NGAL in the ED

• Research type

  Research Study

• Full title

  Utility of blood Neutrophil gelatinase-associated lipocalin (NGAL) in the early diagnosis of acute kidney injury in the Emergency Department, incorporating a method evaluation for the Siemens ADVIA 2400® chemistry analyser

• IRAS ID

  136287

• Contact name

  Patrick Nee

• Contact email

  patrick.nee@sthk.nhs.uk

• Sponsor organisation

  St Helens & Knowsley Teaching Hospitals NHS Trust

• Research summary

  The main aim of the study is to determine the diagnostic utility of a single quantitative blood measurement of Neutrophil Gelatinase-associated Lipocalin (NGAL) in the diagnosis Acute Kidney Injury (AKI) in patients admitted to hospital from the emergency department.

  The secondary objective is to investigate the differences, if any, in NGAL values obtained from Serum gel blood samples and EDTA plasma samples.

  Data collected and statistical analysis may show trends within the studied patient groups may enhance published knowledge on topics such as:

  • Is NGAL able to indicate AKI earlier than established routine tests?
  • Can NGAL be used to identify patients who are at higher risk from Contrast Induced nephropathy?
  • Can a single NGAL measurement on admission be indicative of acute kidney injury
  The laboratory objective is to certify that the Siemens ADVIA® 2400 laboratory analyser that is used in this study can test NGAL with a high level of accuracy and precision and therefore produce reliable results for NGAL in fitting with MHRA and CPA guidelines for quality. The NGAL Test™ is manufactured by BioPorto® Diagnostics. It is CE marked and has been validated for use by Alpha Laboratories Ltd. and Siemens Diagnostics®. Preliminary in house evaluation studies are necessary before any patient data is collected for the study.

  Urea is an important test when distinguishing between transient and persistent AKI. A greater increase in blood Urea than in Creatinine may indicate that the patient has insipid/transient AKI. In grossly Haemolysed samples, urea results are invalidated. Previous renal function may be unknown and urine is unlikely to be available for analysis
  Blood NGAL concentration could complement the diagnosis as the test is unaffected by haemolysis This will be looked at in the laboratory method evaluation.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  13/NW/0737

• Date of REC Opinion

  20 Nov 2013

• REC opinion

  Favourable Opinion