ASTUTE140
Meter
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Intended Use
The Astute Medical NEPHROCHECK
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
in patients 21 years of age or older.
Principles of Operation
The ASTUTE140
generated from the test sample in the NEPHROCHECK
addition of the sample, the NEPHROCHECK
sample is inserted into the ASTUTE140
signal from each of the two immunoassays (TIMP-2 and IGFBP-7) into a concentration
and then multiplies these concentrations into a single numerical test result and displays
this result to the user. The results from the individual biomarkers are not displayed—
only the single numerical test result is displayed. Multiple quality control procedures
are performed to ensure that the test results are accurate (See "ASTUTE140
Quality Control (EQC)" on p. 50 and "External Liquid Quality Control (LQC)" on p. 56
for details).
Results of the test are displayed on the ASTUTE140
printed using the meter's internal printer, or electronically transmitted to a connected
laboratory information system (LIS).
©Astute Medical, Inc. 2020 PN 300153MULTI Rev A 2020/01/07
Please read these instructions carefully before using the ASTUTE140
Please refer to the assay-specifi c Product Insert for detailed test information.
Meter uses an optical system to measure the fl uorescent signal
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Introduction
Test System is intended to be used in conjunction
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Test System is intended to be used
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Test cartridge. After the
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Test cartridge containing the patient
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Meter. The meter then converts the fl uorescent
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Meter's LCD screen and may be
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Meter.
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Electronic
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