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NEPHROCHECK®
Aid in the risk assessment for moderate or severe acute kidney injury
The NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients 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 acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older.
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 that confirm that the NEPHROCHECK Test procedure is performed correctly.
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
- After Astute140® Meter maintenance or servicing
- In accordance with local, state, and/or federal regulations or accreditation requirements
The NEPHROCHECK® Calibration Verification (Cal Vers) Kit
The NEPHROCHECK Calibration Verification (Cal Vers) Materials are five levels of calibration and verification materials used to verify calibration of the NEPHROCHECK Test System. Good laboratory practice suggests that the NEPHROCHECK Calibration Verification Kit be tested:
- At least once every six months
- After Astute140 Meter maintenance or servicing
- In accordance with local, state, and/or federal regulations or accreditation requirements
The Astute140 Meter Kit
The Astute140 Meter is a bench-top/tabletop analyzer that converts the fluorescent signal from each of the two biomarker 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
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 daily, in accordance with your local, state, and/or federal regulations or accreditation requirements and standard quality control procedures.
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NEPHROCHECK Test Kit Package Insert
NEPHROCHECK Liquid Controls Kit Package Insert
NEPHROCHECK Liquid Controls Kit SDS
NEPHROCHECK Calibration Verification Kit Package Insert
Astute140® Electronic Quality Control Device SDS