rocalcitonin (PCT) Serum Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of procalcitonin（PCT) content in human serum. Procalcitonin(PCT) also known as the Pre calcitonin, is composed of 116 amino acids. Its molecular weight around 12.7kD. PCT is expressed by neuroendocrine cells (including C cells of the thyroid gland, lung and pancreas), and it is decomposed into thyrocalcitonin (immature), carboxyl terminal peptide and amino terminal peptide by enzyme decomposition. Only a small amount of PCT is contained in the blood of healthy people. PCT will be significantly increased after bacterial infection.

PCT is a specific marker of inflammatory disorder caused by bacterial infection and a significant indicator of SIRS and sepsis caused by bacterial infection, especially severe sepsis and septic shock. PCT plays an important role in identifying inflammatory disorder caused by infection and non-infection (such as autoimmune inflammation and acute rejection after transplantation). Meanwhile, PCT detection is of great significance in guiding the rational use of antibacterials, evaluating therapeutic effect and shortening the using time of antibacterials.

【Test principle】

The assay is a double-antibody sandwich immunoassay for quantitative determination of PCT 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 PCT monoclonal antibody Ⅰ on the conjugate pad. The complex spreads ahead along the nitrocellulose membrane captured by PCT monoclonal antibody Ⅱ on the test line. The more PCT the sample contains, the more complexes the test line accumulates. The intensity of fluorescent antibody signal reflects the amount of captured PCT. The immunofluorescence quantitative analyzer produced by our company can detect the concentration of PCT in the sample.

【Package】

25 Tests /Box

【Materials provided】

Contents

25        Cartridges

1                                Calibration Card

One cartridge contains:

PCT monoclonal antibody Ⅰ        200-400ng

PCT monoclonal antibody Ⅱ        800±80ng

Goat-anti-mouse IgG antibody       800±80ng

【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. If not, store the sample 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.

【Basic information】

Registrant / Manufacturing Enterprise/After-sale Company: Nanjing Norman Biological Technology Co., Ltd

Address: No.197 Pharmaceutical Valley Road, Jiangbei New Area, Nanjing, Jiangsu 210000, China.

Production address: No.197 Pharmaceutical Valley Road, Jiangbei New Area, Nanjing, Jiangsu 210000, China; 13th Floor, Building A, Phase 1, Sino-Danish Eco Life Science Industrial Park, No.3-1 Xinjinhu Road, Jiangbei New Area, Nanjing, Jiangsu 210000, China.

Tel: +86-25-58602219

Fax: +86-25-85670933

Website: https://www. normanbio.com

    https://normanbiological.en.alibaba.com

©2021 Nanjing Norman Biological Technology Co., Ltd

All rights Reserved.