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The xTAG® Cystic Fibrosis 60 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transment conductance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the world's most common and North American-prevalent mutations. The xTAG Cystic Fibrosis 60 Kit v2 is a qualitative genotyping test that provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.

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The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the world's most common and North American-prevalent mutations. The xTAG Cystic Fibrosis 39 Kit v2 is a qualitative genotyping test that provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.

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The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay is a qualitative in vitro diagnostic system used to simultaneously detect 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The variants include those recommended in 2004 by the American College of Medical Genetics (ACMG) and in 2011 by the American College of Obstetricians and Gynecologists (ACOG). The test is intended for carrier screening in adults of reproductive age, in confirmatory diagnostic testing of newborns and children, and as an initial test to aid in the diagnosis of individuals with suspected cystic fibrosis. The results of this test are intended to be interpreted by a board-certified clinical molecular geneticist or equivalent and should be used in conjunction with other available laboratory and clinical information. This test is not indicated for use for newborn screening, fetal diagnostic testing, pre-implantation testing, or for stand-alone diagnostic purposes. The test is intended to be used on the Illumina MiSeqDxTM Instrument.

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. Testing begins with genomic DNA from a peripheral whole blood sample. The genomic DNA is processed through the library preparation steps, which specifically amplifies the intended genomic regions of each sample while also adding the indexes for sample identification. Flow cell capture sequences are also added to the amplified products. The resulting sample libraries are then transferred into a MiSeqDx reagent cartridge which contains all of the reagents required for cluster generation and sequencing (Sequencing By Synthesis). The MiSeqDx Cartridge, MiSeqDx Flow Cell, and MiSeqDx SBS Solution (PR2) are then inserted into the MiSeqDx instrument, which performs cluster generation, sequencing and data analysis.

The Illumina MiSeqDx(TM) Cystic Fibrosis Clinical Sequencing Assay is a targeted sequencing in vitro diagnostic system that re-sequences the protein coding regions and intrones of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene in genomic DNA isolated from human periphers collected in K2EDTA. The test detects single nucleotide variants, and small InDels within the region sequenced, and additionally reports on two deep intronic mutations and two large deletions. The test is intended to be used on the Illumina MiSeqDx Instrument. The test is intended to be used as an aid in the diagnosis of individuals with suspected cystic fibrosis (CF). The test is most appropriate when the patient has an atypical or non-classic presentation of CF or when other mutation panels have failed to identify both causative mutations. The results of the test are intented by a board-certified clinical molecular geneticist or equivalent and should be used in conjunction with other available information including clinical symptoms, other diagnostic tess, and family history. This test is not indicated for use for stand-alone diagnostic testing, for pre-implantation testing, carrier screening, newborn screening, or population screening.

The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. Testing begins with genomic DNA from a peripheral whole blood sample. The genomic DNA is processed through the library preparation steps, which specifically amplifies the intended genomic regions of each sample while also adding the indexes for sample identification. Flow cell capture sequences are also added to the amplified products. The resulting sample libraries are then transferred into a MiSeqDx reagent cartridge which contains all of the reagents required for cluster generation and sequencing (Sequencing By Synthesis). The MiSeqDx Cartridge, MiSeqDx Flow Cell, and MiSeqDx SBS Solution (PR2) are then inserted into the MiSeqDx instrument, which performs cluster generation, sequencing and data analysis.

The xTAG® Cystic Fibrosis 60 kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG) plus some of the world's most common and North American prevalent mutations. The xTAG Cystic Fibrosis 60 kit v2 is a qualitative genotyping test which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes. Indication(s) for use: same as intended use.

The xTAG CFTR 60 kit v2 includes the following components: - xTAG PCR Primer Mix v2 - . xTAG ASPE Mix A v2 - xTAG ASPE Mix B v2 . - xTAG Bead Mix A v2 . - . xTAG Bead Mix B.v2 - xTAG 10X Buffer . - . Platinum® TFI Exo(-) DNA Polymerase - Platinum® TFI Reaction Buffer, 5x . - . TFI 50mM MgCl2 - xTAG Shrimp Alkaline Phosphatase . - xTAG Exonuclease I . - xTAG Strepavidin-Phycoerythrin Conjugate .

The xTAG® Cystic Fibrosis 39 kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the worlds most common and North Americanprevalent mutations. The xTAG Cystic Fibrosis 39 kit v2 is a qualitative genotyping test which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.

The xTAG CFTR 39 kit v2 includes the following components: - PCR Primer Mix v2 including dNTPs designed to simultaneously produce 23 amplimers of the CFTR gene (24 in the presence of CFTR del 2, 3). - ASPE Mix A v2 including dNTPs contains primers designed to hybridize to either wild-type or mutant alleles ◆ with proprietary sequences at their 5' ends designed to specifically hybridize to complementary sequences coupled to a given bead population in Bead Mix A. - Bead Mix A v2 contains spectrally distinguishable populations of polystyrene beads internally dyed with red and . infrared fluorochromes coupled to proprietary DNA sequences designed to specifically hybridize to complementary sequences on the ASPE primers in ASPE Mix A v2. - 10X Buffer - Platinum® TFI DNA Polymerase . - Platinum® TFI Reaction Buffer . - TFI MgCl2 . - Shrimp Alkaline Phosphatase . - Exonuclease I . - Strepavidin-Phycoerythrin Conjugate . - xTAG Data Analysis Software (TDAS) CFTR .

The Verigene CFTR and Verigene®CFTR PolyT Nucleic Acid Tests are qualitative in vitro diagnostic devices used to genotype a panel of mutations and variants in vitro transmembrance regulator (CFTA) consisted institute and variants in the cystic fibrosis transmission is see about to the of micrations and variants in the cystic fibrosis transmembrance regulator (CFFT) gene in genomic DNA isolated from human peripheral whole blood (CF7 / ) gene includes mutations and variations and variations and virus and virus and variations and variations and variations and Obstericians and Gyneologists (ACOG). The Verigene CFTA Nucleic Acid Test provides information intended to be used for carrier testing in adults of reproductive age and in confirmatory diagnostic testing of newborns and children. These tests are not indicated for use in fetal diagnostic or pre-implantation testing and not indicated for stand-alone is in retal dagnostic of pre-implantation testing and not indicated for stand-alone diagnostic purposes. The results should be used in conjunction w other available alono diagnostic purposes. The results should be used in conjunction with other available laboratory and clinical information. Both tests are intended to be u

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The eSensor® CF Genotyping Test is an in vitro diagnostic device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA samples isolated from human peripheral whole blood specimens. The panel includes mutations and variants recommended by the 2004 American College of Medical Genetics (ACMG). The eSensor® CF Genotyping Test is a qualitative genotyping test that provides information intended to be used for cystic fibrosis carrier screening as recommended by ACMG and the 2005 American College of Obstetricians and Gynecologists (ACOG) for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children. The test is not indicated for use in fetal diagnostic or pre-implantation testing. This test is also not indicated for stand-alone diagnostic purposes and results should be used in conjunction with other available laboratory and clinical information. The eSensor® CF Genotyping Test is intended for use on the eSensor® XT-8 System.

The eSensor® CF Genotyping Test on the eSensor® XT-8 System is an in vitro diagnostic device for performing hybridization and genotyping of multiple mutations and/or polymorphisms in an amplified DNA sample. A single-use, disposable test cartridge is used to perform hybridization and genotyping. The cartridge contains an EEPROM chip which transmits the cartridge lot number, expiration date and protocol identity to the XT-8 instrument. The analysis process for each sample consists of three steps: 1) Genomic DNA isolated from whole blood obtained using EDTA as anti-coagulant is combined with PCR Mix and Taq polymerase enzyme and is subjected to amplification of target sequences by PCR using a thermal cycler. 2) Amplified DNA is treated with exomuclease enzyme to generate single-stranded target DNA. 3) Single-stranded, amplified target DNA is mixed with hybridization and genotyping reagents and transferred to an eSensor® CF Genotyping Tet cartinge, and the cartridge is inserted in the eSensor® XT-8 Instrument controls the circulation of the sample inside the cartridge to allow hybridization at a controlled temperature and then detects and genotypes the sample by voltammetry. Genotyping of the test panel polymorphisms is achieved by a sandwich assay principle: 1) Each pair of electrodes contains a different synthetic oligonucleotide capture probe which is complementary to one of the target DNA fragments. 2) The hybridization reagents contain pairs of ferrocenc-labeled synthetic oligonucleotide signal probes; one member of each pair is complementary to the major allele sequence of the target polymorphism, while the second member of the pair is complementary to the minor allele sequence. Each member of the probe pair has a ferrocene label with a different oxidation potential for each allele. 3) Single-stranded, amplificd target DNA hybridizes to its specific capture probe, and in turn hybridizes to the allele-specific, ferrocenc-labeled signal probe. 4) Each electrode of the array is analyzed by voltammetry; the target polymorphism is determined by the location of the electrode containing the capture probe, and the genotype is identified by the ratio of signals from the allclespecific ferrocene labels. The array also includes positive and negative confirm the hybridization reaction and detect non-specific signals. Upon completion of the test, the EEPROM chip on the cartridge contains information that prevents its re-use with a new sample. The eSensor® XT-8 instrument analyzes the results and provides a report of the test results.

InPlex™ CF Molecular Test is an in vitro diagnostic device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA samples isolated from human peripheral whole blood specimens. The panel includes mutations and variants recommended by the 2004 American College of Medical Genetics (ACMG). The InPlex™ CF Molecular Test is a qualitative genotyping test that provides information intended to be used for cystic fibrosis carrier screening as recommended by ACMG and the 2005 American College of Obstetricians and Gynecologists (ACOG) for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children. The test is not indicated for use in fetal diagnostic or pre-implantation testing. This test is also not indicated for stand-alone diagnostic purposes and results should be used in conjunction with other available laboratory and clinical information.

InPlex™ CF Molecular Test amplifies specific regions of the CF7R gene in genomic DNA extracted from human whole peripheral blood. Each amplified DNA sample is subsequently mixed with Cleavase® enzyme and buffer then added to a loading port on an InPiex™ microfluidic card. An InPlex™ card contains eight sample-loading ports, each connected to 48 independent reaction chambers. Twenty-eight of these reaction chambers contain dried assay mixes specific for reporting the 23 ACMG/ACOG recommended CF7R mutations and variants. The remaining chambers consist of a "No Invader" Control", an Independent Quality Control. and several unused chambers. After an InPlex™ card is loaded; the channels are mechanically sealed using a micro-fluidic card sealer, isolating each individual reaction chamber from all other chambers. The card is then incubated to allow individual Invader® reactions to occur. Following incubation, the card is read in a multi-well fluorometer and the raw signal data are imported into the InPlex™ CF Molecular Test Call Reporting Software for final result analysis.

The Cystic Fibrosis Genotyping Assay is a qualitative in vitro diagnostic device used to genotype a panel of mutations and variants in the cystic fibrosis transmembrane conductance requlator (CFTR) gene in genomic DNA isolated from human whole blood specimens. The panel includes mutations and variants recommended by the American College of Medical Genetics (ACMG, 2004) and the American College of Obstetricians and Gynecologists (ACOG, 2005) plus additional multiethnic mutations. The Cystic Fibrosis Genotyping Assay provides information intended to be used for carrier screening in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. This test is not indicated for use in fetal diagnostic or pre-implantation testing. This test is also not indicated for stand-alone diagnostic purposes.

The Cystic Fibrosis Genotyping Assay is designed to genotype the normal and mutant alleles at 30 loci of the CFTR gene using purified human genomic DNA. Genotype coverage includes the panel of 23 mutations recommended by the American College of Medical Genetics (ACMG) 2004 guidelines for use in CF population carrier screening. Coverage also includes 9 additional mutations as part of an expanded core panel to support genetic diversity of multiethnic populations that may be underserved by the ACMG panel alone (e.g. Hispanic, African American). In addition to core panel coverage, the assay is designed to detect polythymidine variants (5/7/9T) within intron 8 of the CFTR gene and polymorphisms (1506V, I507V, and F508C) within Exon 10 of the CFTR gene, in accordance with ACMG guidelines. Purified genomic human DNA is prepared by standard purification methods. A multiplex polymerase chain reaction (PCR) is then performed to amplify the genomic DNA sample with 16 pairs of PCR primers and DNA polymerase. Next, the oligonucleotide ligation assay (OLA) is performed on the CFTR amplicons. Allele-specific OLA probes hybridize to the respective normal, mutant, and variant alleles and become ligated with fluorescent-labeled common probes by the ligase enzyme. The OLA probes are varied in length due to the addition of inert mobility modifiers. The ligated, fluorescent-labeled DNA fragments are separated on the Celera CEGA-16™ Instrument System by electrophoresis. Detection is based on size and fluorescent label. The ligation products are then identified and genotyped by analysis with the CEGA-16 software and assay-specific configuration disk. The CF GT Assay also contains Reflex OLA reagents for the detection of the polythymidine 5/7/9T variants in intron 8 of the CFTR gene and for the detection of the I506V, I507V, and F508C polymorphisms in Exon 10 of the CFTR gene. The CFTR R117H mutation, along with the 5T variant of the 5/7/9T polymorphism in intron 8 on the same chromosome (cis), can cause classical CF if another CF mutation is present on the other chromosome. As a result, reflex testing for the 5/7/9T variant with the CF 5/7/9T Reflex OLA assay is recommended when the R117H mutation is detected. The CF Exon 10 Reflex OLA assay is used to verify a homozygous deletion of the F508 or 1507 codon and to exclude a potential false-positive result due to interference by certain non-CF causing variants at codons 506, 507, and 508. The CF Exon 10 Reflex OLA assay will distinguish between a true homozygous F508del or I507del from a sample containing one F508del or I507del allele plus the benign variants of I506V, I507V or F508C, respectively. The same software contained on the configuration disk is used to report reflex testing genotyping information.