Materiały źródłowe

• #1 Hepatitis C virus: Screening, diagnosis, and interpretation of laboratory assays

  https://pmc.ncbi.nlm.nih.gov/articles/PMC3943138/

  An estimated 3% of the world population is infected with Hepatitis C virus (HCV), a hepatotropic RNA virus, transmitted primarily via the blood route. […] The mainstay in diagnosing infection with HCV is to initially screen high risk groups for antibodies to HCV (anti-HCV). […] Nucleic acid amplification tests (NAT) are used as confirmatory tools, and also to determine viral load prior to initiating treatment. […] Genotyping is an important tool in clinical management to predict the likelihood of response and determine the optimal duration of therapy. […] All health care practitioners need to understand how to establish or exclude a diagnosis of HCV infection and to interpret the tests correctly. […] In the absence of a preventive or therapeutic vaccine, and also of post-exposure prophylaxis against the virus, it is imperative to diagnose infection by HCV so as to prevent hepatic insult and the ensuing complications that follow, including primary hepatocellular carcinoma (HCC).

• #1 Testing for Hepatitis C | Hepatitis C | CDC

  https://www.cdc.gov/hepatitis-c/testing/index.html

  Getting tested for hepatitis C is the only way to find out if you have HCV infection. […] You should get tested for hepatitis C at least once in your life. […] Some people may need periodic testing. […] If you find out you have hepatitis C, your doctor can give you lifesaving treatment. […] It is important to get tested for hepatitis C, especially if you think you’ve been exposed. […] Many people do not have symptoms, so testing is the only way to know if you have hepatitis C. […] CDC recommends hepatitis C screening for all adults 18 and older at least once in their lifetime. […] CDC recommends at least one-time testing for people who currently inject drugs, or even did so once or long ago. […] Antibody tests are used to find out if you have ever been infected with HCV. […] If your antibody test is positive or reactive, the doctor or the lab will automatically do a second test on your blood to see if you still have the virus in your body.

• #1

  https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

  HCV infection is diagnosed in 2 steps: Testing for anti-HCV antibodies with a serological test identifies people who have been infected with the virus. […] If the test is positive for anti-HCV antibodies, a nucleic acid test for HCV ribonucleic acid (RNA) is needed to confirm chronic infection and the need for treatment. […] Innovative new test such as HCV core antigen are in the diagnostic pipeline and will enable a one-step diagnosis of active hepatitis C infection in the future. […] Early diagnosis can prevent health problems that may result from infection and prevent transmission of the virus. […] WHO recommends testing people who may be at increased risk of infection. […] WHO recommends that all adults have access to and be offered HCV testing with linkage to prevention, care and treatment services.

• #1 Laboratory Tests and Hepatitis C – Viral Hepatitis and Liver Disease

  https://www.hepatitis.va.gov/hcv/screening-diagnosis/laboratory-tests.asp

  Laboratory tests for hepatitis C are divided into four general categories: […] Screening for hepatitis C virus (HCV) is done with a serologic test for the HCV antibody (Ab). […] Diagnosis of chronic hepatitis C requires the presence of HCV RNA, commonly called hepatitis C viral load. […] Once it is determined that HCV RNA is present, the specific genotype and subtype of the virus can be determined with a genotype test. […] The HCV Ab test is used for initial screening for hepatitis C. […] A positive antibody test result should be followed up with an HCV RNA test to confirm that viremia is present. […] The presence of HCV RNA is required to confirm chronic HCV infection. Therefore, a positive HCV Ab screening result must be followed by a test for the HCV RNA. […] There are 4 major reasons that HCV RNA tests are used: To confirm a positive HCV Ab result and make the diagnosis of current HCV infection. […] Genotype testing is performed by analyzing the sequences of various regions of the HCV genome. […] RAV testing is done in most patients who have failed a prior DAA-containing regimen before they initiate re-treatment with another DAA regimen.

• #1 Hepatitis C virus: Screening, diagnosis, and interpretation of laboratory assays

  https://pmc.ncbi.nlm.nih.gov/articles/PMC3943138/

  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 (AASLD) recommends screening for HCV for the following individuals: Recipient of blood or blood components (red cells, platelets, fresh frozen plasma). […] Virological diagnosis of HCV infection is based on two categories of laboratory tests, namely serologic assays detecting specific antibody to HCV (anti-HCV) (indirect tests) and assays that can detect, quantify, or characterize the components of HCV viral particles, such as HCV RNA and core antigen (direct tests). […] The serologic window between HCV infection and the detection of specific antibodies varies from patient to patient. […] Confirmation of serological reactive tests may be done by a nucleic acid test (NAT) for detection of HCV RNA. […] The diagnosis of HCV infection is established with antibody screening followed by NAT for HCV RNA for confirmation as well as for follow-up of patients on treatment.

• #1 Hepatitis C (Hep C) Transmission Sexually, Symptoms, Curable

  https://www.medicinenet.com/how_is_diagnosis_of_hepatitis_c_made/views.htm

  How is hepatitis C diagnosed? […] There are several blood tests for the diagnosis of hepatitis C infection. Blood can be tested for antibodies to hepatitis C (anti-HCV antibody). It takes about 8-12 weeks on average, and up to 6 months, for antibodies to develop after the initial infection with hepatitis C, so screening for antibodies may miss a few newly infected individuals. Having antibodies is not an absolute indication of active, multiplying hepatitis C virus, but if the antibody test is positive (antibody is present), the statistical probability of active infection is greater than 99%. […] Several tests are available to measure the amount of hepatitis C virus in a person’s blood (the viral load). The hepatitis C virus’s RNA can be identified by a type of test called polymerase chain reaction (PCR) that detects circulating virus in the blood as early as 2-3 weeks after infection, so it can be used to detect suspected acute infection with hepatitis C early infection. It also is used to determine whether active hepatitis is present in someone who has antibodies to hepatitis C and to follow the viral load during treatment.

• #1 Hepatitis C RNA Qualitative Testing: Test of Hepatitis C – Viral Hepatitis and Liver Disease

  https://www.hepatitis.va.gov/hcv/patient/diagnosis/labtests-RNA-qualitative-testing.asp

  Hepatitis C RNA qualitative testing – Hepatitis C for Patients […] The qualitative HCV RNA tests will report whether the hepatitis C virus is present in the bloodstream or not. The result is reported as either „detected” or „not detected.” […] If a qualitative RNA test is positive (detected), then it is confirmed that the patient has chronic hepatitis C. The „qualitative” test is more accurate than the „quantitative” test because qualitative tests are able to detect very low levels of the virus. […] If a patient has a quantitative test that shows no detectable virus, but has a positive result with the qualitative test, it means there is a very low level of virus that can be detected only with the qualitative test. […] The qualitative test will become negative during hepatitis C treatment and indicates a good response.

• #1 Testing for Hepatitis C | Hepatitis C | CDC

  https://www.cdc.gov/hepatitis-c/testing/index.html

  If you might have been exposed to HCV within the past 6 months, your doctor should order a NAT for HCV RNA rather than an HCV antibody test. […] A non-reactive or negative antibody test result means you are not currently infected with HCV. […] A reactive or positive antibody test result means you have been infected with HCV at some point in your life. […] If your antibody test is reactive, the doctor will automatically test your blood sample for the virus using the NAT for HCV RNA. […] If the NAT test is positive, that confirms you are currently infected with HCV. […] If you do have a reactive antibody test and a positive NAT for HCV RNA, you will need to talk to your doctor about how to stay healthy.

• #1 Hepatitis C Virus Diagnostics: The Road to Simplification

  https://pmc.ncbi.nlm.nih.gov/articles/PMC6385922/

  The ambitious goal of eliminating viral hepatitis as a public health problem by 2030 will require major efforts to prevent new infections, but perhaps more importantly, there will have to be a dramatic increase in diagnosing those already infected and linking them to care. […] The traditional approach to HCV diagnosis requires an initial antibody (Ab) test to document exposure, followed by a confirmation of ongoing viremia, usually using a polymerase chain reaction (PCR) based assay to quantify the level of HCV RNA in the blood. […] Current Ab and HCV RNA assays have very high sensitivity and specificity, making false positive and false negative results rare occurrences. […] The real challenge of the traditional approach is the need for two blood tests. […] The simplest solution to ensuring an HCV RNA test is done for all positive Ab tests is to reflex the testing.

• #1 Hepatitis C: What to know now about testing and treatment | Mass.gov

  https://www.mass.gov/info-details/hepatitis-c-what-to-know-now-about-testing-and-treatment

  A 2022 DPH survey of laboratories found that only 1/3 of clinical laboratories in Massachusetts currently conduct CDC-recommended reflex testing. […] DPH urges laboratories and health care providers to update operational practices to support, as a standard of practice, reflex testing on same-day samples. […] Universal testing is strongly recommended for: All adults aged 18 years and older, at least once in their lifetime. […] Testing regardless of age or setting is recommended for anyone at risk: People who inject drugs and shared needles, syringes, or other injection equipment, even if once or many years ago. […] Routine periodic testing is recommended for: People with ongoing risk, especially people who inject drugs.

• #1 Hepatitis C Workup: Approach Considerations, Hepatitis C Antibody Test, Qualitative and Quantitative Assays for HCV RNA

  https://emedicine.medscape.com/article/177792-workup

  Other baseline studies include the following: Complete blood cell (CBC) count with differential, International normalized ratio (INR), Liver function tests, including levels of ALT and AST, alkaline phosphatase, albumin, and total and direct bilirubin, Calculated glomerular filtration rate (eGFR), Thyroid function studies, Screening tests for coinfection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV), Screening for alcohol abuse, drug abuse, and/or depression, Hepatitis B virus (HBV) testing with hepatitis B surface antigen (HBsAg) (to identify coinfection), as well as hepatitis B surface antibody (anti-HBs) and antibody against hepatitis B core antigen (anti-HBc) (for evidence of previous infection). […] Liver biopsy is not considered mandatory before the initiation of treatment for hepatitis C, but it may be helpful for assessing the activity and severity of hepatitis C virus-related liver disease. However, some experts recommend biopsy only in the following situations: The diagnosis is uncertain, Other coinfections or disease may be present, The patient being considered for treatment has normal liver enzyme levels and no extrahepatic manifestations, The patient is immunocompromised.

• #1 Core Concepts – Diagnosis of Acute HCV Infection – Screening and Diagnosis of Hepatitis C Infection – Hepatitis C Online

  https://www.hepatitisc.uw.edu/go/screening-diagnosis/acute-diagnosis/core-concept/all

  Acute hepatitis C virus (HCV) infection is defined as the 6-month period following the acquisition of hepatitis C virus. […] The rationale for choosing 6 months as the time period to define acute infection is based on evidence that most individuals who spontaneously clear HCV will do so by 6 months. […] Very early infection typically refers to patients with a positive HCV RNA and documented HCV antibody seroconversion, with this scenario being the most definitive for diagnosing acute HCV infection. […] The key laboratory studies utilized in the evaluation of possible acute hepatitis C are HCV RNA, anti-HCV, and alanine aminotransferase (ALT). […] Patients who become infected with HCV will typically develop abnormal laboratory findings in the following order: detectable HCV RNA, followed by elevation in ALT, and then anti-HCV.

• #1 Diagnosis and Management of Hepatitis C | AAFP

  https://www.aafp.org/pubs/afp/issues/2015/0615/p835.html

  Assessing the degree of liver fibrosis and cirrhosis is necessary in patients with confirmed HCV infection to determine the urgency of treatment because the degree of liver fibrosis predicts disease progression and clinical outcomes. The Metavir scoring system grades fibrosis from 0 to 4, and treatment should be considered in patients with substantial fibrosis (score of 2 or greater). […] Liver biopsy is the preferred method to assess degree of fibrosis. However, noninvasive tests, such as direct biomarkers and liver elastography, may be used. Patients with chronic HCV infection should be assessed for hepatitis B and HIV infections, which may accelerate liver fibrosis.

• #1 HCV Testing and Linkage to Care | HCV Guidance

  https://www.hcvguidelines.org/evaluate/testing-and-linkage

  Among persons with a negative HCV-antibody test who were exposed to HCV within the prior 6 months, HCV-RNA or follow-up HCV-antibody testing 6 months or longer after exposure is recommended. […] HCV-RNA testing can also be considered for immunocompromised persons. […] Among persons at risk of reinfection after previous spontaneous or treatment-related viral clearance, HCV-RNA testing is recommended because a positive HCV-antibody test is expected. […] Quantitative HCV-RNA testing is recommended prior to initiation of antiviral therapy to document the baseline level of viremia (ie, baseline viral load). […] HCV genotype testing may be considered for those in whom it may alter treatment recommendations. […] Persons found to have a positive HCV-antibody test and negative results for HCV RNA by PCR should be informed that they do not have evidence of current (active) HCV infection but are not protected from reinfection.

• #1 Clinical Practice Guidance for Testing, Managing, and Treating Hepatitis C Virus Infection: 2023 Update by AASLD-IDSA

  https://www.idsociety.org/practice-guideline/hcv-guidance/

  The Infectious Diseases Society of America and the American Association for the Study of Liver Diseases have collaboratively developed evidence-based guidance regarding the diagnosis, management, and treatment of hepatitis C virus (HCV) infection since 2013. […] The Guidance Panel first recommended universal HCV screening for all adults aged 18 years in 2019, concomitant with congruous draft recommendations from the US Preventive Services Task Force (USPSTF) and the CDC. […] The rationale for universal HCV screening includes cost-effectiveness; improved HCV case finding; shifting epidemiology of HCV infection with incident infections occurring primarily in young adults; and the availability of safe, cost-effective direct-acting antiviral (DAA) treatment. […] For initial HCV testing, the Guidance Panel recommends HCV antibody screening with reflex HCV RNA testing to establish the presence of active infection (as opposed to spontaneous or treatment-induced viral clearance).

• #1 Point-of-Care RNA Testing for Hepatitis C | INHSU

  https://inhsu.org/intervention/point-of-care-rna-testing-for-hepatitis-c/

  This is a guide to point-of-care testing for hepatitis C (HCV) RNA. This guide provides an overview of how point-of-care HCV RNA testing works and how you can implement it in your service setting. […] A point-of-care test is a test that is performed close to or near where a person is receiving care, has a fast time to result, and may lead to an immediate and informed change in patient management, potentially facilitating a reduced number of visits leading to increased linkage to care. […] In this How-To Guide, we will focus on the Xpert® HCV Viral Load Fingerstick test, a point-of-care test which runs on the GeneXpert System, manufactured by Cepheid. This point-of-care test (or assay), tests for HCV RNA using finger-stick capillary whole blood. […] A blood sample for point-of-care HCV RNA testing can be collected and interpreted by trained health care professionals, frontline workers, and peers.

• #1

  https://www.who.int/news/item/24-01-2023-new-who-study-making-diagnosis-of-hcv-more-accessible-and-closer-to-the-community-using-poc-hcv-viral-load-assays

  Today, Lancet Gastroenterology and Hepatology published a key new WHO-led study in collaboration with the University of Bristol showing the benefit of using a quick clinic-based diagnostic test for hepatitis C virus (HCV) infection over a standard laboratory-based test. […] The standard approach to diagnosis of chronic HCV infection is initial screening with an HCV antibody test, followed by a laboratory-based molecular HCV viral load (VL) testing, to confirm the presence of active virus and need for treatment. […] HCV VL assays performed on point-of-care (POC) devices outside of the laboratory and in a clinic near to where patients receive care are being increasingly used as an alternative approach to laboratory-based diagnosis. […] This new study pooled results from 45 studies (around 50% were from LMICs) and compared POC HCV viral load assays with centralized, laboratory-based standard approaches. It showed that using POC HCV viral load assays led to faster times from initial HCV antibody screening to starting on treatment (19 days compared to 67 days).

• #1 Hepatitis C Virus Diagnostics: The Road to Simplification

  https://pmc.ncbi.nlm.nih.gov/articles/PMC6385922/

  Another mechanism for enabling reflex testing is the use of dried blood spot (DBS) testing for HCV. […] The ability to obtain an immediate test result avoids the need for return visits and tracking down individuals who do not return. Point of care (POC) tests have been developed for HCV Ab and, more recently, for HCV RNA. […] The purpose of HCV RNA testing is to confirm viremia. Detection of the core antigen (Ag), a part of the viral nucleocapsid, in the blood also confirms active infection. […] The main limitation of core Ag testing is the slightly reduced sensitivity; that is, most assays have a threshold of detection equivalent to ~10,000 IU/mL of HCV RNA. […] If POC core Ag test could be developed at low cost, it could potentially obviate the need for Ab testing at all, which would greatly simplify testing, particularly in resource limited settings. […] Different solutions may work better in different clinical settings, but simplification, particularly the use of reflex RNA testing for Ab positive samples, will be critical if we are going to reach the ambitious global elimination targets by 2030.

• #1 Current advances in Hepatitis C diagnostics | Journal of Biological Engineering | Full Text

  https://jbioleng.biomedcentral.com/articles/10.1186/s13036-024-00443-2

  The effective treatment of HCV relies on early diagnosis and antiviral medication. This is essential to minimize liver damage and prevent transmission. […] The traditional two-step testing process for HCV infection can be time-consuming. […] There is a clear and urgent need for the development of rapid, low-cost HCV diagnostics that can be used for at-risk populations, especially since HCV prevalence is higher among populations with limited access to healthcare. […] For treatment monitoring, the diagnostics must be highly sensitive to support the sustained virological response (SVR) standard for successful treatment, which equates to the virus being undetectable in the bloodstream. […] The initial antibody test can determine if the patient has ever been infected with HCV. […] The current gold standard NAAT for diagnosis of active HCV infection is reverse transcription polymerase chain reaction (RT-PCR) due to its ability to detect infection soon after exposure and its high sensitivity allowing for detection of small amounts of HCV RNA found in the bloodstream. […] The current two step screening process for HCV has several limitations that inhibit its effectiveness, especially for high-risk, low-resource populations. […] Overall, there has been considerable progress made toward improving HCV diagnostics from their current commercial standards.

• #1 Current and Future Diagnostics for Hepatitis C Virus Infection

  https://www.mdpi.com/2227-9040/13/2/31

  The Xpert HCV Viral Load test (a real-time RT-PCR) designed in 2015 and manufactured by Cepheid combines all steps of real-time RT-PCR into a single cartridge leveraging microfluidics. […] The Xpert HCV test and its associated GeneXpert Express System have recently been approved by the FDA for operations under a CLIA (Clinical Laboratory Improvement Amendments) Certificate Waiver. […] The emerging technologies being developed are paramount in improving affordability and sensitivity. […] POC rapid RNA detection can detect HCV when an active infection occurs, and antibodies are yet to be produced. […] If developed for HCV, these technologies can be used for the detection of other viral diseases.

• #1 Hepatitis C: Practice Essentials, Background, Pathophysiology

  https://emedicine.medscape.com/article/1996209-overview

  Tests for detecting HCV infection include the following: Hepatitis C antibody testing: Enzyme immunoassays (EIAs), rapid diagnostic tests (RDTs), and point-of-care tests (POCTs), Qualitative and quantitative assays for HCV RNA (based on polymerase chain reaction [PCR] or transmission-mediated amplification [TMA]), HCV genotyping, Serologic testing (essential mixed cryoglobulinemia is a common finding). […] Liver biopsy is not mandatory before treatment but may be helpful. Some restrict it to the following situations: The diagnosis is uncertain, Other coinfections or disease may be present, The patient has normal liver enzyme levels and no extrahepatic manifestations, The patient is immunocompromised. […] Treatment of acute hepatitis C has rapidly evolved and continues to evolve. HCV infection has become a curable disease, although a vaccine does not yet exist.

• #1 Core Concepts – Diagnosis of Acute HCV Infection – Screening and Diagnosis of Hepatitis C Infection – Hepatitis C Online

  https://www.hepatitisc.uw.edu/go/screening-diagnosis/acute-diagnosis/core-concept/all

  In the United States, the gold standard for the laboratory diagnosis of acute HCV is an HCV antibody seroconversion (documented negative HCV antibody test followed by a positive antibody test), combined with a positive HCV RNA test and elevated ALT. […] The key laboratory studies utilized in the evaluation of possible acute hepatitis C are HCV RNA, HCV antibody, and ALT; the HCV antibody and the HCV RNA tests should be ordered simultaneously and as separate orders, not as an HCV antibody/HCV RNA reflex test, which can miss acute HCV infection. […] The CDC 2020 case definition for acute hepatitis C includes clinical criteria, laboratory criteria, case classification as probable or confirmed, and criteria to distinguish a new case from an existing case.

• #1 Hepatitis C – Wikipedia

  https://en.wikipedia.org/wiki/Hepatitis_C

  HCV is spread primarily by blood-to-blood contact associated with injection drug use, poorly sterilized medical equipment, needlestick injuries in healthcare, and transfusions. […] Diagnosis is by blood testing to look for either antibodies to the virus or viral RNA. […] Chronic hepatitis C is defined as infection with the hepatitis C virus persisting for more than six months based on the presence of its RNA. […] Hepatitis C testing typically begins with blood testing to detect the presence of antibodies to the HCV, using an enzyme immunoassay. […] If this test is positive, a confirmatory test is then performed to verify the immunoassay and to determine the viral load. […] It takes about 6-8 weeks following infection before the immunoassay will test positive. […] Diagnosing patients is generally a challenge as patients with acute illness often present with mild, non-specific flu-like symptoms, while the transition from acute to chronic is sub-clinical.

• #1 Hepatitis C – Symptoms, diagnosis and treatment | BMJ Best Practice

  https://bestpractice.bmj.com/topics/en-us/128

  Hepatitis C virus transmission is through percutaneous exposure to infected blood, most commonly through injection of illicit drugs or transfusion of unscreened blood and blood products in developed countries, or via unsafe injection practices in resource-poor countries. […] Following acute exposure to hepatitis C virus, many patients develop chronic hepatitis C. Most infections are asymptomatic; however, hepatic inflammation is often present and can lead to progressive hepatic fibrosis. […] Hepatitis C is an inflammation of the liver caused by the hepatitis C virus (HCV). Infection may present as an acute illness (e.g., fatigue, arthralgia, jaundice) in approximately one third of patients; however, the majority of patients are asymptomatic. […] Patients with acute infection may spontaneously clear the virus. Chronic infection causes liver inflammation and fibrosis, and a significant number of these patients will develop cirrhosis and liver failure or liver cancer over a period of approximately 20 to 50 years. The infection rarely resolves spontaneously in patients with chronic infection.

• #1 Diagnosis and Management of Hepatitis C | AAFP

  https://www.aafp.org/pubs/afp/issues/2015/0615/p835.html

  Hepatitis C virus (HCV) infection, a major cause of chronic liver disease and cirrhosis, is predominantly transmitted by exposure to blood or body fluids. Screening for HCV with an anti-HCV antibody test is recommended for all adults at high risk of infection, and one-time screening is recommended in adults born between 1945 and 1965. If the anti-HCV antibody test result is positive, current infection should be confirmed with a qualitative HCV RNA test. In patients with confirmed HCV infection, quantitative HCV RNA testing and testing for HCV genotype is recommended. An assessment of the degree of liver fibrosis with liver biopsy or noninvasive testing is necessary to determine the urgency of treatment. […] The U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention recommend periodic HCV screening for all adults at high risk of infection and one-time screening in adults born between 1945 and 1965. An anti-HCV antibody test is recommended to screen for HCV infection (sensitivity of 95%, specificity of 99%, positive likelihood ratio of 95, and negative likelihood ratio of 0.05). If the anti-HCV antibody test result is positive, current infection should be confirmed with a qualitative measurement of HCV RNA.

• #1 Diagnosis of patients with suspected chronic hepatitis C infection | Annals of Hepatology

  https://www.elsevier.es/en-revista-annals-hepatology-16-articulo-diagnosis-patients-with-suspected-chronic-S1665268119317211

  A sensitive quantitative HCV RNA assay is recommended for diagnosis because it also provides information on the viremia. […] The differentiation between acute and chronic HCV infection depends on the clinical presentation, namely the presence of symptoms, such as jaundice, and whether or not there is a prior history of prolonged elevated ALT levels. […] Approximately 30% of the patients with chronic HCV infection have normal ALT levels at diagnosis, regardless of the age and gender, and many of them maintain normal liver function tests during prolonged follow-up.

• #1 Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

  https://www.mdpi.com/2075-4418/11/7/1253

  The simplification of current hepatitis C diagnostic algorithms and the emergence of digital diagnostic devices will be very crucial to achieving the WHO’s set goals of hepatitis C diagnosis (i.e., 90%) by 2030. […] Point-of-care (POC) rapid diagnostic tests (RDTs; POC-RDTs), RNA reflex testing, hepatitis C self-test assays, and dried blood spot (DBS) sample analysis have been proven their diagnostic worth in real-world clinical experiences both at centralized and decentralized diagnostic settings, in mass hepatitis C screening campaigns, and hard-to-reach aboriginal hepatitis C populations in remote areas. […] The present review article overviews the significance of current and emerging hepatitis C diagnostic packages to subvert the public health care burden of this ‘silent epidemic’ worldwide.

• #1

  https://www.natap.org/2018/HCV/061918_03.htm

  HCV diagnostics are essential to achieve global elimination. […] The world has embraced the call for global elimination of hepatitis C virus by 2030. […] Global access to hepatitis C virus diagnostics will be a keystone to success. […] Key challenges must be overcome and systems optimized to ensure widespread access to existing diagnostics. […] Improving access to rapid, simple, and affordable HCV diagnostics is critical to achieve global HCV elimination. […] The high efficacy and low toxicity of the new DAAs provide an exceptional opportunity to greatly simplify HCV diagnosis and care. […] HCV diagnosis of active infection through direct detection of the HCV virus is the only test required for patient treatment and care. […] The Holy Grail Point-of-Care Diagnostic Assay for Active Hepatitis C Virus Infection That Links All People with Hepatitis C Infection to Immediate Care Is Essential to Achieve Global Elimination.

• #1 Symptoms, transmission, and current treatments for hepatitis C | DNDi

  https://dndi.org/diseases/hepatitis-c/facts/

  Hepatitis C infection is diagnosed in two steps: A serological test is used to test for hepatitis C antibodies, produced by the body to fight the infection. A nucleic acid test is used to test for hepatitis C ribonucleic acid to confirm chronic infection. This test is needed because about 30% of people infected with hepatitis C whose infection clears up by itself will still test positive for hepatitis C antibodies long after they are no longer infected. […] Existing diagnostic tests remain too complex and/or too expensive for countries with limited budgets, weak health systems, or both. Simple, more affordable tests are needed. […] We are working with FIND and the Ministry of Health in Malaysia to simplify hepatitis C screening and make it more widely available.

• #1 Clinical Infrastructure – Stop Hepatitis C

  https://www.stophepatitisc.com/for-professionals/clinical-infrastructure/

  To implement HCV screening, evaluation, and management, our STOP HCC-HCV program offers practical tools and strategies to achieve high rates of baby boomer HCV screening and evaluation and treatment chronic HCV. […] Where possible, the EMR offers an essential component of successful HCV screening through a best practice alert (BPA) that notifies clinicians and staff when a patient is eligible for screening (e.g. ages 18 – 79). […] The most efficient test to order is an anti-HCV antibody that reflexes to a quantitative HCV RNA on the same blood sample to confirm chronic HCV. […] Eligible patients for HCV screening: All adults ages 18 – 79. […] Identify chronically infected patients (i.e. HCV RNA positive), along with the test results to stage the disease (described within the clinical protocols).

• #1

  https://www.natap.org/2018/HCV/061918_03.htm

  To eliminate HCV by 2030 as a public health concern, HCV care will need to be simplified to „test and treat” for all. […] The world can expect the arrival of transformational technologies in the next few years. […] Investments to maximize smart phone diagnostic innovations may provide opportunities to improve health care more broadly, including improved surveillance data collection in remote and resource-limited settings. […] The availability of new materials and innovative solutions such as 3-dimensional printing are also likely to further reduce costs and facilitate the scale-up of many of these technologies.

• #1 Hepatitis C: Symptoms, What It Is, How You Get It, Treatment

  https://my.clevelandclinic.org/health/diseases/15664-hepatitis-c

  They may order blood tests, including: Hepatitis C antibody test: This shows whether your blood contains antibodies to the virus. Hepatitis C RNA test: This test shows if the virus is still active. Genotype test: There are at least six strains or genotypes of hepatitis C. This test shows which strain you have. Your provider will use test results to recommend treatment. Liver function test: This test checks on your livers overall health. Transient elastography: This is an ultrasound of your liver. It measures the amount of fibrosis or stiffness in your liver. […] The most common treatment for chronic hepatitis C is direct-acting antiviral (DAA) medication. DAAs reduce the amount of virus in your body. Research shows these medications cure most cases of chronic hepatitis C. […] Yes, it can. About 25% of people with acute hepatitis C recover completely, meaning the virus goes away. And treatment can cure chronic hepatitis C if you receive a diagnosis and treatment before the infection causes serious liver damage.

• #1 Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

  https://www.mdpi.com/2075-4418/11/7/1253

  In this review, we decipher the potential roles of current and emerging simplified HCV diagnostic algorithms to achieve the global goal of HCV diagnosis, treatment, and reduction in HCV-associated mortalities according to WHO set goals by 2030. […] The simplification of the HCV care cascade including rapid HCV screening, infection diagnosis, treatment uptake, and cure monitoring as the realistic goals of their national hepatitis plan by some nations as well as international guidelines have resulted in substantial individual and global efforts to minimize new HCV outbreaks and enhanced the cure for HCV affected populations.

• #2 HCSRN – Overview: Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR, Asymptomatic, Serum

  https://www.mayocliniclabs.com/test-catalog/Overview/113122

  Hepatitis C virus (HCV) is recognized as the cause of most cases of posttransfusion hepatitis and is a significant cause of morbidity and mortality worldwide. In the United States, HCV infection is quite common, with an estimated 2.4 million chronically HCV-infected individuals. […] Laboratory testing for HCV infection usually begins by screening for the presence of HCV-specific antibodies in serum, using an U.S. Food and Drug Administration-approved screening test. Specimens that are repeatedly reactive by screening tests should be confirmed with HCV tests with higher specificity, such as direct detection of HCV RNA by reverse transcription polymerase chain reaction or HCV-specific antibody confirmatory tests. […] HCV antibodies are usually not detectable during the first 2 months following infection, but they are usually detectable by the late convalescent stage (>6 months after onset) of infection. These antibodies do not neutralize the virus and they do not provide immunity against this viral infection.

• #2 Hepatitis C: Diagnosis and Management | AAFP

  https://www.aafp.org/pubs/afp/issues/2021/1200/p626.html

  Screening recommendations and treatment guidelines for hepatitis C virus (HCV) infection have been updated. Universal screening with an anti-HCV antibody test with follow-up reflex HCV RNA polymerase chain reaction testing for positive results to confirm active disease is recommended at least once for all adults 18 years and older and during each pregnancy. […] Anti-HCV antibody testing (third-generation enzyme-linked immunosorbent assay with 99% sensitivity and specificity) is the screening test of choice with follow-up reflex HCV RNA polymerase chain reaction testing for positive results to confirm the active disease. […] The Centers for Disease Control and Prevention recommends universal HCV screening at least once for all adults 18 years and older and during each pregnancy. […] The U.S. Preventive Services Task Force recommends screening all asymptomatic adults (including people who are pregnant) 18 to 79 years of age and people younger or older who are at high risk of infection.

• #2 Hepatitis C: What to know now about testing and treatment | Mass.gov

  https://www.mass.gov/info-details/hepatitis-c-what-to-know-now-about-testing-and-treatment

  A 2022 DPH survey of laboratories found that only 1/3 of clinical laboratories in Massachusetts currently conduct CDC-recommended reflex testing. […] DPH urges laboratories and health care providers to update operational practices to support, as a standard of practice, reflex testing on same-day samples. […] Universal testing is strongly recommended for: All adults aged 18 years and older, at least once in their lifetime. […] Testing regardless of age or setting is recommended for anyone at risk: People who inject drugs and shared needles, syringes, or other injection equipment, even if once or many years ago. […] Routine periodic testing is recommended for: People with ongoing risk, especially people who inject drugs.

• #2

  https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

  HCV infection is diagnosed in 2 steps: Testing for anti-HCV antibodies with a serological test identifies people who have been infected with the virus. […] If the test is positive for anti-HCV antibodies, a nucleic acid test for HCV ribonucleic acid (RNA) is needed to confirm chronic infection and the need for treatment. […] Innovative new test such as HCV core antigen are in the diagnostic pipeline and will enable a one-step diagnosis of active hepatitis C infection in the future. […] Early diagnosis can prevent health problems that may result from infection and prevent transmission of the virus. […] WHO recommends testing people who may be at increased risk of infection. […] WHO recommends that all adults have access to and be offered HCV testing with linkage to prevention, care and treatment services.

• #2 HCSRN – Overview: Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR, Asymptomatic, Serum

  https://www.mayocliniclabs.com/test-catalog/Overview/113122

  Current screening serologic tests to detect antibodies to HCV include enzyme immunoassay and chemiluminescence immunoassays. […] Despite the value of serologic tests to screen for HCV infection, several limitations of serologic testing exist: There may be a long delay (up to 6 months) between exposure to the virus and the development of detectable HCV-specific antibodies in immunocompromised individuals. […] Reactive screening test results should be followed by a supplemental or confirmatory test, such as a nucleic acid test for HCV RNA or HCV antibody confirmatory test. Nucleic acid tests provide a very sensitive and specific approach for the direct detection of HCV RNA. […] If the hepatitis C virus (HCV) antibody screen is reactive, then HCV RNA by reverse transcription polymerase chain reaction) will be performed at an additional charge.

• #2 Core Concepts – Hepatitis C Diagnostic Testing – Screening and Diagnosis of Hepatitis C Infection – Hepatitis C Online

  https://www.hepatitisc.uw.edu/go/screening-diagnosis/diagnostic-testing/core-concept/all

  Initial testing for the diagnosis of hepatitis C infection uses serologic assays that detect human antibodies generated as a response to hepatitis C virus (HCV) infection. A positive HCV antibody test indicates one of the following three scenarios: (1) active infection, (2) past HCV infection that has resolved or been cured, or (3) a false-positive test. None of these anti-HCV antibody tests can differentiate whether the infection is new (acute), chronic, or no longer present. […] The HCV NAT becomes positive approximately 1 to 2 weeks after initial HCV infection. The NAT test has become the gold standard supplemental test for patients who have a positive HCV EIA screening test. The NAT can determine whether a patient with a positive HCV antibody test has current (active) or resolved HCV infection.

• #2 HCV RNA PCR: What to know about hepatitis C testing

  https://www.medicalnewstoday.com/articles/320736

  Doctors often use a quantitative test when establishing the diagnosis and to monitor the amount of HCV in the bloodstream during treatment. This lets them know how well the body is responding to the treatment, as well as helping them decide on any necessary changes in treatment. […] Doctors use the qualitative HCV RNA PCR test to determine whether or not the hepatitis C virus is present in the blood. […] 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. […] 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. […] HCV RNA PCR tests are an important part of diagnosing and treating HCV. Even after the initial diagnosis, individuals will still require periodic blood tests to make sure treatment is working.

• #2 Clinical manifestations, diagnosis, and treatment of acute hepatitis C virus infection in adults – UpToDate

  https://www.uptodate.com/contents/clinical-manifestations-diagnosis-and-treatment-of-acute-hepatitis-c-virus-infection-in-adults

  Clinical manifestations, diagnosis, and treatment of acute hepatitis C virus infection in adults […] By convention, acute hepatitis C virus (HCV) infection refers to the first six months of HCV infection following presumed HCV exposure. While HCV infection is estimated to account for 15 percent of symptomatic cases of acute hepatitis in the United States, the majority of patients with acute HCV go undetected. This is due in large part to the fact that patients with acute HCV are typically asymptomatic. […] Guidelines for the diagnosis and management of HCV infection were released jointly by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), are continuously updated, and can be accessed at www.hcvguidelines.org. The discussion in this topic is generally consistent with those guidelines. […] Most patients who are acutely infected with HCV are asymptomatic. Symptomatic patients may experience jaundice, nausea, dark urine, and right upper quadrant pain. Patients with acute HCV infection typically have moderate to high serum aminotransferase elevations.

• #2 Hepatitis C Reflex Testing

  https://www.health.ny.gov/diseases/communicable/hepatitis/hepatitis_c/providers/reflex_testing.htm

  The 2023 amendment to the New York State Testing Law requires if the hepatitis C screening test is reactive, a hepatitis C ribonucleic acid test (RNA) must be performed on the same specimen, or a second specimen collected at the same time as the initial hepatitis C screening test specimen, to confirm diagnosis of current infection. This is also referred to as reflex testing. This amendment is to ensure complete and timely diagnosis of HCV. 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.

• #2 HCV Testing and Linkage to Care | HCV Guidance

  https://www.hcvguidelines.org/evaluate/testing-and-linkage

  Among persons with a negative HCV-antibody test who were exposed to HCV within the prior 6 months, HCV-RNA or follow-up HCV-antibody testing 6 months or longer after exposure is recommended. […] HCV-RNA testing can also be considered for immunocompromised persons. […] Among persons at risk of reinfection after previous spontaneous or treatment-related viral clearance, HCV-RNA testing is recommended because a positive HCV-antibody test is expected. […] Quantitative HCV-RNA testing is recommended prior to initiation of antiviral therapy to document the baseline level of viremia (ie, baseline viral load). […] HCV genotype testing may be considered for those in whom it may alter treatment recommendations. […] Persons found to have a positive HCV-antibody test and negative results for HCV RNA by PCR should be informed that they do not have evidence of current (active) HCV infection but are not protected from reinfection.

• #2 Hepatitis C: Practice Essentials, Background, Pathophysiology

  https://emedicine.medscape.com/article/1996209-overview

  Hepatitis C is an infection caused by the hepatitis C virus (HCV) that attacks the liver and leads to inflammation. […] General baseline studies in patients with suspected hepatitis C include the following: Complete blood cell count with differential, Liver function tests, including levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, albumin, and total and direct bilirubin, Calculated glomerular filtration rate (eGFR), Thyroid function studies, Screening tests for coinfection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV), Screening for alcohol abuse, drug abuse, or depression, Hepatitis B virus (HBV) testing with hepatitis B surface antigen (HBsAg) (to identify coinfection), as well as hepatitis B surface antibody (anti-HBs) and antibody against hepatitis B core antigen (anti-HBc) (for evidence of previous infection), Serum pregnancy testing in women of childbearing age before initiating a treatment regimen that includes ribavirin or that includes direct-acting antiviral agents (DAAs) without ribavirin.

• #2 Hepatitis C Workup: Approach Considerations, Hepatitis C Antibody Test, Qualitative and Quantitative Assays for HCV RNA

  https://emedicine.medscape.com/article/177792-workup

  Other baseline studies include the following: Complete blood cell (CBC) count with differential, International normalized ratio (INR), Liver function tests, including levels of ALT and AST, alkaline phosphatase, albumin, and total and direct bilirubin, Calculated glomerular filtration rate (eGFR), Thyroid function studies, Screening tests for coinfection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV), Screening for alcohol abuse, drug abuse, and/or depression, Hepatitis B virus (HBV) testing with hepatitis B surface antigen (HBsAg) (to identify coinfection), as well as hepatitis B surface antibody (anti-HBs) and antibody against hepatitis B core antigen (anti-HBc) (for evidence of previous infection). […] Liver biopsy is not considered mandatory before the initiation of treatment for hepatitis C, but it may be helpful for assessing the activity and severity of hepatitis C virus-related liver disease. However, some experts recommend biopsy only in the following situations: The diagnosis is uncertain, Other coinfections or disease may be present, The patient being considered for treatment has normal liver enzyme levels and no extrahepatic manifestations, The patient is immunocompromised.

• #2 How is Hep C Diagnosed & Which Healthcare Professional Treats it?

  https://www.hepc.com/diagnosed-with-hepatitis-c

  There are several blood tests that healthcare professionals can perform to find out if you have hep C, including: The hep C antibody test, which can tell if you’ve ever been infected with the virus. The hep C virus RNA test, which can tell if you have a current infection. RNA is the virus’ genetic material. […] Your primary healthcare professional or a specialist can help you understand your condition and provide appropriate care. […] A genotype is the genetic variation in the DNA of the virus you have. There are 6 main genotypes of hep C. In the United States, about 74% of people with hep C have genotype 1. Some treatments work against all hep C genotypes, whereas others only work on some genotypes. If you and your healthcare professional determine that treatment is right for you, your genotype and your degree of liver damage may factor into the treatment decision.

• #2 Diagnosis, Treatment of Hepatitis C Using Point-of-Care Assays | Today’s Clinical Lab

  https://www.clinicallab.com/diagnosis-treatment-of-hepatitis-c-using-point-of-care-assays-27023

  Lancet Gastroenterology and Hepatology published a key new WHO-led study on January 24, 2023, in collaboration with the University of Bristol showing the benefit of using a quick, clinic-based diagnostic test for hepatitis C virus (HCV) infection over a standard laboratory-based test. […] The standard approach to diagnosing chronic HCV infection includes an initial screening with an HCV antibody test followed by a laboratory-based molecular HCV viral load (VL) test that confirms the presence of an active virus and the need for treatment. […] HCV VL assays performed on point-of-care (POC) devices outside of the laboratory and in clinics close to where patients receive care are being increasingly used as an alternative to laboratory-based diagnosis. […] This new study pooled results from 45 studies (around 50 percent were from LMICs) and compared POC HCV viral load assays with centralized, laboratory-based standard approaches. It showed that POC HCV viral load assays reduced the time it took from initial HCV antibody screening to starting the treatment (19 days compared to 67 days).

• #2 Diagnosis, Treatment of Hepatitis C Using Point-of-Care Assays | Today’s Clinical Lab

  https://www.clinicallab.com/diagnosis-treatment-of-hepatitis-c-using-point-of-care-assays-27023

  These findings led to recent WHO recommendations for the adoption of POC HCV viral load testing as an alternate approach to laboratory-based platforms for rapid diagnosis and treatment of HCV infection. […] The POC assay can be offered in harm-reduction clinics, primary care clinics, prisons, mobile units, or even in community clinics, and presents the possibility of a one-stop, same-day diagnosis and treatment of HCV infection. […] WHO is encouraging affected countries to consider including the use of POC assays in their national policies on hepatitis C.

• #2 FIND explores new diagnostic technologies with the potential to confirm hepatitis C infection in community settings – FIND

  https://www.finddx.org/publications-and-statements/press-release/find-explores-new-diagnostic-technologies-with-the-potential-to-confirm-hepatitis-c-infection-in-community-settings/

  FIND explores new diagnostic technologies with the potential to confirm hepatitis C infection in community settings […] Both companies will receive support to test the feasibility of cartridge-based hepatitis C virus (HCV) core antigen immunoassays for detection of HCV infection, for use in rapid diagnostic tests at the point of care […] The Foundation for Innovative New Diagnostics (FIND) today announced awards to support the development, manufacture and feasibility testing of two prototype hepatitis C virus (HCV) core antigen (cAg) immunoassays for confirmatory HCV diagnosis at the point of care (POC) […] HCV cAg testing could be an attractive alternative to HCV RNA detection, and an HCV cAg assay is already recommended by the European Association for the Study of the Liver (EASL) […] An HCV CAg POC test is likely to be a cheaper alternative to HCV RNA detection technologies, and can be potentially used as a single-step diagnosis for chronic HCV infection in high-prevalence settings, streamlining the HCV cascade of care and reducing loss to follow up

• #2 Current and Future Diagnostics for Hepatitis C Virus Infection

  https://www.mdpi.com/2227-9040/13/2/31

  The Xpert HCV Viral Load test (a real-time RT-PCR) designed in 2015 and manufactured by Cepheid combines all steps of real-time RT-PCR into a single cartridge leveraging microfluidics. […] The Xpert HCV test and its associated GeneXpert Express System have recently been approved by the FDA for operations under a CLIA (Clinical Laboratory Improvement Amendments) Certificate Waiver. […] The emerging technologies being developed are paramount in improving affordability and sensitivity. […] POC rapid RNA detection can detect HCV when an active infection occurs, and antibodies are yet to be produced. […] If developed for HCV, these technologies can be used for the detection of other viral diseases.

• #2

  https://www.natap.org/2018/HCV/061918_03.htm

  To eliminate HCV by 2030 as a public health concern, HCV care will need to be simplified to „test and treat” for all. […] The world can expect the arrival of transformational technologies in the next few years. […] Investments to maximize smart phone diagnostic innovations may provide opportunities to improve health care more broadly, including improved surveillance data collection in remote and resource-limited settings. […] The availability of new materials and innovative solutions such as 3-dimensional printing are also likely to further reduce costs and facilitate the scale-up of many of these technologies.

• #2

  https://www.natap.org/2018/HCV/061918_03.htm

  HCV diagnostics are essential to achieve global elimination. […] The world has embraced the call for global elimination of hepatitis C virus by 2030. […] Global access to hepatitis C virus diagnostics will be a keystone to success. […] Key challenges must be overcome and systems optimized to ensure widespread access to existing diagnostics. […] Improving access to rapid, simple, and affordable HCV diagnostics is critical to achieve global HCV elimination. […] The high efficacy and low toxicity of the new DAAs provide an exceptional opportunity to greatly simplify HCV diagnosis and care. […] HCV diagnosis of active infection through direct detection of the HCV virus is the only test required for patient treatment and care. […] The Holy Grail Point-of-Care Diagnostic Assay for Active Hepatitis C Virus Infection That Links All People with Hepatitis C Infection to Immediate Care Is Essential to Achieve Global Elimination.

• #2 Hepatitis C – Symptoms, diagnosis and treatment | BMJ Best Practice

  https://bestpractice.bmj.com/topics/en-us/128

  Hepatitis C virus transmission is through percutaneous exposure to infected blood, most commonly through injection of illicit drugs or transfusion of unscreened blood and blood products in developed countries, or via unsafe injection practices in resource-poor countries. […] Following acute exposure to hepatitis C virus, many patients develop chronic hepatitis C. Most infections are asymptomatic; however, hepatic inflammation is often present and can lead to progressive hepatic fibrosis. […] Hepatitis C is an inflammation of the liver caused by the hepatitis C virus (HCV). Infection may present as an acute illness (e.g., fatigue, arthralgia, jaundice) in approximately one third of patients; however, the majority of patients are asymptomatic. […] Patients with acute infection may spontaneously clear the virus. Chronic infection causes liver inflammation and fibrosis, and a significant number of these patients will develop cirrhosis and liver failure or liver cancer over a period of approximately 20 to 50 years. The infection rarely resolves spontaneously in patients with chronic infection.

• #2 Hepatitis C Virus: Diagnosis and Treatment

  https://liverfoundation.org/liver-diseases/viral-hepatitis/hepatitis-c/diagnosing-hepatitis-c/

  Diagnosing Hepatitis C […] Diagnosing Hepatitis C […] If you’re at risk for Hepatitis C, speak to your healthcare provider today about getting tested. […] Talk to your doctor about getting tested for Hepatitis C if you: […] The CDC (Center for Disease Control) recently recommended that all people born between during this time have a 1-time screening test for Hepatitis C. […] Most people (about 70% – 80%) with an acute Hepatitis C infection do not experience any symptoms or show signs of the infection. […] Hepatitis C is transmitted or spread when the blood from a Hepatitis C-infected person enters the bloodstream of someone who is not infected. […] There is no vaccine to prevent Hepatitis C, but there is research being done to develop one. […] However, treatment options are available and Hepatitis C may be cured (or cleared from the body). […] The Hepatitis C virus is considered cured if the virus is not detected in your blood when measured with a blood test 3 months after treatment is completed.

• #2 Hepatitis C – Symptoms, diagnosis and treatment | BMJ Best Practice

  https://bestpractice.bmj.com/topics/en-us/128

  Key diagnostic factors include the presence of risk factors. […] Other diagnostic factors include constitutional symptoms, jaundice, ascites, signs of hepatic encephalopathy, and extrahepatic manifestations. […] 1st investigations to order include hepatitis C virus (HCV)-antibody enzyme immunoassay (EIA), hepatitis C virus (HCV) RNA polymerase chain reaction (PCR), and serum aminotransferases. […] Investigations to consider include viral genotyping, hepatitis C virus (HCV) core antigen assay, non-invasive tests of liver fibrosis or elasticity, aspartate aminotransferase-to-platelet ratio index (APRI), liver biopsy, and testing for co-infection.

• #2 FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test | FDA

  https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test

  Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C. […] The authorization of this test enables a test-and-treat approach where a person can be tested for HCV, and if positive for HCV RNA, be linked to care and potentially receive treatment during the same health care visit. […] Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options, said Jeff Shuren, M.D., J.D., director of the FDAs Center for Devices and Radiological Health.

• #2 Hepatitis C – What Is Hep C? Symptoms, Causes, Diagnosis, Treatment

  https://www.webmd.com/hepatitis/digestive-diseases-hepatitis-c

  Peginterferon alfa-2a (Pegasys). This is a medicine that acts like a protein your immune system makes. It’s used to treat both hepatitis B and C by reducing the amount of virus in your body. […] Peginterferon alfa-2b (PEG-Intron). This is another medicine that acts like a protein your immune system makes. It’s used mainly to treat hepatitis C. […] Is Hepatitis C Curable? […] Yes, hepatitis C can be cured in most people with a direct-acting antiviral (DAA) medication. […] About 12 weeks after your treatment ends, your doctor will test your blood to make sure the virus is gone. If it is, thats called a sustained virologic response, which means you’re cured. If youre not cured, your doctor may suggest trying again with a different DAA drug regimen.

• #2 Hepatitis C virus: Screening, diagnosis, and interpretation of laboratory assays

  https://pmc.ncbi.nlm.nih.gov/articles/PMC3943138/

  An estimated 3% of the world population is infected with Hepatitis C virus (HCV), a hepatotropic RNA virus, transmitted primarily via the blood route. […] The mainstay in diagnosing infection with HCV is to initially screen high risk groups for antibodies to HCV (anti-HCV). […] Nucleic acid amplification tests (NAT) are used as confirmatory tools, and also to determine viral load prior to initiating treatment. […] Genotyping is an important tool in clinical management to predict the likelihood of response and determine the optimal duration of therapy. […] All health care practitioners need to understand how to establish or exclude a diagnosis of HCV infection and to interpret the tests correctly. […] In the absence of a preventive or therapeutic vaccine, and also of post-exposure prophylaxis against the virus, it is imperative to diagnose infection by HCV so as to prevent hepatic insult and the ensuing complications that follow, including primary hepatocellular carcinoma (HCC).

• #3 Hepatitis C Virus Diagnostics: The Road to Simplification

  https://pmc.ncbi.nlm.nih.gov/articles/PMC6385922/

  The ambitious goal of eliminating viral hepatitis as a public health problem by 2030 will require major efforts to prevent new infections, but perhaps more importantly, there will have to be a dramatic increase in diagnosing those already infected and linking them to care. […] The traditional approach to HCV diagnosis requires an initial antibody (Ab) test to document exposure, followed by a confirmation of ongoing viremia, usually using a polymerase chain reaction (PCR) based assay to quantify the level of HCV RNA in the blood. […] Current Ab and HCV RNA assays have very high sensitivity and specificity, making false positive and false negative results rare occurrences. […] The real challenge of the traditional approach is the need for two blood tests. […] The simplest solution to ensuring an HCV RNA test is done for all positive Ab tests is to reflex the testing.

• #3 Hepatitis C – Symptoms and causes – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/hepatitis-c/symptoms-causes/syc-20354278

  Hepatitis C is a viral infection that causes liver swelling, called inflammation. Hepatitis C can lead to serious liver damage. […] The U.S. Preventive Services Task Force recommends that all adults ages 18 to 79 years be screened for hepatitis C. Screening is for everyone, even those who don’t have symptoms or known liver disease. […] Chronic hepatitis C follows the same course no matter what the genotype of the infecting virus. But treatment can vary depending on viral genotype. However, newer antiviral drugs can treat many genotypes. […] The U.S. Preventive Services Task Force recommends that all adults ages 18 to 79 years be screened for hepatitis C. Screening is very important for people at high risk of exposure.

• #3 SciELO Brazil – Laboratory testing for hepatitis C Laboratory testing for hepatitis C

  https://www.scielo.br/j/bjid/a/Kg7RxGrbVdpDH5wPPbXdptb/

  Serological diagnosis of patients infected with the hepatitis C virus (HCV) can be performed using two categories of tests: indirect tests, which detect antibodies against HCV; and direct tests, which detect, quantify, or characterize components of the viral particle, such as HCV RNA testing and testing for detection of the HCV core antigen. […] The specificity of the EIA tests available on the market that detect anti-HCV was determined to be higher than 99%, whereas their sensitivity, which was more difficult to determine due to the lack of gold standard tests with high sensitivity, was 95-99%. […] In contrast, the use of nucleic acid testing (NAT) makes it possible to differentiate between viremic and nonviremic individuals by detection of HCV RNA, allowing the clinician a differentiated approach to anti-HCV-positive individuals.

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