Export Snapshot

Minimum order

1000 Numbers

HSN Code

901890

Origin

India

Lead time

On request

Port of dispatch

On request

Packaging

Standard export packaging

Shelf life / storage

As per product specification

Export markets served

AO BW LR NP ZM

Ability to customise

As per OEM brief

Values shown are for Labgene Bio-Tech Private Limited.

MDR 2017 and ISO13485:2016

Company Labgene Bio-Tech Private Limited

Labgene Bio-Tech Private Limited

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.

FIEO Registered

View profile →

Established

2019

Employees

51–100

GST

24AADCL8897L1ZQ

IEC code

AADCL8897L

Export markets

AO BW LR NP ZM

Member since

Jul 2025

Turnover

$2 MM - $5 MM

Incorporation type

On request

MDR 2017 and ISO13485:2016

Product details

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.

Lateral flow chromatographic immunoassay with double antigen sandwich format

Antibodies against HCV core, NS3, NS4, and NS5 proteins

Human whole blood, serum, and plasma

Within 15 minutes

100% both, validated against ELISA and confirmed by National Institute of Biologicals (NIB), India

Venipuncture and fingerstick samples

2°C to 30°C

Test devices, assay buffer, and accessories

25 Tests/Box and 50 Tests/Box

Hospitals, diagnostic labs, blood banks, field screening, clinics, health campaigns

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

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 Labgene Bio-Tech Private Limited

Minimum order

1000 Numbers

Lead time

On request

Payment terms

As per negotiated commercial agreement

Frequently asked by buyers

Can the Labgene HCV Ab Rapid Test Kit detect both acute and chronic HCV infections?

Yes, the test detects antibodies produced against both acute and chronic Hepatitis C infections by targeting multiple antigenic regions of the virus.

Is the Labgene HCV Ab Rapid Test Kit suitable for use with fingerstick blood samples?

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.

What makes this test kit's antigen targeting unique compared to other HCV rapid tests?

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.

How stable is the Labgene HCV Ab Rapid Test Kit under transportation and storage conditions?

The kit remains stable when stored between 2°C and 30°C, allowing for safe use in varied environmental conditions without compromising test performance.

What quality validation has the Labgene HCV Rapid Test Kit undergone?

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.

Is specialized equipment required to perform the test?

No additional instruments or equipment are necessary, making the test simple and practical for quick diagnostics in professional settings.

What sample types can be tested with the Labgene HCV Antibody Rapid Test Kit?

It supports testing of human whole blood (venipuncture or fingerstick), serum, and plasma samples.

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