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Elecsys® T3

Electro-chemiluminescence immunoassay (ECLIA)


for the in vitro quantitative determination
of total triiodothyronine in serum and plasma
Indication
The determination of T3 is utilized in the diagnosis of T3-hyperthyroidism, the detection of early stages of hyperthyroidism and for
diagnosis of thyrotoxicosis factitia.

Test principle: two-step competitive assay with analyte liberation


Streptavidin microparticle

Ru Biotinylated T3
ANS

fT3 in the sample Ru 9 min 9 min Ru Measurement


Ru

Protein-bound T3 Ru
in the sample Ru

Ruthenylated polyconal Ru
antibody against T3

1st incubation (9 minutes)


30 μL of the patient sample including free T3 (fT3) and protein-bound T3 are incubated with a T3-specific antibody labeled
with a ruthenium complex and ANS (­ 8-anilino-1-naphthalene sulfonic acid) that liberates protein-bound T3.

2nd incubation (9 minutes)


After addition of streptavidin-coated microparticles and biotinylated T3, the free binding sites of the labeled antibody
become occupied, with formation of an antibody-hapten complex. The entire complex becomes bound to the solid phase via
interaction of biotin and streptavidin.

Measurement
The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the
­surface of the electrode. Unbound substances are then removed. Application of a voltage to the electrode then induces
chemiluminescent emission which is measured by a photomultiplier.
Elecsys technology
ECL (ElectroChemiLuminescence) is Roche’s technology for immunoassay detection. Based on this technology and combined
with well-designed, specific and sensitive immunoassays, Elecsys delivers reliable results. The development of ECL immunoas-
says is based on the use of a ruthenium-complex and tripropylamine (TPA). The chemiluminescence reaction for the detection
of the reaction complex is initiated by applying a voltage to the sample solution resulting in a precisely controlled reaction.
ECL technology can accommodate many immunoassay principles while providing superior performance.

Elecsys® T3 test characteristics


Testing time 18 min
Test principle Two-step competitive assay with analyte liberation
Calibration 2 point
Sample material Serum
Li-, Na-, NH4+-heparin plasma
K3-EDTA, Na-citrate, NaF, K-oxalate plasma
Sample volume 30 μL
Detection limit 0.30 nmol/L
Measuring range 0.30 - 10 nmol/L
Traceability Gravimetry
Total imprecision (NCCLS) cobas e 411 analyzer, E2010: 4.1 - 5.4 %
cobas e 601 / e 602 modules, E170: 3.4 - 4.5 %
Expected values* 1.3 - 3.1 nmol/L (95th percentile)
* For detailed information about reference intervals in children, adolescents and pregnant women, refer to the brochure “Reference Intervals for
Children and Adults”, Cat. No. English: 04640292, German: 04625889. Each laboratory should investigate the transferability of the expected
values to its own patient population and if necessary determine its own reference ranges.

Typical T3 findings
Low T3 Normal T3 High T3
Primary hypothyroidism Compensated struma Primary hyperthyroidism
Central hypothyroidism Compensated adenoma Central hyperthyroidism
Euthyroidism with low binding proteins Subclinical hyperthyroidism Receptor insufficiencies
Thyrotoxicosis factitia Subclinical hypothyroidism Euthyroidism with high binding proteins
Isolated T3 hyperthyroidism

Order information
Elecsys® T3 200 tests 11731360
T3 CalSet 4 x 1 mL 11731548
PreciControl Universal 2 x 3 mL each 11731416

COBAS, COBAS E, LIFE NEEDS ANSWERS and ELECSYS


are trademarks of Roche.

©2011 Roche

Roche Diagnostics Ltd.


CH-6343 Rotkreuz
Switzerland
www.cobas.com

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