Intended use

Thyroid Stimulating Hormone (TSH) Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of thyrotropin（TSH ) content in human serum. TSH is a glycoprotein consisting of an α-subunit, which is common among the members of the glycoprotein hormone family and a hormone specific β-subunit.It is one of the hormones secreted by the anterior pituitary, and its main function is to control and regulate the activity of the thyroid gland. The determination of thyroid stimulating hormone in serum (plasma) is one of the important indexes to diagnose and treat hyperthyroidism and hypothyroidism and to study the hypothalamic-pituitary-thyroid axis. In the treatment of hyperthyroidism and hypothyroidism, the TSH can be used as a judgment index of the curative effect. It can also be used to observe the reserve function of the pituitary TSH . TSH detection is the primary screening test to identify the thyroid function. A slight change in the free thyroid concentration results in a significant adjustment of the TSH concentration to the reverse direction.

Test principle

The assay is a double-antibody sandwich immunoassay for quantitative determination of TSH concentration based on immunofluorescence technology. Add the sample to the sample well of the cartridge. Through chromatography, the sample reacts with the fluorescent latex particles coated with TSH monoclonal antibody I on the conjugate pad. The complex spreads ahead along the nitrocellulose membrane captured by TSH monoclonal antibody Ⅱ on the test line. The more TSH the sample contains, the more complexes the test line accumulates. The intensity of fluorescent antibody signal reflects the amount of captured TSH. The immunofluorescence quantitative analyzer produced by our company can detect the concentration of TSH in the sample.

Package

25 Tests /Box

Materials provided

Contents

25     Cartridges

1       Calibration Card

25     Disposable Tips

Accessories required but not provided

Immunofluorescence quantitative analyzer（NRM-FI-1000）

Reagent strip incubator

TSH Control

Storage and stability

Sealed: The kit must be stored at 10-30℃, valid for 18 months.

Opened: The cartridge must be used within 1 hour once its foil pouch is opened.

Warnings and precautions

For in vitro diagnostic use.

The package insert must be carefully followed. Reliability of the test results cannot be guaranteed if there are any deviations from the package insert.

Safety precautions

CAUTION: This product requires the handling of human samples. It is recommended that all human sourced materials are considered potentially infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 211 or other appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents.

Appropriate protective measures should be taken in the collection, processing, storage, mixing of the sample and testing process; once the sample and the reagent contact skin, wash with plenty of water; if skin irritation or rash occurs, get medical advice/attention.

Samples, used cartridge and disposable tips may be potentially infectious. Proper handling and disposal methods should be established by the laboratory in accordance with local regulations.

Handling precautions

Do not use the kit beyond the expiration date. The production date and expiration date are on the label.

Different batches of reagents, calibration cards and cartridges cannot be mixed.

The cartridge is disposable and cannot be reused.

Please do not use obviously damaged kit or cartridge.

Do not insert the cartridge wetted by other liquids into the analyzer, in order not to damage and pollute the instrument.

Please avoid high temperature in the lab.

The calibration card and immunofluorescence quantitative analyzer should keep away from vibratile and electromagnetic environment when used. Slight vibration of the instrument is normal. Do not pull out the cartridge during testing.

To avoid contamination, wear clean gloves when operating with reagent kits and samples.

For a detailed discussion of handling precautions during system operation, refer to the NORMAN service information.

Specimen collection and preparation

The serum must be collected by standard tubes or pro-coagulation tube filled inside with separation gel. The sample is advised to be tested immediately. Serum should be stored at 2-8℃; If testing is delayed more than 24 hours, then store the sample at -20℃ or below

Heat inactivated and hemolysis samples should be abandoned. If there is precipitation in the serum, centrifugation must be done before testing.

The samples must reach room temperature (10-30℃) before the test. The cryopreserved sample can only be used after complete melting, rewarming and mixing. Avoid repeating freezing and thawing samples.

Procedure

Preparation

Installation of the immunofluorescence quantitative analyzer（NRM-FI-1000）and incubator

Please read the operator’s manual of the immunofluorescence quantitative analyzer (NRM-FI-1000) and reagent strip incubator carefully before use.

Calibration Card installation

Each box contains a lot-specific Calibration Card to correct for lot-to-lot deviation.

Turn on the power switch, according to the system self-test prompt, waiting for the instrument to display the main interface.

Press “Assay Management”.

Insert the Calibration Card into the card slot following the direction of the arrow, then press “Read". Confirm the lot number of the Calibration Card with the reagent relevant information, then press "Ok".

Press “Return” to the main interface.

Cartridge

Cartridge needs to reach room temperature before opened.

Test procedure

Remove the cartridge (after reaching room temperature), draw in 90μL of the sample to the well and incubate it for 15 minutes in the reagent strip incubator.After incubation insert the cartridge into the immunofluorescence quantitative analyzer (NRM-FI-1000) using the cartridge arrows as a guide, and click start, then the instrument will scan the cartridge automatically.

Caution

Please check the direction of the cartridge before insertion and assure the insertion is correct.

Dilution

If a sample with TSH higher than the limit of the kit of 100 mIU/L and a definitive result is required, the sample should be manually diluted with normal saline and then re-assayed according to the test procedure. The maximum valid dilution ratio is 2 times, the detection limit is 200 mIU/L.