What is NGAL

1. The optimal marker for early diagnosis of acute kidney injury (AKI);
2. Independent risk index to evaluate the progression of chronic kidney disease (CKD);

Intended Use 

The test kit is primarily for the in-vitro qualitative determination of NGAL content in human urine. 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 indicator which can exactly reflect the level of kidney damage in chronic kidney disease patients.

Principle of the Procedure 
The reagent is based on one-step lateral flow immunoassay to detect NGAL concentrations qualitatively. 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.

Clinical significance

1. This kit is 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 30ºC, 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.

Test Method
Immunochromatographic Method 

PERFORMANCE CHARACTERISTICS/FEATURES

• Specimen: Urine.
• Accuracy: > 99 %.
• High Sensitivity: 20 ng/mL
• Certification: Declaration of conformity according to the directive 98/79/EC.
• Format: Strip, cassette, midstream
• Wide linear range: 20-300ng/mL
• Small sample size: Urine 2-3 drops

MATERIALS PROVIDED

• One Step NGAL Rapid Test Kit, individually packed.
• Package insert.
• Disposable pipette.

       


MATERIALS REQUIRED BUT NOT PROVIDED

• Specimen collection container.
• Timer.

 HOW TO USE

1. Bring tests, specimens to room temperature (15-30 °C) before use.
2. Remove the test from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.
3. Place the test device on a clean and level surface.
4. Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 μl) to the specimen well (S) of the device and start the timer.
5. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
6. Read the result at 5 minutes.

STORAGE

Original packaging should be stored in the 4-30 ºC, a cool, dark, dry place,  frozen is avoid.
The period of validity: 24 months .

OUR SERVICES

8-24 hours online services
OEM,ODM and Customized is available
Quickly delivery time
Quickly and professional service after sales

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