Medical Rapid Diagnostic Test Kits For hs-CRP+CRP 

Methodology                                                                                 

Fluorescence Immunoassay

Product Name                                                                              

General Name:hs-CRP+CRP Test Kit(Fluorescence Immunoassay)

Package                                                                                           

Test card: Aluminum foil pouch 1pc/bag, desiccant

Package size: 25pcs/box

Product show                                                                               

hs-CRP +CRP whole blood/plasma specs                         

Intended use                                                                                

The test kit is primarily for the in vitro quantitative determination of hs-CRP and CRP 

content in human blood plasma and human whole blood. CRP is a kind of acute phase

reaction protein. Its concentration is low among the health body, while rises sharply 

when the body infection and tissue damage. CRP is the marker of inflammation and 

tissue damage. Its rising degree is related to the degree of infection and inflammation. 

Therefore, it can be used for detecting the routine inflammation and cardiovascular 

inflammation, providing the diagnosis, treatment and monitoring information of 

inflammatory disease.

Applicable Instruments                                                           

The test has to be performed on the series of immunofluorescent analyzer NRM-FI-1000

from Nanjing Norman Biological Technology Co. Ltd.

Main components                                                                      

1.Test kit contains: 25 test cards and an IC card.The test card is composed of plastic shell 

and test strip.The main components of test strip: Sample pad, Whole blood pad, bonding 

pad, nitrocellulose membrane, absorbent paper, PVC base plate. 

2.Diluents (400μl×25 / 10ml×1 bottle): composed of phosphate, surface active agent, 

etc. PH=7.4±0.2.

Materials required (but not provided):

1.Timer

2.Centrifuge tube

3.Pipette

4.Disposable tips

Storage And Stability                                                                

The reagent box must be stored from 4 to 30℃, and the period of validity is 12 months. 

The reagent strip must be used within 1 hour once its foil pouch has been opened. Do not

use the strip beyond the expiration date printed on the outside of the box.

Package                                                                                           

Test card: Aluminum foil pouch 1pc/bag, desiccant.

Package size: 25pcs/box.

Storage And Stability                                                                

1.The reagent box must be stored from 4 to 30℃, and the period of validity is 12 months. 

2.The reagent strip must be used within 1 hour once its foil pouch has been opened. 

3.Do not use the strip beyond the expiration date printed on the outside of the box. 

Advantage                                                                                      

1.Strong anti-interference ability.

2.Sample types: whole blood or plasma.

3.Small sample size: 10ul.

4.Wide testing range:0.5-200mg/l.

5.High sensitivity.

6.Good reproducibility.

7.Single sample test or batch test.

Cliniacal significance                                                                

1.Whole process CRP detection contains: ultra sensitivity C- reactive protein  (hs-CRP) and

    conventional CRP.

2.Normal reference value: hs-CRP<1.0mg/l, CRP<1.0mg/l.

3.Identification and diagnosis of bacterial and viral infections.

4.Determination of the inflammation degree.

5.Detection of postoperative infection and complications.

6.Risk prediction of cardiovascular disease.

7.Assist to manage the use of antibiotics and efficacy evaluation.

Clinical Background                                                                  

Mildly elevated CRP levels have been linked to increased risk for various cardiovascular-

related disorders, including coronary heart disease (CHD), peripheral artery disease (PAD), 

incident stroke, congestive heart failure, sudden cardiac death, atrial fibrillation, and 

diabetes.

1.The predictive value of hs-CRP for cardiovascular events is independent of other 

established risk factors, including LDL-cholesterol.

2.Mildly elevated hs-CRP levels also predict recurrent CHD events and poor prognosis in 

some patients, including those who have PAD or who have had a stroke or acute coronary 

syndrome (ACS).

3.Furthermore, in ACS patients receiving statin therapy, measurement of hs-CRP levels 

can improve the prediction of death or acute coronary events.

Quality Control                                                                            

Using immunefluorescence quantitative analyzer and relevant X detection kit (immune-

fluorescence techniques) to test quality control product, repeat 10 times, calculate average

and CV. If CV≤15%, the average in the scale of quality control product, then the instrument 

and reagent performance can meet requirements.

Applicable department                                                            

emergency,ICU, respiration, obstetrics and gynecology, gastroenterology pediatrics, 

orthopedics, urgical, ncology, hematology etc.

Related kits                                                                                   

About us                                                                                         

Nanjing Norman Biological Technology Co., Ltd is dedicated to R&D and manufacturing of 

automated chemiluminescence system. Founded in 2008, Norman biological has been

upholding the idea that R&D shapes future ,and concentration determines success. Ever 

since the beginning,Norman has been focusing on developing and manufacturing

chemiluminescence and immunofluorescence  reagents.

Agent wanted                                                                               

If you are interested in working with us, please feel free to contact.

Why us                                                                                            

Manufacturer and Exporter for nearly 10 years with self R&D Research Center;

Professional After-Sale service with On-site support worldwide; 

CE/ISO13485 Certifications

OEM and ODM are available !