HCV ELISA (Blood Banking)

HCV ELISA Test Kit – Vanguard Diagnostics

Qualitative Detection of Hepatitis C Virus Antibodies in Human Serum or Plasma

The Vanguard HCV ELISA Test Kit is a third-generation enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to Hepatitis C Virus (HCV) in human serum or plasma. This kit uses recombinant antigens representing Core, NS3, NS4, and NS5 regions of the virus to deliver high sensitivity and specificity. It is designed for use in diagnostic laboratories and blood screening facilities.

Intended Use

The Vanguard HCV ELISA Test Kit is intended for the qualitative detection of anti-HCV antibodies in human serum or plasma. This third-generation ELISA is used in:

• Blood donor screening
• Clinical diagnostics
• HCV surveillance programmes

The test aids in identifying individuals exposed to HCV. Results should be interpreted by qualified professionals alongside clinical and laboratory findings. This test is not intended for home use.

Principle of the Test

This assay follows the indirect ELISA principle. Microwells are pre-coated with recombinant HCV antigens. After serum or plasma is added:

1. HCV antibodies bind to the antigens if present.

2. An enzyme-linked anti-human IgG is added, binding to the immune complex.

3. After incubation, a substrate is introduced to develop colour.

4. Colour intensity is proportional to the antibody concentration and is measured spectrophotometrically at 450 nm.

Key Features

• Third-generation ELISA with high sensitivity and specificity
• Detects antibodies against multiple HCV epitopes (Core, NS3, NS4, NS5)
• Colour-coded reagents and break-apart microwells
• Fast and efficient workflow (~90–105 mins)
• IFU-compliant design and validated performance

Kit Components

• 96 Microwell strips (recombinant HCV antigen-coated)
• Sample diluent
• Enzyme conjugate
• Wash buffer concentrate (20X)
• Substrate buffer with hydrogen peroxide
• TMB substrate (101X)
• Stop solution
• Positive and negative controls
• Instruction manual

Sample Requirements

• Sample type: Human serum or plasma (EDTA, citrate, or heparin)

• Avoid multiple freeze–thaw cycles

• Store samples at 2–8°C (short-term) or –20°C (long-term)

Test Procedure Summary

1. Add 100 µL of diluted sample/control to each well

2. Incubate at 37°C for 60 minutes

3. Wash wells 5 times

4. Add 100 µL of enzyme conjugate, incubate 30 minutes

5. Wash again; add 100 µL of working substrate

6. Incubate at 37°C for 15 minutes in the dark

7. Add 100 µL stop solution

8. Read at 450 nm within 30 minutes

Interpretation of Results

• Positive: Absorbance ≥ Cut-off value

• Negative: Absorbance < Cut-off

• Ensure control results meet validation criteria

Storage & Stability

• Store kit components at 2–8°C
• Do not freeze
• Stable for 18 months from manufacturing date.

Warnings & Precautions

• For in vitro diagnostic use only
• Treat all specimens and reagents as potentially infectious
• Do not mix components from different kit lots
• Do not use expired reagents
• Follow biosafety guidelines when handling materials

Quality Control

Each kit includes internal positive and negative controls to ensure validity. Controls should be run with each batch of tests.

Ordering Information

• Format: 96 Tests

• Catalogue No: Refer to label

• Storage: 2–8°C

• Manufacturer: Vanguard Diagnostics Pvt. Ltd.

Frequently Asked Questions (FAQs)

Q: What samples are suitable for the HCV ELISA test?

A: Human serum or plasma (collected with EDTA, heparin, or citrate) can be used.

Q: What is the detection principle?

A: It is based on indirect ELISA with recombinant HCV antigens detecting anti-HCV antibodies.

Q: How long does the test take?

A: The total assay time is approximately 90 to 105 minutes.

Q: How should the kit be stored?

A: Store all components at 2–8°C. Do not freeze.

Q: What is the shelf life of the HCV ELISA kit?

A: 18 months from the date of manufacture under proper storage conditions.