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Test Code LAB20430 Trofile Co-Receptor Tropism Assay

Reporting Name

Trofile Phenotypic Corecept Tropism

Useful For

Detect HIV-1 coreceptor tropism; determine eligibility for CCR5 antagonist therapy such as maraviroc (Selzentry)

Performing Laboratory

Monogram Biosciences, Inc

Specimen Type

Plasma EDTA


Specimen Required


Specimen Type: Plasma

Container/Tube: Lavender-top (EDTA) or plasma preparation tube (PPT)

Specimen Volume: 3 mL

Collection Instructions: Draw blood in either PPT (pearl top) or lavender-top (EDTA) tubes.

Centrifuge specimen within six hours of collection. Remove plasma from cells immediately, and transfer specimen to a screw-capped, plastic vial. Freeze 3 mL of PPT plasma or EDTA plasma immediately, send specimen frozen.

 

To avoid delays in turnaround time when requesting multiple tests, please submit separate frozen specimens for each test requested.

 

RECOMMENDED:

1.       Patient's most recent viral load

2.       Viral load collection date

 

Note:   1.  Intended to use only for patients with viral loads greater than or equal to 1000 copies/mL. For best results, viral loads should be confirmed within two weeks prior to submission for testing at Monogram.

           2.  Patient samples submitted <30 days apart are considered duplicate and will be cancelled.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma EDTA Frozen 14 days

Day(s) Performed

Sunday through Saturday

CPT Code Information

87999

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FFTRP Trofile Phenotypic Corecept Tropism 57182-8

 

Result ID Test Result Name Result LOINC Value
Z1038 Tropotype Result 57182-8
Z1039 Note: Not Provided
Z1040 Activity of CCR5 antag anticipated? Not Provided

Interpretation

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 CCR5 or CXCR4 to enter CD4+ cells. Mixed-tropic populations contain viruses with two or more tropisms.

 

Non-reportable

Co-receptor tropism could not be determined by the Trofile assay. Common causes of a non-reportable result are viral load <1,000 copies/mL, reduced viral fitness, or compromised sample collection/handling.

 

Method Description

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 is a cell-based approach to determine a patient’s HIV co-receptor tropism (or Tropotype). Trofile uses the complete gp160 coding region of the HIV-1 envelope protein ensuring that all of the determinants of tropism are tested. CLIA validation experiments demonstrate that Trofile is 100% sensitive at detecting 0.3% CXCR4-using minor variants.

 

This class of drugs binds to CCR5 and blocks CCR5-mediated HIV entry into host cells. Trofile is used to determine whether a CCR5 antagonist may be an appropriate drug for a patient. Several clinical trials on CCR5 antagonists have demonstrated the positive and negative predictive value of Trofile in clinical settings.

 

Report Available

29 to 39 days

Reject Due To

Other PPT not centrifuged; insufficient volume; heparinized plasma; non frozen specimens

Method Name

Polymerase chain reaction (PCR) amplification and viral culture.