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VIDAS® NEPHROCHECK®  
[TIMP-2 • IGFBP-7]

Know Sooner. Intervene Earlier. Avoid AKI.

VIDAS NEPHROCHECK identifies kidney stress before damage occurs, aiding in the risk assessment for moderate to severe acute kidney injury (AKI).1

 

 


What is Acute Kidney Injury?

AKI, previously referred to as acute renal failure (ARF), is an abrupt decrease in kidney function. It is a syndrome that is defined by a rapid increase in serum creatinine, decrease in urine output, or both. According to KDIGO (Kidney Disease: Improving Global Outcomes), there are 3 stages of AKI.2


Acute Kidney Injury Stages2

Note: Up to 50% of kidney function may be lost before any changes occur in SCr or UO.3,4

 

Stage 1

Stage 2

Stage 3

Serum Creatinine (sCr)

Increase to ≥ 1.5 times baseline

or

Increase by ≥ 0.3 mg/dl (≥ 26.5 μmol/l)

2.0–2.9 baseline

 

 

3.0 baseline, or increase to ≥ 4.0 mg/dl (≥ 353.6 μmol/l) within 48 hours; or initiation of renal replacement therapy

Urine output (UO)

<0.5 ml/kg/h for 6 hours

<0.5 ml/kg/h for ≥ 12 hours

<0.3 ml/kg/h for ≥ 24 hours


Causes and Clinical Impact of AKI

AKI is common among critically ill and post-cardiac-surgery patients, with many causes that include sepsis, nephrotoxic drugs, and circulatory shock.2,5-6

Here are some figures that summarize the clinical impact of AKI:

  • Sepsis alone accounts for ~50% of AKI cases.7
  • Up to 50% of critically ill patients develop AKI during hospitalization.8
  • Hospital stay lengthens by 1–3 days.9
  • Cardiac surgery patients with AKI are ~2-7x more likely to develop chronic kidney disease (CKD) at one year.10

Early identification enables timely protective measures and may prevent kidney failure.


VIDAS NEPHROCHECK

VIDAS NEPHROCHECK is a risk assessment that provides early insight into kidney stress before kidney damage occurs, supporting clinicians in ruling out AKI risk or initiating protective interventions.1 It runs on the VIDAS 3 immunoassay testing system.

The intended use of VIDAS NEPHROCHECK is in conjunction with clinical evaluation. It should be used in patients (21 years of age or older) who currently have or have had within the past 24 hours acute cardiovascular and/or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. 

VIDAS® NEPHROCHECK® Kit Contents

TIMP-2 and IGFBP-7

The assay detects TIMP-2 and IGFBP-7, two biomarkers associated with cell-cycle arrest, which indicates renal tubular stress.1 This allows for prompt intervention and prevention of AKI. 


The Benefits of VIDAS NEPHROCHECK

Early Indicator

 

Elevates as early as four hours after ICU admission,12 which is days faster than SCr.

Specific to AKI

 

TIMP-2 and IGFBP-7 biomarkers rise only with AKI and are unaffected by common comorbidities, such as sepsis.11

High Sensitivity

 

VIDAS NEPHROCHECK identifies up to 89.9% of patients who will develop AKI.13


How to Interpret VIDAS NEPHROCHECK Results

The concentration from each protein is converted into a single numerical result called the AKIRISK™ Score, which has an easy-to-interpret single cutoff. 

VIDAS NEPHROCHECK Result

What it Means*

Negative AKIRISK Score ≤ 0.30

Patient is at lower risk of developing moderate to severe AKI within 12 hours of assessment

Positive AKIRISK Score > 0.30

Patient is at increased risk of developing moderate to severe AKI within 12 hours of assessment

*Should not be used as a standalone test. Test results must be evaluated with other clinical laboratory test information. Refer to the VIDAS NEPHROCHECK Instructions for Use for full interpretation information. 


Clinical Evidence for VIDAS NEPHROCHECK

There are numerous studies demonstrating that care guided by VIDAS NEPHROCHECK significantly reduces moderate-to-severe (Stage 2–3) AKI after cardiac surgery compared with routine post-operative care.14-16 For summaries of these studies, download the Acute Kidney Injury Literature Compendium below. 

Technical Details 

Number of tests per kit

60

Sample type / prep

Urine sample – centrifuge 10 min at 1000 × g, +2 to +25 °C

Contents of kit

60 ready-to-use strips + 60 SPR devices, C1 Liquid Control (1.2 mL), S1 Liquid Calibrator (1.6 mL)

Processing time

~46 minutes

Throughput

Up to 12 tests per run

Sample stability (urine supernatant)

5 hr room temp / 24 hr refrigerated / 6 mo frozen (2 freeze–thaw cycles)

Quality control

Can be run day-of-use concurrently with patient tests

Calibration

Each new lot or every 56 days

LIS connection

Bidirectional

System footprint

24″ L × 29.5″ W × 25.2″ H

vidas-3-instrument

The VIDAS® 3 Immunoassay Analyzer

VIDAS 3 is the new-generation VIDAS analyzer that is designed with your lab’s specific needs and workflow in mind. It is equipped with increased automation, traceability and connectivity for greater productivity. VIDAS 3 helps you provide precise and accountable test results for the benefit of clinicians and their patients:17

  • Reliable and easy-to-use instruments with random access and small footprint. 
  • Well adapted to rapid response laboratories.
  • Factory-calibrated, Single-dose tests which reduce the need for additional controls.
  • Short time to result.

Helpful Resources

REFERENCES:
  1. Kashani K, et al. Crit Care. 2013;17:R25.
  2. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int Suppl 2012; 2:1-138.
  3. Ronco C, et al. Crit Care. (London, England) 2012;16:313-313.
  4. Sharma A, et al. Nephron Clin Pract. 2014;127:94-100.
  5. Kellum J, et al. Nat Rev Dis Primers 2021;7(1):52. doi: 10.1038/s41572-021-00284-z
  6. Nadim M, et al. Nat Rev Nephrol. 2020:16(12);747-64. doi.org/10.1038/s41581-020-00356-5
  7. Alobaidi R, et al. Semin Nephrol. 2015; 35(1):2-11.
  8. Mandelbaum T et al. Crit Care Med. 2011; 39(12):2659-2664.
  9. Dasta JF, et al. Nephrol Dial Transplant. 2008; 23(6):1970-1974.
  10. Legouis D, et al. Br J Anaesth. 2018;121(5):1025-1033
  11. Heung M, et al. Am J Kidney Dis. 2016; 67(5):742-752.
  12. Meersch M, et al. PLOS ONE. 2014;9:e93460
  13. VIDAS® NEPHROCHECK® Package Insert US. On file at bioMérieux.
  14. Engelman DT, et al. J Thorac Cardiovasc Surg. 2020;160:1235-1246.e2.
  15. Meersch M, et al. Intensive Care Med. 2017;43:1551-1561.
  16. Zarbock A, et al. Anesth Analg. 2021;133:292-302.
  17. VIDAS® 3 User Manual US Version. On file at bioMérieux.