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.
Product Show
Package & Delivery
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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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