service