GENOMER® qPCR Test Kits

GENOMER® HBV qPCR Test Kit

An in vitro nucleic acid amplification test for quantification of Hepatitis B Virus (HBV) DNA in human serum or plasma. Intended to assist in the management of patients with chronic HBV infection and to form a strategy for anti-viral therapy.

  • Validated for use with fresh or frozen human serum or plasma (EDTA)
  • Quantification Standards: 1×10⁴ to 1×10⁷ IU/mL
  • Limit of Detection: 10 IU/mL
  • Linear range: 10 IU/mL to 1×10⁹ IU/mL
  • Diagnostic specificity ≥ 99%
  • Detects and quantifies all HBV genotypes
  • System failure rate ≤ 1%

GENOMER® HCV qPCR Test Kit

An in vitro nucleic acid amplification test for quantification of Hepatitis C Virus (HCV) RNA in human serum or plasma. Intended to assist in the management of patients with chronic HCV infection and to form a strategy for anti-viral therapy.

  • Validated for use with fresh or frozen human serum or plasma (EDTA)
  • Quantification Standards: 1×10⁴ to 1×10⁷ IU/mL
  • Linear range: 10 IU/mL to 1×10⁹ IU/mL
  • Diagnostic specificity ≥ 99%
  • Detects and quantifies all HCV genotypes
  • System failure rate ≤ 1%

GENOMER® HCV Genotyping qPCR Test Kit

An in vitro nucleic acid amplification test for detection and differentiation of Hepatitis C Virus (HCV) genotypes. Can identify HCV genotypes 1a, 1b, 2, 3, 4, 5 and 6 (6a/6b). Intended to assist in the management of patients with chronic HCV infection.

  • Identifies HCV genotypes 1a, 1b, 2, 3, 4, 5 and 6 (6a/6b)
  • Validated for use with fresh or frozen human serum or plasma (EDTA)
  • Limit of Detection: 10-89 IU/mL depending on genotypes
  • Diagnostic specificity ≥ 99%
  • System failure rate ≤ 1%

GENOMER® HIV qPCR Test Kit

An in vitro nucleic acid amplification test for quantification of Human Immunodeficiency Virus (HIV) RNA in human serum or plasma. Intended to assist in the management of patients with chronic HIV infection and to form a strategy for anti-viral therapy.

  • Validated for use with fresh or frozen human serum or plasma (EDTA)
  • Dual Targets minimize false negative results
  • Quantification Standards: 1×10⁴ to 1×10⁷ IU/mL
  • Detects and quantifies all subtypes of HIV-1 M group and Circulating Recombinant Forms
  • System failure rate ≤ 1%

GENOMER® HPV 26 Screening Kit

A real-time PCR test for qualitative detection of nucleic acids from 24 high-risk and 2 low-risk Human Papillomavirus (HPV) DNA in one tube. HPV infections are very common, with oncogenic types associated with cervical cancer development.

  • Multiple targets in single tube
  • Ready-to-use kit
  • Human RNase P as internal control
  • CE marked
  • Assay duration: 60 minutes
  • Limit of Detection: 48 IU/mL
  • No cross-reactivity with potential cross-reactive markers

GENOMER® HPV 14 Genotyping Kit

HPV genotyping is important for medical indications of HPV testing. Genotyping better identifies women at high risk of dysplasia and is an accurate indicator of treatment failure in follow-up after treatment for cervical dysplasia. Essential for monitoring HPV vaccination effects.

  • Multiple targets (14 targets in 5 tubes)
  • Ready-to-use kit
  • Human RNase P as internal control
  • CE marked
  • Assay duration: 60 minutes
  • Limit of Detection: 42 IU/mL
  • No cross-reactivity with potential cross-reactive markers