Quantitative IVD Rapid Test Kits 

For NGAL 

Methodology                                                                                 

Fluorescence immunoassay

Product Name                                                                             

General Name:NGAL Test Kit(Immunofluorescence)

NGAL                                                                                               

The optimal marker for early diagnosis of acute kidney injury(AKI)

Independent risk index to evaluate the progression of chronic kidney disease(CKD)

NGAL Urine Specs                                                                     

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 NGAL content in 

human urine. The molecular weight of NGAL is approximately 25kDa, covalent bindings 

in neutrophil gelatinase. NGAL is a kind of growth factor which is mainly involved in 

occurrence and growth of early renal epithelium. It is low in epithelium of healthy tissue 

such as kidney, lung, stomach and colon. In the process of ischemic and toxicity of renal 

injury, NGAL in renal tubular epithelial cells will be significantly increased and in the first 

two hours, urine NGAL levels will be increased significantly. Therefore, the NGAL is a 

sensitive marker of early acute kidney injury. NGAL is also a kind of new potential maker 

reflecting chronic kidney damage. It is a powerful and independent risk indicators which 

can exactly reflect the level of kidney damage in chronic kidney disease patients.

Principle of the Procedure                                                     

The reagent is based on immunefluorescence sandwich assay to detect NGAL 

concentrations quantitatively. Using the pipette provided, drop diluted sample into the

sample well. During testing, specimen reacts with the particles coated with anti- NGAL 

monoclonal antibody I which has conjugated with fluorescent latex. The mixture migrates 

upward on the nitrocellulose membrane by capillary action to react with anti-NGAL 

monoclonal antibody II on the test line. The intensity of fluorescent antibody signal reflects 

the amount of captured NGAL. Immunefluorescence quantitative analyzer produced by 

our company can detect the concentration of NGAL in the sample.

Clinical significance                                                                  

1.Optimal indicator for early diagnosis of acute kidney injury.

2.Real-time risk stratification of acute kidney injury.

3.Treatment and detection of acute kidney injury and prognosis evaluation.

Applicable Instruments                                                           

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.

Specimen Collection and Preparation                               

1.The blood plasma specimen is suggested to use 1: 9 Na-Citrate blood collection 

    tube for collecting and the specimen is suggested to be tested within 4hours.

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

Test Method                                                                                  

Immunefluorescence techniques

Instruction for use 

1.Please read the manual and instrument operation carefully before using.

2.Check whether the equipment can operate regularly, and prepare other related                materials. 

3.Allow the test device, buffer and specimen balanced to room temperature 

(15-30℃) prior to testing. Minimizing exposure to damp air.

Test Procedure                                                                            

1.Open the Immune-fluorescence quantitative analyzer.

2.Check whether the batch number of IC card and reagent box is consistent, and 

    then insert IC card into the instrument to get the curve we wanted.

3.Remove the test device from the protective pouch and place it on a flat surface. 

   Draw in 30μl of blood plasma sample to the centrifugal tube, and dilute with 90μl 

   of diluents. After gently mix the sample, add 90ul of diluted sample into the sample 

    well. Place the test strip at room temperature for 10 minutes.

4.Insert the test card into the hole of immune-fluorescence quantitative analyzer, and 

    click start, the instrument will scan the test card automatically.

5.Immune-fluorescence quantitative analyzer detects results automatically and 

   calculates the content of D-Dimer in the sample.

6.Specimens, used strip and transfer pipettes may be potentially infectious. Proper 

    handling and disposal methods should be established by the laboratory direction 

    in accordance with local regulations.

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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. 

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