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The first rapid test for semi-quantitative detection of NGAL in urine for early screening of kidney damage in dogs
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.
read moreThe role of NGAL as an early marker of Acute Kidney Injury (AKI), Chronic Kidney Disease (CKD) and Urinary
Tract Infection (UTI) has been the subject of recent studies in dogs, which confirm its clinical utility and prognostic role in enabling rapid therapeutic intervention.
KI SCREENING TEST is a lateral flow immunochromatographic device, for professional use, for semi-quantitative detection of NGAL in dog urine samples. It can be used by veterinary professionals in order to early detect the presence of kidney injuries in dogs in just 10 minutes.
read moreBy comparing the intensity of the test line (T) with the colour chart provided, the concentration of NGAL in the urine can be semi-quantitatively detected, which is directly proportional to the severity of kidney damage and indicative of potential clinical settings.
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% |
*The number of test contents and accessories may vary depending on the commercial reference purchased:
test cassette
vial with dropper containing the diluent
pipette for urine sampling
comparative card
instructions for use
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.
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.
1. Davis J, Raisis AL, Miller DW, Hosgood GL, Rossi G. Analytical validation and reference intervals for a commercial multiplex assay to measure five novel biomarkers for acute kidney injury in canine urine. Res Vet Sci. 2021 Oct;139:78-86.
2. Lee YJ, Hu YY, Lin YS, Chang CT, Lin FY, Wong ML, Kuo-Hsuan H, Hsu WL. Urine neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute canine kidney injury. BMC Vet Res. 2012 Dec 28;8:248.
3. Nabity M, Hokamp J. Urinary Biomarkers of Kidney Disease in Dogs and Cats. Vet Clin North Am Small Anim Pract. 2023 Jan;53(1):53-71. doi: 10.1016/j.cvsm.2022.07.006. Epub 2022 Oct 19. PMID: 36270837.
4. Steinbach S, Weis J, Schweighauser A, Francey T, Neiger R. Plasma and urine neutrophil gelatinase-associated lipocalin (NGAL) in dogs with acute kidney injury or chronic kidney disease. J Vet Intern Med. 2014 Mar-Apr;28(2):264-9. doi: 10.1111/jvim.12282.
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