Current Hepatitis C Testing Recommendations
Recently, several organizations have issued hepatitis C virus screening recommendations. In general, major guidelines now recommend routine one-time universal HCV testing for adults 18 years of age and older, routine HCV screening of pregnant individuals, screening younger persons at risk of acquiring HCV, and repeat screening for those with ongoing risk for HCV acquisition.
Hepatitis C And Health
How can health-care personnel avoid exposure to HCV?
Avoiding occupational exposure to blood is the primary way to prevent transmission of bloodborne illnesses among health-care personnel. To promote blood safety in the workplace, health-care personnel should consult infectious-disease control guidance from the National Institute for Occupational Safety and Health and from CDC. Depending on the medical procedure involved, Standard Precautions may include the appropriate use of personal protective equipment .
What is the risk of acquiring hepatitis C after being accidentally exposed to HCV-contaminated blood or body fluids in the workplace?
Although sharps injuries have decreased in recent decades due to improved prevention measures, they continue to occur, placing health-care personnel at risk for several bloodborne pathogens like hepatitis C. A recent analysis of several studies revealed an overall 0.2% risk for infection among those exposed to HCV-antibody-positive blood through needlestick or sharps injuries . Updated guidelines for management and treatment of hepatitis Cexternal icon are available to provide guidance for health-care personnel who become infected via exposure to contaminated blood at the workplace.
Other than needlesticks, do other exposures place health-care personnel at risk for hepatitis C?
Should HCV-infected health-care personnel be restricted in their work?
Interpreting Hcv Rna Test Results
It is essential that the provider understands how to interpret HCV RNA test results, especially during the course of HCV treatment.
|Result of HCV RNA Test||Interpretation|
|A quantified viral load — any exact number||Ongoing HCV infection|
|“Detected”||The HCV RNA is detectable but the number of international units is so low that it cannot be quantified accurately. This indicates extremely low level of virus is present.|
|“< 12 IU/mL” or “< 15 IU/mL” or “< 25 IU/mL” All of these are “less than the LLOQ”||HCV RNA is undetectable. No virus is detected at all in the patient’s serum specimen.|
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Roche Launches Dual Antibody Antigen Hepatitis C Virus Diagnostic Test
Elecsys HCV Duo allows independent and simultaneous determination of early-stage infection and those who are recovering or showing signs of a chronic problem.
Roche has launched the Elecsys HCV Duo immunoassay in countries that accept the CE Mark.1
Elecsys HCV Duo is the first available immunoassay that allows the independent and simultaneous determination of the hepatitis C virus antigen and antibody status from a single human plasma or serum sample. The test can be used to detect early-stage infection, as well as identify patients who are recovering or show signs of chronic infection that could lead to other diseases, including liver cancer.1
With improved hepatitis screening, health care systems have the opportunity to eliminate the disease through improved prevention, testing and treatment services, Thomas Schinecker, CEO of Roche Diagnostics, said in a statement.
The addition of the Elecsys HCV Duo assay to our HCV testing portfolio can help in the fight to eliminate the hepatitis C virus. The launch of this innovative dual antigen and antibody diagnostic test underlines our commitment to support clinicians and their patients in reducing the impact of infectious diseases, where its needed most, Schinecker said.1
Additionally, this can lead to earlier intervention for individuals and reduce the number of clinic visits needed to take additional test samples. This can also alleviate some of the burden that testing can have on health care systems.1
What Does A Reactive Hcv Antibody Test Result Mean
A reactive or positive antibody test means you have been infected with the hepatitis C virus at some point in time.
Once people have been infected, they will always have antibodies in their blood. This is true if they have cleared the virus, have been cured, or still have the virus in their blood.
A reactive antibody test does not necessarily mean that you currently have hepatitis C and a follow-up test is needed.
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Other Things To Know:
- After a successful course of treatment for hepatitis C, the hepatitis C antibody remains detectable, but the hepatitis C RNA will be undetectable.
- If you plan to donate blood, you will be tested for the hepatitis C antibody and will be turned away even if you do not have an active infection.
- Any patient with a positive test result for the hepatitis C antibody should have additional tests to determine whether or not the virus is still active.
Limitations Of Using Only Risk
A prior study that analyzed effectiveness of risk-based HCV screening found that 45 to 85% of adults with chronic HCV infection in the United States were unaware of their HCV infection status. Problems with using risk-based screening were highlighted in the Chronic Hepatitis Cohort Study survey of 4,689 persons living with HCV infection who were asked about their choice of location and reason for their HCV testing. The study analyzed data from 2006-2010 that revealed that 60% of persons living with HCV had their initial testing ordered at a physician’s office and 45% underwent testing because of clinical indications related to liver disease fewer than 25% of the persons with HCV infection had identifiable risk factors for acquiring HCV that would have prompted testing using the 1998 CDC Risk-Based HCV Screening Recommendations. Notably, 78% of those diagnosed with HCV were born during the time period of 1945 to 1965.
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Clinical Features And Natural History
Persons with acute HCV infection are typically either asymptomatic or have a mild clinical illness like that of other types of viral hepatitis . Jaundice might occur in 20%30% of persons, and nonspecific symptoms might be present in 10%20% of persons. Fulminant hepatic failure following acute hepatitis C is rare. The average time from exposure to symptom onset is 212 weeks . HCV antibodies can be detected 410 weeks after infection and are present in approximately 97% of persons by 6 months after exposure. HCV RNA can be detected as early as 12 weeks after exposure. The presence of HCV RNA indicates current infection .
Hepatitis C Testing And Diagnosis
Doctors will start by checking your blood for:
Anti-HCV antibodies: This blood test is the first — and sometimes only — one you may get. Also called the ELISA screen, it checks for antibodies that your body releases to fight the virus. These are proteins your body makes when it finds the hep C virus in your blood. They usually show up about 12 weeks after infection. Your test will be either negative or positive for antibodies. It usually takes a few days to a week to get results, though a rapid test is available in some places.
What the results mean
Negative . This is when your blood shows no signs of HCV antibodies. Most of the time, thatâs because you never came in contact with the virus and you do not have hep C.
Sometimes, your negative result can be false, meaning you have HCV. That may happen if you:
- Took the test too soon after your exposure. This test checks for only HCV antibodies, which can take several months to appear.
- Have HIV, a donated organ, or other conditions that weaken your immune system, which can suppress your antibodies
- Get hemodialysis for kidney problems
If youâve been exposed in the last 6 months, youâll need to be retested.
Positive . This means youâve been infected with HCV. But false positives are surprisingly common. More than 1 in 5 people who test positive donât actually have hepatitis C. Possible reasons include:
What the results mean
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Diagnosis And Hepatitis C Elimination
In one report, the National Academies of Sciences, Engineering, and Medicine explored the feasibility of hepatitis C elimination and concluded that hepatitis C could be eliminated as a public health problem in the United States, but that substantial obstacles exist . In another report, specific actions were recommended to achieve elimination considering information, interventions, service delivery, financing, and research . These reports were the culmination of decades of progress in the development of HCV infection diagnostic and therapeutic tools.
The 2012 CDC guidelines recommended that pregnant women be tested for hepatitis C only if they have known risk factors . However, in 2018, universal hepatitis C screening during pregnancy was recommended by the American Association for the Study of Liver Diseases and IDSA . This report expands hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection is < 0.1%.
Time For Processing Hcv Ab Test Results
The turnaround time for 3rd-generation EIAs is at least 1 day. Many labs do not perform the tests on site and must send specimens to another lab for processing, which may further increase the turnaround time.
A point-of-care test is also available. The OraQuick® HCV Rapid Antibody Test is an FDA-approved test that can be performed with a fingerstick . It is also a CLIA-waived test and therefore can be used in clinic offices and outreach facilities. Results are reported as reactive or nonreactive within 20 minutes. Just as for the standard HCV Ab test done in the lab, a positive OraQuick® test must be confirmed by an HCV RNA test. The sensitivity and specificity of the test is similar to that of the laboratory-based assays.
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Aasld/idsa Hcv Testing Guidance
The American Association for the Study of Liver Diseases and Infectious Diseases Society of America guidance for hepatitis C addresses HCV testing in the section HCV Testing and Linkage to Care. The AASLD/IDSA recommends one-time, routine, opt out HCV testing for all individuals aged 18 years and older, one-time testing for persons younger than age 18 who have increased risk for acquiring HCV, periodic testing for persons who have risk activity for acquiring HCV, and annual testing for men with HIV who have condomless sex with men men who have sex with men and are on HIV preexposure prophylaxis and people who inject drugs . The AASLD/IDSA recommendations for testing incorporate birth-cohort screening as well as testing based on risk behaviors, risk exposures, and medical conditions associated with acquisition of HCV.
Testing Procedures And Costs
The test for HCV antibodies, as well as follow-up blood tests, can be done in most labs that perform routine blood work.
A regular blood sample will be taken and analyzed. No special steps, such as fasting, are needed on your part.
Many insurance companies cover hepatitis C testing, but check with your insurer first to be sure.
Many communities offer free or low-cost testing, too. Check with your doctors office or local hospital to find out whats available near you.
Testing for hepatitis C is simple and no more painful than any other blood test.
But if youre at risk for the disease or think you may have been exposed to the virus, getting tested and starting treatment if necessary can help prevent serious health problems for years to come.
CDC recommends that all adults ages 18 years and older should be screened for hepatitis C except in settings where the prevalence of HCV infection is less than 0.1%.
Also, all pregnant women should be screened during each pregnancy, except in setting where the prevalence of HCV infection is less than 0.1%.
Hepatitis C is often associated with sharing needles . But there are other methods of transmission.
For example, healthcare workers who are regularly exposed to other peoples blood are at higher risk for contracting the virus.
Getting a tattoo from an unlicensed tattoo artist or facility where needles may not be properly sterilized also increases the risk of transmission.
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Explanation Of Test Results:
If this test result is positive, it means your body was exposed to the hepatitis C virus and made antibodies . However, it does not tell you whether you are still infected with hepatitis C. If the antibody test result is positive, you should be tested for hepatitis C RNA , which determines whether you are chronically infected. The lab will perform this RNA test automatically if your hepatitis C antibody test is positive.
If the antibody test result is negative, it means you have not been infected with the hepatitis C virus, and further testing for hepatitis C usually is not needed.
Tests After The Diagnosis
Once the doctor knows you have hep C, theyâll do tests to find out more about your condition. This will help determine your treatment. They could include:
- Genotype tests to find out which of the six kinds of hepatitis C you have.
- Liver function tests. They measure proteins and enzymes levels, which usually rise 7 to 8 weeks after youâre infected. As your liver gets damaged, enzymes leak into your bloodstream. But you can have normal enzyme levels and still have hepatitis C.
- Tests to check for liver damage. You might get:
- Elastography. Doctors use a special ultrasound machine to feel how stiff your liver is.
- Liver biopsy. The doctor inserts a needle into your liver to take a tiny piece to examine in the lab.
- Imaging tests. These use various methods to take pictures or show images of your insides. They include:
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Enzyme Immunoassays For Detection Of Hepatitis C Antibody
The HCV Ab test is used for initial screening for hepatitis C. The test is performed by enzyme immunoassays , which detect the presence of hepatitis C antibodies in serum. The result of the test is reported as positive or negative. Third-generation EIAs have a sensitivity/specificity of approximately 99%. However, the presence of HCV Ab does not indicate whether the infection is acute, chronic, or resolved. A positive antibody test result should be followed up with an HCV RNA test to confirm that viremia is present.
Hepatitis C Reflex Testing
To ensure complete and timely diagnosis of HCV, HCV reflex testing is recommended following a reactive hepatitis C antibody screening test. Reflex testing means the laboratory will perform the hepatitis C antibody test, and if the result is positive, the laboratory will immediately perform an HCV RNA test on the same specimen. If the subsequent HCV RNA test is negative, HCV infection is effectively ruled out for most patients. If the reflex HCV RNA test is positive, a diagnosis of active HCV infection has been confirmed, and the individual should be referred directly for HCV care and treatment.
Reflex testing obviates the need for the patient to return for follow-up testing should the initially HCV antibody test be reactive. If the RNA test is negative, the work-up is done, and the patient may be reassured.
- Rationale for reflex testing:
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Meaning Of Hcv Viral Load
The number of HCV RNA international units per milliliter of blood must be measured before treatment and during the course of treatment, to assess response. Before treatment, however, the HCV viral load is not related to the patient’s liver disease severity or HCV prognosis. This is important for patients and providers to understand.
Note: In hepatitis B, unlike hepatitis C, a higher HBV DNA viral load does correlate with increased disease severity and increased likelihood of outcomes such as hepatocellular carcinoma.
Who Should Get Tested For Hepatitis C
The CDC recommends that you get tested at least once no matter what. Definitely get screened if any of these things apply to you:
- You were born between 1945 and 1965.
- You use or inject drugs.
- You have ever injected drugs — even if it was just once or a long time ago.
- Youâre on kidney dialysis.
- You have abnormal alanine aminotransferase levels .
- You had a blood transfusion, blood components, or an organ transplant before July 1992.
- Youâve ever gotten clotting factor concentrates made before 1987.
- You received blood from a donor who later tested positive for hepatitis C virus.
- Youâre a health care worker, first responder, or have another job that exposes you to HCV-infected needles.
- You were born to a mother with HCV.
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What To Do If The Hcv Antibody Test Is Reactive
If the antibody test is reactive or positive, you need an additional test to see if you currently have hepatitis C. This test is called a nucleic acid test for HCV RNA. Another name used for this test is a PCR test.
If the NAT for HCV RNA is:
- Negative you were infected with hepatitis C virus, but the virus is no longer in your body because you were cured or cleared the virus naturally.
- Positive you now have the virus in your blood.
If you have a reactive antibody test and a positive NAT for HCV RNA, you will need to talk to a doctor about treatment. Treatments are available that can cure most people with hepatitis C in 8 to 12 weeks.
Hepatitis C Testing Strategy
The goal of hepatitis C screening is to identify persons who are currently infected with HCV. Hepatitis C testing should be initiated with a U.S. Food and Drug Administration -approved anti-HCV test. Persons who test anti-HCV positive are either currently infected or had past infection that has resolved naturally or with treatment. Immunocompetent persons without hepatitis C risks who test anti-HCV negative are not infected and require no further testing. Persons testing anti-HCV positive should have follow-up testing with an FDA-approved nucleic acid test for detection of HCV RNA. NAT for HCV RNA detection determines viremia and current HCV infection. Persons who test anti-HCV positive but HCV RNA negative do not have current HCV infection. CDC encourages use of reflex HCV RNA testing, in which specimens testing anti-HCV positive undergo HCV RNA testing immediately and automatically in the laboratory, using the same sample from which the anti-HCV test was conducted. Hepatitis C testing should be provided on-site when feasible.
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