1. Intended use Immunoassay for the in vitro quantitative determination of total
triiodothyronine in human serum.
2. Summary
Triiodothyronine (T3) is the hormone principally responsible for
the development of the effects of the thyroid hormones on the
various target organs. T3 (3,5,3’-triiodothyronine) is mainly
formed extrathyroidally, particularly in the liver, by enzymatic
5’-deiodination of T4.
Accordingly, the T3 concentration in serum is more a reflection of
the functional state of the peripheral tissue than the secretory
performance of the thyroid gland.A reduction in the conversion of
T4 to T3 results in a decrease in the T3 concentration.
It occurs under the influence of medicaments such as propanolol,
glucocorticoids or amiodarone and in severe non-thyroidal illness,
and is referred to as “low T3 syndrome”. As with T4, over 99 % of
T3 is bound to transport proteins.
However, the affinity of T3 to them is around 10-fold lower.(1, 2,
3, 4)The determination of T3 is utilized in the diagnosis of
T3-hyperthyroidism, the detection of early stages of
hyperthyroidism and for indicating a diagnosis of thyrotoxicosis
factitia.(5, 6, 7)The T3 assay employs a competitive test principle
with polyclonal antibodies specifically directed against T3.
Endogenous T3, released by the action of 8-anilino-1-naphthalene
sulfonic acid (ANS).
2. Reagents Materials provided • Coated Microplate, 8 x 12 strips, 96 wells, pre-coated with T3
derivant. • Calibrators, 6 vials, 1 ml each, ready to use; Concentrations:
0(A), 0.5(B), 1(C), 2(D), 4(E) and 8(F) ng/ml. • Enzyme Conjugate, 1 vial, 6.0 mL of HRP (horseradish peroxidase)
labeled sheep monoclonal Anti-T3 in Tris-NaCl buffer containing BSA
(bovine serum albumin). Contains 0.2% ProClin300 preservative. ANS
1mg/mL. • Substrate, 1 vial, 11ml, ready to use, (tetramethylbenzidine)
TMB. • Stop Solution, 1 vial, 6.0 ml of 1 mol/l sulfuric acid. • Wash Solution Concentrate, 1 vial, 25 ml (40X concentrated),
PBS-Tween wash solution. • IFU, 1 copy. • Plate Lid: 1 piece.
Materials required (but not provided) • Microplate reader with 450nm and 620nm wavelength absorbent
capability.= • Microplate washer. • Incubator. • Plate shaker. • Micropipettes and multichannel micropipettes delivering 50μl with
a precision of better than 1.5%. • Absorbent paper. • Distilled water
Company Profile
Biovantion Inc is independent from international department of
Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro
diagnostic reagents manufacturer engaged in the research,
development, production, and focus on clinical testing for
infectious diseases, such as Hepatitis virus, Noro virus, Parvo
virus test kits, our products include rapid test cassette and Elisa
kits.
All our products have been registered in National Medical Products
Administration of China, in year 2020 we get Certificate of ISO
13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from
SGS. More importantly, we have awarded the registration certificate
from National Medical Products Administration for Diagnostic Kit
for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during
the outbreak in China, and also we developed COVID-19 Antigen test
; Neutralizing Antibody Test, these products selling well all
overthe world