Quantitative IVD Rapid Test Kits For Cys-C

                 Quantitative IVD Rapid Test Kits 

                                          For Cys-C

Methodology                                                                                 

Fluorescence Immunoassay

Cys-C                                                                                                

 One of optimal indicator to reflect the impaired glomerular filtration function .

Optimal endogenous indicator for GFR evaluation.

Metabolic Characteristics

Constant production rate. not affected by age, sex and nutritional status.

Freely pass through glomerular filtration, no secretion from tubular.

Completely absorbed in proximal tubule.

Completely degraded after being absorbed, no longer enter the loop

Product Name                                                                              

General Name:Cys-C Test Kit(Immunofluorescence)

Package                                                                                           

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

Package size: 25pcs/box

Intended use                                                                                

The test kit is primarily for the in vitro quantitative determination of Cys-C content in 

human blood serum. Cys-C is a kind of good endogenous marker which reflects the 

changes of GFR. The change of Cys-C concentration is not affected by inflammation, 

infection, tumor and liver function. It doesn't relate to gender, muscle mass, diet, body

surface area. Cys-C is used in the assessment of Diabetic nephropathy filtration function 

early renal injury, the early diagnosis of Hypertensive renal damage, the assessment of the

recovery of renal function renal transplant patients, the monitoring of the change of renal

patients with hemodialysis, the assessment of old people's renal function, the diagnosis of 

children's renal diseases, the monitoring of renal function in tumor chemotherapy 

and so on.

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, bonding pad, nitrocellulose membrane, 

Anti-MIgG, 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

Advantage                                                                                      

High sensitivity:0.2mg/l

High accuracy: 99% correlation with LEAMAN

Wide linear range:0.2-10mg/l

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.

Specimen Collection and Preparation                               

1.The whole blood specimen is suggested to use EDTA as anticoagulant, and the specimen 

    is suggested to be tested within 4hours.

2.Precipitation is not allowed existing in under test blood plasma. If there is precipitation, 

    must do centrifugal process first. Heat inactivated sample and hemolysis sample should  

    be abandoned.

3.The specimens must be returned to room temperature before testing.

Quality Control                                                                           

Using immunefluorescence quantitative analyzer and relevant Cys-C 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.

Clinical Significance                                                                  

As the indicator of renal injury, Cys-C is better than creatinine, urea nitrogen, etc. 

Sensitivity of Cys-C in serum detecting diabetic and nephropathy is better than micro

proteinuria and relevant indicators. Cys-C can distinguish glomerulus and renal tubular 

disease, it is the optimal indicator of early diabetic and hypertensive nephropathy.

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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 instruments and reagents.

Norman's manufacture center is located in the Yuhua District and owns an over 2,000m2 

GMP-approved clean workshop. The R&D base, which is over 2,000m2 , is located in state-

level new Jiangbei district. Now there are over 100 R&D engineers, 40% of which hold a 

PhD or master's degree.

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