Product Information

Intended Use and Indications for the NephroCheck Test System

The NephroCheck Test is an in vitro diagnostic device that quantitatively measures TIMP-2 (Tissue Inhibitor of Metalloproteinase 2) and IGFBP-7 (Insulin-like Growth Factor Binding Protein 7) proteins associated with kidney function in human urine by fluorescence immunoassay on the Astute140 Meter.

The test result is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment of acute kidney injury in the critically ill. The NephroCheck Test is indicated for prescription use only.

The NephroCheck Test System

Using the NephroCheck Test Kit

The NephroCheck Test System is a single-use cartridge designed to detect biomarkers of acute kidney injury, TIMP-2 and IGFBP-7. The test provides results in 20 minutes.

The test procedure involves the operator applying a fresh or thawed clinical urine sample (mixed with labeled fluorescent conjugate) to the NephroCheck Test Cartridge, then inserting the test cartridge into the Astute140 Meter for incubation, reading, result calculation and result display.

Each NephroCheck Test Cartridge contains RFID cards to ensure kit expiration date and lot-specific information is downloaded. Each cartridge also includes two detection zones (one positive and one negative control) as procedural controls that are run automatically with every sample to confirm that the NephroCheck Test procedure is performed correctly.

 

Part Number: 500003
Order Product Code: 500003AM

Drawings showing how to use the NephroCheck Test System

The NephroCheck Liquid Controls Kit

The NephroCheck Liquid Controls are two levels of external controls used for the quality control monitoring of the NephroCheck Test System. Good laboratory practice suggests that the NephroCheck Liquid Controls be tested:

  • Every 30 days
  • With each new lot number of NephroCheck Test Kits
  • With each new shipment of NephroCheck Test Kits
  • In accordance with the laboratory standard quality control procedures

 

Part Number: 500005
Order Product Code: 500005AM

The Astute140 Meter Kit

The Astute140 Meter is a bench-top/tabletop analyzer that converts the fluorescent signal from each of the two biomarkers assays, TIMP-2 and IGFBP-7, contained within the test cartridge into a single numerical result.

The NephroCheck Test results are available on the Astute140 Meter in approximately 20 minutes.

The Astute140 Meter Kit has multiple quality checks:

  • Calibrated at factory
  • Internal system checked with each start-up
  • External quality control procedure checks calibration
  • Internal sensor ensures proper temperature operating range

 

Part Number: 500000
Order Product Code: 500000AM

The Astute140 Electronic Quality Control (EQC) Device

The EQC procedure verifies the calibration of the Astute140 Meter to confirm that the meter is functioning properly, including the following meter systems: positioning system, optic system and other internal systems.

Astute140 EQC Device components:

  • Astute140 Electronic Quality Control Device
  • Astute140 Electronic Quality Control RFID Card

It is recommended that the Astute140 EQC procedure be run in accordance with the best practices of your institution.

 

Part Number: 400013
Order Product Code: 400013AM