Test Code HIVGD HIV-1 Genotypic Drug Resistance Sequencing (Plasma)
Clinical Indications
HIV-1
Genotypic Drug Resistance
Sequencing detects viral genomic mutations known to confer
resistance to antiretroviral therapies and provides an estimate
of
susceptibility to medications including:
•Nucleoside reverse-transcriptase inhibitors (NRTI)
•Non-nucleoside reverse-transcriptase inhibitors (NNRTI)
•Protease inhibitors (PI)
•Integrase inhibitors (INI)
Susceptibility profile is determined based on the Stanford
University HIV
Drug Resistance Database.
See the Stanford University website for a complete list of
regions
evaluated, associated susceptibility and references:
http://hivdb.stanford.edu/pages/references.html.
Additional Test Codes
Epic Order Name: HIV1 GENOTYPIC
DRUG
RESISTANCE
(aka HIVGD)
Sunquest Order Code: HIVGD
Epic Px Code: LAB2955
Specimen Collection Type
Preferred: PPT (pearl top EDTA)
Acceptable: Lavender (EDTA) or Yellow
(ACD
solution)
Minimum Collection Volume
1.0 mL
Reference Range
Subtype of HIV-1 will be reported as
B, A, AE, AG, C, D or G. Mutations in the protease inhibitor,
reverse-transcriptase, and integrase genes will be reported as
indicating the mutation detected/None. Interpretation of gene
mutations and association with antiviral resistance will be
reported as Susceptible, Potential low-level resistance,
Low-level
resistance, Intermediate resistance, or High-level resistance.
Critical Value
N/A
Interpretation
The HIV-1
Genotypic Drug Resistance
assay utilizes RT-PCR amplification with
primers in highly conserved viral genomic regions to amplify
three
fragments covering HIV-1 subtypes B, A,
AE, AG, C, D, and G. These three regions include protease, a
large
portion of reverse-transcriptase where resistance mutations
have
been reported, and integrase. The fragments are purified and
sequenced using sequencing primers from conserved regions of
the
fragments. The trimmed derived sequence is examined for
resistance
mutations using the curated Stanford University HIV-1 Drug Resistance
Database (Soo-Yon R. et. al.,
2003) and the REGA HIV-1 subtyping tool to determine the subtype
(de
Oliveira T. et. al. 2005 and Alcantara LCJ. et. al. 2009). The
Stanford University
HIV-1 Drug
Resistance Database detects
mutations known to confer resistance to antiretroviral
therapies.
Mutations are scored and these scores are converted to provide
qualitative results estimating susceptibility to medications.
These
medications include nucleoside reverse-transcriptase
inhibitors,
non-nucleoside reverse-transcriptase inhibitors, protease
inhibitors and integrase inhibitors. The actual quantitative
score
can be provided to physicians at their request. The minimum
sequences that are required to generate a valid result are
codons
10-93 for protease inhibitors (PI), codons 40-219 for
nucleoside
reverse transcriptase inhibitors (NRTI),
codons 90-348 for non-nucleoside reverse transcriptase
inhibitors
(NNRTI), and
codons 51-263 for integrase
inhibitors.
Rejection Criteria
HIV-1
RNA
concentrations too low to allow antiviral resistance testing
(see
above for minimum volume; patient must have a recent viral load
greater than 600 copies/mL), whole blood frozen, specimens
beyond
their acceptable length of time from collection as listed in
the
specimen stability, or specimen types other than those listed.
Specimen Availability for Add-on Testing
This test cannot be added on (Critical frozen)
Specimen Stability
Frozen: 7 days
Refrigerated: Unacceptable
Ambient: Unacceptable
Day(s) Performed
Varies
Performing Lab- Department
TUKHS-BH-Mail Outs
CPT Code
87901, 87906
LOINC Code
N/A
Test Alias
HIV
Genotyping,
HIV
Resistance
HIV-1 Drug
Resistance Mutation
Analysis
HIV-1
Genotyping for Drug Resistance
Additional Information / Notes
Turnaround time: 4-6 business days from receipt of specimen
Note: If an HIV-1 viral load PCR test is ordered at the
same time, the genotype
specimen will be held until this testing has been completed and
a
sufficient viral load reported.