The effects of modifying proficiency testing materials on thyroid function test results. A College of American Pathologists Ligand Assay Survey Study.
OBJECTIVE
To gain insight on the matrix effects, and possible clinical implications, resulting from diluting and concentrating proficiency testing survey material used for the measurement of thyroid function tests.


METHODS
To the standard set of five proficiency survey samples, three supplementary "Wildcard" samples were added. These additional samples were manufactured by overfilling and underfilling vials prior to lyophilization so as to vary the thyroxine-binding protein concentrations. Survey participants measured thyroxine, free thyroxine, and the triiodothyronine uptake and related tests on the Wildcard samples. In addition, free thyroxine indices were calculated.


METHODS
The first mailing of the 1995 College of American Pathologists (CAP) Ligand Assay--Series 1 Survey.


METHODS
Results obtained from the regular set of survey samples and the Wildcard set were compared to values expected by the laws of conservation of matter and mass action.


METHODS
The approximately 2000 participants of the first mailing of the 1995 CAP Ligand Assay--Series 1 Survey.


RESULTS
Numerous assays systems did not give the predicted results, including all of the single-step radioimmunoassays for free thyroxine and over three quarters of free thyroxine index determinations.


CONCLUSIONS
Varying the dilution of proficiency survey material produced results that were not predicted by the laws of conservation of matter and of mass action. Although these observations may have been the result of matrix effects, one cannot rule out the possibility that certain thyroid assays may not work in clinical situations having abnormal thyroxine-binding protein concentrations.
Steele
B W
BW
Department of Pathology, University of Miami (Fla) School of Medicine 33136, USA.
Witte
D L
DL
Whitley
R J
RJ
Klee
G G
GG
Chan
D W
DW
D003625:Data Collection; D005612:Freeze Drying; D006801:Humans; D008954:Models, Biological; D011786:Quality Control; D011863:Radioimmunoassay; D011869:Radioligand Assay; D012015:Reference Standards; D013960:Thyroid Function Tests / Q000379:methods / Q000592:standards*; D013961:Thyroid Gland / Q000502:physiology; D013974:Thyroxine / Q000032:analysis; D013975:Thyroxine-Binding Proteins / Q000032:analysis; D014284:Triiodothyronine / Q000032:analysis
D013975:Thyroxine-Binding Proteins; D014284:Triiodothyronine; D013974:Thyroxine