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Test method 

Specified technical procedure for detection of an analyte

(synonymous with assay).

Screening

Tests of high diagnostic sensitivity suitable for large‐scale 

application.  

Confirmation

Test methods of high diagnostic specificity that are used to 

confirm results, usually positive results, derived from other 

test methods.

Collaborative Study Validation

Validation study carried out at multiple sites using the same 

method and equipment on common samples.  Primarily used 

to determine reproducibility (inter‐laboratory variability).