Hepatitis C point of care test.
The newly launched Hep C point of care test.
The hep C test is a rapid, fourth generation, qualitative immuno-assay for detection of antibodies to Hepatitis C virus (HCV) in human serum / plasma. The test employs a cocktail of genotype cross-reactive recombinant antigens derived from the core, NS3, NS4, and NS5 regions of multiple HCV genotypes.
What is Hepatitis C?
Hepatitis C is a blood-borne virus that infects the cells of the liver.
Hepatitis C was discovered in the 1980s when was known as non-A non-B hepatitis. It can cause inflammation of and sometimes significant damage to the liver and affect its ability to perform its many, varied and essential functions. Hep C is a liver disease (hepatitis means inflammation of the liver), recent research has shown that hepatitis C affects a number of other areas of the body including the digestive system, the lymphatic system, the immune system and the brain.
hepatitis-c-virus
How many people are affected?
There are an estimated 130-170 million people worldwide infected with hepatitis C but the level of infection, known as prevalence, varies widely from country to country. In some countries, such as Egypt it is over 10%; in the US it is believed to be nearly 2% and in northern Europe around 1%. Transmission is by contact with infected blood.
Hepatitis C is an RNA virus. RNA viruses mutate much more than DNA viruses.
This ability to change makes it harder for the bodys immune system to locate and destroy them. In hepatitis C there are 7 major variations of the virus, known as genotypes and labelled 1 to 7. Different genotypes predominate in different parts of the world. One genotype cannot change into another but it is possible, although rare, to be infected with more than one genotype at the same time.
How does the disease progress?
A hepatitis C infection is usually categorised into two stages Firstly as an acute infection (following initial infection) and secondly a chronic infection. Often the acute stage refers to the first 6 months of infection and does not necessarily mean there are any noticeable symptoms. Approximately 20% of those infected with hepatitis C will naturally clear the virus from their body and experience no long-term affects from the infection
Hepatitis C infection and its progress is extremely varied and unpredictable. Although many people experience very few symptoms for long periods, sometimes decades. Others can be very symptomatic from the beginning. Some people will progress to develop fibrosis and cirrhosis (scarring) of the liver, liver cancer or end stage liver disease, which may ultimately require a liver transplant, while others experience very little liver damage even after many years. Confusingly there seems to be no clear relationship between the degree of liver damage and the experience of symptoms.
How would I know if I was Hep C positive?
In the absence of symptoms, many people are unaware that they have a hepatitis C infection until some time after infection. Another reason so many people with hepatitis C remain undiagnosed is that many of the symptoms are subjective, at least in severity, and easy to put down to something else. So, for example, depression, fatigue, skin problems, insomnia, pain and digestive disorders could all have other causes. For these reasons hepatitis C is often referred to as the silent epidemic. That is why early and accurate diagnosis is essential for treatment and recovery.
If you think you have ever been at risk of contracting Hepatitis C, talk to a medical professional about having a test, such as your GP or another trained professional.
If you gave birth whilst infected with Hepatitis C, and your child is now over a year old, you should talk to your doctor about testing children for Hepatitis C.
If you decide to go ahead with testing, blood samples(s) will be taken from you and blood tests run to find out:
- if you’ve ever been infected with Hepatitis C - Hepatitis C Antibody Test
- if there is still Hepatitis C virus circulating in your body and how much - Hepatitis C Virus RNA (PCR) and Viral Load Tests
- what strain of Hepatitis C infection you have – Hepatitis C Genotype Test
Other tests that look for liver damage might include an ultrasound scan, which takes a picture of the liver, or a biopsy where a needle is used to take a tiny piece of the liver for examination.
Principles of the Hep C Assay
MHS Hep C rapid test utilizes the principle of Immunochromatography, a unique two-site immunoassay on a nitrocellulose membrane. The membrane is stripped with a cocktail of recombinant antigens derived from the core, NS3, NS4, and NS5 regions of multiple HCV genotypes at the test region. The conjugate pad contains Protein-A gold conjugate. As the test specimen flows through the membrane test assembly, the Protein-A colloidal gold conjugate complexes with the HCV specific antibodies in the specimen and travels on the membrane due to capillary action.
This complex moves further on the membrane to the test region where it is immobilized by the HCV antigens coated on the membrane. This leads to the formation of a colored band. The development of a colored band in the test region indicates the presence of antibodies to HCV in the specimen.
The unreacted Protein-A gold conjugate and unbound complex, move further on the membrane and are subsequently immobilized by the control reagent coated on the membrane at the control region (C), forming a colored band. This control band acts as a procedural control and serves to validate the results.
How does the Hep C test work?
The MHS rapid Hep C Test:
HCV is a single-stranded RNA virus containing a linear genome with a length of about 9,600 nucleotides with positive polarity.
Hep C Casette
It is now recognized that HCV Infection is the major etiological agent of post transfusion hepatitis type non-A, non-B. HCV Infection frequently progresses to chronic liver disease. On the basis of phylogenetic analysis, HCV has been grouped into six major genotypes, each of which contains one or more subtypes. The distribution of HCV genotypes varies in different geographical areas.
The first-generation HCV antibody test became commercially available in early 1990s and was widely used. As more reactive recombinant antigens were identified from conserved regions of the HCV genome, newer serologic assays were introduced.
Third-generation assays were introduced in the late 1990s. In these assays, a recombinant NS5 antigen has been added to the antigens used in the second-generation assays. These third-generation assays have higher sensitivities and specificities than second-generation assays and are much less strongly influenced by the Infecting genotype.
The first, second and third generation HCV antibody assays still lack sensitivity in seroconversions or show inexplicable discrepancies with confirmatory assays. This is primarily due to poor cross-reactivity with the current HCV genotype 1 antigen-based assays. To solve this problem fourth generation assays using antigens from multiple HCV genotypes that includes genotypes 2 & 3 apart from genotype 1, containing universally conserved epitopes, are been developed and evaluated.
MHS Hep C rapid test is a fourth generation assay that uses a cocktail of recombinant antigens that is broadly cross-reactive to all major HCV genotypes.
How accurate is the Hep C Rapid test?
SENSITIVITY & SPECIFICITY DATA
Six hundred and thirty samples-out of which one hundred and ten HCV positive specimen and five hundred and twenty HCV negative specimen were tested with Hep C rapid test and compared with commercially available ELISA. The results are as shown below.
| Specimen Data | Total | Hep C rapid test | Commercial ELISA |
| Total Number | 630 | 628 | 630 |
| HCV Positive | 110 | 110 | 110 |
| HCV Negative | 520 | 518 | 520 |
Based on this evaluation:
Sensitivity of Hep C rapid test 100%
Specificity of Hep C rapid test 99.6%
It is an approved medical device and ce marked.
CE Marked.
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