Sorted By Test Name - Mayo Medical Laboratories

Policies - Mayo Medical Laboratories
• Standard Method - This test uses a standard method. Its performance characteristics were
determined by Mayo Clinic in a manner consistent with CLIA requirements.
• FDA Approved, Cleared, or Exempt (IVD) - This test has been cleared or approved by the U.S. Food
and Drug Administration (or is exempt from FDA review) and is used per manufacturer’s instructions.
Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA
requirements.
• FDA Modified - This test has been modified from the manufacturer's instructions. Its performance
characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.
• Analyte Specific Reagent (ASR) - This test was developed using an analyte specific reagent. Its
performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA
requirements. This test has not been cleared or approved by the U.S. Food and Drug
Administration.
• Laboratory Developed Test - This test was developed and its performance characteristics determined
by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or
approved by the U.S. Food and Drug Administration.
• Investigational Use Only (IUO) - This test uses a kit labeled by the manufacturer as "investigational
use only" and it is used per manufacturer's instructions. Its performance characteristics were
determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been
cleared or approved by the U.S. Food and Drug Administration.
• Research Use Only (RUO) - This test uses a reagent or kit labeled by the manufacturer as "research
use only" and it is used per manufacturer's instructions. Its performance characteristics were
determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been
cleared or approved by the U.S. Food and Drug Administration.
Test Development Process
Mayo Medical Laboratories serves patients and health care providers from Mayo Clinic, Mayo Health
System, and our reference laboratory clients worldwide. We are dedicated to providing clinically useful,
cost-effective testing strategies for patient care. Development, validation, and implementation of new and
improved laboratory methods are major components of that commitment.
Each assay utilized at Mayo Clinic, whether developed on site or by others, undergoes an extensive
validation and performance documentation period before the test becomes available for clinical use.
Validations follow a standard protocol that includes:
• Accuracy
• Precision
• Sensitivity
• Specificity and interferences
• Reportable range
• Linearity
• Specimen stability
• Specimen type comparisons
• Urine preservative studies: stability at ambient, refrigerated, and frozen temperatures and with 7
preservatives; at 1, 3, and 7 days
• Comparative evaluation: with current and potential methods
• Reference values: using medically evaluated healthy volunteers, male and female, across age
groups. The number of observations required for each test is determined by biostatistic analysis.
Unless otherwise stated, reference values provided by Mayo Medical Laboratories are derived from
studies performed in our laboratories. When reference values are obtained from other sources, the
source is indicated in the “Reference Values” field.
• Workload recording
• Limitations of the assay
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Current as of January 4, 2013 7:15 pm CST 800-533-1710 or 507-266-5700 or MayoMedicalLaboratories.com Page 10