What is PCR
True confirmation of the presence and reproduction of the virus in the body is the detection of virus C RNA using a qualitative PCR method.
A blood test using the quantitative PCR method allows you to clarify the viral load (the number of viral copies in 1 ml of blood). This indicator is very important for deciding the issue of antiviral therapy. If less than 750 RNA copies/ml is detected, this indicates a minimal viral load. If the indicator is less than 2x106 copies/ml, the viral load is low. Indicators above 2x106 RNA copies/ml indicate high viremia.
Antiviral therapy is most effective when viremia is low. Viral load indicators for hepatitis C do not reflect the severity of the disease; this requires additional examinations to identify the degree of damage to liver cells, impaired liver function, and signs of cirrhotic changes in the liver. HCV cannot provide such information in a blood test.
How is blood drawn?
Before donating blood for a study that can evaluate the functioning of organs, check metabolism and the need for minerals and vitamins, you need to fulfill a number of requirements:
- Mental and physical stress must be avoided.
- For two days you should not drink alcohol or eat heavy food. Fatty and fried foods are excluded. It is better to eat easily digestible foods.
- You are allowed to drink water before taking the test.
- Blood is taken in the morning on an empty stomach from 8 to 11 o'clock. This is due to the fact that it is during these hours that the presence of hormones most closely matches the actual indicators.
- Blood is taken from a vein and laboratory testing is performed to determine the presence of antibodies and antigens in the blood plasma. As a biomaterial, venous blood is of higher quality than capillary blood. You can donate blood during the day, but before collection it is important not to eat for 4-6 hours. These rules are necessary to prevent false results.
This is interesting: What blood and urine parameters will be high with hepatitis C?
HCV research results
The analysis can be done in the laboratory of private clinics or public clinics and hospitals. The study takes two days. You should not smoke half an hour before blood collection.
Indications for HCV testing:
- The patient belongs to a certain risk group.
- The patient has already had the hepatitis virus.
- Lack of appetite, accompanied by weight loss and nausea.
- Unreasonable pain throughout the body.
- A sharp increase or change in the level of liver transaminases.
- Screening examinations.
There are two types of research:
1. Enzyme-linked immunosorbent assay (ELISA) allows you to find traces of a previous disease (antibodies). If the person’s body is familiar with the virus, the result will be positive (+); when the person has not had hepatitis, the result will be negative (-). But the results of ELISA are not the final basis for making a diagnosis. The fact is that antibodies only confirm the immune response to the virus. They are produced by the immune system when the virus is in the blood. In certain patients, the hcv test detects antibodies over several years of life, but the virus itself is not in the blood.
Under such circumstances, doctors talk about a false positive result. How can this result happen? Sometimes test systems that are insensitive to certain genotypes are used. Another explanation may be the fact that the infected organism itself neutralized the hepatitis virus, but this outcome is typical for a small number of patients. Often antibodies indicate chronic hepatitis. A false result can be obtained if there is rheumatoid factor in the blood.
Sometimes it happens that the hcv test shows a false negative result. This indicates the presence of a virus in the body, but ELISA does not recognize it. This is explained by the fact that infection with the virus supposedly occurred about 6 months ago, the immune system had not yet had time to react and produce antibodies. Typically, 70% of patients have antibodies at the first symptoms of hepatitis.
2. Polymerase chain reaction (PCR) detects hepatitis DNA molecules. Already 1–3 weeks after infection, thanks to the sensitivity of the PRC, the presence of the virus in the blood can be diagnosed. At the end of the test, it becomes clear whether the person has chronic hepatitis or whether the antibodies were produced by the immune system after an illness. A positive result indicates hepatitis, and a negative result indicates recovery or absence of exacerbations of the disease in the chronic form.
Quantitative analysis is a study that determines the viral load (the concentration of the virus in 1 ml of blood). A high concentration of the virus indicates a poor chance of recovery for the patient; a low concentration, on the contrary, significantly increases these chances. The effectiveness of hepatitis treatment with antiviral drugs can be monitored by determining the activity of HCV. The resistance of the hepatitis C virus to interferon depends on the genotype, which is determined by another test. As a result, an appropriate treatment strategy is selected.
But a diagnosis cannot be made based on one test result; confirmatory tests should always be performed. Tests are also indicated to monitor treatment. Their results in no way replace other methods for diagnosing hepatitis, but, on the contrary, are a complement. The final diagnosis is made by the doctor.
Accuracy of anti-HCV blood test
Anti-HCV diagnostics is a modern and fairly accurate method
, it allows you to determine the presence of the hepatitis C pathogen starting from the fifth to sixth week after infection. The virus will not be detected in plasma if it replicates less than two hundred copies per milliliter. If the calculation is carried out in international units, this is less than forty international units per milliliter. If there are more than a million viral particles in one milliliter of plasma, the presence of viremia is established.
HCV blood test, what is it?
Understanding the significance of antibodies and antigens is a good place to start. An antigen is a foreign or invading protein substance that enters the body. Your body's immune system defends against antigens by creating its own special proteins that bind to the invader to destroy them. These are antibodies, also known as immunoglobulin.
The production of antibodies against antigens is known as your “immune response.” Many of the following tests are used to measure your immune response. Acute or chronic? Acute illness means a short, sharp illness of sudden onset that can be severe, but most people recover within a few weeks without lasting effects. A chronic disease is an illness that lasts a long time, possibly for the rest of a person's life.
A false positive result for carriage of the hepatitis C virus is established in approximately every tenth case. The reason for such statistics is a violation of the method of blood sampling and analysis, changes in hormonal levels, or non-compliance with the doctor’s recommendations for preparing for the test. According to WHO data, four percent of the world's population are convalescents with hepatitis C.
It will also read a positive result after hepatitis vaccination. One infection with hepatitis A is thought to induce lasting immunity against further infection. Tests are done to look for antigens and antibodies in the blood. It is a sign or indication that.
You have been infected with a virus in the past, you have a new infection and your infection will probably go away on its own, your infection has become chronic. These antigens and antibodies are known as serological or viral "markers". A positive result indicates an infection. The term "surface" refers to the outer surface of the virus itself. The emergence of antibody and subsequent clearance of the virus at a very low level is known as “seroconversion.” The speed at which this happens will vary from person to person and may take months or years.
Analysis transcript
The norm for these methods is a “not detected” or “negative” result. Opposite values are signs of the presence of an infectious agent in the body.
For more accurate information, the surface and nuclear proteins of the virus are also determined.
In rare cases, the test may give a false result.
A false positive result can be obtained only in 10% of cases. And it is usually associated with concomitant pathology, which requires drug suppression of the immune system. This often happens when:
- oncological neoplasms;
- autoimmune diseases;
- chronic infectious processes.
A false negative result can be obtained if the diagnosis is not followed correctly:
- duration of infection less than 6 weeks;
- low-quality reagents;
- individual characteristics.
To exclude errors, it is always necessary to confirm the diagnosis using PCR.
A positive result confirming the presence of the disease can be expressed in the following forms.
- Acute phase: IgM anti-HAV “-”, HBsAg “-”, anti-HCV “+” with PCR anti-HCV “+”. Signal criterion for death >3.8. The ALT multiplicity exceeds the norm by more than 7 times.
- Chronic phase: IgG anti-HCV “+” with PCR anti-HCV “+”. Signal criterion for death >3.8. At the same time, the quantitative determination of liver transaminases in the blood may remain within normal limits.
In conclusion, you can see the results of the study, which are also described in one word. What do they mean?
- “Not detected” - hepatitis RNA is not detected or its quantitative composition in the blood is less than 200 copies/ml, up to 40 IU/ml;
- “Detected” - 2 copies/ml - indicators are below normal, but already indicate possible infection;
- “Detected” - 6 copies/ml - confirms the presence of viral particles in the body. But it characterizes low viremia, which is the most favorable sign for the patient in terms of treatment and possible prognosis;
- “Detected” - > 2x106 copies/ml - indicates the presence of high viremia, which clearly increases the chances of the acute course becoming chronic;
- “Detected” - > 1.0x108 copies/ml - such a numerical value indicates a possible excess of the linear range of the disease.
Additionally, you can find other analyzer values: “anti hcv abbott architect “-” - indicates the purity of the blood from the virus, “anti hcv igg m” or “anti hcv abbott architect “+” - the presence of the virus in the blood in the acute phase or relapse of the disease .
You should never let your life take its course. It is better to entrust your health to specialists, since pathology detected in time can be treated much better and occurs with fewer complications.
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Decoding the results obtained
Anti HCV interpretation should be carried out by a specialized specialist (infectious disease specialist or hepatologist). Normal antibodies to hepatitis C
Decoding the results
should not exist in the human body.
However, a false negative result is possible if:
- period of the “serological window”;
- concomitant immunodeficiency (with viral damage to the immune system, the production of antibodies stops);
- oncological lesions of the hematopoietic system.
A false positive HCV AgAt ELISA result is sometimes noted when:
- pregnancy (due to the production of specific protein compounds similar in structure to immunoglobulins);
- autoimmune pathologies (in such diseases, the production of antibodies is unpredictable);
- disorders of the hematopoietic system;
- recovery from the acute phase of hepatitis C (in some people, the virus is destroyed by the immune system without drug therapy);
- previous antiviral therapy (immunoglobulins can last up to 3–5 years or more);
- in a child under 3 years of age at birth after pregnancy to an infected or treated mother;
- concomitant severe infections (regardless of their etiology), in which case erroneous results are possible due to the massive release of antibodies in response to viral or bacterial tissue damage.
Clinic
About 80% of those exposed to the virus develop a chronic infection. It is determined by the presence of viral replication for at least six months. During the first few decades of infection, most patients experience no or minimal symptoms.
Chronic hepatitis C may manifest itself only as fatigue or a moderate decrease in intellectual performance. Chronic infection after several years can lead to cirrhosis or liver cancer. Liver enzyme levels remain normal in 7-53% of patients. Late relapses after treatment occur, but they are difficult to distinguish from reinfection.
Steatohepatitis (fatty liver) occurs in about half of those infected and is usually present before the development of cirrhosis. Typically (80% of cases), this change affects less than a third of the liver. Worldwide, hepatitis C is responsible for 27% of liver cirrhosis and 25% of hepatocellular carcinoma. 10-30% of those infected develop cirrhosis within 30 years. Cirrhosis is more common in those infected with hepatitis B, Schistosoma, or HIV, in alcoholics, and in males. In patients with hepatitis C, excess alcohol increases the risk of developing cirrhosis by 100 times. With developing liver cirrhosis, the risk of hepatocellular carcinoma is 20 times greater. This transformation occurs at a rate of 1-3% per year.
Infection with hepatitis B in addition to hepatitis C increases this risk even further. Cirrhosis of the liver can lead to portal hypertension, ascites (accumulation of fluid in the abdomen), bruises or bleeding, varicose veins (especially in the stomach and esophagus, which can cause hidden bleeding), jaundice, and a syndrome of cognitive impairment known as hepatic encephalopathy. Ascites occurs at some stage in more than half of cases of chronic infection.
According to the Russian Ministry of Health, 20-30 years after infection with hepatitis C, the probability of developing liver cirrhosis ranges from 4% to 45%. The progression of liver fibrosis is nonlinear and lasts, as a rule, for 20-40 years from the moment of infection. In some patients this process occurs extremely slowly.
The most serious extrahepatic manifestations of chronic hepatitis C are cryoglobulinemic vasculitis, cryoglobulinemic nephritis, and B-cell lymphoma.
Indications for testing
Hepatitis C antibody tests are used to screen people for infection, including those without signs or symptoms but with risk factors for liver disease or those who have been exposed to the virus.
Hepatitis C is a disease caused by HCV infection. This leads to liver destruction, killing healthy cells when Anti HCV is present in a blood test. There are several tests that doctors order to check for the hepatitis C virus. Many of those infected have no symptoms and are unaware of the condition. Acute HCV infection may cause minor nonspecific signs, but chronic infection may be quiet for a decade or two before causing enough liver damage to affect liver function.
About 15-25% of people infected with the hepatitis C virus clear it from their bodies without treatment. Others will develop scarring of the liver. Left untreated, it can lead to cirrhosis, liver failure, or liver cancer over time. Treatments are available to help people with hepatitis C. If you think you may have been exposed to the virus, get tested.
Common causes of infection:
- blood transfusion or drug administration;
- injury from contaminated needles or sharp objects (eg, razor blades, tattoo tools);
- sexual intercourse;
- infection of a newborn at birth from an HCV-infected mother (up to five percent of cases).
HCV ag can lead to liver disease, which has the following symptoms:
- nausea;
- dark urine;
- jaundice;
- fatigue;
- diarrhea;
- decreased appetite;
- frequent bruising;
- abdominal pain.
On a note!
Hepatitis C is contagious, but it can only be transmitted to another person through sexual contact or through blood, a break in the skin, or mucous membranes.
Who needs an Anti-HCV blood test?
The test can be taken without a doctor's referral. This service is provided by various laboratories and medical centers. However, there are certain cases that require research:
- Desire to become a blood donor.
- Transfusion of blood or its components in the past.
- Close contacts with an infected person, including sexual intercourse (the possibility of infection through unprotected sexual contact has not been reliably confirmed, but cannot be ruled out).
- Injecting drug use.
- The birth of a child from a sick mother - the baby needs to be tested for anti-HCV, because the probability of infection is up to 20%.
- Increased levels of ALT, AST due to medical intervention.
- Secondary signs of liver damage (to exclude/confirm the presence of the disease).
- Setting the effectiveness of treatment.
Typically, antibody testing is carried out en masse, as a means of selective diagnosis in a certain area. However, anyone can take the test themselves if they notice symptoms of liver damage.
Analysis results
A blood test for Anti HCV is prescribed in the following cases:
- If you have symptoms such as nausea, problems with appetite, body aches, signs of jaundice.
- When the level of liver transaminases is high.
- If a person is at risk.
- To determine the form of the disease.
- To identify the cause of inflammation in the liver.
- To detect concomitant pathologies.
- In order to determine the level of damage.
If anti hcv total is positive, not every person knows what this means. Anti-HCV analysis indicates the presence of antibodies in the blood that are produced to fight hepatitis C. An interesting fact is that these antibodies remain in human blood forever.
To put it differently, when anti hcv is positive, this does not mean that the disease is developing; it may not exist. Thus, when a positive result is received, there is no need to panic.
This is due to the fact that:
- This analysis periodically gives a false positive result; this happens in most cases in pregnant women, which is the norm. In addition, this situation is possible in the presence of autoimmune diseases, tumors and other infections. In addition, a false positive result occurs due to the use of immunosuppressants and after undergoing vaccination.
- Anti-HCV-total shows the presence of infection in the past, that is, self-healing could have already occurred, although this happens extremely rarely.
- This disease is treatable.
Possible indications for research
Anyone can get tested for hcv infection. No special indications are needed for this, other than the person’s desire to undergo this blood test. But there is a category of persons who are subject to mandatory research. These include:
- Blood donors;
- People who have received a transfusion of blood, its components or drugs based on it;
- Increased levels of liver transaminases (ALAT, AST), especially after previous surgical interventions, childbirth and other medical procedures;
- Suspicion of viral hepatitis C or the need to exclude this diagnosis;
- Negative tests for hepatitis B virus in the presence of symptoms of liver inflammation;
- Monitoring the effectiveness of therapy for hcv infection and resolving issues regarding further treatment tactics.
PCR analysis
An HCV RNA test (hepatitis C virus RNA determination), often called a hepatitis C PCR test, is a blood test that directly detects the genetic material of the hepatitis C virus (each virus is one RNA particle).
This test is most often performed by PCR, hence the name hepatitis C PCR. There are qualitative and quantitative tests for HCV RNA. A qualitative analysis indicates the presence of a virus in the blood. This test must be performed on all patients who have antibodies to hepatitis C. Its result may be “detected” or “not detected.” Reference values (values that should be normal) are “not detected.” A "detected" result may indicate that the virus is multiplying and infecting more and more liver cells. A qualitative PCR test has a certain sensitivity (10-500 IU/ml). This means that if the virus is present in the blood in a very low concentration (below the sensitivity threshold of the method), a “not detected” result may be obtained.
Therefore, when conducting high-quality PCR in patients with low viremia (virus concentration), for example, those undergoing antiviral therapy, it is important to know the sensitivity of the diagnostic system. To monitor the virological response during antiviral therapy, it is advisable to use a diagnostic system with a sensitivity of at least 50 IU/ml
These criteria are met, for example, by COBAS AMPLICOR HCV-TEST analyzers (analytical sensitivity 50 IU/ml or 100 copies/ml), RealBest HCV RNA (analytical sensitivity 15 IU/ml or 38 copies/ml) and others.
Where is it safe to buy new drugs to treat hepatitis C? In our opinion, the most optimal and reliable way is to use the services of providers proven over the years on our forum, who have already helped hundreds of patients get rid of this disease.
PCR diagnosis of hepatitis C
The polymerase chain reaction is considered the most accurate and modern method for identifying RNA and DNA chains of any nature. Hepatitis C virus contains ribonucleic acid, and the frequent occurrence of false positive results in anti-HCV blood tests makes it an ideal candidate for this test.
It is a good idea to discuss your concerns with a healthcare professional or counselor who is trained to help you cope with hepatitis and others. associated social problems such as. If this happens, it's worth speaking to your doctor, as many advisers are willing to write to your mortgage or insurance company outlining your health and life expectancy. Who's to say: This is often a difficult decision, but consider what a positive result could mean for your family and sexual partner, and whether those people should also consider testing. Related patient handout written by the authors of this article.
There are qualitative and quantitative types of diagnostics, of which the second is the most indicative. The negative side of this diagnostic tool is its high cost, as well as the duration of the study, due to which the HCV blood test is the most affordable, and if it is performed correctly, the number of errors is minimal.
Features of the course of the disease
This is the first of a two-part article on hepatitis C that will appear in the next issue of American Family Physician. Hepatitis C, caused by the hepatitis C virus, is a major public health problem in the United States. All genotypes are pathogenic, and there appears to be no correlation between genotype and source of infection. Why do most patients constantly become infected?
However, successive changes in the viral genome lead to variants that are not recognized by pre-existing antibodies that would normally neutralize or prevent infection. The generation of these neutralization mutant proteins appears to be the mechanism by which the virus establishes and maintains a persistent infection. The lack of an effective neutralizing antibody response also means that natural infection does not protect against reinfection with the same or different genotypes of the virus.
The ways of spreading the disease can be divided into groups:
People who:
Clinical features and natural history
For the same reason, there is no effective prophylaxis before or after post-exposure therapy. Only 15 percent of patients require hospitalization, and fulminant disease is rare. This aspect of hepatitis C requires long-term follow-up to ensure proper diagnosis and management.
The progression of chronic liver disease is usually insidious: it is slow and without symptoms or physical signs in most patients for the first two decades after infection. Chronic hepatitis is often not recognized until symptoms of advanced liver disease develop.
An HCV blood test is a laboratory method for diagnosing hepatitis C; its mechanism of action is based on identifying antibodies of the Ig G and Ig M types, which begin to be actively produced when virus antibodies appear in the blood. What it is? These are pathogenic microorganisms that appear several weeks or even months after a person is infected.
When is the test ordered?
Type C virus spreads quickly in the blood and infects liver cells. Once infected, cells begin to actively divide, spreading and infecting tissue. The body reacts to the threat and begins to produce antibodies to hepatitis C. In most cases, the body's natural resistance is not enough to fight the disease and the patient requires serious medication. Hepatitis of any type can cause complications and cause severe liver damage. Children are especially susceptible to the disease.
Viral hepatitis spreads rapidly, especially in warm and humid climates. Poor sanitation only increases the chances of infection. Antibodies to HCV can be detected using a blood test several weeks after infection. Therefore, after contact with a patient, not one, but two or three blood tests may be needed.
In some cases, examination is mandatory, in others it is recommended:
- If the mother is sick with the hepatitis C virus, the child may also have this disease. The probability of infection is 5-20% depending on the presence of viral RNA in the blood.
- Unprotected sex with an infected person. Doctors do not have a clear opinion about the relationship between hepatitis and sexual relations, as well as direct evidence. However, according to statistics, people who are sexually active have a higher chance of contracting the virus than those who are monogamous.
- Hepatitis C can often be found in drug addicts (infection through syringes and blood).
- When visiting a dentist, tattoo artist, piercer, or manicurist, infection is possible, but such cases occur extremely rarely.
- Blood donors must undergo an anti-HCV test before the procedure.
- Before surgery, blood is tested for viruses.
- If the liver test value is elevated based on the result of a biochemical blood test, additional tests are performed.
- After contact with the patient, an examination is required. Several tests are prescribed at different intervals.
More often, examination and blood donation for hepatitis are carried out en masse during random diagnostic testing (screening) in a certain geographical area. Such measures help prevent outbreaks of viral disease epidemics. The patient himself can seek medical help if he discovers characteristic signs of hepatitis.
What it is
A blood test for HCV is a diagnosis of the hepatitis C virus. This diagnostic method is based on the principle of detecting IgG and IgM class antibodies in the patient’s blood plasma. This test is also called a blood test for anti-HCV or anti-HCV.
The hepatitis C virus is an RNA virus. It affects liver cells and leads to the development of hepatitis. This virus can multiply in many blood cells (monocytes, neutrophils, B lymphocytes, macrophages). It is characterized by high mutational activity, due to which it has the ability to evade the protective mechanisms of the body's immune system.
Most often, the hepatitis C virus is transmitted through blood (through unsterile needles, syringes, piercing instruments, tattooing, during organ transplantation, blood transfusion). There is also a risk of transmission of infection during sexual intercourse, from mother to child during childbirth.
If foreign microorganisms (in this case the hepatitis C virus) enter the human body, the immune system begins to produce protective antibodies - immunoglobulins. Antibodies to hepatitis C are abbreviated as “anti-HCV” or “anti-HCV”. This refers to total antibodies of the IgG and IgM classes.
Hepatitis C is dangerous because in most cases (about 85%) the acute form of the disease is asymptomatic. After this, the acute form of hepatitis becomes chronic, which is characterized by a wave-like course with slightly pronounced symptoms during the period of exacerbation. In this case, advanced disease contributes to the development of liver cirrhosis, liver failure, and hepatocellular carcinoma.
In the acute period of the disease, a blood test for anti-HCV will reveal antibodies of the IgG and IgM classes. During the chronic course of the disease, immunoglobulins of the IgG class are detected in the blood.
Indications for analysis
Indications for prescribing a blood test for anti-HCV are the following conditions:
- the presence of symptoms of viral hepatitis C - body aches, nausea, lack of appetite, weight loss, possible jaundice;
- increased levels of liver transaminases;
- previous hepatitis of unknown etiology;
- examination of patients at risk of infection with viral hepatitis C;
- screening examinations.
Analysis transcript
The result of this blood test may be positive or negative.
- A positive blood test result for HCV may indicate acute or chronic viral hepatitis C or a previous illness.
- A negative result indicates the absence of hepatitis C virus in the body. Also, a negative blood test result for the hepatitis C virus occurs at an early stage of the disease, with a seronegative form of the hepatitis virus (about 5% of cases).
Notes
- ↑
- Alla Astakhova.
.
Healthcare Blog
(July 27, 2017). - ↑ Ray, Stuart C.
Chapter 154: Hepatitis C // Mandell, Douglas, and Bennett's principles and practice of infectious diseases / Stuart C. Ray, David L. Thomas. — 7th. - Philadelphia, PA: Churchill Livingstone, 2009. - ISBN 978-0443068393. - ↑
- ↑ Nicot, F.
Chapter 19. Liver biopsy in modern medicine. // Occult hepatitis C virus infection: Where are we now?. - 2004. - ISBN 978-953-307-883-0. - ↑
- ↑
- ↑
- ↑
- Alla Astakhova.
.
Healthcare Blog
(July 28, 2017). - ↑ Wilkins, T;
Malcolm JK; Raina D; Schade RR. (English) (PDF). American family physician (1 June 2010). - . www.who.int. Retrieved November 9, 2020.
- Center for Drug Evaluation and Research.
(English). www.fda.gov (19 December 2012). Retrieved August 5, 2020. - . MD Magazine (February 18, 2014). Retrieved August 5, 2017.
- . www.gilead.com (December 6, 2013). Retrieved August 5, 2017.
- AbbVie.
(English). www.prnewswire.com (16 January 2015). Retrieved August 5, 2020. - Super User.
. stop-hcv.ru (June 3, 2015). Retrieved August 5, 2020. - (English). www.fda.gov (24 July 2015). Retrieved August 5, 2017.
- . hepatit-stop.ru (May 27, 2016). Retrieved August 5, 2017.
- . www.gilead.com (October 10, 2014). Retrieved August 5, 2017.
- (English). news.abbvie.com (19 December 2014). Retrieved August 5, 2020.
- (English). www.fda.gov (24 July 2015). Retrieved August 5, 2017.
- Office of the Commissioner.
(English). www.fda.gov (January 28, 2016). Retrieved August 4, 2017. - (English). www.fda.gov (28 May 2016). Retrieved August 4, 2017.
- (English). news.abbvie.com (25 July 2016). Retrieved August 4, 2020.
- . www.genome.jp. Retrieved August 4, 2020.
- Office of the Commissioner.
(English). www.fda.gov (18 July 2017). Retrieved August 4, 2017. - Office of the Commissioner.
(English). www.fda.gov (August 3, 2017). Retrieved August 4, 2017. - . www.medscape.com. Retrieved May 23, 2020.
- ↑ (English). clinicaltrials.gov (9 December 2015). Retrieved August 3, 2020.
- ↑
- Office of the Commissioner.
(English). www.fda.gov (18 July 2017). Retrieved July 19, 2017. - (English). www.healio.com (20 April 2017). Retrieved August 5, 2020.
- . www.hcv-trials.com (April 2017). Retrieved August 5, 2017.
- Alla Astakhova.
.
Healthcare Blog
(July 28, 2017). - Alla Astakhova.
.
Healthcare Blog
(July 29, 2017). - ↑ Vladimir Chulanov.
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Healthcare Blog
(July 13, 2017). - . pmarchive.ru (December 23, 2010). Retrieved November 21, 2016.
- . ITPCru - Treatment Preparedness Coalition
. - . ITPCru - Treatment Preparedness Coalition
. - . Center for Molecular Diagnostics at the Central Research Institute of Experimental Physics
. (unavailable link) - . Interregional public organization for assistance to patients with viral hepatitis
. - . Stop - Hepatitis C
(September 2, 2001). - . grls.rosminzdrav.ru. Retrieved October 21, 2020.
- . clinicaltrials.gov (October 19, 2016). Retrieved November 21, 2020.
- . www.natap.org (November 13, 2016). Retrieved April 26, 2017.
- . www.natap.org (February 16, 2017). Retrieved April 26, 2017.
- (English). www.cocrystalpharma.com (15 August 2017). Retrieved August 16, 2020.
What does it mean to have antibodies to hepatitis C?
Antibodies to hepatitis C in most cases are discovered accidentally during examinations for other diseases, medical examinations, preparation for surgery and childbirth. For patients, these results come as a shock, however, there is no need to panic.
The presence of antibodies to hepatitis C - what does this mean? Let's look at the definition. Antibodies are specific proteins that the immune system produces in response to a pathological agent entering the body. This is a key point: you don’t have to have hepatitis for antibodies to appear. There are rare cases when the virus enters the body and leaves it freely, without having time to trigger a cascade of pathological reactions.
Another situation that often occurs in practical healthcare is false positive test results. This means that antibodies to hepatitis C were found in the blood, but in reality the person is completely healthy. To exclude this option, you need to take the test again.
The most serious reason for the appearance of antibodies to hepatitis C is the presence of the virus in liver cells. In other words, positive test results directly indicate that a person is infected.
To confirm or exclude the disease, it is necessary to undergo additional examinations:
- Determine the level of transaminases in the blood (ALT and AST), as well as bilirubin and its fractions, which is included in the standard biochemical analysis.
- Retest for hepatitis C antibodies in a month.
- Determine the presence and level of HCV RNA, or the genetic material of the virus, in the blood.
If the results of all these tests, especially the HCV RNA test, are positive, then the diagnosis of hepatitis C is considered confirmed, and the patient will then require long-term observation and treatment by an infectious disease specialist.
At-risk groups
The risk group is numerous:
- doctors and nurses who perform blood collection, transfusions, and surgeries;
- drug addicts, prostitutes, homosexuals;
- patients who need donor blood;
- patients with irreversible kidney damage;
- people who have promiscuous sex.
This is interesting: Genotypes of the hepatitis C virus: what is it, analysis, which is the most dangerous?
Blood with the HCV virus can be transmitted through promiscuity, infected syringes, during childbirth, and poorly treated instruments in salons and hospitals. The pathogen is not transmitted in everyday life with dishes, during breastfeeding, or through the air.
How long does it take to test for hepatitis?
The test for hepatitis C takes one to five business days. In most cases, the test results are ready the next day after the blood is drawn.
Tests and frequency of testing in patients not receiving antiviral therapy
Indicators Frequency of examination Notes Total bilirubin and fractions AsATAl Complete blood count, including platelets Once every 6–12 months Frequency of examination can be determined individually depending on previous indicators, the course of the disease, the presence of cirrhosis and concomitant diseases Total protein and fractions Iron Glucose Amylase Once every 12 months Frequency of examination is determined individually depending on previous indicators Blood urea Creatine 1 time in 12 months The frequency of the study is determined individually depending on the previous indicators Alpha-fetoprotein 1 time in 6 months If the indicator increases, ultrasound and CT scan are prescribed Autoantibodies Once If the indicators are changed, the frequency of the study is individual depending on the previously obtained data Thyroid hormones Once If the parameters are changed, the frequency of the study is individual depending on the previously obtained data HBsAg 1 time in 12 months The study for HBsAg is carried out to exclude mixed hepatitis and acute hepatitis B (in case of enzymatic exacerbation) HCV RNA 1 time in 12 months ( qualitative analysis)* *Quantitative analysis is not carried out if the result of the qualitative analysis is negative; ultrasound of the abdominal cavity once every 12 months. When signs of portal hypertension appear, the frequency of the study is determined individually by endoscopy. Once (if clinical and biochemical signs of disease progression are detected) When VRVP is detected, the frequency of the study is determined individual liver biopsy once every 5–6 years
With stable indicators - once every 5–6 years
To obtain reliable results of laboratory tests, it is necessary: before the study, refrain from physical activity, stress and alcohol intake, do not smoke for at least an hour before taking blood; 2-3 days before the study, you should limit your intake of fatty, fried and spicy foods; do not eat after dinner (and make dinner itself light): you can drink only water and not a drop of juice, tea, coffee (especially with sugar); On the eve of the test, go to bed at your usual time and get up no later than an hour before the blood is taken.
Diagnostics
Diagnosis of hepatitis C is currently not difficult and begins with collecting anamnesis, identifying possible contacts with the source of infection, and determining the extent of previously performed invasive medical interventions. Next, the doctor conducts a visual examination of the skin and palpates the abdominal cavity.
Instrumental and laboratory techniques make it possible to determine the degree of advanced disease in just a few days. The most common diagnostic techniques exclude erroneous diagnosis, as they provide the most accurate indicators.
Liver puncture biopsy . An invasive operation that provides maximum diagnostic benefit. A special instrument is used to pierce the abdominal cavity, reach the liver, from where a piece of liver tissue is “plucked off”. The resulting biopsy is examined to determine the degree of destruction of hepatocytes, the presence of an oncological process, etc. The manipulation is invasive and is carried out under the control of ultrasound equipment.
Ultrasound of the abdominal organs . An informative method for visualizing the liver, pancreas, and spleen. Allows you to identify the degree of fibrosis, the presence of ascitic fluid and damage to other target organs suffering from the pathogenic effect of the virus.
Fiber scanning (elastometry) . The modern non-invasive equivalent of a biopsy. Carry out on the Fibroscan device. The purpose of the study is to obtain a complete picture of the condition of the liver as a whole, and not just one or several of its fragments.
CT, MRI . High-precision methods for visualizing internal organs and assessing their condition. They will help in diagnosis, in assessing the success of therapy, and in the early detection of severe complications of an infectious disease.
Self-diagnosis . If there was a questionable contact, enzyme-linked immunosorbent test systems will help to detect antibodies to the hepatitis C virus (Anti-HCV, ELISA-anti-HCV DIAplus, etc.). Such products are sold without a prescription in almost every pharmacy, are inexpensive, and easy to use. Detailed instructions included with each package will help you carry out a preliminary analysis on your own. The sensitivity of the tests is approximately 96%.
How to get tested for hepatitis C in a clinic? At a consultation appointment, the doctor gives a referral to a general clinical laboratory, where they do a hemogram, a blood test for biochemistry (biomaterial is taken strictly on an empty stomach), a test for the presence of hcv antibodies, etc.
PCR analysis
RNA determination is carried out by polymerase chain reaction, which can be performed using several methods:
- Reverse transcription (RT-PCR or RT-PCR) . It is done by enzymatic production of the required number of copies of specific fragments of complementary DNA with a preceding stage of reverse transcription. The method has been used since 1990. The enzyme used is DNA-dependent DNA polymerase from the bacteria Thermophilus termus. Detection is carried out in real time, which eliminates microbial contamination and increases specificity and sensitivity. Data is recorded automatically, which eliminates incorrect interpretation of PCR analysis results.
- “Nested” PCR is one of the subtypes of RT-polymerase chain reaction . Performed in some laboratories to improve sensitivity and specificity. It differs from the classical one in the use of two pairs of primers.
- Ligase reaction for RNA detection (LR) . The analysis is based on the property of DNA-dependent DNA ligase to ligate (“crosslink”) phosphodiester bond breaks in DNA under the influence of ATP and Mg2+.
- Transcription-mediated amplification (TMA) . The technique involves a complex mechanism of interaction between RNA and complementary DNA. The advantage of this method is the speed of execution (up to 40 minutes) and high sensitivity (up to 50 copies/ml).
- Hybridization using branched probes . Currently, analysis is practically not carried out due to low sensitivity.
The total result is presented in table form, for example:
Qualitative PCR | |
HCV not detected | Norm |
HCV detected | Further research needed |
Quantitative PCR | |
600–3ˑ105 IU/ml | Low viral load |
3ˑ105–8ˑ105 IU/ml | Average viral load |
More than 8ˑ105 IU/ml | High viral load |
Experts recommend conducting tests in stages. First, high-quality PCR, which shows whether the hepatitis C pathogen is in the body. If the result is positive, a quantitative test is performed, demonstrating the intensity of infection, then genotyping of the hepatitis C virus. How many days the analysis is done depends on the specific laboratory. On average, this period is 2–6 days.
Genotyping is intended to determine the exact type of hepatitis C virus. This is necessary to prescribe appropriate therapy and predict the possible development of the disease. The study is also carried out using the PCR method, the analysis is repeated only once.
False suspicion
False suspicion of HCV may arise due to incorrect interpretation of ELISA results. In a third of cases, the pathology occurs in an acute form, and with an adequate immune response it is suppressed and does not become chronic.
However, the penetration of the virus into the body provokes the production of antibodies (AB), which are detected by ELISA. Therefore, if the test result is positive, it is necessary to conduct PCR (if necessary, several tests at intervals of 2-3 weeks), confirming or refuting the alleged diagnosis.
How long does it take for it to appear after infection?
The minimum period when it is possible to identify pathological markers (HCV RNA) in a laboratory is 10–14 days. If a person suspects the possibility of infection, and the test result is negative, it should be repeated a week later. It is advisable to carry out high-quality PCR.
Clinical symptoms of the disease may not appear for a long time, even if the virus is actively multiplying in the liver. But 1–3 months after infection, weakness, increased fatigue, and spontaneous low-grade fever sometimes occur.
Types of antibodies
Methods such as the determination of Anti HCV igm and Anti HCV core igg have been developed as indicators for determining the diagnosis, condition and prognosis of a viral disease. Clinical application of these markers is necessary in early diagnosis and prognosis of acute disease. To separate it from an acute outbreak in carriers of infection and to distinguish between past and current illness in second-generation HCV-positive patients. The formation of total Anti-HCV at is different; their presence can be determined 3-4 weeks after infection.
IgM antibodies appear earlier and are then replaced by IgG and remain high for several months. At the same time, IgM is found in almost all patients with acute illness. After the viral illness ends, the level of IgM antibodies decreases, but may increase again during the reactivation period.
The avidity of specific IgG antibodies is low during primary viral infection and increases over time. Antibodies appear soon after the onset of symptoms and the appearance of the surface antigen of the virus. A negative IgG result may indicate no recent or previous infection.
Types of Antibodies
Depending on what antibodies are detected, the doctor can draw a conclusion about the patient’s health status. A variety of cells may be found in a biological sample. Antibodies are divided into two main types. IgM appears in the blood 4-6 weeks after the virus enters the body. Their presence indicates the active reproduction of viral cells and a progressive disease. IgG can be detected in a blood test in patients with chronic hepatitis C. This usually occurs 11-12 weeks after infection with the virus.
Some laboratories can use a blood sample to determine not only the presence of antibodies, but also individual proteins of the virus. This is a complex and expensive procedure, but it greatly simplifies diagnosis and gives the most reliable results.
Laboratory research methods are constantly being improved. Every year there is an opportunity to improve the accuracy of the analyzes performed. When choosing a laboratory, it is better to give preference to organizations with the most qualified employees and the latest diagnostic equipment.
Types of antibodies
As already written above, in the diagnosis of an infectious disease, antibodies of at least 2 types are determined: M and G. The technical capabilities of enzyme immunoassays make it possible to determine antibodies to various structures of the hepatitis C virus, for example, to nuclear proteins. The need for a particular test for antibodies to the hepatitis C virus is assessed by the attending physician.
Modern laboratories detect the following antibodies to the hepatitis C virus:
- anti-HCV total (IgG + IgM);
- anti-HCV core IgG and anti-NS (NS3, NS4 and NS5);
- anti-HCV IgM.
The result of any test for antibodies to the hepatitis C virus in itself is not a basis for making a diagnosis and prescribing specific therapy. Any tests are assessed comprehensively by the treating doctor. In addition to serological tests, certain biochemical parameters are examined for each patient.
Anti-HCV IgG
IgG antibodies are produced starting from 5-6 weeks from the moment of penetration of the hepatitis C pathogen. They persist throughout the patient’s life, even after successful treatment, as a result of an encounter with an infectious agent. They can be detected as an incidental finding during a serological examination of a carrier of the hepatitis C virus.
Modern diagnostic test systems detect antibodies of this class only as part of total antibodies (IgG + IgM).
Anti-HCV IgM
IgM is the so-called “acute-phase” antibodies, confirming an acute inflammatory process. They are synthesized during the period of acute hepatitis or exacerbation of the chronic form of the disease, starting from 2-3 weeks of illness. The content of class M immunoglobulins (antibodies) gradually decreases after the clinical symptoms subside. This class of antibodies is not detected in the blood if viral replication has stopped.
The a-HCV-IgM test is prescribed at the stage of the initial examination of the patient. It is one of the markers on the basis of which a decision is made on the advisability of starting specific antiviral treatment. The cost of this analysis is quite affordable. Its price varies from 500 to 600 Russian rubles.
Anti-HCV total (total)
aHCV or anti-HCV – these are the names of total antibodies (IgG + IgM). Since this is a mixture of two classes of antibodies, it is impossible to determine which class of antibodies is predominant or absent. Antibodies of class M appear 2-3 weeks after the virus enters the human body, antibodies of class G appear somewhat later, at 4-6 weeks.
Total antibodies are determined in the patient’s blood for life and are used to detect infection of people with this infectious agent, but are not the basis for making a diagnosis.
The cost of the study is low - in the range of 460-500 Russian rubles.
Anti-NS (NS3, NS4 and NS5)
IgG core and a-NS3, a-NS4, a-NS5 are a group of specific antibodies that appear from the 11-12th week of infection on the nuclear proteins of the hepatitis C pathogen. The core component is a structural component of the core of the hepatitis C virus, and NS3, NS4, NS5 – non-structural components (protein substances). After infection, antibodies can be detected after 4-5 weeks.
There is conflicting information on how to interpret them. There is an opinion that the appearance of antibodies to the structural components of the hepatitis C virus is confirmation of active replication of the virus, a possible marker of chronicity of the process and rapid progression of the disease.
Antibodies to non-structural proteins can be detected in various combinations. All three components (a-NS3, a-NS4, a-NS5) or only one can be found in the same patient. Their absence is not a reliable prognostic criterion for a favorable outcome of the disease.
Determination of antibodies to the structural and non-structural components of the hepatitis C virus is not available in all laboratories, since their diagnostic value is questionable.
Basic biochemical blood tests for hepatitis C
Biochemical blood tests help establish the functional state of many human organs and systems.
Blood test for liver enzymes ALT and AST
Liver enzymes are synthesized intracellularly. They take part in the synthesis of amino acids. A large number of them are found in the cells of the liver, heart, kidneys and skeletal muscles. When organs are damaged (violation of the integrity of cell membranes), enzymes enter the blood, where their levels increase. Increased levels of enzymes are recorded with damage (lysis, destruction) of liver cells, myocardial infarction and other diseases. The higher the level of transaminases in the blood serum, the more cells were destroyed. ALT predominates in liver cells, AST predominates in myocardial cells. When liver cells are destroyed, the ALT level increases 1.5 - 2 times. When myocardial cells are destroyed, the AST level increases 8-10 times.
When diagnosing chronic viral hepatitis, it is necessary to pay attention to the AST/ALT ratio (de Ritis coefficient). An excess of AST over ALT indicates liver cell damage
- The AST norm for men is up to 41 units/l, for women - up to 35 units/l, for children over 12 years old - up to 45 units/l.
- The ALT norm for men is up to 45 units/l, for women - up to 34 units/l, for children 12 years of age and older - up to 39 units/l.
- Normally (in healthy people), the AST/ALT ratio ranges from 0.91 to 1.75.
Blood test for bilirubin
Bilirubin is a breakdown product of hemoglobin. Bilirubin in the blood is contained in the form of indirect (up to 96%) and direct (4%). The process of decomposition of this substance occurs mainly in the liver cells, from where it is excreted from the body with bile. When liver cells are destroyed, the level of bilirubin in the blood serum increases. Normally, the content of total bilirubin is less than 3.4 - 21.0 µmol/l. At a level of 30 - 35 µmol/l and above, bilirubin penetrates the tissues, causing the skin and sclera to become jaundiced.
Rice. 6. Jaundice is one of the signs of liver damage.
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Methods for detecting hepatitis C virus
In addition to HCV analysis, it is possible to determine the presence of the so-called “gentle killer” in the blood in several other ways, including:
- – is considered one of the most effective and accurate diagnostic methods. It allows you to detect the RNA of the virus in the human body and carried out even if the result is positive
HCV analysis for definitive diagnosis
.
- Conducting a rapid test for the presence of the hepatitis C pathogen
- the sensitivity of this method is about ninety-six percent, which allows you to provide information about the presence of the pathogen in human biological environments in the shortest possible time.
There are also research methods that usually precede referral of a patient for HCV analysis. It is these diagnostic tools that provide information that leads a specialist to believe that there is inflammation of liver cells of viral etiology:
When is the test ordered?
Hepatitis C virus infection is the most common chronic blood-borne infection in the United States; it is also one of the leading known causes of liver disease in the United States. In the United States, it is the single leading cause of chronic liver disease and is therefore the leading reason for liver transplantation in adults.
Six major genotypes have been identified. Hepatology: a textbook on liver diseases. 4th ed. . The terminology associated with viral hepatitis is complex, but understanding some of the basic terms used and the meaning of key test results will help inform you about your condition.
- Ultrasound diagnostics and elastometry.
- Clinical blood test.
- Coagulogram.
- Biochemical with liver tests.
Infection detection methods
Above, we told you when you need to donate blood for viral hepatitis C, and what test it is advisable to do first. We rightly did not indicate antibodies in this list, since the anti hcv analysis may in some cases be much less informative than PCR. But what exactly is determined in each case?
Genome and genotyping
Doctors know, for example, that a test such as PCR identifies the main antigen, or genome.
As a result of the analysis, a very specific region of the ribonucleic acid of the causative agent of hepatitis C is determined. In modern laboratories, for example, the Invitro laboratory, the following genotypes can be identified: 1a, 1b, 2a, 2b, 2c, 2i, 3, 4, 5a, 6. PCR method is very highly specific and never produces errors. This means that another virus cannot be mistaken for hepatitis C, and the specificity of this method is 100% in diagnosing viral infections in the body.
The six most common genotypes of the virus were discussed above. In our country, the first genotype is most common, then 3, and then the second genotype of hepatitis C. There are recommendations from the Ministry of Health of the Russian Federation from 2014, according to which a study of the genotype of the virus should in any case be carried out for all patients.
The diagnostic method for genotyping is a fragment of a specific section of the nucleic acid of the virus, which is characteristic of a certain genotype.
Antibodies
A blood test for hcv will be incomplete without determining the quantitative immune response that occurs when infected with the hepatitis C virus. The absence of antibodies may indicate either the absence of infection or the opposite fact. Thus, in the acute course of hepatitis, early after infection, antibodies simply do not have time to develop, and a negative answer says nothing about the presence of the virus or its absence.
Anti HCV (HCV)+
If the result is positive, or if total antibodies are detected, the analysis indicates that there is an infection or recovery is underway. A positive result does not say anything about the chronic course of hepatitis, or about the acute form of the disease. This is indistinguishable, just like the phases of the infectious process: there is illness or gradual recovery. In both cases, antibodies to HCV will be positive.
Signs in men and women
Upon visual examination of patients with damaged liver, you may notice a nodular rash resembling urticaria, acne, hair loss or complete absence of hair in the armpit.
Ultrasound will help not only visualize, but also take photos of current changes in the abdominal organs.
Ultrasound signs that appear in the early stages of the disease are identical in women and men:
- changes in the size and vascular pattern of the organ;
- parenchyma heterogeneity;
- the presence of areas with increased echogenicity, granularity, fibrosis of the liver tissue;
- swollen lymph nodes;
- dilation of the bile ducts;
- portal hypertension (in advanced stages of the disease).
In the acute form of the disease, the first signs of laboratory changes in the hemogram are a tendency towards leukopenia, aplastic anemia and agranulocytosis. This indicates severe and sometimes fatal autoimmune reactions. Bile pigments are found in the urine.
In a biochemical blood test, a more than 10-fold increase in alanine aminotransferase (ALT) activity and a change in aspartate aminotransferase (AST) levels are recorded. In the icteric form of the disease, bilirubin increases, which stabilizes within a month after the onset of jaundice. During HCV infection, gamma-glutamyl transpeptidase (GGT) increases.