Multicenter evaluation of a fully mechanized soluble transferrin receptor assay on the Hitachi and cobas integra analyzers. the determination of reference ranges.
Soluble transferrin receptor (sTfR) is reported to be a reliable marker for the diagnosis of iron deficiency, especially when iron metabolism is influenced by inflammatory disorders such as infection, chronic inflammation and cancer-related anemia. In the present multicenter study the analytical performance of a recently introduced, latex-enhanced immunoturbidimetric assay for the determination of soluble transferrin receptor (Tina quant [a] sTfR, Roche Diagnostics) on different fully mechanized analyzers such as Hitachi 917 and 911, and Cobas Integra 400 and 700 was evaluated. Within-run and between-run imprecision showed good results (CV<5% and <7%, respectively). The assay was found to be linear over a wide measuring range (0.4-35 mg/l). Endogenous substances did not interfere with the test results. Comparison of serum sTfR concentrations with those of heparinized plasma revealed good correlation (r>0.976). Method comparison with an existing fully mechanized method as well as with ELISA tests for sTfR showed very good correlation (r>0.987). Because of the lack of international standardization the results differed from each other up to 2.5-fold. The 95% of serum levels in healthy individuals ranged from 1.9 to 4.4 mg/l (n=427). However, the reference ranges should be reported in a sex-dependent manner, as 2.2-5.0 mg/l for men (n=211) and as 1.9-4.4 mg/l for premenopausal (n=216) and postmenopausal (n=45) women. The Tina quant [a] sTfR assay enables the precise, accurate, rapid and convenient determination of sTfR concentrations for routine clinical chemistry purposes.
Institut für Klinische Chemie und Laboratoriumsdiagnostik, Universitätsklinikum Düsseldorf, Germany. susanne.kolbe-busch@uni-duesseldorf.de
Susanne
S
Kolbe-Busch
Johannes
J
Lotz
Gerd
G
Hafner
Norbert J C
NJ
Blanckaert
Georg
G
Claeys
Giovanni
G
Togni
Jürgen
J
Carlsen
Ralf
R
Röddiger
Lothar
L
Thomas
D000293:Adolescent; D000328:Adult; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000175:diagnosis; D005260:Female; D006403:Hematologic Tests; D006801:Humans; D007841:Latex Fixation Tests / Q000379:methods / Q000592:standards; D008297:Male; D008875:Middle Aged; D009391:Nephelometry and Turbidimetry / Q000379:methods* / Q000592:standards; D011990:Receptors, Transferrin / Q000097:blood*; D012016:Reference Values; D015203:Reproducibility of Results; D012737:Sex Factors; D012995:Solubility
D011990:Receptors, Transferrin