KI Screening Test (5Pk. Product Code: 800087-5)

Neutrophil Gelatinase Associated Lipocalin (NGAL), a protein synthesised by many tissues, is freely filtered by the glomeruli and reabsorbed by renal tubules. Tubular damage results in increased NGAL in the urine due to reduced reabsorption of the filtered NGAL from the plasma and an increased release of NGAL from damaged proximal and distal tubules.

CLINICAL
When used in the setting of a clinical trial on dogs, the device showed that a urinary NGAL concentration of 20 ng/mL was the cutoff capable of distinguishing the presence of AKI, with a sensitivity of 97.6%. The device was therefore found to be a clinically relevant diagnostic tool for identifying the risk of AKI in the clinical setting.

ANALYTICAL
The test was evaluated on 180 urine samples from different clinical settings of urinary tract disease by comparing it with the gold standard (ELISA, BioPorto Diagnostics inc).
The analytical performance, understood as the ability of the device to detect the presence of NGAL above the Limit of Detection (LoD), measured were as follows:

Specificity  98.15%

Sensitivity  99.21%

Accuracy    98.9%

TEST KIT COMPONENTS

X1 Test Cassette
X1 Vial with dropper containing the diluent
X1 Pipette for urine sampling
X1 Comparative card
X1 Instructions For Use (IFU)

TEST PROCEDURE

1. Collect the urine sample;
   2. Deposit the collected sample into the vial, previously opened, and mix the solution;
   3. Add the obtained liquid into the sample well (S) indicated on the cassette and wait 10 minutes;
   4. Read the result by comparing the lines obtained with the card provided.

INTERPRETING THE RESULTS

NGAL < 4 ng/mL: no kidney damage.

NGAL ~4 ng/mL: low risk of acute kidney injury.

NGAL ~20 ng/mL: intermediate risk of acute kidney injury. Consider the possible presence of CKD (Chronic Kidney Damage) or UTI (Urinary Tract Infections) in differential diagnostics.

NGAL > 90 ng/mL: high risk of acute kidney injury or chronic kidney damage.

ADDITIONAL INFORMATION

1. CLICK HERE FOR PRODUCT PRESENTATION

2. CLICK HERE FOR PRODUCT FLYER

3. CLICK HERE FOR INSTRUCTIONS FOR USE (IFU)

4. CLICK HERE FOR CLINICAL STUDY

4. CLICK HERE FOR CLINICAL VALIDATION:  SENSITIVITY, SPECIFICITY & ACCURACY