Monday, January 23, 2023

Hepatitis C Antibody W/reflex To Pcr

How Much Does The Test Cost

Point-of-care hepatitis C virus RNA testing: A step by step guide

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.

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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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 Is Often Asymptomatic

Offer testing to anyone with a risk factor or clinical indication.

Risk factors:

  • shared drug-use equipment, even once
  • received personal services , with nonsterile equipment
  • exposed to blood during sexual activity
  • received blood, blood products, or organ transplant before 1992
  • received medical care where non-sterile equipment may have been used
  • born, travelled, or lived in a region where hepatitis C is common
  • born to a mother with hepatitis C
  • diagnosis of HIV or hepatitis B
  • clinical clues or symptoms of liver disease
  • occupational exposure

Enzyme Immunoassays For Detection Of Hepatitis C Antibody

The HCV Ab test is used for initial screening for hepatitis C. The test is performed by enzyme immunoassays , which detect the presence of hepatitis C antibodies in serum. The result of the test is reported as positive or negative. Third-generation EIAs have a sensitivity/specificity of approximately 99%. However, the presence of HCV Ab does not indicate whether the infection is acute, chronic, or resolved. A positive antibody test result should be followed up with an HCV RNA test to confirm that viremia is present.

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Interpreting Hcv Rna Test Results

It is essential that the provider understands how to interpret HCV RNA test results, especially during the course of HCV treatment.

Result of HCV RNA Test Interpretation
A quantified viral load any exact number Ongoing HCV infection
Detected The HCV RNA is detectable but the number of international units is so low that it cannot be quantified accurately. This indicates extremely low level of virus is present.
< 12 IU/mL or < 15 IU/mL or < 25 IU/mL All of these are less than the LLOQ HCV RNA is undetectable. No virus is detected at all in the patients serum specimen.

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.

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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.

Can I Take The Test At Home

Viral Hepatitis A and E

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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Other Things To Know:

  • The viral load measurement does not tell us anything about the severity of a patients 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.

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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Hepatitis C Testing Strategy

The goal of hepatitis C screening is to identify persons who are currently infected with HCV. Hepatitis C testing should be initiated with a U.S. Food and Drug Administration -approved anti-HCV test. Persons who test anti-HCV positive are either currently infected or had past infection that has resolved naturally or with treatment. Immunocompetent persons without hepatitis C risks who test anti-HCV negative are not infected and require no further testing. Persons testing anti-HCV positive should have follow-up testing with an FDA-approved nucleic acid test for detection of HCV RNA. NAT for HCV RNA detection determines viremia and current HCV infection. Persons who test anti-HCV positive but HCV RNA negative do not have current HCV infection. CDC encourages use of reflex HCV RNA testing, in which specimens testing anti-HCV positive undergo HCV RNA testing immediately and automatically in the laboratory, using the same sample from which the anti-HCV test was conducted. Hepatitis C testing should be provided on-site when feasible.

What Does A Negative Hcv Antibody Test Result Mean

A negative antibody test result usually means that the person has not been infected with hepatitis C .

The body needs at least two months to make antibodies. People with weakened immune systems are not always able to produce antibodies. This might happen in people with autoimmune disorders , HIV-positive people with a CD4 cell count below < 200 cells/mm3, and people taking immunosuppressants.

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Hcv Core Antigen Testing

The hepatitis C core antigen is a viral protein. Since the core antigen is part of hepatitis C virus, it can usually be found in the bloodstream two weeks after infection.

Since HCV core antigen testing is simpler and less expensive than viral-load testing, some experts suggest using it in resource-limited settings. Core antigen testing can be usedoften with HCV antibody testingto detect acute HCV or to confirm chronic HCV infection. HCV core antigen testing can also be used to measure treatment outcome. Although it does not detect low levels of HCV , usually the hepatitis C viral load is much higher in people who relapse after HCV treatment.

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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Summary Of The Literature

For the all-adult review, the initial literature search yielded 4,867 studies. Twenty-nine duplicates were identified. Of 4,838 unique studies, 4,170 were deemed irrelevant by title/abstract screening, resulting in 668 full texts for review. Among these, 368 studies had data available to extract.

For the pregnancy review, the initial literature search yielded 1,500 studies. Two duplicates were identified. Of 1,498 unique studies, 1,412 were deemed irrelevant by title/abstract screening, resulting in 86 full texts for review.

The supplementary review yielded an additional 1,038 and 195 studies among all adults and pregnant women, respectively. Of these, 912 and 168 , respectively, were deemed irrelevant by title/abstract screening, resulting in 126 and 27 , respectively, full texts for review. One study was added to the pregnant women review outside of the formal literature search .

Considering all 104 applicable studies, the median anti-HCV positivity prevalence among all adults was 6.6% . Median anti-HCV positivity prevalence was 1.7% for the general population , 7.5% for ED patients , 3.3% for birth cohort members , 9.3% for others/multiple risk factors , 54.2% for persons who use drugs , 5.2% for persons with HIV or sexual risk , and 4.7% for immigrants . Considering 26 applicable studies among pregnant women, median anti-HCV positivity prevalence was 1.2% .

How Is A Person Tested For Hepatitis C

3. How to Read an ANA IFA Pattern 3 Steps

A viral-load test is used to check for hepatitis C in the bloodstream. Usually, hepatitis C virus can be found in a persons bloodstream two weeks after he or she becomes infected.

*Except in case of recent risk or in people with a weakened immune system**During the first six months after HCV infection, a person may spontaneously clear the virus if there was a recent risk, repeat viral-load testing to confirm chronic hepatitis C infection

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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.

Clinical Features And Natural History

Persons with acute HCV infection are typically either asymptomatic or have a mild clinical illness like that of other types of viral hepatitis . Jaundice might occur in 20%30% of persons, and nonspecific symptoms might be present in 10%20% of persons. Fulminant hepatic failure following acute hepatitis C is rare. The average time from exposure to symptom onset is 212 weeks . HCV antibodies can be detected 410 weeks after infection and are present in approximately 97% of persons by 6 months after exposure. HCV RNA can be detected as early as 12 weeks after exposure. The presence of HCV RNA indicates current infection .

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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?

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.

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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.

Explanation Of Test Results:

If this test result is positive, it means your body was exposed to the hepatitis C virus and made antibodies . However, it does not tell you whether you are still infected with hepatitis C. If the antibody test result is positive, you should be tested for hepatitis C RNA , which determines whether you are chronically infected. The lab will perform this RNA test automatically if your hepatitis C antibody test is positive.

If the antibody test result is negative, it means you have not been infected with the hepatitis C virus, and further testing for hepatitis C usually is not needed.

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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.

    Time For Processing Hcv Ab Test Results

    Vertically transmitted infections (TORCH infections)

    The turnaround time for 3rd-generation EIAs is at least 1 day. Many labs do not perform the tests on site and must send specimens to another lab for processing, which may further increase the turnaround time.

    A point-of-care test is also available. The OraQuick® HCV Rapid Antibody Test is an FDA-approved test that can be performed with a fingerstick . It is also a CLIA-waived test and therefore can be used in clinic offices and outreach facilities. Results are reported as reactive or nonreactive within 20 minutes. Just as for the standard HCV Ab test done in the lab, a positive OraQuick® test must be confirmed by an HCV RNA test. The sensitivity and specificity of the test is similar to that of the laboratory-based assays.

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