Reference Range

The simplest performance parameter to define is usually the reference range of the test. The reference range of a test is the range of values found in individuals who do not have the disease or condition that is being assayed by the test. Verification of the reference range is usually accomplished by assaying specimens from healthy donors to show that they produce a negative result. Given that it is much easier to find healthy individuals than those afflicted with a specific disease, the verification of this parameter is quite easy. Terms that might be used to define the reference range result are "not detected", "wild type," or "negative." For quantitative assays, the reference range will be reported as below a particular quantitative measurement (i.e., "less than 400 copies/mL"). For analytical tests (such as human leukocyte antigen [HLA] typing or HCV genotyping), each patient specimen being tested should possess the analyte being assayed. The testing laboratory could determine that the reference range is not applicable to the results of these types of assay.

Table 1

Assay Verification Requirements

Regulatory agency or organization

CLIA CAP

Table 1

Assay Verification Requirements

Regulatory agency or organization

CLIA CAP

Assay type/clearance

FDA-cleared tests

All non-FDA cleared tests

All tests

Requirements for verification

Reportable range

Reportable range

Reportable range

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