GENOMER® SARS-COV-2 RNA qPCR Test Kit
SARS-CoV-2 RNA qPCR Kit is a real-time PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in respiratory samples such as human oropharyngeal (OP) swab, nasopharyngeal (NP) swab or combined nasopharyngeal (NP) and oropharyngeal (OP) swab from individuals who are suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.
Single tube, multiple targets
Dual Targets suggested by US CDC and WHO (RdRp, ORF1ab and N-gene)
Human RNase P as an internal control
CE marked
Assay duration: 69 mins
The Limit of Detection (LoD) value is 58 copies/mL
No cross-reactivity with the potential cross-reactive markers shown using both in silico analysis and wet testing.
GENOMER® HBV qPCR Test Kit
GENOMER® HBV qPCR Test Kit is an in vitro nucleic acid amplification test for quantification of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) using GENOMER® Viral Nucleic Acid Purification Kit and Stratagene Mx3000p/Mx3005p or LineGene 9600 or LightCycler 2.0 or Rotor-Gene 3000/6000 or Applied Biosystems 7500 or BIO-RAD CFX96 Real-Time PCR Detection System for amplification, detection and analysis.
GENOMER® HBV qPCR Test Kit is intended to assist in the management of patients with chronic HBV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. GENOMER® HBV qPCR Test Kit is not intended to screen blood and blood products for the presence of HBV DNA or to confirm the diagnosis of infection with HBV.
Validated for use with fresh or frozen human serum or plasma collected in EDTA anticoagulant.
Quantification Standards ranging from 1 x 10^4 IU/ml ve 1 x 10^7 IU/ml
The Limit of Detection (LoD) value is 10 IU/mL
Linear range is between 10 IU/mL and 1 x 10^9 IU/ml
Diagnostic specificity is ≥ 99 %
Can detect and quantify all HBV genotypes
Whole system failure rate is ≤1 %
GENOMER® HCV qPCR Test Kit
GENOMER® HCV qPCR Test Kit is an in vitro nucleic acid amplification test for quantification of Hepatitis C Virus (HCV) RNA in human serum or plasma (EDTA) using GENOMER® Viral Nucleic Acid Purification Kit and Stratagene Mx3000p/Mx3005p or LineGene 9600 or LightCycler 2.0 or Rotor-Gene 3000/6000 or Applied Biosystems 7500 or BIO-RAD CFX96 Real-Time PCR Detection System for amplification, detection, and analysis.
GENOMER® HCV qPCR Test Kit is intended to assist in the management of patients with chronic HCV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. GENOMER® HCV qPCR Test Kit is not intended to screen blood and blood products for the presence of HCV RNA or to confirm the diagnosis of infection with HCV.
Validated for use with fresh or frozen human serum or plasma collected in EDTA anticoagulant.
Quantification Standards ranging from 1 x 10^4 IU/mL to 1 x 10^7 IU/mL
Linear range is between 10 IU/mL and 1 x 10^9 IU/mL Diagnostic specificity is ≥ 99%
Can detect and quantify all HCV genotypes
Whole system failure rate ≤1 %
GENOMER® HCV Genotyping qPCR Test Kit
GENOMER® HCV Genotyping qPCR Test Kit is an in vitro nucleic acid amplification test for detection and differentiation of the genotypes of Hepatitis C Virus (HCV) RNA in human serum or plasma (EDTA) using GENOMER® Viral Nucleic Acid Purification Kit and BIO-RAD CFX96-IVD Real-Time PCR Detection System.
GENOMER® HCV Genotyping qPCR Test Kit can identify HCV genotypes 1a, 1b, 2, 3, 4, 5 and 6 (6a/6b). GENOMER® HCV Genotyping qPCR Test Kit is intended to assist in the management of patients with chronic HCV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. GENOMER® HCV Genotyping qPCR Test Kit is not intended to screen blood and blood products for the presence of HCV RNA or to confirm the diagnosis of infection with HCV.
Can identify HCV genotypes 1a, 1b, 2, 3, 4, 5 and 6 (6a/6b).
Validated for use with fresh or frozen human serum or plasma collected in EDTA anticoagulant
The Limit of Detection (LoD) value is between 10-89 IU/mL depending on genotypes
Diagnostic specificity is ≥ 99 %10^
Whole system failure rate is ≤1 %
GENOMER® HIV qPCR Test Kit
GENOMER® HIV qPCR Test Kit is an in vitro nucleic acid amplification test for quantification of Human Immunodeficiency Virus (HIV) RNA in human serum or plasma (EDTA) using GENOMER® Viral Nucleic Acid Purification Kit and Stratagene Mx3000p/Mx3005p or LineGene 9600 or LightCycler 2.0 or Rotor-Gene 3000/6000 or Applied Biosystems 7500 or BIO-RAD CFX96 RealTime PCR Detection System for amplification, detection and analysis.
GENOMER® HIV qPCR Kit is intended to assist in the management of patients with chronic HIV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. GENOMER® HIV qPCR Test Kit is not intended to screen blood and blood products for the presence of HIV RNA or to confirm the diagnosis of infection with HIV.
Validated for use with fresh or frozen human serum or plasma collected in EDTA anticoagulant.
Dual Targets minimize the risk of false negative test results due to the potential mutations in the target regions of the HIV-1 genome covered by the oligos
Quantification Standards ranging from 1 x 10^4 IU/mL to 1 x 10^7 IU/mL
Can detect and quantify all subtypes of HIV-1 M group and Circulating Recombinant Forms
Whole system failure rate is ≤1 %
GENOMER® HPV 26 Screening Kit
Human papillomavirus (HPV) infections are very common and viral DNA can be detected from skin, oral and anogenital samples from all human populations. Currently, over 200 types of HPV have been fully characterized and predominantly assigned into three genera: Alphapapillomavirus, Betapapillomavirus and Gammapapillomavirus. Among the 65 HPV types belonging to Alphapapillomavirus (Alpha-HPV types), a limited set of viruses are considered oncogenic and associated with the development of cervical cancer and its precursor lesions. The oncogenic HPVs causing essentially all cervical cancers are phylogenetically clustered in one clade composed of species Alpha-5, Alpha-6, Alpha-7, Alpha-9, and Alpha-11.
GENOMER® HPV 26 Screening Kit is a real-time PCR test intended for the qualitative detection of nucleic acids from 24 high-risk and 2 low-risk Human Papillomavirus (HPV) DNA in one tube.
Multiple targets in single tube
Ready-to-use kit
Human RNase P as an internal control
CE marked
Assay duration: 60 mins
The Limit of Detection (LoD) value is 48 IU/mL
No cross-reactivity with the potential cross-reactive markers shown using both in silico analysis and wet testing.
GENOMER® HPV 14 Genotyping Kit
HPV genotyping is important for most of the major medical indications of HPV testing. For example, genotyping of HPV has been shown to be an accurate indicator of treatment failure in follow-up after treatment for cervical dysplasia. In cervical screening, HPV genotyping better identifies women at high risk of dysplasia than does a nongenotyping HPV test and monitoring of the types that are associated with the highest risk for cancer is particularly important. The monitoring of the effect of HPV vaccination requires adequate HPV genotyping to evaluate whether vaccine HPV types disappear from the population and how the prevalence of nonvaccine types is affected.
Multiple targets (14 targets in 5 tubes)
Ready-to-use kit
Human RNase P as an internal control
CE marked
Assay duration: 60 mins
The Limit of Detection (LoD) value is 42 IU/mL
No cross-reactivity with the potential cross-reactive markers shown using both in silico analysis and wet testing.