ADmark ApoE Genotype Analysis & Interpretation (Symptomatic)
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
SISAR and RFLP
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Whole Blood EDTA
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
10 mL whole blood collected in a lavender top EDTA tube
and sent ambient.
1. Collection date is required.
2. Clinical indications/symptoms for patients under 60 years
NOTE: Athena does not perform ApoE testing for individuals
under the age of 18.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimens other than
Anticoagulants other than
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Whole Blood EDTA||Ambient (preferred)||72 hours|
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
A final report will be faxed under separate cover.
TEST PERFORMED BY ATHENA DIAGNOSTICS
377 PLANTATION ST
FOUR BIOTECH PARK
WORCESTER, MA 01605
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
- Corder EH, et al. Science 1993; 261:921-923
- Athena Diagnostics, Inc., ApoE Reported Results, Data on file
- Welsh-Bohmer, et al. Annals of Neurology 1997; 42:319-325
- Saunders, AM et al. Lancet 1996; 348:90-93
- Motter R, et al. Annals of Neurology 1995; 38:643-47
- Tanzi R, et al. Lancet 1996; 347:1091-1095
Method Description Describes how the test is performed and provides a method-specific reference
ApoE genotyping was performed by restriction endonuclease
digestion of PCR amplified genomic DNA. This analysis, as performed
here, is greater than 99% accurate.
This testing service is covered by U.S. Patent Number 5, 508,167.
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by Athena Diagnostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investig- ational or for research only. Athena Diagnostics is licensed under the Clinical Laboratory Improvement Amend- ments of 1988 (CLIA) to perform high complexity clinical testing. Athena Diagnostics has performed assay validation studies and has developed its laboratory protocols and operating procedures in consultation with experts in the field and in accordance with standards of the National Committee on Clinical Laboratory Standards (NCCLS).
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|Z2274||ApoE Genotyping||In Process|