Диагностический реагент CRP

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Характеристики

  Package Insert

Hipro™ CRP Test

 (Nephelometry immunoassay Method)

[Product Name]

General name:C-reactive proteinTest Kit

(Rate Scattering Turbidimetric Method)

Trade Name: CRP test

[Intended Use]

This product is used to determine the content of C-reactive proteinTest Kit(CRP) in human serum.

[Principle]

The antibody of C-reactive protein Test Kit is coated on the latex surface. The CRP in the sample and the antibody 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 CRP levels. Using specific protein analyzer to measure the intensity of scattered light, the concentration of CRP 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]

Whole Blood; store for 48 hours under 2-8℃.

[Testing Procedure]

[Reference Range]

Diagnosis of Infection and inflammation for adults, the reference value: CRP<10mg/L

Without inflammation, the risk of cardiovascular disease: CRP<1.0 mg/L.

For newborn and children, the reference value is 95% of adults:

Newborn (Age 0-3 weeks): 0.1-4.1 mg/L

Children (Age 2 months- 15 years): 0.1-2.8 mg/L

It is important testing the concentration of CRP in the acute phase of the disease, 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 bilirubin≤684μmol/L,triglyceride≤15mmol/L it has no interference to this determination

[Technical Parameter]

Linearity range: 0.5mg/L~200mg/L,r≥0.990

Accuracy: recovery rate±10%

Limit of detection: 0.3mg/L

Within-batch Precision: ≤8%

Batch-batch Difference: ≤10%

[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]

Shang Hong, Wang Liu three, Shen Ziyu and so on. National Clinical Laboratory Practice (Fourth Edition) [M] Beijing: People's Medical Publishing House,2015:412-413.

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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