HCV Test for Sale

Specifications of HCV Test

Key Features of HCV Test Products

High Sensitivity and Specificity – Modern HCV tests deliver exceptional accuracy, minimizing false positives and negatives. Advanced immunoassays and nucleic acid tests (NAT) ensure reliable detection of HCV antibodies, antigens, and RNA.

Rapid Results – Many HCV tests provide results in 20–30 minutes, enabling quick diagnosis and timely intervention. Rapid test kits are ideal for point-of-care (POC) settings with limited lab infrastructure.

Multiple Testing Methods – HCV diagnostics include:

• ELISA/CLIA for antibody/antigen screening

• PCR-based NAT for viral load quantification

• Rapid lateral flow assays for decentralized testing

• Automation Compatibility – Automated platforms (e.g., chemiluminescence analyzers) enhance throughput, reduce human error, and standardize results for high-volume labs.

• Early Detection Capability – Fourth-generation ELISA tests detect both HCV antibodies and core antigens, shortening the window period post-infection compared to antibody-only assays.

• Genotyping Options – Specialized PCR tests identify HCV genotypes (1–6), guiding personalized treatment strategies.

• User-Friendly Design – Rapid tests feature simple procedures (fingerstick blood/serum/plasma), requiring minimal training—ideal for resource-limited areas.

• Regulatory Compliance – Tests adhere to WHO, FDA, and CE standards, ensuring global acceptability.

• Cost-Effectiveness – Scalable solutions cater to diverse budgets, from low-cost rapid kits to high-precision automated systems.

• Dual/Multipanel Testing – Some assays integrate HCV with HIV/HBV screening, streamlining co-infection detection.

HCV Test – Standard Operating Procedure

1. Sample Collection & Preparation

Specimen Types: Serum, plasma (EDTA), or whole blood

Collection:

Draw 3-5 mL venous blood in serum separator tube (for ELISA/CLIA)

For fingerstick samples (rapid test), wipe away first blood drop, collect second drop

Processing:

Centrifuge at 3000 rpm for 10 min (serum/plasma)

Avoid repeated freeze-thaw cycles

2. Test Procedure

A. Rapid Test (Lateral Flow)

• Bring test device to room temperature (15-30°C)

• Add 50μL serum/plasma or 3 drops whole blood to sample port

• Immediately add 2 drops buffer

• Read results at 20 minutes (maximum)

B. ELISA Method

• Load 100μL samples/controls into anti-HCV coated wells

• Incubate 60 min at 37°C

• Wash 5× with 300μL wash buffer

• Add 100μL enzyme conjugate, incubate 30 min

• Repeat wash, add 100μL TMB substrate

• Stop with 50μL stop solution after 15 min

• Read at 450/620nm

C. PCR Testing

• Extract RNA using viral RNA kit

• Prepare PCR mix:

• 10μL RNA template

• 15μL master mix (primers/probes)

Run real-time PCR:

• Reverse transcription: 50°C for 15 min

• Amplification: 40 cycles of 95°C/15 sec → 60°C/1 min

3. Result Interpretation

Rapid Test:

• Positive: Both control (C) and test (T) lines

• Negative: Only control line

• Invalid: No control line → repeat

ELISA:

• Calculate cutoff value (NC mean + 0.6)

• Sample OD ≥ cutoff = Reactive

PCR:

• Positive: Ct ≤40 with proper curve shape

• Negative: No amplification or Ct >40

4. Quality Control

• Run positive/negative controls with each batch

• For PCR: Include internal control in each sample

• Document all QC data

Note: Always follow manufacturer's instructions for specific test kits. Store reagents as specified.