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HemoCue
®
Albumin 201
QUICK REFERENCE GUIDE
HemoCue and our distributors will provide our customer with technical support.
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
Frequently Asked Questions
How do I get a CLIA Certificate of Waiver?
To obtain a Certicate 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?
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.
Specimen collection and preparation
The rst morning urine specimen after rest is recommended since muscle activity inuences
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.
The concentration of albumin in spot urine samples, even if collected as the rst-morning
urine, are subject to variability from the degree of dilution or concentration of the urine be-
cause of variability in hydration. For additional information, please refer to the package insert
for the HemoCue Urine Albumin Microcuvettes.
900619 130515 BERGSTENS, HBG
Introduction
System components
HemoCue Albumin 201
Analyzer
HemoCue Urine Albumin
Microcuvettes
The HemoCue
®
Albumin 201 system is classied as Waived under the CLIA guidelines and
can be used by all laboratories holding a certicate of waiver. If the laboratory modies the
HemoCue Albumin 201 test procedure, the test no longer meets the requirements for waived
categorization. A modied test is considered to be highly complex and is subject to all appli-
cable CLIA requirements.
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.
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.
The HemoCue Albumin 201 Analyzer is delivered together with:
- Operating Manual
- Quick Reference Guide
- Power Adapter