Frequently Asked Questions Introduction

Frequently Asked Questions Introduction
Introduction
Frequently Asked Questions
The HemoCue® Albumin 201 system is classified as Waived under the CLIA guidelines and
can be used by all laboratories holding a certificate of waiver. If the laboratory modifies the
HemoCue Albumin 201 test procedure, the test no longer meets the requirements for waived
categorization. A modified test is considered to be highly complex and is subject to all applicable CLIA requirements.
How do I get a CLIA Certificate of Waiver?
The HemoCue Albumin 201 system consists of the HemoCue Albumin 201 Analyzer
and the HemoCue Urine Albumin Microcuvettes. The system provides rapid, simple
and reliable quantitative determination of albumin in urine with accuracy and
precision.
Store the HemoCue Urine Albumin Microcuvettes in their package in a refrigerator,
at 35 - 46 °F. Do not store the cuvettes in the freezer. The cuvettes are stable until the
expiration date printed on each container as well as on each individual package. Do not use a
cuvette past the expiration date.
Note! The complete test procedure including Quality Control recommendations should be
read before performing the test.
This guide is to be used as a reference. For complete instructions and expected values,
please refer to the HemoCue Albumin 201 system Operating Manual and the package
insert for HemoCue Urine Albumin Microcuvettes or contact HemoCue America, Technical
Support: 800-426-7256. Please note that the system is only to be used for the analysis
of albumin in human urine.
To obtain a Certificate of Waiver, call your state department of health for an application and
refer to the Centers for Medicare and Medicaid Services CLIA program.
How should I store my cuvettes?
HemoCue® Albumin 201
Quick Reference Guide
Specimen collection and preparation
The first morning urine specimen after rest is recommended since muscle activity influences
the excretion of albumin in urine. Spot samples during the day may be used, but higher results
can be expected.
•The system is designed for testing at the point-of care using fresh urine, preferably within
1-2 hours from collection. Frozen specimen should not be used.
•The turbidity scale in the operating manual can be used to detect the grade of turbidity.
Cloudy samples should not be analyzed.
System components
HemoCue Albumin 201
Analyzer
HemoCue Urine Albumin
Microcuvettes
The concentration of albumin in spot urine samples, even if collected as the first-morning
urine, are subject to variability from the degree of dilution or concentration of the urine because of variability in hydration. For additional information, please refer to the package insert
for the HemoCue Urine Albumin Microcuvettes.
- Operating Manual
- Quick Reference Guide
- Power Adapter
900619 130515
The HemoCue Albumin 201 Analyzer is delivered together with:
Contact us at:
HemoCue America
250 South Kraemer Boulevard
Brea, CA, 92821
Phone (General): 800-881-1611
Orders: 800-323-1674
Technical Support: 800-426-7256
Fax (Cust. Service): 800-333-7034
www.hemocue.com
BERGSTENS, HBG
HemoCue and our distributors will provide our customer with technical support.
Setup
Test procedure
Take the time to examine and familiarize yourself with the
contents of the HemoCue Albumin 201 system.
The Albumin 201 system is classified as Waived under the CLIA guidelines and can
be used by all laboratories holding a CLIA certificate of waiver. Note! The complete test
procedure including QC recommendation should be read before performing the test.
1 The analyzer
Button to open the lid.
2 Cuvettes*
1 Pipette a drop
2 Fill the cuvette
3 Wipe off the cuvette
the cuvette
4 Insert
in the analyzer
Pipette a drop of urine onto a laboratory
plastic film, such as Parafilm. Use fresh urine
specimens and avoid cloudy samples.
- Open the single packaged cuvette.
- Hold the cuvette by the rectangular end as shown in the photo and bring it into contact with the urine sample. Allow the cavity of the cuvette to fill completely in one step. Do not refill the cuvette.
- The cuvette cannot be overfilled. If too little specimen is added, discard and repeat with a new cuvette.
When completely filled, carefully wipe off the
excess urine from the outside of the cuvette with
a clean lint free wipe. Visually inspect that no
sample is drawn out of the cuvette during this
procedure.
Open the lid and place the filled cuvette into
the cuvette holder, it is important that the
cuvette ”snaps” properly into the cuvette
holder. Start measurement as soon as possible
but no later than 30 seconds after filling the
microcuvette by gently closing the lid.
5 Close the lid
6 Record the result
7 Discard the cuvette
8 Maintenance
ON/OFF
button.
Make sure that the analyzer lid is closed.
Press and hold the left button until the
display is activated. The display shows the
version number and an internal quality
control, the ”self test” is performed.
Three flashing dashes are displayed when
the analyzer is ready for use.
3 Quality Control (QC)*
Take out only as many cuvettes from the
package as you need for immediate
use. Keep unused cuvettes in the original
package in the refrigerator.
- The system should be verified by measuring a
commercially available urine albumin control on days of testing, for each new shipment of cuvettes and new lots. HemoCue recommends the control material
EuroTrol AlbuTrol. If the control result is out of range, please refer to the Operating Manual for corrective action.
Do not run patient samples unless the QC results are
in the expected range. Contact HemoCue America,
Technical Support, if the problem persists. Results for
QC testing should be documented in the laboratory
records.
-Every time the analyzer is turned on it will automa
tically perform an internal QC, the ”self test”. The self test verifies the performance of the optical unit of the analyzer.
Erroneous handling
of the system
The cuvette holder should be cleaned after
each day of use. The cover glasses of the optical
unit should be cleaned when directed to do so
in the Troubleshootong Guide. Please refer to
the Operating Manual.
Please note that erroneous
readings may occur if the
system is not handled
according to manufacturer’s
recommendations. In such
cases error codes may not
be displayed. For further
information read the Troubleshoting Guide in the Operating
Manual.
*For information and order
- HemoCue Urine Albumin Microcuvettes
-EuroTrol AlbuTrol
contact HemoCue America (order).
The display shows
and three fixed dashes.
Within 90 seconds, the result is displayed in mg/L.
Record the result. The result will remain on the
display until the lid is opened. If the display shows: - LLL, the result is below 7 mg/L
- HHH, the result is above 150 mg/L
- Exx, an error has occured
See the Troubleshooting Guide and the Maintenance
section in the Operating Manual for additional
information.
Open the lid and discard the used cuvette.
Close the lid. When the display shows the the
HemoCue symbol and three flashing dashes,
the analyzer is ready for a new measurement.
When the measurements for the day have been
completed, switch off the analyzer with the
ON/OFF button.
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