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BIORON Diagnostics GMBH

BIORON Diagnostics GMBH

BIORON Diagnostics GmbH is a lifescience products company and provides all components for PCR, including polymerases, dNTPs and ready-to-use mastermixes, especially for IVD products.
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Covid-19 BIORON Diagnostics GMBH

Clinical Laboratory

SARS-CoV-2 RNA Detection Kit
RealLine SARS-CoV-2 Lyo

The RealLine SARS-CoV-2 lyo assay kit is intended for the detection of coronavirus SARS-CoV-2 RNA in clinical specimens (nasopharyngeal and oropharyngeal swabs, sputum, bronchoalveolar lavage fluid) using reverse transcription of pathogen’s RNA with subsequent cDNA amplification by Real-Time Polymerase chain reaction (RT-qPCR) with fluorescence detection. The kit is intended for use with block-type cyclers such as CFX 96 (Bio-Rad, USA), RealLine Cyclers (BIORON Diagnostics GmbH) and DT-96 (DNA-Technology, Russia).
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SARS-CoV-2 Detection Kit
RealLine SARS-CoV-2 Detection Kit

The RealLine SARS-CoV-2 Detection Kit is an in vitro Nucleic Acid Test (NAT) – pathogen detection-based product – that is designed to detect SARS-CoV-2 (COVID-19 virus, 2019-nCoV) and SARS-like coronaviruses in human biological samples with the Polymerase Chain Reaction (PCR) method. Samples are human biological materials: nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, sputum. The kit is intended for use with RealLine Cycler (BIORON Diagnostics GmbH), and equivalent cyclers.
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SARS-CoV-2 / Influenza A+B Detection Kit
RealLine SARS-CoV-2 / Influenza A+B

The RealLine SARS-CoV-2 / Influenza A+B Detection Kit is designed to detect SARS-CoV-2 coronavirus, Influenza A virus and Influenza B virus in human biological samples with the Polymerase Chain Reaction (PCR) method. Samples are human biological materials: nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, and sputum. The kit is intended for use with RealLine Cycler (BIORON Diagnostics GmbH), and equivalent cyclers.
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About BIORON Diagnostics GMBH

BIORON Diagnostics GmbH is a lifescience products company and provides all components for PCR, including polymerases, dNTPs and ready-to-use mastermixes, especially for IVD products.

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Hepatitis C Virus Test
RoboGene HCV RNA Quantification Kit 3.0

The RoboGene HCV RNA Quantification Kit 3.0 is intended for Real-Time PCR quantification of Hepatitis C Virus (HCV) RNA in human EDTA- or citrate plasma and serum samples. The assay is purposed for the clinical management of patients with chronic HCV in conjunction with clinical presentation and other laboratory markers for HCV infection.
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Treponema pallidum DNA Test
RealLine Treponema Pallidum Kit

The RealLine Treponema pallidum kit is intended for the detection of Treponema pallidum DNA from clinical specimens by Real-Time PCR. The kit can be used with sample material derived from scrapings of epithelial cells (urethral, cervical, vaginal), as well as tissue fluid from erosive and ulcerative lesions of the skin and mucous membranes.
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B. Burgdorferi Sensulato Group Test
RealLine Borrelia Burgdorferi s. l. Kit

The RealLine Borrelia burgdorferi s. l. kits detect the B. burgdorferi sensulato group (Borrelia afzelii, Borrelia garinii, Borrelia burgdorferi sensustricto) DNA from ticks and clinical samples by Real-Time PCR. The kit can be used with various sample materials such as blood serum, plasma, cerebrospinal fluid and tick suspension samples.
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Clinical Laboratory

Hepatitis C Virus Test
RoboGene HCV RNA Quantification Kit 3.0

The RoboGene HCV RNA Quantification Kit 3.0 is intended for Real-Time PCR quantification of Hepatitis C Virus (HCV) RNA in human EDTA- or citrate plasma and serum samples. The assay is purposed for the clinical management of patients with chronic HCV in conjunction with clinical presentation and other laboratory markers for HCV infection.
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Treponema pallidum DNA Test
RealLine Treponema Pallidum Kit

The RealLine Treponema pallidum kit is intended for the detection of Treponema pallidum DNA from clinical specimens by Real-Time PCR. The kit can be used with sample material derived from scrapings of epithelial cells (urethral, cervical, vaginal), as well as tissue fluid from erosive and ulcerative lesions of the skin and mucous membranes.
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B. Burgdorferi Sensulato Group Test
RealLine Borrelia Burgdorferi s. l. Kit

The RealLine Borrelia burgdorferi s. l. kits detect the B. burgdorferi sensulato group (Borrelia afzelii, Borrelia garinii, Borrelia burgdorferi sensustricto) DNA from ticks and clinical samples by Real-Time PCR. The kit can be used with various sample materials such as blood serum, plasma, cerebrospinal fluid and tick suspension samples.
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Human Papillomavirus HPV Test
RealLine HPV 6 / 11 Kit

The RealLine HPV 6 / 11 kit is intended for the sensitive detection and differentiation of the common low-risk Genotypes 6 and 11 of the Human Papillomavirus (HPV). All the components of the CE Mark kit are lyophilized and ready-to use.
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Gonorrhoeae Test
RealLine Neisseria Gonorrhoeae Kit

The RealLine Neisseria gonorrhoeae kit is designed for the sensitive detection of Neisseria gonorrhoeae DNA in clinical samples by real-time PCR. The kit is designed for qualitative diagnosis of Neisseria gonorrhoeae DNA which are gram-negative motile bacteria and one of the most common sexually transferred diseases.
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TBEV Test
RealLine TBEV Kit

The RealLine TBEV kit is designed for the sensitive detection of Tick-Borne Encephalitis Virus (TBEV) RNA in clinical samples or from ticks by one-step real-time RT-PCR. The kits are designed for in vitro diagnostics and qualitative detection.
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Hepatitis D Test
RoboGene HDV RNA Quantification Kit 2.0

The RoboGene HDV RNA Quantification Kit 2.0 is intended for real-time PCR quantification of Hepatitis D Virus (HDV) RNA in human EDTA plasma or serum samples using the INSTANT Virus RNA/DNA Kit. The assay is intended for the clinical management of patients with chronic HDV infections in conjunction with symptoms and other laboratory markers of the disease. It is intended to assess viral response to antiviral treatment as measured by changes in plasma and serum HDV RNA levels.
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Human Papillomavirus (HPV) Test
RealLine HPV HCR Genotype

The RealLine HPV HCR Genotype kit is intended for the differential determination of DNA of high carcinogenic cancer human papillomavirus (HPV) types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 isolated from clinical specimens using extraction kits. The kit is intended for the analysis of clinical materials: epithelial cell swabs. The assay is based on the real-time polymerase chain reaction (PCR) method with fluorescent detection of the amplified product.
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Anaplasma / Ehrlichia Test Kit
RealLine Anaplasma / Ehrlichia

The RealLine Anaplasma / Ehrlichia kit is designed to detect DNA of Anaplasma phagocytophilum and DNA of Ehrlichia muris and Ehrlichia chaffeensis isolated from specimens using the RealLine Extraction 100 extraction kit. It is designed for the analysis of clinical materials such as leukocyte blood fraction, blood serum (plasma) and tick suspension samples. The assay is based on the real-time polymerase chain reaction (PCR) method with fluorescent detection of the amplified product.
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STI Test Kit
RealLine Trichomonas Vaginalis / Gardnerella Vaginalis

The RealLine Trichomonas vaginalis / Gardnerella vaginalis kit is intended for the detection of Trichomonas vaginalis and Gardnerella gonorrhoeae DNA in clinical specimens (urogenital and cervical swabs, semen, prostate fluid, urine) using the method of real-time polymerase chain reaction (PCR) with fluorescence detection of amplified product. The kit contains 96 tubes (0.2 ml) in strips with lyophilized Mastermix and reagents required for 96 tests, including control samples and the positive control sample.
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Hepatitis B Test
RealLine HBV Quantitative

The RealLine HBV quantitative kit is intended for the detection and quantitative determination of Hepatitis B virus (HBV) DNA in blood serum (plasma), using the method of real-time polymerase chain reaction (PCR) with fluorescence detection of amplified product. The kit RealLine HBV quantitative is designed to detect HBV DNA isolated from serum (plasma) using the RealLine Extraction 100 and 1000 NA extraction kits on Real-time PCR detection systems.
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Hepatitis B Virus DNA Quantification Assay
RoboGene HBV DNA Quantification Kit 3.0

The RoboGene HBV DNA Quantification Kit 3.0 is intended for real-time PCR quantification of Hepatitis B Virus (HBV) DNA in human EDTA- or citrate plasma and serum samples. The assay is intended for the clinical management of patients with Hepatitis B in conjunction with clinical presentation and other laboratory markers for HBV infection. It is not intended for use as a screening test for the detection of HBV DNA in blood or blood products or as a diagnostic test to confirm the presence of a HBV infection.
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Viral RNA/DNA Kit
INSTANT Virus RNA/DNA Kit

The INSTANT Virus RNA/DNA Kit has been designed for isolation of both viral RNA and DNA from different kinds of starting material using an extraction procedure based on a new kind of chemistry (patent pending). The INSTANT Virus RNA/DNA Kit is optimized for the rapid preparation of highly pure viral RNA and DNA from cell free fluid biological samples, such as plasma and serum, and works with 400 µl liquid samples.
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HSV-1/HSV-2 Real-Time PCR Test
RealLine HSV-1/HSV-2 Kit

The RealLine HSV-1/HSV-2 kit is intended for the detection and differentiation of HSV-1 DNA and HSV-2 DNA in clinical samples by Real-Time PCR. The kit is designed for in vitro diagnostics and provides qualitative detection.
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Automated Nucleic Acid Extraction System
MAGNETITE

The MAGNETITE is a fully automated nucleic acid extraction system for 16 samples and uses magnetic bead-based technology for the purification of high purity DNA and RNA. Its short processing time of 25 minutes makes it a fast and efficient solution for Real-Time PCR.
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SARS-CoV-2 / Influenza A+B Detection Kit
RealLine SARS-CoV-2 / Influenza A+B

The RealLine SARS-CoV-2 / Influenza A+B Detection Kit is designed to detect SARS-CoV-2 coronavirus, Influenza A virus and Influenza B virus in human biological samples with the Polymerase Chain Reaction (PCR) method. Samples are human biological materials: nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, and sputum. The kit is intended for use with RealLine Cycler (BIORON Diagnostics GmbH), and equivalent cyclers.
More details

SARS-CoV-2 Detection Kit
RealLine SARS-CoV-2 Detection Kit

The RealLine SARS-CoV-2 Detection Kit is an in vitro Nucleic Acid Test (NAT) – pathogen detection-based product – that is designed to detect SARS-CoV-2 (COVID-19 virus, 2019-nCoV) and SARS-like coronaviruses in human biological samples with the Polymerase Chain Reaction (PCR) method. Samples are human biological materials: nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, sputum. The kit is intended for use with RealLine Cycler (BIORON Diagnostics GmbH), and equivalent cyclers.
More details

SARS-CoV-2 RNA Detection Kit
RealLine SARS-CoV-2 Lyo

The RealLine SARS-CoV-2 lyo assay kit is intended for the detection of coronavirus SARS-CoV-2 RNA in clinical specimens (nasopharyngeal and oropharyngeal swabs, sputum, bronchoalveolar lavage fluid) using reverse transcription of pathogen’s RNA with subsequent cDNA amplification by Real-Time Polymerase chain reaction (RT-qPCR) with fluorescence detection. The kit is intended for use with block-type cyclers such as CFX 96 (Bio-Rad, USA), RealLine Cyclers (BIORON Diagnostics GmbH) and DT-96 (DNA-Technology, Russia).
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HPV Kit
RealLine HPV Kit

BIORON Diagnostics offers a wide range of detection kits for different types of the Human papilloma Viruses i.e. the RealLine HPV HCR Screen Kit which detects 14 different high carcinogenic risk types of the Human Papilloma Viruses in one test. The advantages of RealLine HPV HCR Screen kit include same extraction and PCR protocol, same internal control system, and all are CE-IVD marked.
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Tick Borne Infections Kit
RealLine Tick Borne Infections

BIORON Diagnostics offers detection kits for tick borne diseases such as Tick borne Encephalitis (FSME), Borreliosis, Anaplasmosis, Ehrlichiosis, Babesiosis and Rickettsiosis. The advantages of RealLine Tick borne Infection kits include one extraction for RNA and DNA, tests work with clinical samples and ticks, all tick-borne tests can be performed simultaneously, and high sensitivity for the human pathogen subspecies of Borrelia burgdorferi s.l. complex.
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STI Kit
RealLine STI Kit

BIORON Diagnostics offers a wide range of detection kits for different Sexually Transmitted Diseases as single detection kits or multiplex kits i.e. RealLine Chlamydia trachomatis / Neisseria gonorrhoeae double kits in different formats. The advantages of RealLine STI kits include same extraction and PCR protocol, same internal control system, and all are CE-IVD marked.
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DNA/RNA Extraction Kit
RealLine Extraction 100

The RealLine Extraction 100 kit is designed for DNA and RNA extraction from clinical samples, including whole blood/dried blood spots (DBS), serum (plasma), urine and stool (feces). It can be applied in clinical practice during diagnostics of different human infections and diseases by the polymerase chain reaction (PCR) method and by reverse transcription with subsequent polymerase chain reaction (RT-PCR).
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V600E Assay Kit
RealLine BRAF Detect V600E

The RealLine BRAF Detect V600E assay kit is intended for the detection of the V600 mutation in the BRAF gene by real-time PCR. It requires no post-PCR processing and minimizes the risk of contamination, as detection is performed in the same sealed tube without any further handling steps.
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HBV/HCV/ HIV Assay Kit
RealLine HBV / HCV / HIV (Str-format)

The RealLine HBV / HCV / HIV (Str-format) assay kit is intended for differential detection of hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA, and human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) RNA in blood serum (plasma). It uses a method based on the DNA or cDNA fragment (obtained from RNA by reverse transcription) amplification in polymerase chain reaction (PCR) with hybridization fluorescent detection in real time.
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Reagent Kit
RealLine DNA – Express

The RealLine DNA – Express reagent kit is designed for rapid (15 minutes) extraction of DNA from epithelial cell scrapings and allows independent extraction of DNA from 100 samples. It is intended for use in clinical practice in the process of diagnostics of sexually transmitted infections (STI) and for the assessment of treatment.
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Magnetic Rack
MagicMag Rack

The MagicMag Rack is a unique magnetic rack for 12 tubes (1.5 ml or 2.0 ml) with tilt mechanism and strong magnets for short incubation time. There is no need to move the tubes during the purification process as the magnet itself turns towards or away from the tubes for the washing and incubation steps.
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PCR Cycler
RealLine Cyclers

Bioron’s RealLine Cyclers for Real-Time-PCR-Assays are available in 48 well and 96 well format devices for research or high sample throughput lab applications. They are compatible with commercially available plates and tubes, and several cyclers can be operated by one computer.
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