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Hipro™ Anti-CCP Test

(Nephelometry Immunoassay method)

[Product Name]

General name:Anti-Cyclic Peptide Containing Citrulline Antibody Test Kit

(Nephelometry immunoassay Method)

Trade Name: Anti-CCP test

[Intended Use]

This product is used to determine the content of Anti-Cyclic Peptide Containing Citrulline Anti-body (Anti-CCP) in human serum.

[Principle]

The antigen of Anti-Cyclic Peptide Containing Citrulline is coated on the latex surface. The Anti-CCP in the sample and the antigen become to immune complexes by Latex agglutination reaction. The immune complexes will produce the phenomenon of light scattering which is proportional to the intensity of scattered light and samples of Anti-CCP levels. Using specific protein analyzer to measure the intensity of scattered light, the concentration of Anti-CCP is determined by comparing the turbidity of samples to the standard concentration.

[Packing of the Kits]

[Main Components]

[Storage and Validity Period]

Store at: 2~8℃

Validity Period: 1 year

[Suitable Machine]

This product is suitable for HP-083/4-I, HP-083/4-II, HP-AFS nephelometry immunoassay analyzers.

[Sample Requirements]

Fasting blood collection and separation of serum as soon as possible; avoid hemolysis; store at 2~4℃ for 3 days.

[Testing Procedure]

[Reference Range]

Normal reference range: <45U/mL l.

Recommended that each laboratory establish its own reference range

[Limitations of the Method]

1. This product is based on latex agglutination system, only suitable for the specific analyzer.

2. This result is for clinical reference only; comprehensive consideration should be combined with the clinical management of patients with symptoms / signs, medical history, other laboratory tests and treatment response.

3. When hemoglobin>5g/L, triglyceride>5mmol/L, or bilirubin>97μmol/L, it has interference to this determination

[Technical Parameter]

Linearity range: 5U/mL~100U/mL

Accuracy: recovery rate 90%-110%

Limit of detection: 5U/mL

Within-batch Precision: ≤10%

Batch-batch Difference: ≤15%

[Precautions]

1,This kit is only for IVD.

2,If the regent is splashed on the skin or eyes, wash with water.

3,Do not use the kits beyond shelf life. Do not mix different batches of reagents.

[References]

The ministry of health department of the People's Republic of China. The National      Clinical Test Procedures (3rd edition) [M]. Nanjing: southeast university press, 2006.

Manufacturer: Shijiazhuang Hipro Biotechnology Co.,ltd

Address:No.3 Building,Block C,Fangyi Tech. Park, No. 313Zhujiangdadao Street,Shijiazhuang,050035  China

Tel: 86-0311-83855889

Fax: 86-0311-83859087

EU Representative:

Name: Lotus Global Co., Ltd

Address: 15 Alexandra Road, London, NW8 0DP, UK

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