HIV-1 Integrase Genotype

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Test Name: HIV-1 Integrase Genotype
Reference Lab: QNI
Test Code: 16868
Shipping Temp: Frozen: 42 days
Specimen Type: 2 mL plasma collected in an EDTA (lavender-top); 2 mL CSF
TAT: 4 days
CPT Code: 87906
Cost: _
Additional Comments: _
FDA Approved Test: YES_ NO_ LDT_
Medical Director/Pathologist: approved by
Billing Completed by_ Date_ Time_

Test Code

Quest Code

16868

Alias/See Also

16868

CPT Codes
87906

Includes

Raltegravir Resistance
Elvitegravir Resistance
Dolutegravir Resistance
Bictegravir Resistance
Cabotegravir Resistance

Preferred Specimen

2 mL plasma collected in an EDTA (lavender-top) or PPT (white-top) tube

Minimum Volume

0.6 mL

Other Acceptable Specimens

2 mL CSF collected in a sterile leak-proof container

Instructions

Do not freeze whole blood or any samples stored in primary tube. Freshly drawn specimens (whole blood) may be stored at 2-25° C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation. If shipping frozen, transfer plasma to a leak-proof transport tube, then freeze prior to shipment. Follow manufacturer's instructions for collection tube handling.

CSF: Collect CSF using standard procedures. Transfer to a sterile, leak-proof container. Ship frozen.

Transport Temperature

Frozen

Specimen Stability

Room temperature: 24 hours
Refrigerated: 6 days
Frozen: 42 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Plasma received frozen in the plasma preparation tube (PPT) • Serum • Whole blood greater than 24 hours old • Frozen whole blood

Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) • Sequencing

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

A.M.

Reference Range

See Laboratory Report

Clinical Significance

Incomplete virologic suppression allowing continued viral replication in the presence of drugs can result in the emergence of drug resistant virus leading to therapeutic failure. The emergence of integrase strand transfer inhibitor (INSTI) drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on INSTI containing regimens (Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services). This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.

Performing Laboratory

Quest Diagnostics Nichols Institute

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.