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Hepatitis C Ab W Refl To Hcv Rna Qn Pcr

Natural History Following Infection With Hcv

Hepatitis C can present as acute or chronic hepatitis. Most of the cases of acute hepatitis C are asymptomatic. Symptomatic acute hepatitis with jaundice is seen in 10-15% of patients only and can be severe, but fulminant liver failure is rare. Spontaneous clearance is observed in 25-50% of those with symptomatic infection and in 10-15% of those with asymptomatic infection. The natural history following exposure to HCV is summarized in .

Natural history following infection with hepatitis C virus

Chronic hepatitis C is marked by the persistence of HCV RNA in the blood for at least 6 months after the onset of acute infection. The risk of progression to chronic infection by HCV is influenced by various factors including:

  • Age at the time of infection

  • Gender

  • Ethnicity

  • Coinfection with human immunodeficiency virus , HBV

  • Concomitant alcohol consumption

  • Comorbid conditions like cancer, immunosuppression, insulin resistance, nonalcoholic steatohepatitis, obesity, etc.

Results From The Qualitative Test

Doctors use the qualitative HCV RNA PCR test to determine whether or not the hepatitis C virus is present in the blood.

If the virus is present, the test will be positive. If the test does not detect the virus, the result will be negative.

If the result is positive, a person will then need a quantitative HCV RNA PCR test. For this reason, many doctors now prefer to skip the first test and use the quantitative test straight away.

The quantitative test results show how much HCV is in the body. However, whether low or high, the viral load does not reflect levels of damage to the liver.

Other blood tests, ultrasounds, and, rarely, a liver biopsy will help a doctor determine overall liver health.

After using an HCV RNA PCR test to confirm the presence of HCV, doctors will work out which strain of the virus is active in the body. This helps a doctor plan the course of treatment.

The primary goal of treatment is to bring down the viral load in the body until it is entirely free of the virus. Doctors know this as a sustained virologic response .

SVR occurs when the virus is undetectable for 12 weeks or longer after treatment.

Achieving SVR is the best outcome of treatment, as it often means the person is free from hepatitis C, or that treatment has cured hepatitis C.

Doctors will also combine treatments with other tests that monitor for complications of HCV, including cirrhosis and liver cancer.

Question 3 Why Does Quest Diagnostics Also Report Results As Log Iu/ml

This makes it easier to understand whether a change in viral load is clinically meaningful.

Replicate PCR test results using the same specimen can vary analytically by as much as 0.5 log IU/mL thus, only changes greater than 0.5 log IU/mL from one measurement to the next are considered to represent true changes in viral load.3 Reporting the viral load results in log IU/mL units helps the healthcare provider accurately interpret changes in viral load and better assess a patient’s response to antiviral treatment.

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What To Know About Hepatitis C Testing

The HCV RNA PCR test is a blood test that helps a doctor diagnose hepatitis C. The test measures the level of the hepatitis C virus in the bloodstream.

Hepatitis C is an infection that causes scarring in the liver and reduces function in this vital organ. Severe HCV can lead to liver failure. However, early diagnosis can reduce the risk of severe infection.

In this article, we look at how the test works and what the results mean.

The HCV RNA PCR test is a blood test. A lab technician looks for the genetic material of the HCV virus, or its ribonucleic acid . They use a process called a polymerase chain reaction .

The results of the HCV RNA PCR test help a doctor recommend different ways of reducing the viral load. The viral load indicates how many HCV viral particles are in the blood.

If a doctor suspects that a person has HCV, they will recommend this test early on in the diagnostic process, even if it is not the first test they carry out.

The test can detect the presence of the virus itself, rather than the antibodies that the body creates in response to the virus.

This means that a person does not have to wait until symptoms of the infection develop for a diagnosis.

It can take an average of 68 weeks for antibodies to become detectable after an HCV infection begins. However, a doctor can identify the virus itself after about 1-2 weeks by using PCR or another means of direct virus detection.

Doctors use the HCV RNA PCR in one of two ways:

Other Hepatitis C Tests

After an individual has received a reactive or positive result from a hepatitis C antibody test, they will need to have two follow-up tests.

The first test checks to see whether a person still has the virus the other measures the amount of the virus in the blood.

The first test is the hep C RNA qualitative test, also known as the PCR test. A positive result means that a person has the hepatitis C virus. A negative result means that the body has cleared the virus without treatment.

The second test is the hep C RNA quantitative test. The result of this test is given as a number rather than a positive or negative. This is because the test compares the amount of the virus in the body before, during, and after treatment.

The number given as a result of this test is known as the viral load. The lower amount of the hepatitis C virus in the blood, the better the chances that a person can eliminate the virus from their body.

After hepatitis C virus is diagnosed, other tests may be needed:

Certain behaviors, experiences, and medical procedures increase the risk of getting the hepatitis C virus, which is transmitted by contact with blood.

The following are risk factors for contracting the virus:

The Centers for Disease Control and Prevention advise all baby boomers get tested for hepatitis C. Baby boomers are people born between 1945 and 1965. They are five times more likely to have the virus than other adults.

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Iatrogenic Exposure And Postexposure Prophylaxis

The potential of health care delivery to transmit HCV to healthcare worker is increasingly being recognized especially if infection control or disinfection practices are inadequate and contaminated equipment is shared among patients. The mechanisms of transmission in the healthcare setting are related to:

  • Improperly cleaned, disinfected, or sterilized equipment

  • Medication administration

  • Blood sampling

The CDC in collaboration with healthcare infection control practices advisory committee has issued recommendations following occupational exposure to HCV. These recommendations emphasize that each institution should have its own policy regarding follow-up of personnel who sustain percutaneous or permucosal exposure to suspected HCV infected blood. They minimally recommend:

  • Baseline testing for anti-HCV in source.

  • Baseline and follow-up testing for anti-HCV and alanine aminotransferase levels in exposed at 6 months and 1 year postexposure.

  • Confirmation by NAT of all anti-HCV reactive results.

  • Education of workers about the risk for and prevention of blood-borne infections.

  • Questions For Your Doctor About Test Results

    Patients receiving hepatitis C testing may find it helpful to ask questions about their test results. Questions to consider include:

    • What type of hepatitis C test did I receive?
    • What was my test result?
    • How do you interpret the results of the hepatitis C tests that I had?
    • Do I need any follow-up tests based on my test result?

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    Discusses Physiology Pathophysiology And General Clinical Aspects As They Relate To A Laboratory Test

    Hepatitis C virus is recognized as the cause of most cases of posttransfusion hepatitis and is a significant cause of morbidity and mortality worldwide. In the United States, HCV infection is quite common, with an estimated 2.4 million chronic HCV carriers.

    Laboratory testing for HCV infection usually begins by screening for the presence of HCV antibodies in serum, using an FDA-approved screening test. Specimens that are repeatedly reactive by screening tests should be confirmed with HCV tests with higher specificity, such as direct detection of HCV RNA by reverse transcription-PCR or HCV-specific antibody confirmatory tests.

    HCV antibodies are usually not detectable during the first 2 months following infection, but they are usually detectable by the late convalescent stage of infection. These antibodies do not neutralize the virus and they do not provide immunity against this viral infection. Decrease in the HCV antibody level in serum may occur after resolution of infection.

    Current screening serologic tests to detect antibodies to HCV include enzyme immunoassay and chemiluminescence immunoassay . Despite the value of serologic tests to screen for HCV infection, several limitations of serologic testing exist:

    -There may be a long delay between exposure to the virus and the development of a detectable HCV antibody

    -False-reactive screening test result can occur

    -A reactive screening test result does not distinguish between past and present HCV infection

    What The Quantitative Results Mean

    The quantitative test results indicate the exact amount of HCV in your blood. This number helps your doctor confirm whether you have a high or low viral load.

    Measuring your viral load before treatment allows your doctor to monitor your viral load during and after treatment.

    The viral load measurement doesnt indicate how severe your HCV infection or cirrhosis is. Your doctor will need to take a biopsy, or tissue sample, from your liver to learn more about how your liver has been affected by an HCV infection.

    The viral load results from the quantitative PCR test can range from 15 to 100,000,000 IU/L.

    If your results are:

    • Fewer than 15 IU/mL: The virus is detected, but the amount cant be measured exactly. You may need to return later for another test to see if the measurement changes.
    • Fewer than 800,000 IU/mL: A low viral load is detected.
    • More than 800,000 IU/mL: A high viral load is detected.
    • More than 100,000,000 IU/mL: The virus is detected and active infection is taking place.
    • Inconclusive: HCV RNA cant be measured, and a new sample needs to be taken.

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    Hepatitis C Ab With Reflex To Hcv Rna Qn Pcr

    The Hepatitis C AB with reflex to HCV RNA, QN, PCR test contains 1 test with 2 biomarkers.

    Hepatitis C AB with reflex to HCV RNA, QN, PCR

    IMPORTANT – THIS IS A REFLEX TEST AND AN ADDITIONAL CHARGE OF $129 WILL BE APPLIED IF THE Hepatitis C Antibody is reactive.

    If Hepatitis C Antibody is reactive, then Hepatitis C Viral RNA, Quantitative, Real-Time PCR will be performed at an additional charge of $129.00

    For the detection of active HCV infection in HCV antibody positive individuals.

    Clinical Significance

    Hepatitis C Virus is a major cause of hepatitis. The clinical symptoms of an HCV infection are variable. Infection with HCV results in a chronic infection in 50 to 80% of cases. The “window” between HCV acquisition and seroreactivity is highly variable up to six months.

    Risk Of Hcv Infection In Recipients Of Blood Transfusion

    Prior to 1992, blood transfusions carried a high risk of HCV infection, approximately 15-20% with each unit transfused. In 1988, 90% of cases of posttransfusion hepatitis were due to NANBH viruses which was later found out to be due to HCV. The move to all-volunteer blood donors instead of paid donors had significantly reduced the risk of posttransfusion hepatitis to 10%. Screening of blood further reduced the rate of posttransfusion hepatitis C by a factor of about 10,000 to a current rate of 1 per million transfusions. The few cases that still occur are due to newly infected people donating blood before they have developed antibodies to the virus, which can take up to 6-8 weeks.

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    Question 2 Why Are Hcv Rna Results Being Reported In Iu/ml

    Results are reported in international units per milliliter to facilitate comparisons between results generated by different test methods. This is important because the various methods used by different laboratories are not standardized against each other. Use of IU/mL reporting units helps to make the comparison of viral load results across different methods more reliable.

    Taking A Hepatitis C Test

    Hepatitis C testing is conducted on a sample of blood. Blood samples can be collected by a doctor, nurse, technician, or other health care provider from an adult patients vein using a small needle or a skin prick on a childs heel.

    For an at-home hepatitis C test, patients collect a blood sample according to the manufacturers directions. Instructions provided in the test kit detail the steps to obtain a small sample of blood and mail it for testing.

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    Question 9 How Does The Hcv Genotype Test Differ From The Hcv Ns3 Ns5a And Ns5b Tests For Drug Resistance

    The LiPA genotype test is designed to identify all 6 major HCV genotypes. In contrast, the NS3, NS5a, and NS5b drug resistance tests detect mutations associated with drug resistance for a particular HCV genotype. They are not intended for determining HCV genotype and subtype. Separate test codes for drug resistance testing are available, depending on the HCV genotype and the gene of interest:

    • Hepatitis C Viral RNA Genotype 1 NS3 Drug Resistance
    • Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance
    • Hepatitis C Viral RNA Genotype 1 NS5b Drug Resistance
    • Hepatitis C Viral RNA Genotype 3 NS5a Drug Resistance

    The HCV genotype test should be performed before ordering an applicable HCV drug resistance test.

    References

  • AASLD-IDSA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C. . Updated July 6, 2016. Accessed February 3, 2017.
  • Holmberg SD, Spradling PR, Moorman AC, et al. Hepatitis C in the United States. N Engl J Med. 2013 368:1859-1861.
  • Kleiber J, Walter T, Haberhausen G, et al. Performance characteristics of a quantitative, homogeneous TaqMan RT-PCR test for HCV RNA. J Mol Diagn. 2000 2:158-166.
  • Screening For Hcv Infection

    HCV screening has several potential benefits. By detecting HCV infection early, antiviral treatment can be offered earlier in the course of the disease which is more effective than starting at a later stage. Further, early detection together with counseling and lifestyle modifications may reduce the risk of transmission of HCV infection to other people. The optimal approach to screen for HCV is to test the individuals having risk factors for exposure to the virus. The American Association for the Study of Liver Diseases recommends screening for HCV for the following individuals:

    • Recipient of blood or blood components .

    • Recipient of blood from a HCV-positive donor.

    • Injection drug user .

    • Persons with following associated conditions

    • persons with HIV infection,

    • persons who have ever been on hemodialysis, and

    • persons with unexplained abnormal aminotransferase levels.

    • Children born to HCV-infected mothers.

    • Healthcare workers after a needle stick injury or mucosal exposure to HCV-positive blood.

    • Current sexual partners of HCV-infected persons.

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    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.

    Other Things To Know:

    • The viral load measurement does not tell us anything about the severity of a patient’s liver disease or the degree of fibrosis . For that information, the patient would need additional testing.
    • It is not necessary to check the viral load repeatedly during treatment.
    • If a quantitative HCV RNA result is reported as “< 15 IU/L,” this means that the quantitative test cannot measure the hepatitis C virus. It may mean that there is no detectable HCV RNA at all, but it may mean that the level of virus is just too low for the test to pick it up.

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    Hepatitis C Antibody With Reflex To Pcr

    Hepatitis C Ab w/RFLX PCR
    Lab Code
    Hepatitis C Antibody w/Reflex PCR
    Description

    The Qualitative detection of Hepatitis C virus IgG and IgM antibodies in human sera by the FDA approved Abbott ARCHITECT Anti-HCV test two-step chemiluminescent immunoassay.

    In the first step, sample, assay diluent, and recombinant HCV antigen coated paramagnetic microparticles are combined. Anti-HCV present in the sample binds to the rHCV coated microparticles. In the second step, anti-human IgG/IgM acridinium-labeled conjugate is added, which binds to IgG and IgM anti-HCV. Then pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units .

    The presence or absence of IgG/IgM anti-HCV in the sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an ARCHITECT Anti-HCV calibration. Specimens with signal to cutoff values 1.00 are considered reactive for IgG/IgM anti-HCV. Specimens with S/CO values < 0.79 are considered nonreactive and specimens with S/CO values between 0.80 and 0.99 are Indeterminate.

    Reactive anti-HCV will reflex to Hepatitis C RNA, Quantitative for confirmation with an additional charge.

    For anti-HCV testing without PCR reflex for REACTIVE results, see Hepatitis C Antibody without PCR reflex on reactive samples .

    Synonyms

    Blood Transfusion Issues And Donor Counseling

    Guidelines for donor notification for donors positive for transfusion transmissible infections are outlined in An Action Plan for Blood Safety by National AIDS Control Organization 2004. A blood donor is offered an option to know his TTI status at the time of registration for blood donation after due counseling and give consent for the same.

    Notifying donors regarding a single positive screening test is fraught with the risk of causing undue anxiety and stress to a donor. If a screening test is positive, the blood unit should be immediately discarded. Presently there are no guidelines regarding confirming the test results before informing the donor. In case of samples with low S/CO and grey zone samples, a retesting of the donor samples using a different assay would be imperative before notifying the donor. There are clear cut guidelines regarding donor notification and referral for HIV positive blood donors with integrated counseling and testing centers available for the same. Donors who are positive for viral hepatitis markers have to be counseled by blood bank staff. An algorithm for donor counseling for HCV positive donors is outlined in .

    Algorithm for donor counseling for HCV positive donors

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