The NGAL Test for Acute Kidney Injury
The NGAL Test is a CE-marked diagnostic tool designed to aid in the early detection of Acute Kidney Injury (AKI). By measuring NGAL levels, clinicians can identify potential kidney damage hours or even days before changes in serum creatinine are detectable.
Product Name | The NGAL Test Reagent Kit |
|---|---|
| Kit Contents | 1 ready-to-use NGAL Buffer Solution (R1), 35 mL; 1 ready-to-use Immunoparticle suspension (R2), 7 mL; Instructions for Use |
| Test Method | Particle-enhanced turbidimetric immunoassay (PETIA) for use on automated clinical chemistry analyzers |
| Sample Type | Human urine, EDTA plasma, and heparin plasma |
| Sample Stability | 1 day at room temperature (20-25ªC); 3 days at 2-8ºC; 1 year frozen at -70ºC or below, stable for 3 freeze/thaw cycles |
| Number of Tests per Kit | Approximately 100 determinants (Varies by analyzer.) |
| Sample Analysis Time | Approximately 10 minutes (Varies by analyzer.) |
| Shelf Life | 24 months from manufacturing. See expiry date on the label. |
| Regulatory Status | CE Marked and available for in vitro diagnostic use in the European Union; registered in Canada, Israel and Korea; available for Research Use Only in the United States. |
| Reference | Description | Packaging |
| ST001CA | NGAL reagent set | R1 35mL ; R2 7mL |
| ST002CA | NGAL calibrator set | 5x 1mL |
| ST003CA | NGAL control set | 3x 1mL (low) ; 3x 1mL (high) |
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Clinical Utility
Why NGAL Matters
NGAL is a small protein expressed by renal tubular cells in response to cellular stress and injury. Unlike serum creatinine, which reflects changes in kidney function after damage has already occurred, NGAL serves as a marker of structural kidney injury.
Because NGAL is released rapidly following tubular damage, it provides a “troponin-like” signal for the kidneys, offering insight into injury processes before measurable loss of function becomes apparent. This distinction supports earlier risk identification and complements traditional functional markers in clinical assessment.
Clinical Challenge
Acute Kidney Injury Requires Earlier Insight
Acute Kidney Injury (AKI) is a sudden decline in kidney function that may develop within hours in critically ill, surgical, or vulnerable patient populations. Clinical recognition is often delayed because conventional indicators such as serum creatinine rise only after significant functional impairment has occurred.
This diagnostic delay limits opportunities for early intervention. Earlier biomarker-based insight can help identify patients at risk of AKI sooner, supporting more timely monitoring, clinical evaluation, and management decisions before irreversible damage develops.
Biomarker Insight
NGAL as an Early Indicator of Kidney Stress
Neutrophil gelatinase-associated lipocalin (NGAL) is released rapidly into blood and urine following renal tubular injury. NGAL concentrations may rise within hours of injury, whereas serum creatinine often changes much later and may be influenced by non-renal factors.
By reflecting tubular stress and injury rather than delayed functional decline, NGAL provides early biochemical insight into kidney health. This enables laboratories and clinicians to identify evolving kidney injury at an earlier stage and use NGAL as a complementary biomarker alongside standard clinical parameters.
NGAL in Clinical Practice
How NGAL Biomarker Enhances AKI Assessment
Early AKI Risk Insight
NGAL levels rise within hours of kidney injury
Adds Damage Insight
NGAL reflects tubular injury rather than just loss of function, improving risk stratification
Supports Clinical Decision-Making
NGAL results can guide management like fluid balance and nephrotoxin avoidance earlier in care.
Pediatric AKI - FDA Cleared
NGAL for AKI Risk Assessment in Pediatric Patients
Acute kidney injury in pediatric patients is often difficult to detect early due to non-specific clinical signs and limitations of traditional functional markers. NGAL has been widely studied as an early biomarker of kidney injury in children, where timely risk assessment may support improved clinical management.
In the United States, a pediatric NGAL assay variant is FDA-cleared for use in patients from 3 months to 21 years, reflecting the established clinical relevance of NGAL in pediatric AKI risk assessment.