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RealStar® Detection Kits
All RealStar® PCR Kits are ready to use real-time PCR systems consisting of master reagents containing enzyme, buffer, primer and probes as well as an internal control, a positive control or quantification standards and PCR grade water.
- Complete, CE-IVD marked Kits
- Same temperature profile and internal control enable parallel testing within kit panel
- Available for most common real-time PCR instruments
- Validated with a number of extraction systems including ExtraStar® chemistry
ExtraStar® Purification Kits
The ExtraStar® Purification Kit contains the necessary reagents for fast and reliable DNA and RNA extraction consisting of Lysis Buffer, Beads, Washing Buffer and Elution Buffer.
- Complete and validated Kits for DNA and RNA extraction
- One-for-All chemistry enables parallel extraction from different sample material
- Available for the “King Fisher Flex” instrument
- Validated with the RealStar® PCR kits
LyteStar™ Detection Kits
The ExtraStar® Purification Kit contains the necessary reagents for fast and reliable DNA and RNA extraction consisting of Lysis Buffer, Beads, Washing Buffer and Elution Buffer.
LyteStarTM TB/NTM PCR Kit
For detection and differentiation of Mycobacterium tuberculosis complex and non-tuberculous mycobacteria (NTM) using real-time PCR
Clinical Performance
The LyteStar™ TB/NTM Kit was clinically evaluated against mycobacteria culture in a study at the Korea University Hospital. The evaluation of the clinical sensitivity was performed with 129 specimens and the evaluation of clinical specificity was conducted with an additional 99 specimens. Results were achieved by comparing the results obtained with the LyteStar™ TB/NTM Kit against results obtained by mycobacteria culture for the individual specimen. Specimens with discrepant results between culture and the LyteStar™ TB/NTM Kit were resolved by review of the patient’s clinical records. Results are summarized below.
LyteStarTM Leptospira PCR Kit
The LyteStar™ Leptospira PCR Kit 1.0 is based on real-time PCR technology, for the qualitative detection of Leptospira-specific DNA. The kit was designed to detect all pathogenic Leptospira species. Detection of an Internal Control is included in the assay to monitor PCR inhibition and prevent false-negative results. The kit has been validated with EDTA whole blood, plasma and urine.
LyteStarTM HIV-2 RT-PCR Kit
The LyteStar™ HIV-2 RT-PCR Kit 1.0 is based on real-time PCR technology, for the detection and quantification of HIV-2 specific RNA. The kit is designed to target the 5’LTR region, utilizing reverse-transcription (RT) reaction to convert RNA into complementary DNA (cDNA), polymerase chain reaction (PCR) for the amplification of specific target sequences and target specific probes for the detection of the amplified DNA. Detection of an Internal Control is included in the assay to monitor PCR inhibition and prevent false-negative results. The kit has been validated with plasma.
SpinStarTM Extraction Kits
SpinStar™ Viral Nucleic Acid Extraction Kit
The SpinStarTM Viral Nucleic Acid Kit is intended for simultaneous purification of viral DNA and RNA from fresh or frozen human serum and plasma, respiratory specimens in VTM and stool. Nucleic acid extraction is based on proven silica membrane technology in spin column format. The purified viral DNA and/or RNA is ready to use for downstream analysis. The SpinStar Viral Nucleic Acid Kit can be used for isolation of viral RNA and DNA from a broad range of RNA and DNA viruses.
SpinStar™ Total DNA Extraction Kit
The SpinStarTM Total DNA Kit is intended for purification of total DNA (e.g. genomic, mitochondrial and of bacterial, viral and parasitic origin) from up to 400 μl human whole blood, serum, plasma, respiratory specimen in VTM and up to 200 μl sputum (pretreated) or stool suspension. Nucleic acid extraction is based on proven silica membrane technology in spin column format. The purified DNA is ready to use for downstream analysis, for example real-time PCR.
SpinStar™ Pretreatment Solution
For ultrasensitive extraction of viral nucleic acids from human serum and plasma.
The SpinStarTM Pretreatment Solution allows concentration of viral DNA and RNA from 1 ml plasma or serum, prior to purification with the SpinStarTM Viral Nucleic Acid Kit. Ultracentrifugation and specialized laboratory equipment are not required.
The Pretreatment Solution forms complexes with nucleic acids, which can be sedimented by centrifugation to form a pellet. This pellet is then resuspended in standard volume of lysis buffer and nucleic acids are subsequently purified using the SpinStarTM Viral Nucleic Acid procedure, enabling efficient and ultrasensitive viral nucleic acid extraction.
SpinStar™ Procedure
The SpinStarTM procedure comprises 4 steps (lyse, bind, wash, elute) and is carried out using SpinStarTM columns in a standard microcentrifuge. The procedure is designed to ensure that there is no sample-to-sample cross-contamination and allows safe handling of potentially infectious samples. The simple SpinStarTM procedure, which is highly suited for simultaneous processing of multiple samples, yields pure nucleic acid in approx. 1 hour.
GeneProof@ - Realtime PCR Detection Kits
All GeneProof® PCR Kits are ready to use real-time PCR systems consisting of master reagents containing enzymes, buffers, primers and probes as well as an internal control, a positive control or a set of calibrators for quantitative analysis of target DNA / RNA.
GeneProof offers an extensive range of fully validated CE IVD certified kits for infectious diseases, genetic and oncogenetic markers, pharmacogenetics, thrombotic mutations, prenatal diagnostics as well as sample preparation and instrumentation.
Key Features and Benefits:
- Complete, CE-IVD certified Kits
- Fully validated on QCMD panels and clinical samples
- Easy handling and PCR set-up with all PCR components provided in a single master mix
- Consolidated cycling profiles and internal controls enable parallel testing of various targets / pathogens from a single sample
- Available for most common real-time PCR instruments on the market
- Validated with a number of extraction systems including GeneProof extraction kits
- Long shelf life and various pack sizes (25, 50, 100) for convenience
- Use of UNG to monitor / prevent carry-over contamination
PathoFinder@ - Syndromic Multiplex PCR Panels
The 2SMARTFinder® technology is PathoFinder’s proprietary state-of-the-art multiplex PCR technology for Real Time Molecular Diagnostics. It enables Single-tube Multiplex Amplification in Real Time (SMART) of up to 22 infectious pathogens. Currently PathoFinder offers 4 syndromic disease panels:
- RespiFinder® 2SMART (22 pathogens causing respiratory infections)
- GastroFinder® 2SMART (18 pathogens causing gastro-intestinal infections)
- MeningoFinder® 2SMART (22 pathogens causing CNS infections)
- STD-Finder® 2SMART (9 most important pathogens causing STD’s)
Key Features and Benefits:
- As sensitive as monoplex Real Time PCR
- Contains an Internal Control
- Contains Amplification Controls
- Contains a Positive Control
- Diagnosis within 2.5 hours after NA extraction
- All enzymes included
- Validated on QCMD panels and clinical samples
- CE IVD certified
PathoNostics@ - Realtime PCR Kits for Fungal Infections and Resistance
PathoNostics offers a broad range of diagnostic CE-IVD kits for the diagnosis of fungal infections with the mission to detect and differentiate the disease causing fungus and simultaneously detect resistance, which allows doctors to initiate a dedicated therapy promptly and save on costs and lives. PathoNostics assays advance the diagnosis of both superficial and invasive fungal infections and allow antifungal therapy to be more appropriately targeted. Following products are currently available:
Products:
AsperGenius® Species Multiplex
– Detection and differentiation of Aspergillus species
AsperGenius® Resistance Multiplex
– Detection and differentiation of Aspergillus species
– Identification of 4 azole resistance markers in Aspergillus fumigatus
DermaGenius® Nail Kit
– Candida albicans, Trichophyton interdigitale, Trichophyton rubrum
DermaGenius® Complete Kit
– Candida albicans, Trichophyton mentagrophytes, Trichophyton interdigitale, Trichophyton rubrum, Trichophyton tonsurans, Trichophyton soudanense, Trichophyton violaceum, Microsporum canis, Microsporum audouinii, Epidermophyton floccosum, Trichophyton benhamiae, Trichophyton verrucosum
PneumoGenius® Multiplex Kit
– Detection and quantification of Pneumocystis jirovecii
– Identification of mutations in DHPS
MucorGenius® Multiplex Kit
– Detection of Mucorales species