HCV ELISA Kit – High Sensitivity Antibody Detection for Hepatitis C

The Vanguard Diagnostics HCV ELISA Kit is a third-generation enzyme-linked immunosorbent assay designed for the qualitative detection of antibodies to Hepatitis C Virus (anti‑HCV) in human serum or plasma. Incorporating recombinant HCV antigens from Core, NS3, NS4, and NS5 regions, the assay delivers excellent clinical performance and is suitable for both diagnostic and donor screening applications.

Intended Use

This kit is intended for in vitro qualitative detection of anti-HCV antibodies in human serum or plasma. It is used to identify individuals who may have been exposed to the Hepatitis C Virus, a major cause of chronic liver disease.

Learn more about Hepatitis C symptoms and testing on the NHS website.

Assay Principle

The test follows a two-step indirect ELISA method:

1. HCV recombinant antigens are coated onto microwells.
2. Patient serum/plasma is added; anti‑HCV antibodies bind if present.
3. HRP-labelled anti-human IgG is introduced, binding to captured antibodies.
4. A chromogenic substrate (TMB) is added, and colour development is proportional to the amount of antibody present.
5. The reaction is stopped and read at 450 nm using a microplate reader.

Kit Components

• Coated microwell plate (96 wells)
• Sample diluent, HRP-conjugate, wash buffer concentrate (20×)
• Substrate A & B, stop solution
• Positive and negative controls
• Adhesive plate covers
• Instruction manual

Storage and Stability

• Store all reagents at 2–8 °C
• Do not freeze
• Shelf life is as indicated on product labelling
• Bring reagents to room temperature before use

Sample Requirements

• Specimen type: Human serum or plasma
• Avoid lipemic, haemolysed, or microbial-contaminated samples
• Store samples at 2–8 °C for ≤5 days, or at ≤–20 °C for long-term storage
• Avoid repeated freeze–thaw cycles

Performance Characteristics

• Sensitivity: > 99.5%
• Specificity: > 99.8%
• Precision: Coefficient of variation (CV) < 10% within and between runs
• Designed to minimise false positives with a two-step antigen-antibody binding approach

Handling & Precautions

• For professional use only
• All biological samples should be treated as potentially infectious
• Do not interchange kit components from different lots
• Follow standard laboratory biosafety guidelines

Related Products

Vanguard offers a range of complementary diagnostic kits that integrate smoothly into existing lab workflows:

• HIV ELISA 4th Gen Kit – Simultaneous detection of HIV‑1/2 antibodies and p24 antigen
• HBsAg ELISA Kit – Detects Hepatitis B surface antigen in serum/plasma
• Typhoid RT-PCR Kit – Real-time PCR assay for Salmonella enterica serovar Typhi

These kits align with similar instrument compatibility and laboratory procedures, supporting efficient diagnostic workflows.

Frequently Asked Questions (FAQs)

What is the HCV ELISA Kit used for?

It is used to screen for anti‑HCV antibodies, indicating prior or current infection with the Hepatitis C Virus.

Is this a quantitative test?

No, this is a qualitative assay. It determines the presence or absence of anti-HCV antibodies, not their concentration.

What type of sample is required?

Human serum or plasma collected under sterile conditions.

How should I store the HCV ELISA kit?

Store at 2–8 °C; do not freeze. Reagents must be brought to room temperature before use.

Can this be used at the point of care?

No, it is intended for use by trained professionals in certified diagnostic laboratories only.

What are the limitations of this test?

Reactive results must be confirmed with supplemental testing such as HCV RNA PCR. Results may not distinguish between resolved and ongoing infection.