Friday, April 19, 2024

Hepatitis C Ab W/reflex To Hcv Rna Qn Pcr

Identifying Patterns Of Risky Behavior

Screening is an opportunity to draw attention to the clients behaviors that put him or her at risk for contracting :

  • Ask for the clients perception of his or her risk for having contracted : How likely do you think it is that the test will be positive?
  • Listen for and identify behaviors that put the client at risk for contracting , B, and C and HIV, especially unprotected sex and sharing injection drug paraphernalia.
  • Assess the clients alcohol consumption.

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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%.

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.

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

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.

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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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.

Determining The Prevalence Threshold For The Recommendations

Although the intent of public health screening is usually to identify undiagnosed disease, many persons previously diagnosed with hepatitis C are not appropriately linked to care and are not cured of their HCV infection, thereby representing an ongoing source of transmission. Therefore, the prevalence threshold of 0.1% should be determined on the basis of estimates of chronic hepatitis C prevalence, regardless of whether hepatitis C has been diagnosed previously.

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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

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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What The Qualitative Results Mean

The qualitative results indicate that HCV is present in your blood. The test result will be either detected or undetected.

Detected means that you do have the virus in your blood. Undetected means that you dont have the virus in your blood, or you have a tiny amount that cant be detected by this test.

The qualitative test results may still be positive even if your viral load has decreased drastically due to treatment.

Hepatitis C Antibody With Reflex To Hcv Rna Quantitative Real

NEW YORK DOH APPROVED: YESCPT Code: SynonymsSpecimenVolumeContainer:

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:

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    Clinical And Laboratory Assessments

    Demographic data, medication history including antiviral agents and comorbidities such as malignancy were assessed based on electronic medical records.

    Laboratory tests included assessments of serology associated with HBV infection, liver function, AFP levels, platelet counts, and antibodies against hepatitis C virus and human immunodeficiency virus. Serologic markers for HBV including HBsAg, anti-HBs, hepatitis B e antigen , and anti-HBe were assessed by chemiluminescent microparticle immunoassays . The concentration of HBsAg was determined using a previously generated Architect HBsAg calibration curve , and the samples with higher than 250 IU/ml HBsAg levels were diluted to 1:5001:1000. By June 2010, qHBsAg more than 250 were expressed as > 250 IU/ml without presenting an exact value. Thus, we divided subjects into 2 groups as those with qHBsAg> 250 IU/ml and those with qHBsAg250 IU/ml in this study.

    Serum HBV DNA levels were measured with Roche COBAS TaqMan quantitative PCR assay, which has a low detection limit of 20 IU/mL. The threshold for anti-HBs positivity was an anti-HBs titer > 10 IU/mL. Blood samples were collected before 10:00 AM after the patients had completed a 12-h overnight fast. All laboratory tests were conducted using standard methods.

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    Additional Specimen Collection Information

    Collect blood in a lithium heparin, green-top, EDTA purple-topor red-top tube. PST and SST are acceptable. Serum orplasma should be separated from contact with the cells within 2hours of collection. Specimens not centrifuged within 4 hours ofcollection may be rejected. Refrigerate the specimen if unable toassay within 8 hours of collection. Samples with > 1+ lipemiamust be cleared prior to analysis.

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    New Testing Options For Hepatitis C Virus

    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.

    Definition Of Hcc Occurrence Cirrhosis And Significant Fibrosis

    HCC was diagnosed according to the guidelines of the American Association for the Study of Liver Disease. The presence of cirrhosis was reviewed according to imaging findings of cirrhotic hepatic change and/or clinical criteria indicating portal hypertension, such as the presence of ascites, esophageal or gastric varix, or splenomegaly with thrombocytopenia.

    Hepatic fibrosis was defined using a noninvasive prediction model Fibrosis-4 index. The equation for FIB-4 index is as follows

    FIB-4=age x AST / x 1/2)

    Subjects with FIB-4> 1.45 were regarded as those who have high probability of advanced fibrosis,.

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    False Reactive Test Results

    What if I have a false reactive test result?

    Every donation given to Canadian Blood Services is tested for infectious diseases caused by the hepatitis viruses B and C, HIV, syphilis and another uncommon virus called HTLV .

    A false reactive test result means your initial screening test was reactivein other words, suggested the presence of something that would prevent you from donating bloodand a more precise follow-up test was negative. Almost all false reactive results occur because of interference with a test and are not necessarily due to testing positive for an infection.

    FAQS

    How does Canadian Blood Services test blood?

    We follow a two-stage testing method that is used in laboratories worldwide. In the first stage, a sensitive screening test looks for the possible presence of infection. If the screening test shows no reaction, the blood is considered free of infection and no further testing is done. However, if the screening test is reactive, further testing is done to sort out whether the reactive result was due to an infection in the blood or interference with the test. The second test identifies markers in the blood that are found only when infection is present.

    Do I need to go to my doctor for repeat testing?

    Yes. Repeat testing should be discussed with your doctor because he/she is in the best position to offer you personal medical advice.

    Do my partner, children, or friends need to worry if Ive had a false reactive result?

    Hepatitis B Blood Tests

    The Hepatitis B Panel of Blood Tests

    Only one sample of blood is needed for a hepatitis B blood test, but the Hepatitis B Panel includes three parts. All three test results are needed to fully understand whether a person is infected or not. Below is an explanation of the 3-part Hepatitis B Panel of blood test results.

  • HBsAg A positive or reactive HBsAg test result means that the person is infected with hepatitis B. This test can detect the actual presence of the hepatitis B virus in your blood. If a person tests positive, then further testing is needed to determine if this is a new acute infection or a chronic hepatitis B infection. A positive HBsAg test result means that you are infected and can spread the hepatitis B virus to others through your blood.
  • anti-HBs or HBsAb A positive or reactive anti-HBs test result indicates that a person is protected against the hepatitis B virus. This protection can be the result of receiving the hepatitis B vaccine or successfully recovering from a past hepatitis B infection. This test is not routinely included in blood bank screenings. A positive anti-HBs test result means you are immune and protected against the hepatitis B virus and cannot be infected. You are not infected and cannot spread hepatitis B to others.
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    Virus Description And Transmission

    HCV is a small, single-stranded, enveloped RNA virus in the flavivirus family with a high degree of genetic heterogeneity. Seven distinct HCV genotypes have been identified. Genotype 1 is the most prevalent genotype in the United States and worldwide, accounting for approximately 75% and 46% of cases, respectively . Geographic differences in global genotype distribution are important because some treatment options are genotype specific . High rates of mutation in the HCV RNA genome are believed to play a role in the pathogens ability to evade the immune system . Prior infection with HCV does not protect against subsequent infection with the same or different genotypes.

    Hepatitis C Antibody Blood Test With Reflex On Positives

    A Hepatitis C Antibody Blood Test with Reflex on Positives is used to assess exposure to hepatitis C virus infection and tests blood safety.

    No fasting required. Stop biotin consumption at least 72 hours prior to the collection.

    Test Results:

    1-3 days. May take longer based on weather, holiday or lab delays.

    No fasting required. Stop biotin consumption at least 72 hours prior to the collection.

    Test Results:

    2-3 days. May take longer based on weather, holiday or lab delays.

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    How To Get Tested

    Hepatitis B testing is typically prescribed by a doctor and performed in a hospital, lab, or other medical setting. Taking a hepatitis B test requires a blood sample, which can be collected by a health care professional.

    For laboratory-based testing, blood is drawn from a patientâs vein. After blood is collected, the sample is sent to a laboratory for analysis.

    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:

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    Educating Clients About Viral Hepatitis

    Clients may believe they know about viral , but their understanding of the disease may not be accurate. It is easy to confuse the three main types of viral , B, and C. Clients may have formed impressions based on limited or incorrect information. Counselors should briefly describe hepatitis A, B, and C, including their prevalence, , and relationship to drug use, as well as to other infections, such as HIV and sexually transmitted diseases. Specific strategies for speaking with clients include:

    • Speak clearly and keep the message simple, focused, and brief.
    • Use language, examples, and concepts that the client understands.
    • Use appropriate visual aids.
    • Frame numerical statements in terms that are easy to visualize. Say 5 out of 100 people rather than 5 percent of the population say more than half instead of the majority.
    • Repeat the information at different times in different ways. The average client retains only approximately one-third of what he or she is told. Summarize essential points.
    • Pay attention to a clients response to the information. For example, if a client stiffens his or her posture, consider saying, I notice that this topic seems to make you uncomfortable. It does for a lot of people. Please tell me what youre feeling right now. Id really like to help you with this.
    • Use the opportunity to describe the potential detrimental effects of alcohol and other substance use on the liver of a person who is infected with HCV.

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