Monday, May 27, 2024

Pcr Quantitative Test For Hepatitis C

How It Is Done

Interpreting HCV PCR (Quantitative) test

The health professional taking a sample of your blood will:

  • Wrap an elastic band around your upper arm to stop the flow of blood. This makes the veins below the band larger so it is easier to put a needle into the vein.
  • Clean the needle site with alcohol.
  • Put the needle into the vein. More than one needle stick may be needed.
  • Attach a tube to the needle to fill it with blood.
  • Remove the band from your arm when enough blood is collected.
  • Put a gauze pad or cotton ball over the needle site as the needle is removed.
  • Put pressure on the site, and then put on a bandage.

Hepatitis C Virus Quantitative Real

The Quantitative, real-time PCR test measures the IU of the HCV RNA per millimeter of plasma or serum. This test is typically only done for known HCV positive individuals. If you are unsure or if you just want to screen for this virus, you may want to order the Hepatitis C Virus Antibody test.

Test results may take 3-5 business days.

Cdc Recommendations For Hepatitis C Screening Among Adults In The United States

  • Universal hepatitis C screening:
  • Hepatitis C screening at least once in a lifetime for all adults aged 18 years and older, except in settings where the prevalence of HCV infection is less than 0.1%*
  • Hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection is less than 0.1%*
  • Onetime hepatitis C testing regardless of age or setting prevalence among people with recognized conditions or exposures:
  • People with HIV
  • People who ever injected drugs and shared needles, syringes, or other drug preparation equipment, including those who injected once or a few times many years ago
  • People with selected medical conditions, including:
  • people who ever received maintenance hemodialysis
  • people with persistently abnormal ALT levels
  • Prior recipients of transfusions or organ transplants, including:
  • people who received clotting factor concentrates produced before 1987
  • people who received a transfusion of blood or blood components before July 1992
  • people who received an organ transplant before July 1992
  • people who were notified that they received blood from a donor who later tested positive for HCV infection
  • Children born to mothers with HCV infection
    • Any person who requests hepatitis C testing should receive it, regardless of disclosure of risk, because many persons may be reluctant to disclose stigmatizing risks

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    What Is The Hepatitis C

    Hepatitis C is an infection of the liver. There are five different types of hepatitis virus that attack the liver. Hepatitis C is the most serious type that can be transmitted through being exposed to contaminated blood. This virus is rarely transmitted through sexual contact. It is either acute or chronic but, there is no vaccine that can help protect us from it. Hepatitis C cannot be transmitted through coughing or sneezing, sharing utensils, hugging and kissing as well as holding hands.

    Unlike other kinds of hepatitis, being infected with hepatitis C does not protect you from being re-infected by it. This virus undergoes a lot of changes when it replicates in our system, this will prevent our immune system to build up an appropriate immune response for future infections.

    The quantitative real time PCR hepatitis C virus test measures the viral load in infected individuals. The count will come as number of international units per mL of blood. It is used measure the amount of viral RNA particles in the blood. It is also used to diagnose an active infection as well as determine the bodys response to therapy, by comparing the before and after count of the virus.

    New Testing Options For Hepatitis C Virus

    Hepatitis C Virus Blood Test

    2017, Volume 27, Number 2

    Danny L. Wiedbrauk, Ph.D., Scientific Director, Virology and Molecular Biology

    Warde Medical Laboratory has a new testing option for diagnosing Hepatitis C Virus infections. The test, Hepatitis C Virus Antibody with Reflex to PCR includes HCV antibody testing with automatic referral to PCR for antibody-Reactive specimens. A final interpretation, based upon CDC guidelines, is provided for all specimens.

    This testing protocol requires submission of two separate sample tubesone serum, the other plasma. The serum tube is tested for HCV antibody and if Reactive, the plasma tube is tested for HCV RNA by a quantitative PCR protocol.

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    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.

    Understanding Of Lab Tests Results

    Please visit the site associated with The American Association for Clinical Chemistry for better understanding of tests. There you will find the most detailed and full information regarding lab tests. In common questions tab you will find answers on the most common questions.

    In addition, you can use a special form to ask the question. It is useful, if there is no answer on your question on the web site. A laboratory scientist will answer your question. It is a part of voluntary service provided by the American Society for Clinical Laboratory Science.

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    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:

    Hepatitis C Pcr Quantitative Blood Test

    Blood Test : HCV RNA By Real Time PCR Quantitative

    The Hepatitis C RNA PCR Quantitative test is used to look for infections with the Hepatitis C virus. This test looks for the genetic material of the virus. Because viral genetic material may be detectable earlier than antibodies that develop in response to an infection, PCR testing can be used to screen for recent exposure. Quantitative PCR testing, also known as viral load testing, is often ordered to monitor how effective a persons treatment is at controlling the virus. This test is also useful as a confirmation for people who have had a positive result from an HCV Abs test. Results for this test are quantitative, meaning they will provide a numerical result for the level of the virus in a persons body.Hepatitis C is a virus spread through contact with infected blood. Nearly 80% of Hepatitis C infections develop into chronic Hepatitis. The number of people worldwide with chronic Hepatitis C infections is around 150 million. Chronic Hepatitis C infections can lead to serious health complications such as Cirrhosis and Liver Cancer. Many HCV infections display no symptoms. When symptoms do occur, some of the most common include:

    Fever Grey feces Jaundice

    Someone who wishes to screen for Hepatitis C but is not concerned about a recent exposure may wish to order the Hepatitis C Antibodies test.Turnaround for the Hepatitis C RNA PCR Quantitative test is typically 5-7 business days.

    Detection Period:



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    Discusses Conditions That May Cause Diagnostic Confusion Including Improper Specimen Collection And Handling Inappropriate Test Selection And Interfering Substances

    A single negative hepatitis C virus RNA test result together with a reactive HCV antibody screen result with a signal-to-cutoff ratio of 8.0 or greater does not rule out the possibility of chronic HCV infection. Repeat testing for HCV RNA in 1 to 2 months is recommended in patient at risk for chronic hepatitis C.

    Infants born to HCV-infected mothers may have false-reactive HCV antibody test results due to transplacental passage of maternal HCV IgG antibodies. HCV antibody testing is not recommended until at least 18 months of age in these infants.

    Performance characteristics have not been established for the following types of serum specimen:

    -Individuals under 10 years of age

    -Grossly icteric

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    Hepatitis C Quantitative Pcr

    Hepatitis C virus is a single stranded RNA virus. Hepatitis C virus is a major cause of chronic liver disease in the United States. Approximately 4 million people in the United States are currently infected. Of those known to be infected, 2.7 million have chronic liver disease. An estimated 40,000 new infections are suspected each year. Of the six different HCV genotypes, genotype 1 is most common, followed by 2 and 3.

    Once HCV infection has been established, quantitative HCV PCR can provide prognostic information. Predictors of response to antiviral therapy include viral load of less than 2,000,000 IU/mL, genotype other than 1, shorter duration of infection, female gender, and low body weight. The HCV positive patient with negative viral load should have the test repeated in 3 to 4 months, because some patients with active infection have intermittently undetectable viral loads.

    Cure is defined as a sustained viral response, which means undetectable HCV RNA using a sensitive PCR assay with a lower limit of detection and lower limit of quantitation of 15 IU/mL. Up to date guidelines can be found at

    Samples having no HCV target detected are reported as not detected. Samples having detectable and quantifiable HCV target are reported as the numeric value up to 200 million IU/mL. The unit of measurement for the Hepatitis C Virus RNA changed from copies/mL to IU/mL in March 2001.


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    Role Of Hcv Core Antigen In A Blood Bank/organ Donor Setting

    As outlined above, the sensitivity of HCV core antigen is inferior to HCV RNA, but superior to no testing. Thus, in a resource limited setting, where HCV RNA testing might be impossible due to cost restrains at present, HCV core antigen testing would allow for a compromise.

    Given the cost of organ transplantation, HCV RNA testing cost is unlikely to be a rate limiting step, and therefore not likely to be relevant to organ donation. Still if currently no HCV RNA testing is performed, HCV core antigen might be better than no testing for infectivity.

    Testing For Hepatitis C


    Two tests need to be done to discover if you have hepatitis C:

    • Antibody test: Which establishes whether you have ever been exposed to the hepatitis C virus.
    • PCR test: Which establishes whether the virus is still active and needs treating.

    The two tests can often be done from one sample of blood which means you may only need to provide the sample once. Both tests can then be done on your sample at the laboratory. However, some services will perform one test and then call you back for a further blood sample to perform the second test.

    Antibody test

    A hepatitis C antibody test is the first test undertaken. This is to determine whether you have ever been exposed to the hepatitis C virus. It works by testing for the presence of antibodies to the virus generated by your immune system. If you receive a negative hepatitis C antibody test but have been experiencing symptoms or have been recently exposed to hepatitis C, then you are likely to be advised to have a second test.

    It is important to remember that there is a window period. This is the short period of time when your immune system may not have had time to produce antibodies. It usually takes between six and twelve weeks for these antibodies to develop. However, in a few people it can take up to six months. So if you have the test within this window period and the result is negative, it does not necessarily mean that you dont have the virus.

    PCR test

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    Requisitions And Kit Ordering

    < 1.50E+01 IU/mL < 1.00E+03 IU/mL HCV RNA detected below the lower limit of quantitation. Unable to quantify. or 1000 IU/mL .)
    1.50 E+01 to 1.00 E+08 IU/mL 1.00 E+03 to 1.00 E+08 IU/mL Viral load will be reported in IU/mL.
    > 1.00E+08 IU/mL > 1.00E+08 IU/mL HCV RNA detected above the upper limit of quantitation. Unable to quantify.

    1Based on internal validation studies performed at PHO Laboratory, HCV RNA testing conducted on DBS is less sensitive than venous-collected samples. The lower limit of detection of HCV RNA using two DBS per test is approximately 1.6 to 2.0 logs higher than a concomitantly tested EDTA plasma or serum sample thus, DBS samples should NOT be used to rule out active HCV infection or to determine whether a patient on treatment has achieved an undetectable HCV RNA level.

    No additional sample is usually required for HCV genotyping, provided there is sufficient volume. The first pre-treatment sample submitted for HCV RNA viral load testing will be used to automatically perform HCV genotyping if the HCV viral load is 125 IU/mL. Refer to the for more information.

    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.

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    Role Of Hcv Core Antigen In Monitoring During And After Therapy

    Monitoring HCV viral load with HCV core antigen during antiviral treatment might be an attractive tool for the future. Unfortunately data are too limited for strong recommendations thereof .1). Especially, there are no data with the newer antivirals available at present. For Pegylated Interferon plus Ribavirin regimens, there have been some studies suggesting that one can predict response as early as day 3, week 1 or week 2.

    How Much Does The Test Cost

    Interpreting HBV DNA PCR (Qualitative) test

    The cost of hepatitis C testing depends on the tests that are performed, where the test is conducted, and a patients health insurance coverage. When testing is ordered by a doctor, patients with health insurance may find it helpful to discuss the cost of hepatitis C testing with their insurance company. In addition to the cost of testing, there may be other out-of-pocket costs such as copays and deductibles.

    For patients without health insurance, or for whom insurance doesnt cover the cost of testing, it may be helpful to discuss the cost of hepatitis C testing with a doctor or hospital administrator.

    At-home hepatitis C testing starts around $49. Some at-home kits test for multiple types of viral hepatitis at once, with the cost of these panels starting around $80.

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    Submission And Collection Notes

    Freshly drawn whole blood specimens collected in a serum separator tube may be stored and/or transported at 2°C to 25°C for up to 24 hours before centrifugation. Following centrifugation, remove serum from cells immediately, and transfer serum into screw-capped cryovial tubes. . Serum specimens may be stored and/or transported at 2°C to 8°C for up to 6 days or at -18°C for up to 12 weeks. If is requested, serum specimens may be stored and/or transported at 2°C to 8°C for up to 72 hours or at -18°C for up to 6 weeks. If more extended storage of serum specimens is required, it must be frozen at -60°C.

    Unspun whole blood must be received at PHOs Laboratory within 24 hours of collection before 2:00 p.m. Monday Friday.

    Refer to for collection criteria and instructions for RNA testing using DBS. DBS samples, when prepared appropriately, will be stable at room temperature for up to 30 days. HCV genotyping will be tested automatically if the HCV Viral load meets testing criteria and has sufficient DBS.

    Hep C Transmission And Pcr In Health Care Settings

    The NSW Ministry of Health recommends that following needlestick and other sharps injury in health care settings, voluntary PCR testing of source individuals should be done.

    In NSW, health care workers who perform exposure prone procedures must be aware of their HCV PCR status. Those who are HCV PCR positive must not perform exposure prone procedures .

    Exposure prone procedures are those with potential for a health care worker to bleed into a patient as the result of a sharps injury, e.g. surgical procedures in body cavities. The NSW Ministry of Health has a longer and more precise definition to guide health care workers .

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