Manufacturer, Brand Owner, Exporter, Startup · Mahesana, Gujarat, India
Labgene Biotech is a leading Indian manufacturer at the forefront of IVD product development. We operate an ISO 13485-certified, WHO-GMP, and USFDA-compliant facility, with all processes driven by hundreds of validated SOPs. Our R&D team has developed over 200 diagnostic tests, with 30+ currently in active use across chain laboratories, government platforms (GEM Portal), private distributors, and international export markets.
Registered address: Mahesana, India.
Industry: Healthcare, Medical Supplies & Pharmaceuticals > Biotechnology.
The Labgene HCV Ab Rapid Test kit is a professional-use, lateral flow chromatographic immunoassay for the qualitative detection of antibodies to Hepatitis C Virus (HCV). This rapid screening tool provides results within 20 minutes using whole blood, serum, or plasma samples. It is designed to assist in the diagnosis of HCV infection by detecting antibodies against key viral antigens.
Product Description
The Labgene HCV Ab Rapid Test kit is a diagnostic device for the qualitative detection of antibodies against the Hepatitis C Virus in human whole blood, serum, or plasma specimens. It is based on a double antigen sandwich principle, utilizing recombinant HCV capture antigens from the core, NS3, NS4, and NS5 regions of the HCV genome. Hepatitis C is a significant global cause of chronic hepatitis and liver disease. Early detection of HCV antibodies is crucial for a clinical diagnosis, enabling timely medical intervention and preventing the progression to chronic liver disease, such as cirrhosis or liver cancer. The test is highly advantageous due to its speed, providing results in just 20 minutes, its ease of use, and the fact that it does not require any external laboratory equipment.
Description provided by labgene bio-tech private limited.
Specifications
Test Principle
Double antigen sandwich immunoassay
Detection Method
Qualitative detection of anti-HCV antibodies
Sample Volume
Whole blood: 20 µL; Serum/Plasma: 10 µL
Assay Time
15 minutes
Temperature Range for Use
2°C to 30°C
Storage Shelf Life
Typically 12-24 months (depending on batch)
Validation Standards
Validated against ELISA and confirmed by National Institute of Biologicals (NIB), India
Test Sensitivity
100%
Test Specificity
100%
Regulatory Compliance
For professional in-vitro diagnostic use
Use cases
Category
Medical Diagnostics > Infectious Disease Test Kits > Hepatitis C Test Kits
Primary application
Wholesale, distribution, and international sourcing
Brand
Not specified
Product type
Product
Logistics & handling
Lead time
On request
Packaging
As per buyer requirement
Storage condition
As recommended by supplier
Origin
India
Form
As listed by supplier
Commercials (this seller)
Minimum order
1000 Numbers
Lead time
On request
Payment terms
As per negotiated commercial agreement.
Checkout type
enquiry
Buyer questions
Frequently asked by buyers
Common questions B2B buyers ask before sourcing HCV Ab Rapid Test Kit (WB, S, P) | Immuno-Chromatographic Assay for Hepatitis C Virus Antibodies. Answers compiled from verified sellers' commercial terms and platform data.
Q: Can the Labgene HCV Ab Rapid Test Kit detect both acute and chronic HCV infections?
A: Yes, the test detects antibodies produced against both acute and chronic Hepatitis C infections by targeting multiple antigenic regions of the virus.
Q: Is the Labgene HCV Ab Rapid Test Kit suitable for use with fingerstick blood samples?
A: Yes, the test has been validated for use with both venipuncture and fingerstick whole blood samples, enhancing its versatility in point-of-care and field settings.
Q: What makes this test kit's antigen targeting unique compared to other HCV rapid tests?
A: This kit utilizes a double antigen sandwich format that targets multiple highly immunodominant proteins of HCV (core, NS3, NS4, NS5), improving diagnostic accuracy and reducing false negatives.
Q: How stable is the Labgene HCV Ab Rapid Test Kit under transportation and storage conditions?
A: The kit remains stable when stored between 2°C and 30°C, allowing for safe use in varied environmental conditions without compromising test performance.
Q: What quality validation has the Labgene HCV Rapid Test Kit undergone?
A: It has undergone rigorous internal validation against ELISA tests and has been confirmed by the National Institute of Biologicals (NIB), India, ensuring 100% sensitivity and specificity.
Q: Is specialized equipment required to perform the test?
A: No additional instruments or equipment are necessary, making the test simple and practical for quick diagnostics in professional settings.
Q: What sample types can be tested with the Labgene HCV Antibody Rapid Test Kit?
A: It supports testing of human whole blood (venipuncture or fingerstick), serum, and plasma samples.
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