Thursday, September 22, 2022

Hepatitis C Antibody Rflx Hcv Rna Pcr

What To Expect During Testing

Hepatitis C Infection with Case â Disorders of the Hepatobiliary Tract | Lecturio

A healthcare provider will take a blood sample for analysis.

Before the test, let them know if youre uncomfortable with certain needles or if youve ever passed out at the sight of blood. They can give you a snack to reduce your risk of fainting.

The needle may sting a little as it enters your skin, and you may have a bruise on the site of the draw for a few days.

Results are usually available within a few days or a few weeks at most.

The HCV RNA PCR test is conducted through a process called polymerase chain reaction . There are two approaches to this process: qualitative and quantitative.

Hepatitis C Viral Load / Hcv Rna Quantitative Testing

Hepatitis C

The viral load of hepatitis C refers to the amount of virus present in the bloodstream. The quantitative HCV RNA tests measure the amount of hepatitis C virus in the blood. The result will be an exact number, such as “1,215,422 IU/L.” Many people refer to the quantitative measurement as the hepatitis C “viral load.”

Viral load tests are used to confirm active hepatitis C infection and are used during treatment to help determine response. If you have lower levels of virus in your blood when you start treatment, you may have a better chance of getting rid of the virus.

How To Get Tested

Hepatitis C testing is performed by a doctor. Testing requires a blood sample, which can be collected in a hospital, lab, or other medical setting. Blood is often drawn from a vein in the arm or, in children, taken by pricking the skin. After blood is collected, the sample is sent to a laboratory for analysis.

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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:

The Quantitative Hcv Rna Test Is Checked Before A Patient Starts Treatment

G. Diagnosis

For each patient, the result can be described as either a “high” viral load, which is usually > 800,000 IU/L, or a “low” viral load, which is usually < 800,000 IU/L. It’s not uncommon to have a viral load in the millions. Today’s hepatitis C treatments are very effective with both high and low viral loads. An undetectable HCV viral load 10-12 weeks after hepatitis C is completed is associated with a cure.

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Hepatitis C Antibody Without Pcr Reflex On Reactive Samples

Hepatitis C Ab w/o PCR
Lab Code
Hepatitis C Antibody w/o 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.

For anti-HCV testing with PCR reflex for REACTIVE results, see Hepatitis C Antibody with Reflex to PCR . Reactive anti-HCV will reflex to Hepatitis C RNA, Quantitative for confirmation with an additional charge.

Synonyms

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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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 don’t have the virus.

PCR test

New Testing Options For Hepatitis C Virus

Viral Hepatitis C

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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When Should I Get Hepatitis C Testing

When used for early detection in patients without symptoms of hepatitis C, screening is recommended at least once for all adults aged 18 years or older, except in locations with very low prevalence of HCV. Screening is also recommended during pregnancy and for patients of any age with risk factors for HCV infection. In patients with risk factors, periodic screening is recommended for as long as risk factors persist.

Risk factors for HCV include:

  • Current or past injectable drug use
  • Having a blood transfusion or organ transplant before July 1992
  • Receiving kidney dialysis
  • Pain in the abdomen or joints
  • Nausea, vomiting, or loss of appetite
  • Jaundice or yellowish skin and eyes

Hepatitis C testing may also be performed when liver tests are abnormal or when diagnosing the cause of existing liver damage.

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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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:

Are Test Results Accurate

HCV &  other Hepatitis Viral Infection

Although no test is perfect, hepatitis C testing is an important and accepted method of testing for HCV. In order to reduce the risk of inaccurate results, doctors take steps to verify a patients diagnosis. For example, a positive test result for hepatitis C antibody requires confirmation with HCV RNA testing.

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Hepatitis C Antibody With Reflex To Hcv Rna Quantitative Real

Synonyms: HCV with Reflex HCV Antibody Anti HCVSpecimen: Serum or EDTA PlasmaVolume: 4.0 mLContainer: Gel-barrier tube or EDTA tube

Collection:

  • Collect and label sample according to standard protocols.
  • Gently invert tube 5 times immediately after draw. DO NOT SHAKE.
  • Let tube stand in a vertical position to allow blood to clot 30 minutes.
  • Centrifuge for 10 minutes.
  • Draw and gently invert 8 to 10 times.
  • Centrifuge for 10 minutes.
  • Pre-squeeze transfer pipet bulb and draw off approximately 2/3 of the upper plasma layer.Note: This ensures that the buffy coat and red cells remain undisturbed.
  • Aliquot plasma into labeled transport tube labeled as EDTA plasma and cap tightly. Discard original tube.
  • Store transport tube refrigerated at 2-8°C until ready to ship.
  • Transport: Store serum or EDTA plasma at 2°C to 8°C after collection and ship the same day per packaging instructions provided with the Cleveland HeartLab shipping box.

    Stability:

    Ambient : 72 hoursRefrigerated : 14 daysFrozen : 30 daysDeep Frozen : 30 days

    Causes for Rejection: Specimens other than serum or EDTA plasma improper labeling samples not stored properly samples older than stability limits moderate hemolysis gross lipemia

    Methodology: Immunoassay

    Turn Around Time: 2-3 days

    Reference Range:

    Signal to Cut-off < 1.00

    Limitations: Results obtained from immunosuppressed patients should be interpreted with caution. Patients receiving mouse antibody therapy may produce false-negative results.

    How Much Does The Test Cost

    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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    What Do The Results Mean

    There are two results from a hepatitis C antibody test.

    • A non-reactive or negative test result means that the person does not have the virus. The exception is if someone has come into contact with the virus recently, such as through contaminated blood. If this is the case, they will need to have another test.
    • A reactive or positive test result means that the person has had the virus at some point but does not mean that they still have it. Further tests will be needed to check whether the virus is still active in the body and if treatment will be required.

    Once diagnosed with hepatitis C, a person will need to undergo a series of different tests to see how the virus has affected their body.

    These tests will check for any liver damage, identify how well the liver is working, and help a healthcare professional to decide on treatment.

    Hepatitis C is treated with medication known as an antiviral. It gets this name because it aims to clear the virus out of the body.

    Another aim of the medication is to slow down damage to the liver. It may also reduce the chance of a person getting liver cancer or developing serious liver scarring, known as cirrhosis.

    A person with hepatitis C will require regular testing during treatment to see how well the medication is working. Keeping healthy, getting enough sleep, and avoiding drugs and alcohol can help treatment to work.

    All Adults Pregnant Women And People With Risk Factors Should Get Tested For Hepatitis C

    A Deep Dive into Hepatitis C

    Most people who get infected with hepatitis C virus develop a chronic, or lifelong, infection. Left untreated, chronic hepatitis C can cause serious health problems, including liver damage, cirrhosis, liver cancer, and even death. People can live without symptoms or feeling sick, so testing is the only way to know if you have hepatitis C. Getting tested is important to find out if you are infected so you can get lifesaving treatment that can cure hepatitis C.

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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

    -Grossly lipemic

    -Grossly hemolyzed

    -Presence of particulate matter

    Can I Take The Test At Home

    At-home hepatitis C tests are available that allow patients to collect a blood sample at home and mail it to a laboratory for testing. Test samples are collected through pricking a finger with a sharp object, called a lancet, thats included in the test kit.

    At-home HCV testing is a form of hepatitis C antibody testing and does not test for hepatitis C RNA or the strains genotype. Testing for hepatitis C at home is not a substitute for testing performed by a health care professional, and positive test results may need to be confirmed by laboratory-based testing.

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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.

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