Kidney Injury Test Being Developed for Clinical Chemistry Analyzers

A biomarker for early diagnosis and prognostic stratification of acute kidney injury will soon be available for clinical chemistry analyzers.

Called neutrophil gelatinase-associated lipocalin (NGAL) the biomarker is a small protein expressed in neutrophils and certain epithelia, including the renal tubules. Renal expression of NGAL is dramatically increased in kidney injury, and NGAL is released into both urine and plasma. NGAL levels rise within 2 hours of the insult, making NGAL an early and sensitive biomarker of kidney injury. It responds earlier than all other renal status markers, showing a proportionate response to injury, leading to early diagnosis and prognostic stratification.

Existing methods of determining kidney damage, e.g., the commonly used measurement of serum creatinine, only indicates renal failure resulting from a prior kidney injury at a relatively late stage (24-72 hours) after the injury has occurred, making it worthless for early diagnosis.

Up until now only enzyme-linked immunosorbant assay (ELISA)-based NGAL assays have been commercially available and the lack of a more suitable assay platform has been impeding the translation of this promising biomarker from research into routine diagnostics.

BioPorto Diagnostics (Gentofte, Denmark) will expand its NGAL portfolio with the launch of the turbidimetric NGAL test. The test is designed for routine diagnostic use on a wide range of automated clinical chemistry analyzers that are already running in central laboratories in hospitals all over the world. The test combines high diagnostic performance with fast turnaround time and therefore addresses the acute aspect of NGAL evaluation. The test works with both urine and blood samples.

BioPorto develops and markets antibodies and antibody-based products, including tests to diagnose human disease, both for the benefit of individual patients and to promote efficiency in the health sector.

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