Clinical BackgroundThyroid disease is common in the general population, and its prevalence increases with age. Because the signs and symptoms of the disease often resemble other disorders, before initiating treatment physicians need to determine whether the patient actually has thyroid disease or something else.

Wondfo Thyroid Function Tests are quantitative tests that check the levels of the hormones (triiodothyronine(T3) & thyroxine(T4)) made by human thyroid gland, and the thyroid stimulating hormone (TSH) made by the pituitary gland in the brain, which acts on the thyroid gland.

TSH is recognized as an exquisitely sensitive indicator of thyroid status. T3, T4 are used to confirm a thyroid disorder when this is suggested by an abnormal TSH result.

Thyroid Function Rapid Quantitative Test

Hypothalamus(TRH)

Pituitary (TSH)

Thyroid Gland(T3 & T4)

PeripheralTissues

T3 & T4

-

T4 T3

+

+

+

Hypothalamic-Pituitary-Thyroid Axis

T3, T4, TSH

● Simple-to-use

● Sensitive

● Reliable

● Accurate

● Rapid: get result in 15 minutes

● Stable: store at room temperature

● Long shelf life: 24 months

25 Tests

TM

25 Tests

TM

25 Tests

Content:

>25 × Test Cassettes

>1 × ID Chip

>1 × Instruction Manual

Lot No.:Mfg:Exp:Storage:

TM TSH (Thyroid - stimulating hormone)

Rapid Quantitative TestFor Finecare FIA System Use Only

TM

Qarad b.v.b.a.Cipalstraat 3, B-2440 Geel, Belgium

Cat. No.: W220

Highlights

Source of pathology

Hypothalamus/pituitary

Hypothalamus/pituitary

Hyperthyroidism

Hypothyroidism

Disease causing conditions

Benign tumor of the pituitary (adenoma) or thyroid hormone resistance

Secondary hypothyroidism or "central" hypothyroidism

Primary hyperthyroidism i.e. Graves' disease

Congenital hypothyroidism (cretinism), Primary hypothyroidism i.e. Hashimoto's thyroiditis

TSH level

High

Low

Low

High

T3 T4 level

High

Low

High

Low

Clinical Application

Clinical Significance

● Diagnose and monitor thyroid diseases

● Find the cause of an underactive thyroid gland

● Keep track of thyroid function in hyperthyroidism treatment

● Double-check the diagnosis of congenital hypothyroidism

Parameters

Fluorescence immunoassay

Whole blood/Serum/Plasma

75 μL for one test

15 minutes for one test

10 seconds for one test

Correlation Analysis

Correlation Analysis of T3 Correlation Analysis of T4 Correlation Analysis of TSH

y = 1.005x + 0.0527R² = 0.9627

0.00

2.00

4.00

6.00

8.00

10.00

12.00

0.00 2.00 4.00 6.00 8.00 10.00

Won

dfo

(nm

ol/L

)

Won

dfo

(nm

ol/L

)

Won

dfo

(mIU

/L)

Roche (nmol/L) Roche (nmol/L) Roche (mIU/L)

y = 0.93579x + 10.905R2 = 0.95025

n=331n=284

0

50

100

150

200

250

300

350

0 50 100 150 200 250 300 350

y = 0.9237x + 0.3626R² = 0.9827

n=545

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

90.00

100.00

0.00 20.00 40.00 60.00 80.00 100.00 120.00

Guangzhou Wondfo Biotech Co., Ltd.No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. ChinaTel: +86-20-32296083 Fax: +86-20-32296063E-mail: sales@wondfo.com.cn Websites: www.wondfo.com.cn

Items

Detection principle

Sample type

Sample capacity

Reaction time

Test time

Detection range

Normal range

T3 T4 TSH

0.61 - 9.2 nmol/L

1.3 - 3.1 nmol/L

12.87 - 300 nmol/L

66 - 181 nmol/L

0.1 - 100 mIU/L

0.3 - 4.2 mIU/L