Hep C rapid poc test (Box of 50)

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.

Tests4health hep C 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.

What is Hep C?

 Hepatitis C is a blood-borne virus that   infects the cells of the liver.    

What are the effects of Hep C infection?

Hepatitis C was discovered in the 1980s when it 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.

How many people are infected?

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 Hep C infection 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.

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.

Why test?

Early diagnosis is essential to enable early treatment.

How reliable is the 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.

Based on this evaluation:

Sensitivity of Hep C rapid test 100%

Specificity of Hep C rapid test 99.6%

The Hep C point of care rapid test is very reliable and is CE marked for professional use