The NGAL Test (BioPorto) is intended to be used for detecting acute kidney injury. It got its CE mark in January 2011. Current NICE guidance (NICE clinical guideline 169) recommends using serum creatinine or urine output to detect acute kidney injury. Estimated glomerular filtration (eGFR) may also be used for children and young people. The NGAL Test has been compared with serum creatinine and eGFR testing in clinical studies.
There is limited clinical evidence and statistical information from 3 published observational studies involving a total of 46 patients. The evidence is inconclusive on whether the clinical utility of The NGAL Test is at least equivalent to current diagnostic methods (that is, monitoring of serum creatinine, blood urea nitrogen and urine output).
No publicly available reports were found on how using The NGAL Test would affect resource use. One study assessed the cost effectiveness of a different urinary neutrophil gelatinase-associated lipocalin (NGAL) biomarker for diagnosing acute kidney injury after cardiac surgery in patients in the UK compared with current diagnostic methods. The NGAL strategy was more cost effective than current practice in the base case and sensitivity analysis. Both urine and plasma samples can be used with The NGAL Test, so this evidence is of uncertain value because it only looked at urinary NGAL. There is no research comparing the use of urine and plasma samples, but which is better probably depends on the clinical setting and population. For example, many patients with acute kidney injury stop passing urine, so a plasma sample may then be preferred.