Hepatitis B test kit C004E

hepatitis CAIDSdiagnostic

Brief
The Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR) is intended for qualitative detection and screening of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, Human Immunodeficiency Virus Type 1 (HIV-1) RNA and Human Immunodeficiency Virus Type 2 (HIV-2) RNA in plasma and serum samples from individual human donors. Plasma and serum from all donors may be screened as individual samples. For donations, samples may be tested individually or pooled in groups of six equal-volume samples. For in vitro diagnostic use only. For professional use only.

Advantages

• High sensitivity
  • HBV 2.41 IU/mL
  • HCV 12.38 IU/mL
  • HIV-1 31.68 IU/mL
  • HIV-2 48.34 IU/mL
• High efficiency
  • 576 tests / ~5 h (pooling)
  • 96 tests / ~4.5 h (single)
• Complete subtype/genotype coverage
  • HBV genotypes A–H
  • HCV genotypes 1–6
  • HIV-1 groups M/N/O
  • HIV-2 covered
• Multiple results in one test
  • 4 targets in one reaction
  • Direct discriminative positive results
• Automated workflow
  • Integrated extraction and amplification process
  • Fully automated extraction and amplification
• Cost and space savings
  • One extractor + one amplifier
  • Reduced consumable usage

Parameters
Items: C004E
Product name: Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Package specification: 96 tests/kit
Amplification: Multiplex real-time PCR
Extraction: Magnetic bead method
Sample type: Plasma, Serum
Sample volume: 960 μL
LoD (Individual testing): HBV 2.41 IU/mL; HCV 12.38 IU/mL; HIV-1 31.68 IU/mL; HIV-2 48.34 IU/mL
Storage and validity: Amplification kit: < −15°C, 12 months; Extraction kit: 2–8°C, 12 months
Qualification: CE

Related Instruments

• Natch S Pro — Fully Automated Nucleic Acid Extraction System
• SLAN-96P — Real-Time PCR System

Technical specifications

• Model: C004E
• Assay type: Multiplex real-time PCR for HBV, HCV, HIV-1 and HIV-2
• Package: 96 tests per kit
• Extraction method: Magnetic bead method (automated)
• Sample types: Plasma and serum
• Sample volume required: 960 μL
• Limit of Detection (LoD) individual testing: HBV 2.41 IU/mL; HCV 12.38 IU/mL; HIV-1 31.68 IU/mL; HIV-2 48.34 IU/mL
• Throughput/efficiency: 96 tests ~4.5 h (single); 576 tests ~5 h (pooling)
• Subtype/genotype coverage: HBV genotypes A–H; HCV genotypes 1–6; HIV-1 groups M/N/O; HIV-2 covered
• Result format: Multiple targets in one reaction with direct discriminative positive results
• Automation: Supports fully automated extraction and amplification workflows
• Storage & stability: Amplification kit < −15°C (12 months); Extraction kit 2–8°C (12 months)
• Regulatory qualification: CE