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Hepatitis C Pcr Quantitative Test

What To Know About Hepatitis C Testing

Interpreting HCV PCR (Quantitative) test

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:

Viruses For Analytical Studies

The Chinese National standard for HCV, which has an assigned concentration of 1.25Ã10 IU/mL, was serially diluted in negative human plasma to a final concentration ranging from 1Ã10 to 1Ã10 IU/mL, and were used as reference standards for each real-time PCR run. Analytical verification studies were performed with a commercial panel of clinical specimens containing HCV Gt 1a, Gt 2b, and Gt 3a viruses . For a standardized evaluation, we obtained a Chinese National reference viral quality control plasma preparation panel containing well-characterized HCV RNA levels. These samples were tested extensively and contain HCV RNA levels ranging from no HCV RNA to 107 HCV molecules per mL.

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Hepatitis C Antibody With Reflex To Hcv Rna Quantitative Real

Test Code: 8472

Methodology: Immunoassay

Includes: If Hepatitis C Antibody is reactive, then Hepatitis C Viral RNA, Quantitative, Real-Time PCR will be performed at an additional charge.

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.

Alternative Name: HCV with Reflex,HCV Antibody,Anti HCV

Supply: T01 Red/Gray SST 8.5mL

Preferred Specimen: Serum

Transport Container: Serum Separator Tube

Transport Temperature: Room Temperature

Specimen Stability: Room Temperature: 72 hours

Rejection Criteria: Moderate Hemolysis, Gross Lipemia

For additional supply or collection device information, please contact DLOs Customer Service at 891-2917, option 2.

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What Is Pcr Testing

RNA testing refers to an advanced technology that is used to detect ribonucleic acid from the hep C virus .

Several types of RNA technologies exist with the most commonly-used version being the Polymerase Chain Reaction test. Less commonly used versions include the transcription mediated amplification test which is used as a screening test by Australian blood banks, and the branched chain DNA test which is generally used as a research tool.

Unlike the HCV antibody test that looks for signs that the body has at some time mounted an immune response to HCV, the PCR test looks for current presence of the virus.

With hep C, there are 3 types of PCR tests:

  • PCR viral detection test: it looks for the virus
  • PCR viral load test: it looks for the virus and estimates how many HCV viruses per millilitre of blood
  • PCR genotype test: it looks for the particular genotype of HCV.

When Should I Get Hepatitis C Testing

Changes to Quantitative Viral PCR Reporting of Low Positives

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.

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What To Expect During Testing

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.

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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Was Bedeuten Positive/erhhte Beziehungsweise Negative Hcv

Ein positiver Nachweis von HCV-RNA im Blut kann folgende Ursachen haben:

  • akute Hepatitis C
  • chronische Hepatitis C

Ein negativer HCV-RNA-Test schließt eine HCV-Infektion mit hoher Wahrscheinlichkeit aus. Im Anschluss an eine akute Hepatitis C muss der HCV-RNA-Nachweis über einen längeren Zeitraum negativ bleiben, bevor von einer Ausheilung gesprochen werden kann.Bei der Therapie der chronischen Hepatitis C bedeutet ein negatives HCV-RNA-Ergebnis, dass die Behandlung erfolgreich ist. Allerdings müssen hier regelmäßige Verlaufskontrollen durchgeführt werden.Mehr Informationen zum Thema

Quantitative assays ascertain HCV RNA quantity in blood, using signal amplification or target amplification techniques . RT-PCR is more sensitive than bDNA testing. The HCV RNA level in blood helps predict the likelihood of a response to treatment, and the change in HCV RNA level can also be used to monitor the therapeutic response.

The same quantitative test should be used throughout therapy to avoid confusion, and results should be reported in international units to standardize data. The Versant HCV RNA Assay, version 3.0, is based on bDNA technology and has a dynamic range of 615-7,700,000 IU/mL. Another FDA-approved HCV quantitative test is the Aptima HCV Quant Dx Assay its limit of detection is 3.9 IU/mL in plasma and 3.4 IU/mL in serum.

The following are the best laboratory evidence of acute HCV infection:


Tests After The Diagnosis

Blood Test : HCV RNA By Real Time PCR Quantitative

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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Extraction Of Nucleic Acids

Nucleic acids were extracted from 200 L of serum using a QIAamp MinElute Virus Spin kit according to the manufacturers suggested protocol. The concentration and quality of the extracted DNA and RNA were assessed by Nanovue spectrophotometry and by amplification of a fragment of the gene coding for -actin . The extracted DNA and RNA were stored at 80 °C until use.

Preparation Of Duplex Mutation Primers

The fluorophore primers and the reverse primers were used to amplify a 94-bp fragment in the highly conservative 5 non-coding region of the HCV RNA. The fluorophore primers were quenched by partly complementary oligonucleotides of a single-base mismatched labeled with a quencher at 3-end. All of the primers were selected using the primer premier 5.0 software and were synthesized, purified and labeled by Takara Ltd. Dalian, China.

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Can I Take The Test At Home

You have options for hepatitis C screening, and that includes at-home testing where you can collect a blood sample by a finger prick and send your specimen to a lab. Not all types of HCV testing can be performed at home, and these tests do not screen for hepatitis C RNA or the strains genotype.

The benefit of an at-home test is that it can expose a past or active infection, though it will not reveal which. Its a great way to initially test for HCV before advancing to lab testing. Positive results should be confirmed by a health professional through lab testing.

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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Sensitivity And Linearity Of The Real

The analytical sensitivity of our method was determined by serial dilutions of pFKI389-NS3-3 HCV subgenomic replicon plasmid containing from 0 to 20 × 106 copies tested 5 times each standard dilution was tested in triplicate. The detection limit was determined at 100 HCV copies per reaction with 100% detection ability . The correlation coefficient was 0.99 .

Taking A Hepatitis C Test

Hepatitis C testing requires a blood sample that is gathered from a vein , or by a skin prick. With lab testing, a doctor, nurse, or another health care provider will draw blood and prepare the sample for analysis. If you choose at-home hepatitis C testing, a kit will be mailed to you and generally includes a dried spot card and necessary supplies to collect a blood sample. The kit will include specific instructions for you to follow.

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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:

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

Interpreting HBV PCR (Quantitative) test.

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 B Pcr Quantitative Blood Test

This test is used to look for the presence of Hepatitis B viral genetic material in the blood. The results for this test are quantitative, meaning they provide a numerical result rather than a simple positive or negative. Because Viral DNA is often detectable sooner than antibodies developed in response to an infection, Hep B PCR testing can be used as a screening for people who have had a recent exposure. This test can also be used as a confirmatory test for a previous positive result or to assist in monitoring the effects of antiviral therapy.

Hepatitis B is a viral liver infection that is spread through exposure to infected blood or bodily fluids. It is the most common cause of acute viral Hepatitis. Hepatitis B infections often show no symptoms but when symptoms do occur they are often described as flu-like. Common symptoms include abdominal pain, fever, loss of appetite, nausea, joint pain, fatigue, jaundice, and dark-colored urine. Chronic Hep B infections can cause serious health complications like Cirrhosis and Liver Cancer.

This test is typically ordered by people:

  • Who require screening for Hepatitis B but may not yet be at a point after exposure where a Hep B surface Antigen test will be accurate.
  • Are receiving treatment for Hep B and wish to monitor their viral levels to see how effective their course of treatment is.
  • Require a highly sensitive test to confirm the results of a previous Hepatitis B test.

Detection Period:

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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Hcv Rna Hepatitis C Viral Rna Quantitative


This test is generally useful in monitoring Hepatitis C Virus.

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