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Transcript
Hepatitis C Virus
Test Menu
TM
Screening
Test Name
Test Code
Hepatitis C Antibody
w/reflex to Hepatitis C
RNA Quantitative,
RT-PCR
8587
Specimen Requirements
Clinical Use Summary
4 mL refrigerated serum in a serum
separator tube (SST) (3 mL minimum).
Centrifuge as soon as possible after
clot formation.
Detect HCV antibody and confirm active HCV infection;
establish baseline viral load for treatment monitoring;
If Hepatitis C Antibody is reactive or equivocal, then
Hepatitis C RNA, Quantitative, RT-PCR will be performed
at an additional charge
Specimen Requirements
Clinical Use Summary
Disease Progression
Test Name
Test Code
Hepatitis C Virus RNA,
Quantitative, RT-PCR
905541
3 mL frozen EDTA plasma from 2
lavender-top tubes (2.5 mL minimum).
Centrifuge and transfer plasma to a
plastic, screw-cap polypropylene vial
within 24 hours of collection.
Useful in monitoring response to therapy and/or
disease progression; Reportable range is
15-100,000,000 IU/mL (1.18-8.00 Log IU/mL)
Hepatitis C Viral RNA,
Qualitative, TMA
901153
2 mL frozen EDTA plasma in a PPT
white-top tube (0.6 mL minimum).
Centrifuge and freeze entire tube
within 2 hours of collection.
Useful in confirming HCV infection and to assess
response to therapy; Limit of detection for this assay
is 5.3 IU/mL
Liver Fibrosis,
FibroTest-ActiTest
Panel
906531
3.5 mL frozen serum (2 mL minimum)
from a serum separator tube (SST) or
plain red-top tube. Serum should be
separated from the cells as soon as
possible after visible clot formation
(usually 15-30 minutes after
collection). Avoid freezing and
thawing.
FibroTest and ActiTest permit the non-invasive
evaluation of Hepatitis C (or B) individuals for the
presence of liver fibrosis and liver inflammation,
respectively. The FibroTest and ActiTest scores are
calculated based on patient age, gender and
in serum concentrations of y-glutamyl transferase
(GGT), total bilirubin (TB), a-2 microglobulin,
haptoglobin, apolipoprotein A1 and alanine
aminotransferase (ActiTest). FibroTest and ActiTest
Scores, on a scale of 0.0 to 1.0, are assigned a Metavir
scale indicating the level of fibrosis or inflammation
present.
Please note that this test is not available for patients
<2 years old.
Tests on this chart may change periodically.
Hepatitis C Virus
Test Menu
TM
Pre-treatment and Treatment Response
Test Name
Test Code
Specimen Requirements
Clinical Use Summary
Hepatitis C Viral RNA
Genotype, LiPA®
15294
2 mL frozen EDTA plasma from a PPT
white-top tube or lavender-top tube
(0.6 mL minimum). Centrifuge and
transfer plasma to a plastic, screw-cap
polypropylene vial within 24 hours of
collection.
Determine whether to begin antiviral therapy in patients
with chronic HCV infection; Determine duration and
dosage of treatment; Predict response to therapy;
Minimum viral load of ≥300 IU/mL; If viral load is <300
IU/mL or has not been quantified in the last 1-2 months,
test code 901398 - HCV RNA, Quantitative, RT-PCR w/rflx
Genotype, LiPA® is recommended
Hepatitis C Viral RNA,
Quantitative, RT-PCR,
w/rflx Genotype, LiPA®
901398
3 mL frozen EDTA plasma from a
lavender-top tubes (1.5 mL minimum).
Centrifuge and transfer plasma to a
plastic, screw-cap polypropylene vial
within 24 hours of collection.
Confirm the presence of virus on HCV Ab positive
patients; Establish baseline HCV viral load for
monitoring response to treatment; Determine
treatment duration based on the HCV genotype;
Reflex at additional charge to Genotype LiPA® if viral
load >300 IU/mL
Hepatitis C Viral RNA
NS3 Genotype
906415
2 mL refrigerated or frozen EDTA
plasma from a lavender-top tube or
PPT white-top tube (0.6 mL minimum).
Used to detect boceprevir, simeprevir and paritaprevir
resistance-associated NS3 mutations in NS3 protease
inhibitor treatment-experienced patients and also the
Q80K polymorphism in patients being considered for
a simeprevir-containing regimen.
Hepatitis C Viral RNA
Genotype 1 NS5A
Drug Resistance
906678
2 mL frozen EDTA plasma from a
lavender-top tube (0.6 mL minimum).
Detect mutations or polymorphisms for genotype 1a
or 1b in the NS5A gene associated with NS5A
inhibitor treatment failure
Hepatitis C Viral RNA
Genotype 1 NS5B
Drug Resistance
906679
2 mL frozen EDTA plasma from a
lavender-top tube (0.6 mL minimum).
Detect mutations or polymorphisms for genotype 1a
or 1b in the NS5B gene associated with NS5B
inhibitor treatment failure
Hepatitis C Viral RNA
Genotype 3 NS5A
Drug Resistance
906677
2 mL frozen EDTA plasma from a
lavender-top tube (0.6 mL minimum).
Detect daclatasvir resistance associated
polymorphisms, particularly Y93H for genotype 3 in
the NS5A gene associated with NS5A inhibitor
treatment failure
Hepatitis C Viral RNA
Genotype, LiPA®
w/Reflex to HCV NS5a
Drug Resistance
906685
3 mL frozen EDTA plasma from a
lavender-top tube (1.2 mL minimum).
Genotype used to guide treatment selection and
duration; If HCV Genotype, LiPA® is "GENOTYPE 1",
"GENOTYPE 1a", or "GENOTYPE 1a or 1b" then reflex
Hepatitis C Viral RNA Genotype 1 NS5a Drug
Resistance will be performed at additional charge
Hepatitis C Viral RNA
Quantitative Real-Time
PCR w/Reflexes
906684
3 mL frozen EDTA plasma from a
lavender-top tube (1.8 mL minimum).
Used to obtain HCV viral load, HCV genotype and NS5a
resistance testing when considering treatment with
ZepatierTM or in other circumstances where all three
tests are warranted; If HCV RNA, PCR QT is ≥300 IU/mL
HCV Genotype, LiPA® will be performed at an additional
charge; If HCV Genotype, LiPA® is "GENOTYPE 1",
"GENOTYPE 1a", or "GENOTYPE 1a or 1b" then reflex
Hepatitis C Viral RNA Genotype 1 NS5a Drug
Resistance will be performed at additional charge
Tests on this chart may change periodically.
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