Total long-term within-laboratory precision of cortisol, ferritin, thyroxine, free thyroxine, and thyroid-stimulating hormone assays based on a College of American Pathologists fresh frozen serum study: do available methods meet medical needs for precision?
BACKGROUND
It is important that the total long-term precision of laboratory methods meet the medical needs of the patients being served.


OBJECTIVE
To determine the long-term within- and between-laboratory variation of cortisol, ferritin, thyroxine, free thyroxine, and thyroid-stimulating hormone measurements using commonly available methods and to determine if these variations are within accepted medical needs.


METHODS
Two vials of pooled frozen serum were mailed 6 months apart to laboratories participating in 2 separate College of American Pathologists surveys. The data from those laboratories that analyzed an analyte in both surveys were used to determine for each method the total variance and the within- and between-laboratory components.


METHODS
The study included the A mailing of the 2003 College of American Pathologists Ligand Survey and the C mailing of the Chemistry Survey.


METHODS
For each analyte, total variance was partitioned into within- and between-laboratory components for each analytic method. The within-laboratory variations were then compared with imprecision criteria based on biological variation.


METHODS
The laboratories that reported results on the same analyte using the same method in both surveys.


RESULTS
For each analyte, the median of the long-term within-laboratory variances of each peer group was 78% to 95% of its total-survey variance, and the median long-term within-laboratory coefficients of variation varied from 5.1% to 7.6%. The number of methods that met within-laboratory imprecision goals based on biological criteria were 5 of 5 for cortisol; 5 of 7 for ferritin; 0 of 7 for thyroxine and free thyroxine; and 8 of 8 for thyroid-stimulating hormone.


CONCLUSIONS
For all analytes tested, the total within-laboratory component of variance was the major source of variability in this study. In addition, there are several methods, especially for thyroxine and free thyroxine, that may not meet analytic goals in terms of their imprecision.
Steele
Bernard W
BW
Department of Pathology, University of Miami School of Medicine, Miami, Fla, USA. bsteele@med.miami.edu
Wang
Edward
E
Palmer-Toy
Darryl E
DE
Killeen
Anthony A
AA
Elin
Ronald J
RJ
Klee
George G
GG
D019411:Clinical Laboratory Techniques / Q000592:standards* / Q000706:statistics & numerical data; D003625:Data Collection / Q000592:standards / Q000706:statistics & numerical data; D005293:Ferritins / Q000097:blood*; D006801:Humans; D006854:Hydrocortisone / Q000097:blood*; D015588:Observer Variation; D010338:Pathology, Clinical / Q000592:standards*; D010949:Plasma / Q000737:chemistry*; D013972:Thyrotropin / Q000097:blood*; D013974:Thyroxine / Q000097:blood*; D013995:Time; D014481:United States
D013972:Thyrotropin; D005293:Ferritins; D013974:Thyroxine; D006854:Hydrocortisone