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DC-10-2010
QClamp® KRAS Codon Specific Mutation Test in Codons 12, 13, 59, 61, 117 & 146
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The QClamp® KRAS Codon Specific Mutation Test in Codons 12, 13, 59, 61, 117, & 146 is a real-time qualitative PCR assay for the detection of somatic mutations in and near Codons 12 and 13 in Exon 2, Codons 59 and 61 in Exon 3, and Codons 117 and 146 in Exon 4 in the human KRAS gene, using purified DNA extracted from FFPE (formalin fixed paraffin embedded), cells or tissue.
QClamp® NRAS Codon Specific Mutation Test in Codons 12, 13, 59, 61, 117 & 146
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The QClamp® NRAS Codon Specific Mutation Test in Codons 12, 13, 59, 61, 117, & 146 is a real-time qualitative PCR assay for the detection of somatic mutations in and near NRAS Codon 12 and 13 in Exon 2, Codon 59 and 61 in Exon 3, and Codon 146 in Exon 4 in the human NRAS gene, using purified DNA extracted from FFPE (formalin fixed paraffin embedded), cells or tissue.
QClamp® EGFR Codon Specific Mutation in Codons 719, Ex19Del, 790, 858 & 861
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The QClamp® EGFR Codon Specific Mutation Test in Codons Ex19 Del, Codons 719, 790, 858, & 861 is a real-time PCR assay for the detection of somatic mutations in and near EGFR codon 719 in Exon 18, Exon 19 deletions, codon 790 in Exon 20 and codon 858 and codon 861 in Exon 21, in the human EGFR (epidermal growth factor receptor) gene, using purified DNA extracted from FFPE (formalin fixed paraffin embedded), cells or tissue.
QClamp® BRAF Codon Specific Mutation Test in Codon 600
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The QClamp® BRAF Codon Specific Mutation Test in Codon 600 is a real-time PCR assay for the detection of somatic mutations in and near codon 600 in exon 15, in the BRAF serine/threonine protein kinase gene, using purified DNA extracted from FFPE (formalin fixed paraffin embedded), cells or tissue.
QClamp® JAK2 Codon Specific Mutation Test in Codon 617
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The QClamp® JAK2 Codon Specific Mutation Test in Codon 617 is a real-time PCR assay for the detection of somatic mutations in and near JAK2 codon 617 in Exon 14 in the JAK2 tyrosine kinase gene, using purified DNA extracted from FFPE (formalin fixed paraffin embedded), cells or tissue.
The QClamp® PIK3CA Codon Specific Mutation Test in Codons 542, 545, & 1047 is a real-time qualitative PCR assay for the detection of somatic mutations in the human PIK3CA gene, using genomic DNA extracted from cells or FFPE (formalin fixed paraffin embedded) cells or tissue. Detects: 542, 545 and 1047. Sample type: FFPE or plasma
ColoScape™ Colorectal Cancer Mutation Detection Kit
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Kit for qualitative detection of colorectal cancer associated mutations including APC (codons 1309, 1367, 1450), KRAS (codons 12 and 13), BRAF (codon 600) and CTNNB1 (codons 41 and 45) from blood
Real time PCR test for the detection of bacterial DNA belonging to Klebsiella pneumoniae, Escherichia coli, Streptococcus agalactiae (Streptococcus B or GBS) and Listeria monocytogenes
Real time PCR test for the detection of bacterial DNA belonging to the 8 invasive strains of Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, with differential identification of Haemophilus influenzae type b (Hib)
ViroReal® Kit RSV (A & B) is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR (RT-PCR), for the detection of human respiratory syncytial virus (RSV) strains lineages A and B.
ViroReal® Kit Rhinovirus (A, B, C) is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR (RT-PCR), for the detection of human rhinovirus species A, B, C.
ViroReal® Kit Parainfluenzavirus is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR (RT-PCR), for the detection of parainfluenzavirus 1, 2, 3 and 4 strains (HPIV-1, HPIV-2, HPIV-3, HPIV-4).
ViroReal® Kit Metapneumovirus is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR (RT-PCR), for the detection of human metapneumovirus (hMPV) strains lineages hMPV A and hMPV B.
ViroReal® Kit Monkeypox Virus is a non-automatic rea-time PCR test (research use only) for the qualitative detection of monkeypox virus DNA using real-time polymerase chain reaction. Suitable test materials are DNA extracts from different sample material. The kit detects both clades of Monkeypox Virus, the West African clade and the Congo Basin (Central African) clade. The kit also detects other members of the orthopoxviruses, such as cowpox virus and vaccinia virus, albeit with lower sensitivity.
ViroReal® Kit Influenza B is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR (RT-PCR), for the detection of influenza B virus.
ViroReal Kit Human Coronavirus beta (HKU1, OC43 & MERS)
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ViroReal® Kit Human Coronavirus beta is a real-time PCR assay for detection of RNA of human coronavirus OC43, HKU1 and MERS using multiplex reverse transcription real-time PCR.
ViroReal® Kit Influenza A/B is a non-automated IVD test, based on one-step reverse transcription real-time PCR (RT-PCR), for the qualitative detection of RNA of the matrix protein gene of influenza A virus and the hemagglutinin gene of influenza B virus.
ViroReal Kit Human Coronavirus alpha (NL63 & 229E)
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ViroReal® Kit Human Coronavirus alpha is a real-time PCR assay for detection of RNA of human coronavirus NL63 and 229E using multiplex reverse transcription real-time PCR.
ViroReal® Kit Enterovirus is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR (RT-PCR), for the detection of enterovirus.
BactoReal® Kit A. baumannii & P. mirabilis is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Acinetobacter baumannii (rpoB gene) and Proteus mirabilis (ureC gene) from samples purified from human EDTA blood, aspirates and CSF.
BactoReal® Kit P. aeruginosa & Enterobacter spp. is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Pseudomonas aeruginosa (16S rRNA gene) and Enterobacter spp. (rpoB gene) from samples purified from human EDTA blood, CSF aspirates and biopsies.
BactoReal® Kit vanA & Enterococcus spp. is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Enterococcus spp. (23S rRNA gene) as well as of the vanA resistance gene of Enterococcus from samples purified from human EDTA blood, aspirates, CSF and biopsies.
BactoReal® Kit S. pneumoniae & Streptococcus spp. is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Streptococcus pneumoniae (lytA gene) und Streptococcus spp. (23S rRNA gene) from samples purified from human EDTA blood, aspirates, CSF and biopsies.
BactoReal® Kit Staphylococcus & S. aureus is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Staphylococcus aureus (nuc gene) and Staphylococcus spp. (23S rRNA gene) from samples purified from human EDTA blood, aspirates, CSF and biopsies.
BactoReal® Kit E. coli & Klebsiella is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Escherichia coli (dxs gene), Klebsiella pneumoniae, K. quasipneumoniae, K. variicola, K. oxytoca and K. aerogenes (khe gene) from samples purified from human EDTA blood, aspirates, CSF and biopsies.
BactoReal® Kit H. pylori ClariRes is a non-automated IVD test, based on real-time polymerase chain reaction (PCR), for the qualitative detection of DNA (23S rRNA Gen) of Helicobacter pylori (H. pylori) in combination with
ParoReal Kit Acanthamoeba T4 is a non-automated IVD test, based on real-time PCR, for the qualitative detection of DNA (18S rRNA gene) of Acanthamoeba species of genotype T4 (A. castellani, A. lugdunensis, A. mauritaniensis, A. polyphaga, A. rhysodes, A. royreba). T4 genotype is the most prevalent (approx. 86%) Acanthamoeba genotype causing keratitis worldwide. The test does not detect other Acanthamoeba genotypes (T3, T15, T11, and T5) also causing keratitis.
PanReal Kit Fungi & Bacteria is a multiplex-PCR real-time PCR kit for universal detection of fungi and bacteria. For phylogenetic identification of the pathogen, the PCR product has to be sequenced and analysed by BLAST.
MycoReal® Kit Pneumocystis is a non-automated IVD test, based on real-time PCR, for the qualitative detection of DNA (mt LSU gene) of P. jirovecii. Proper specimens are DNA extracts of samples from the human respiratory tract (bronchoalveolar lavage, BAL).
MycoReal Kit Aspergillus is an in vitro diagnostic real-time PCR test for the detection of Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus, Aspergillus niger and Aspergillus nidulans from samples purified from bronchoalveolar lavage (BAL), blood, aspirate, cerebrospinal fluid and tissue.
MycoReal Kit Candida & A. fumigatus is an in vitro diagnostic test based on real-time PCR, for the qualitative detection of specific DNA of C. albicans, C. dubliniensis, C. glabrata, C. krusei (= Pichia kudriavzevii, Issatchenkia orientalis), C. parapsilosis group, C. tropicalis and Aspergillus fumigatus.
BactoReal® Kit Borrelia burgdorferi sensu lato is an in vitro diagnostic test, based on real-time PCR, for the detection of DNA of Borrelia species belonging to the Borrelia burgdorferi sensu lato (s.l.) complex.
BactoReal® Kit Bartonella spp. is a real-time PCR assay for detection of DNA of B. clarridgeiae, B. elizabethae, B. grahamii, B. henselae, B. koehlerae, B. quintana, B. volans and B. washoensis. Bartonella rochalimae, B. vinsonii and B. bovis are detected with very low sensitivity. Bartonella bacilliformis is not detected.
BactoReal® Kit Bordetella Multiplex is a non-automated IVD test, based on real-time PCR, for the qualitative detection of DNA of Bordetella pertussis, Bordetella parapertussis, Bordetella holmesii and some strains of Bordetella bronchiseptica. This test detects the insertion sequence IS481 of B. pertussis, B. holmesii and B. bronchiseptica as well as the insertion sequence IS1001 of B. parapertussis, B. bronchiseptica and B. holmesii. IS481 or IS1001 may be present in B. bronchiseptica in rare cases
BactoReal® Kit Haemophilus influenzae is an in vitro diagnostic test, based on real-time PCR, for the detection of DNA of encapsulated and unencapsulated (also called nontypeable H. influenzae, NTHi) H. influenzae strains.
BactoReal® Kit Leptospira spp. Multiplex (16S rDNA + LipL32) is a multiplex real-time PCR assay for detection of DNA of pathogenic and intermediately pathogenic Leptospira species.
BactoReal® Kit Leptospira spp. (16S rDNA) is a real-time PCR assay for detection of DNA of pathogenic and intermediately pathogenic Leptospira species.
Kit for identification of the presence of Chlamydia trachomatis (CT) and simultaneous discrimination of serotype L (aetiological venereal linfogranuloma agent - LGV) in both female and male human samples
Kit for quantitative or qualitative detection and genotyping of Human Papillomavirus (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in the urogenital swabs and biopsies16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
Multiplex Real Time PCR test for the quantitative detection of Ureaplasma parvum, Ureaplasma urealyticum and Mycoplasma hominis in the urogenital swabs, urine, prostatic liquid and other biological materials
Real Time PCR test for the qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium and Trichomonas vaginalis in the urogenital swabs, urine, prostatic liquid and other biological materials.
Qualitative determination of the human Cytomegalovirus (CMV DNA) in amniotic fluid, urine and CSF specimens, and for qualitative and quantitative determination in blood and plasma.48 tests
EBV Real Time, qualitative determination of human Epstein Barr Virus (EBV DNA) in blood, plasma and cerebrospinal fluid (CSF) samples and qualitative and quantitative analysis in blood and plasma samples
Qualitative identification by Real Time PCR of the presence of Chlamydia trachomatis (CT) and simultaneous discrimination of serotype L (aetiological venereal linfogranuloma agent - LGV) in both female and male human samples (urine, cervical swabs , urethral and ocular and seminal fluid)
Multiplex Real Time PCR test for the qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium and Trichomonas vaginalis in the urogenital swabs, urine, prostatic liquid and other biological materials
Multiplex Real Time PCR test for the quantitative detection of Ureaplasma parvum, Ureaplasma urealyticum and Mycoplasma hominis in the urogenital swabs, urine, prostatic liquid and other biological materials
Real Time amplification test for quantitative detection of Human Papillomavirus (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) in the urogenital swabs
PCR amplification/fluorescent fragment analysis of the FMR1 CGG triplet repeat region (healthy and premutated alleles: 10 to 200 CGG triplet repeats) by capillary electrophoresis in genetic analyzer
Adellgene® Myotonic Dystrophy Screening is a kit designed for use in clinical laboratories which detects the number of repetitions of CTG of 3´UTR region of the DMPK gene located in chromosome 19 resulting in Myotonic Dystrophy disease. It aims to aid clinical diagnosis associated with clinical findings in myotonic dystrophy type 1 (DM1) that span from mild to severe symptoms.
Adellgene® Myotonic Dystrophy Confirmatory is a kit designed for use in clinical laboratories which detects the number of repetitions of CTG of 3´UTR region of the DMPK gene located in chromosome 19 resulting in Myotonic Dystrophy disease. It aims to aid clinical diagnosis associated with clinical findings in myotonic dystrophy type 1 (DM1) that span from mild to severe symptoms.
Molecular biology kit for the high resolution determination of HLA class II alleles DRB1*04 and DQB1*06: 02 as part of the predisposition to type I diabetes mellitus.