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Test ID: DLDL
Direct LDL, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

200269

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Evaluation of cardiovascular risks

 

Diagnosis of hypobetalipoproteinemia (values <80 mg/dL)

 

Diagnosis of abetalipoproteinemia (values undetectable)

Method Name A short description of the method used to perform the test

Enzymatic Colorimetric

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Direct LDL, S

Aliases Lists additional common names for a test, as an aid in searching

Cholesterol in Low Density Lipoproteins (LDL)
Cholesterol, LDL (Low Density Lipoprotein)
Direct LDL Cholesterol, Serum
Direct LDL, S
LDL (Low Density Lipoprotein) Cholesterol
LDL Cholesterol (order if only LDL indicated)
LDL Direct
LDL Cholesterol (LDLC)

Specimen Type Describes the specimen type needed for testing

Serum Red

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.

Container/Tube: Red top

Specimen Volume: 0.5 mL

Collection Instructions:

1. Fasting (overnight 12-14 hours)

2. Patient must not consume any alcohol for 24 hours before the specimen is drawn.

Additional Information: Patient's age and sex are required.

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.

0.25 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
Serum RedRefrigerated (preferred)7 days
 Frozen 30 days

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Increased low-density lipoprotein cholesterol (LDLC) is widely recognized as a risk factor for atherosclerotic disease, specifically coronary atherosclerosis.

 

Diminished or absent LDLC may be a cause of polyneuropathy.

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.

<160 mg/dL

Interpretation Provides information to assist in interpretation of the test results

Evaluation of cardiovascular risk is based on the following range of values:

Desirable: <100 mg/dL

Low risk: 100-129 mg/dL

Borderline high: 130-159 mg/dL

High: 160-189 mg/dL

Very high: > or =190 mg/dL

 

Values <80 mg/dL indicate hypobetalipoproteinemia.

 

Nondetectable low-density lipoprotein cholesterol indicates abetalipoproteinemia. Related polyneuropathy may exist in affected individuals.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No stimulants, alcohol, or other depressants for at least 24 hours before specimen collection

 

No food for 12-14 hours before collection

 

Water may be taken as needed

 

Physicians must advise diabetic patients on necessary medications and snacks

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), JAMA 2001;285:2486-2497

Method Description Describes how the test is performed and provides a method-specific reference

The method is in a two reagent format and depends upon the properties of a unique detergent. This detergent (Reagent 1) solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. A second detergent (Reagent 2) solubilizes the remaining LDL particles and a chromogenic coupler allows for color formation. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color that is proportional to the amount of LDL cholesterol present in the sample. (LDL Direct Liquid Select Cholesterol Reagent package insert, Genzyme  Diagnostics, Framingham, MA 2009 October)

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.

Monday through Friday; 3rd shift.

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.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location The location of the laboratory that performs the test

New England

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 has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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.

83721

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 IDReporting NameLOINC Code
DLDLDirect LDL, S18262-6