Comparative evaluation of two methods to assay thyroglobulin serum concentrations in patients with differentiated thyroid carcinomas.
OBJECTIVE
This study was aimed at the comparative assessment of the analytical and clinical performances of 2 tests for thyroglobulin (Tg) assays: the Dynotest Tg-Plus immunoradiometric assay (IRMA), a new method that might be of interest for its claimed superior sensitivity compared to other methods, and the HTGK-2 IRMA, one of the test currently used in clinical routine.


METHODS
The study was performed in serum samples from 157 patients with differentiated thyroid carcinoma (DTC). The clinical sensitivity of the test was evaluated in patients with and without thyroid stimulating hormone (TSH) suppression.


RESULTS
The lowest detectable Tg concentration values and the within-assay coefficient of variation (CV) were 0.4 and 0.8 microg/L and 5% and 3% for the Dynotest Tg-Plus assay and the HTGK-2 assay, respectively; the between-assay CV was 6% for both assays. The clinical results of the Dynotest Tg-Plus and those of the HTGK-2 kit were similar in both DTC patient populations, either under or off the TSH suppressive treatment. In spite of the manufacturer's statement that the calibrators of both assays had been standardized against the same common reference (standard CRM 457 of the Community Bureau of References), the Dynotest Tg-Plus test underrated by a factor of 0.5 the Tg values measured by means of HTGK-2 IRMA.


CONCLUSIONS
The sensitivity of the Dynotest Tg-Plus IRMA appears to be similar to that of the HTGK-2 assay.
Ferrari
L
L
Nuclear Medicine Division, Radioisotope Laboratory, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
Seregni
E
E
Aliberti
G
G
Martinetti
A
A
Pallotti
F
F
Villano
C
C
Lucignani
G
G
Bombardieri
E
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D005260:Female; D006801:Humans; D015592:Immunoradiometric Assay / Q000295:instrumentation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D044967:Serum / Q000737:chemistry*; D013954:Thyroglobulin / Q000097:blood*; D013964:Thyroid Neoplasms / Q000097:blood* / Q000175:diagnosis*
D011933:Reagent Kits, Diagnostic; D013954:Thyroglobulin