ISSN:
0884-3996
Keywords:
Luminescence immunoassay
;
thyrotropin
;
coated tube
;
monoclonal antibody
;
Chemistry
;
Biochemistry and Biotechnology
Source:
Wiley InterScience Backfile Collection 1832-2000
Topics:
Biology
,
Chemistry and Pharmacology
Notes:
A recently available chemiluminescence immunoassay (LIA-MAT) for TSH, set up by Byk-Sangtec Diagnostica, has been evaluated and compared with IRMA methods. The system LIA-MAT uses two monoclonal antibodies: one coated on tubes and the other labelled with isoluminol. To compute the within-assay precision profile, we estimated the response error relationship from all the duplicates (420) of eleven experiments. The CV of the response was 4-5% from the maximal response until 10,000 RLU (corresponding to about 1 μlU/ml); in the lower response range the CV worsened up to 8%. The sensitivity, derived from the precision profile, was 0.052 μlU/ml similar to that found in IRMA-MAT (0.044 μlU/ml); the working range extended from 0.33 to 100 μlU/ml. Results from LIA-MAT in the concentration range 1-30 μlU/ml were compared with the consensus mean produced by users of IRMA methods (IRMA-MAT, IRMA-Behring, Maiaclone Serono) participating in an inter-laboratory survey; a good correlation with IRMA techniques was found. The distribution of TSH determinations produced by LIA-MAT on 62 low concentration sample (〈0.3 μlU/ml) from patients unresponsive to TRH test, was found similar to that observed for the kit IRMA Boots-Celltech assumed as reference.
Additional Material:
5 Ill.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1002/bio.1170040127
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