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Test ID: FFTRO
Trofile DNA Co-Receptor Tropism Assay

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

57159

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

To determine the co-receptor tropism (CCR5, CXCR4, or dual/mixed) of a patient's HIV-1 strain for selection of CCR5 co-receptor antagonist therapy, when patient's HIV-1 viral load is <1,000 copies/mL.

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

CD4 cell culture assay for phenotypic recombinant-virus co-receptor tropism.

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

Trofile DNA Phenotypic Corecept Tro

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

CCR5, CXCR4, CR5 FORWARD
Chemokine co-receptor FORWARD
Selzentry, Maraviroc FORWARD
Trofile DNA FORWARD
Tropism DNA FORWARD
Tropotype DNA FORWARD
FTROF

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.

Draw 4 mL blood in a lavender-top (EDTA) tube(s), (Do not centrifuge.) Freeze and ship frozen.

 

Note: Trofile DNA is recommended for patients with undetectable viral loads.

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.

3 mL

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

Hemolysis

NA

Thawing

NA

Lipemia

NA

Icterus

NA

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
Whole Blood EDTAFrozen14 days

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.

Test Performed By:  Monogram Biosciences, Inc.

                              345 Oyster Point Boulevard

                              South San Francisco, CA  94080

Interpretation Provides information to assist in interpretation of the test results

Trofile DNA Viral Classification

 

CCR5 Tropic (R5) HIV-1:

Virus uses CCR5 to enter CD4+ cells.

 

CXCR4 Tropic (X4) HIV-1:

Virus uses CXCR4 to enter CD4+ cells.

 

DUAL /MIXED Tropic (D/M) HIV-1:

Dual-tropic viruses can use either CXCR4 or CCR5 to enter CD4+ cells.  Mixed-tropic populations contain viruses with 2 or more tropisms.

 

Nonreportable:

Co-receptor tropism could not be determined.  Common causes of nonreportable results are reduced viral fitness or compromised sample handling.  Please note that Trofile DNA sample collection and handling instructions differ from Trofile and other Monogram assays.

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

Co-receptor tropism is defined as an interaction of a virus with a specific co-receptor on the target cell. To gain entry into CD4+ cells, HIV must bind to the cell surface CD4 receptor and to one of two co-receptors, CCR5 or CXCR4.  Trofile DNA uses the complete gp160 coding region of the HIV-1 envelope protein ensuring that all of the determinants of tropism tested.

 

Trofile DNA meets the US standards for technical validation as established by the Clinical Laboratory Improvement Amendments.  Trofile DNA is a single cycle pseudovirion based tropism assay that uses the complete gp160 coding region of HIV-1 to evaluate tropism.  Instead of using HIV-1 RNA isolated from patient plasma, Trofile DNA uses cell associated viral DNA taken from whole blood cells infected with HIV.  HIV-1 envelopes encoded by the viral DNA are tested in a cell-based viral infectivity assay in order to determine which co- receptor the HIV-1 virus population is capable of using: CCR5, CXCR4, or both, known as D/M (dual/mixed).

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

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.

14 days

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

16-20 days

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

Monogram Biosciences, Inc

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.

87999

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
Z2283Tropotype Result53923-9
Z2284Interpretation:In Process