HCV ELISA (Blood Banking)

Intended Use: HCV Microwell ELISA is an in vitro enzyme immunoassay for the qualitative determination of antibodies to Hepatitis C Virus (anti-HCV) in human serum or plasma. 

Pack size: 96 Tests 

Shelf life: 18 months 

Storage: 2° to 8° C 

Product overview

The Vanguard Diagnostics HCV ELISA Kit is a third-generation microwell ELISA designed for the qualitative detection of anti-HCV antibodies in human serum or plasma. The assay uses a two-step indirect ELISA approach, with colour development measured at 450 nm using a microplate reader. 

For general information on hepatitis C and testing pathways, see:

• WHO: Hepatitis C fact sheet
• CDC: Hepatitis C diagnosis and testing

Intended use

This kit is intended for in vitro qualitative detection of anti-HCV antibodies in human serum or plasma. 

Assay principle

The test follows a two-step indirect ELISA method: 

1. HCV antigens are coated onto microwells.
2. Patient serum/plasma is added; anti-HCV antibodies bind if present.
3. HRP-labelled anti-human IgG binds to captured antibodies.
4. A chromogenic substrate (TMB) is added; colour development is proportional to antibody presence.
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 lipaemic, 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

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.