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Thyroid Stimulating Hormone (TSH)

The Quantitative Determination of Thyrotropin Concentration in Human Serum by a Chemiluminescence Immunoassay

Summary and explanation of the test

Measurement of the serum concentration of thyrotropin (TSH), a glycoprotein with a molecular weight of 28,000 D and secreted from the anterior pituitary, is generally regarded as the most sensitive indicator available for the diagnosis of primary and secondary (pituitary) hypothyroidism (1, 2). The advent of immunoenzymometric assays has provided the laboratory with sufficient sensitivity to enable the differentiating of hyperthyroidism from euthyroid population and extending the usefulness of TSH measurements. The anti-TSH antibody is coated in the microplate. Another anti-TSH antibody is congugated with HRP as label. The calibrators or serums are added in the wells. After incubating with label, the wells are washed, and then the substrate is added. The RLU is going up with TSH concentration increasing.

Materials provided for 96-well microplate

1.	Microplate	1 piece	96 test/piece
2.	Calibrators	6 tubes	0.5 mL/tube
Concentrate:0, 0.15, 0.6, 2.5, 10, 40mIU/L
3.	Label	1 bottle	12 mL/bottle
4.	Substrate A Substrate B	1 bottle 1 bottle	6 mL/bottle 6 mL/bottle
Before using, the substrates A and B are mixed by equal volume in practicality requisite amount.
5.	Washing buffer	1 bottle	20 mL/bottle
Before using, being diluted to 600ml with distilled water
6.	Instruction book	1 piece	1 piece/kit

Keeping in 2~8degree Celsius, is 12 months.

Specimen collection and preparation

The specimens shall be blood serum in type and the usual precautions in the collection of venipuncture samples should be observed. For accurate comparison to established normal values, a fasting morning serum sample should be obtained. The blood should be collected in a plain red-top venipuncture tube with or without gel barrier. Allow the blood to clot. Centrifuge the specimen to separate the serum from the cells. Samples may be refrigerated at 2~8degree Celsius for a maximum period of five days. If the specimen can not be assayed within this time, the sample may be stored at temperatures of -20degree Celsius for up to 30 days. Avoid repetitive freezing and thawing.

Test procedure

The kit is in room temperature for more than 15mins, then

Unit:μL

Microplate           Blank well          Standards well         Samples well

Calibrators                —                   50                     — Specimens                —                   —                     50 Label                     —                  100                    100

Swirl the microplate gently for 2mins to mix and cover, incubate 45 mins at 37degree Celsius. After washing for 5 times, the substrates are added.

Substrate A                50                   50                    50 Substrate B                50                   50                    50

Or we also can mix the substrates in a bottle before using, and then pipette 100μL to each wells.

Swirl and detect

Detect        After substrates being pipetted, suggest detecting in 1-3 mins by luminometer, one second per well.

The data of concentrate and RLU is fitted in linear by log(X)-log(Y).

Expected values for the TSH (in mIU/L)

Low normal range 0.34

High normal range 5.0

Performance characteristics

A: Precision

With assay precision is less than 10%, between assay precision is less than 15%.

B: Accuracy

Between 90%-110%

C: Sensitivity

Less than 0.05mIU/L

Manufacturing enterprise: Beijing Savant Biotechnology Co., Ltd.

Registration: Beijing Drug Administration(prospective) 2400110, the first word in 2009

Thyroid Stimulating Hormone (TSH)