Albumin 201 Quick Reference Guide May 2013

Quick Reference Guide

2 Pages

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.  The HemoCue Albumin 201 Analyzer is delivered together with: - Operating Manual - Quick Reference Guide - Power Adapter  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  900619 130515 BERGSTENS, HBG  HemoCue and our distributors will provide our customer with technical support.
File Type: PDF
File Size: 1.29 MB
File Name: Albumin 201 Quick Reference Guide May 2013.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions