Managing Hepatitis C at every stage

Click on the topics below to view the HCV tests from Quest Diagnostics.

Monitoring guidance for initial treatment of HCV infection

HCV tests for screening and diagnostic support

HCV tests specific for resistance to direct-acting antiviral agents

HCV tests for monitoring response to treatment

Additional tests before and during treatment of HCV infection

Hepatitis C treatment goals

Quest Diagnostics helps you manage Hepatitis C,
from diagnosis to cure

At Quest, we understand that your goal is to deliver the best care possible for your patients. That's why we offer an extensive range of tests that facilitate Hepatitis C diagnosis and monitoring. In fact, Quest provides industry-leading options for Hepatitis C antibody screening with reflex testing.

We also support you with Patient education tools that make it easier to discuss Hepatitis C testing and treatment.

Screening and Diagnosis
(Primary care)
Disease Progression
(HCPs that manage and treat HCV)
Treatment Response
and Comorbidities

Monitoring guidance for initial treatment of HCV infection1

Labs/Test Baseline2 Week
4
Week
8
Week
12
Week
24
CBC (with or without differential) X X3      
Prothrombin Time with INR X        
Hepatic panel (Albumin, total and direct
bilirubin, ALT/AST and alkaline phosphate)
X X3 X4 X4  
Creatinine level and calculated GFR X X3      
TSH X     X5 X5
HCV genotype and subtype X        
HCV RNA, PCR (Quantitative)6 X X   X X
Testing for the presence of RAVs,
as clinically indicated
X        
Serum pregnancy test7 X        
HBsAg8, anti-HBs, anti-HBc (total) X        
HBV DNA8 X        
HIV9          
HAV10 X        
Evaluation for advanced fibrosis using
liver biopsy, imaging, and/or noninvasive
markers like FibroTest
X11        

To read the AASLD/IDSA guidelines on monitoring patients who are starting Hepatitis C treatment, are on treatment, or have completed therapy, click here.

Tests available for diagnosis and disease management

HCV tests for screening and diagnostic support

Quest tests Test codesl Intended use
Hepatitis C Antibody with
Reflex to Hepatitis C Virus
RNA, Quantitative,
Real-Time PCR
8472(X)
  • Detects HCV antibody and confirms active
    HCV infection
  • Establishes baseline viral load for treatment
    monitoring
Hepatitis C Antibody with Reflex to HCV RNA, PCR with Reflex to Genotype, LiPA® 94345(X)
  • Detects HCV antibody and confirms active
    HCV infection
  • Provides a second reflex to perform genotyping
    on HCV isolates when RNA is detected
  • Reduces the percentage of Ab-positive patients
    who lack appropriate confirmatory RNA testing
    and who do not have genotype testing performed
Hepatitis C Viral RNA, Quantitative, Real-Time PCR 35645(X)
  • Confirms active HCV infection and monitors
    response to therapy

Testing for resistance-associated variants1,m

  • The AASLD/IDSA guidelines recommend testing for the presence of RAVs prior to initiating therapy
  • – NS5a RAVs can impact treatment response in regimens that include an NS5a inhibitor, mainly with genotype 1a and genotype 3 infections
    – RAV testing should be evaluated and performed on an individual basis as the extent of the impact on treatment response differs based on the combination of antivirals

HCV tests specific for resistance to direct-acting antiviral agents

Quest tests Test codesl Intended use
Hepatitis C Viral RNA, Genotype, LiPA® 37811(X)
  • Determines duration of treatment and which regimens to use
Hepatitis C Viral RNA Genotype 3 NS5a Drug Resistance 93325(X)
  • Detects NS5a gene mutations for genotype 3 associated with resistance to NS5a inhibitors
Hepatitis C Viral RNA NS3 Genotype 1 Drug Resistance 90924(X)
  • Detects NS3 gene mutations for genotype 1a or 1b associated with resistance to NS3 protease inhibitors
Hepatitis C Viral RNA Genotype 1 NS5B Drug Resistance 92204(X)
  • Detects NS5B gene mutations for genotype 1a or 1b associated with resistance to NS5B polymerase inhibitors
Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance 92447(X)
  • Detects NS5a gene mutations for genotype 1a or 1b associated with resistance to NS5a inhibitors
Hepatitis C Viral RNA Genotype, LiPA® with Reflex
to HCV NS5a Drug Resistancen
93871(X)
  • Genotype used to guide treatment selection and duration. If genotype is 1a, it will reflex to NS5a drug resistance test (92447)
Hepatitis C Viral RNA, Quantitative Real-Time PCR with Reflexeso 93873(X)
  • Confirms active infection and establishes baseline viral load
  • Genotype used to guide treatment selection and duration. If genotype is 1a, it will reflex to NS5a drug resistance test (92447)
AccuType® IL28B 90251(X)
  • Predicts response to interferon therapy in patients with genotype 1 HCV infection
AccuType® Ribavirin (ITPA) 91416(X)
  • Assesses risk for ribavirin-induced anemia in patients treated for HCV infection
  • Helps establish frequency of monitoring in patients being treated with ribavirin

Guidelines for monitoring response to treatment1,k

  • HCV RNA should be measured after 4 weeks of therapy
    – Repeat at week 6 if detectable at week 4
    – Treatment should be discontinued if viral load increases
    by >10-fold between weeks 4 and 6
  • HCV RNA testing should be repeated 12 and 24 weeks after completing treatment to test for sustained viral responsek

HCV tests for monitoring response to treatment

Quest tests Test codesl Intended use
Hepatitis C Viral RNA, Quantitative, Real-Time PCR 35645(X)
  • Utilized to monitor response to therapy
Hepatitis C Viral RNA, Quantitative Real-time PCR with Reflex to Genotype, LiPA® 11348(X)
  • Confirms active infection and establishes baseline viral load. Genotype used to guide treatment selection and duration
  • Linear range: 15–100,000,000 IU/mL
  • Performs only for baseline evaluation. If baseline RNA is already measured, order genotype LiPA only.
Liver Fibrosis, FibroTest-ActiTest Panel 92688(X)
  • Assists with noninvasive evaluation of liver fibrosis in patients with HCV infection
Hepatic Function Panelp 10256(X)
  • Evaluates liver function, assessing for infection, injury, or inflammation

The AASLD/IDSA guidelines for pretreatment assessment recommend: the evaluation of advanced fibrosis (using liver biopsy, imaging, and/or noninvasive markers) for all persons with HCV infection. This will aid in making an appropriate decision regarding HCV treatment strategy and in determining the need for initiating additional measures for the management of cirrhosis (eg, hepatocellular carcinoma screening).1

Additional tests before and during treatment of HCV infection

Quest tests Test codesl Intended use
CBC (with or without differential) 6399(X)
1759(X)
  • Disease progression assessment
Prothrombin Time with INR 8847(X)
  • Disease progression assessment
Creatinine level and
calculated GFR
375(X)
  • Disease progression assessment
TSH 899(X)
  • Monitor thyroid changes due to interferon use in treatment
Hepatitis A Ab, total 508(X)
  • Evaluation for HAV coinfection and conditions that may accelerate liver fibrosis
HBcAb, total 501(X)
  • Evaluation for HBV coinfection
HBsAb, Qualitative 499(X)
  • Evaluation for HBV coinfection
HBsAg with reflex confirmation 498(X)
  • Evaluation for HBV coinfection
Hepatitis B Virus DNA, Quantitative, Real-Time PCR 8369(X)
  • Monitor HBV DNA levels
HIV-1/2 Antigen and Antibodies, Fourth
Generation, with Reflexes
91431(X)
  • Evaluation for HIV infection
hCG, Total, Quantitative 8396(X)
  • Evaluate pregnancy status as treatment with ribavirin is not recommended during pregnancy

Note: This guidance is not intended to substitute for the physicians learning, experience and knowledge of their patient, and their determination of how to monitor or treat their patient. Please refer to guidelines HCVGuidelines.org for further information or more detail regarding monitoring of HCV patients.

HBV reactivation can occur in HCV/HBV coinfected patients undergoing HCV DAA therapy. Thus, before initiating treatment with HCV DAAs, the FDA strongly advises that all patients be tested for evidence of current or prior HBV infection by measuring HBsAg and HBcAb.2 To learn more, click on the tests Quest has to offer:

Once the decision to treat has been made, the HCV genotype is the primary virologic consideration in treatment selection and duration. Learn more by visiting the Hepatitis C: Screening and diagnosis page.

Hepatitis C treatment goals

Therapy for chronic HCV infection is geared toward eradicating viral infection and preventing complications such as hepatocellular carcinoma, cirrhosis, and liver failure.

Newer treatment options for HCV are designed to cause fewer side effects and be significantly more effective in terms of sustained virologic responses (SVRs).1

Stay informed about the changing Hepatitis C landscape

Watch Laboratory Testing in the Treatment of Hepatitis C: New Drugs, New Tests, New Rules

 

View all Hepatitis C
physician resources

Expert Insight on Hepatitis C
—Recent Advances in Diagnostics and Therapy

 

Contact a Quest Diagnostics sales representative

Speak Hepatitis C is the #1 cause of liver transplants because of the liver damage it can cause.

 

Watch our webinar on the evaluation and management of HIV/HCV coinfection

AASLD=American Association for the Study of Liver Diseases; Ab=antibody; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CBC=complete blood count; CDC=Centers for Disease Control and Prevention; DAAs=direct-acting antiviral agents; FDA=Food & Drug Administration; GFR=glomerular filtration rate; HBcAb=Hepatitis B core antibody; HBsAg=Hepatitis B surface antigen; IDSA=Infectious Diseases Society of America; INR=international normalized ratio; PCR=polymerase chain reaction; RAVs=resistance-associated variants; TSH=thyroid-stimulating hormone; USPSTF=U.S. Preventive Services Task Force.

aInitial treatment of HCV infection includes patients with chronic Hepatitis C who have not been previously treated with IFN, PEG-IFN, RBV, or any HCV DAA agent, whether experimental, investigational, or U.S. FDA approved.
bWithin 12 weeks prior to treatment.
cOr as clinically indicated.
dThose receiving EBR/GZR-Zepatier.
eIf interferon is used.
fAntiviral drug therapy should NOT be interrupted or discontinued if HCV RNA levels are not performed or available during treatment. gWomen and male partners of women of childbearing age should be counseled not to become pregnant while receiving RBV-containing antiviral regimens, and for up to 6 months after stopping. Assessment of contraceptive use and of possible pregnancy is recommended at appropriate intervals during (and for 6 months after) RBV treatment for women of childbearing potential, and for female partners of men who receive RBV treatment.
hIf HBsAg positive, HBV DNA should be tested prior to DAA therapy. Patients with low or undetectable HBV DNA levels should be monitored at regular intervals (usually not more frequently than every 4 weeks) for HBV reactivation with HBV DNA, and those patients with HBV DNA levels meeting treatment criteria should initiate HBV therapy. Information from hcvguidelines.org
iEvaluation for other coinfections and conditions that may accelerate liver fibrosis.
jIn patients suspected of Acute Hepatitis.
kAnd after 6 months of completion of treatment.
lTest codes may vary by location. Please contact your local laboratory or go to www.QuestDiagnostics.com/TestCenter for more information.
mAccording to the AASLD and the IDSA.
nReflex testing may be performed at an additional charge.
oIf Hepatitis C Viral RNA, Quantitative, Real-Time PCR (35645) is positive, Hepatitis C Viral RNA, Genotype, LiPA® (37811) will be performed at an additional charge. pPanel components can be ordered as a group panel or individually. Component test codes include: 7577, 7286, 234, 822, 823.
q10256(F) for Teterboro.

References: 1. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. http://hcvguidelines.org/sites/default/files/HCV-Guidance_April_2017_a.pdf . Accessed April 24, 2017. 2. Food & Drug Administration (FDA). FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV). https://content.govdelivery.com/accounts/USFDA/bulletins/18741e2. Accessed April 24, 2017.