HCV Rapid Test

Product Description:

The Anti-HCV rapid test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of antibodies to Hepatitis C virus (Anti-HCV) in human whole blood, serum or plasma. It is intended for the screening of blood and blood products to be used for transfusion and as an aid in the diagnosis of infection with HCV. The test is recommended for professional use only. All results must be interpreted together with other clinical information or other diagnosis methods available to the physician.

Hepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus (HCV). The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years. In some cases, those with cirrhosis will go on to develop liver failure or other complications, including liver cancer or life-threatening esophageal varices and gastric varices. Hepatitis C virus is a single stranded RNA virus with some structural relations to the flavivirus family. Nucleic acid sequences of HCV cDNA clones provided the basis for the construction of recombinant peptides representing putative Hepatitis C virus proteins. In recent study, proteins of core, NS3, NS4, and NS5 were found to be highly immunogenic among 11 types of Hepatitis C virus proteins. Compared to the earlier generations of HCV test using single or double recombinant antigens, the Anti-HCV rapid test uses multiple recombinant proteins to detect antibodies, so as to obtain an improved sensitivity and specificity.

Test Principle:

The HCV Rapid Test Device (Whole Blood /Serum/Plasma) has been designed to detect antibodies to HCV through visual interpretation of color development in the internal strip. The membrane was immobilized with protein A on the test region. During the test, the specimen is allowed to react with colored recombinant HCV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interacts with reagents on the membrane. If there were enough HCV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

Reagents and Materials Provided

25 X Test devices. Test cassettes are individually sealed in a foil pouch with a dropper and a package of desiccant.

1 X Assay buffer

1 X Instruction for use

Support and Services:

The Colloidal Gold Rapid Test product offers technical support and services to ensure optimal performance and accurate results. Our team of experts is available to answer any questions regarding product use and troubleshooting. Additionally, we offer training and educational resources to help users maximize the benefits of the product. Our services also include product customization and development to meet specific customer needs.

Precautions:

• For professional and IN VITRO diagnostic use only.
• The test should remain in the sealed pouch until use.
• Do not use the kit if the foil pouch is punctured or not well sealed.
• Do not reuse or use kits after the expiration date.
• Do not mix components from kits with different lot number.
• Avoid microbial contamination of reagents.
• Wear gloves during the whole process and avoid reagents or specimen spilling-out. Wash hands thoroughly afterwards.
• Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of the specimens carefully after autoclaving for at least one hour. Alternatively, treat with a 0.5 or 1% solution of sodium hypochlorite for one hour before disposal.
• Dispose the used kit after decontamination of all liquids or solid wastes by following the local law or laboratory rule.