HemoCue
®
Albumin 201
QuiCk RefeRenCe Guide
HemoCue and our distributors will provide our customer with technical support.
Contact us at:
HemoCue, inc.
40 empire drive
Lake forest, CA 92630
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 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?
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 first morning urine specimen after rest is recommended since muscle activity influen-
ces 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 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.
90
06
19 0
80
62
3
introduction
System components
HemoCue Albumin 201
Analyzer
HemoCue urine Albumin
Microcuvettes
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 requi-
rements for waived categorization. A modified test is considered to be highly complex
and is subject to all applicable 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, inc. 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
