For in vitro diagnostic use. Others Harmony prenatal test IVD IVD Harmony® IVD Kit SEQ-ARIOSA-0002 08 011 281 001 8 011 281 001 08011281001 8011281001 08011281001 Ariosa Commercial Rgt Kit CE-IVD Harmony IVD Kit 07613336156049 Other Services 1 kit Not Available undefined The Harmony® prenatal test is a qualitative assay intended to assess the probability of fetal chromosome 13, 18, and 21 trisomy; the probability of fetal 22q11.2 deletion*, the probability of aneuploidy of fetal sex chromosomes; and to determine fetal sex by analysis of plasma-derived cell-free DNA (cfDNA) from a pregnant woman. The results are intended for prenatal screening and are not intended to be the sole basis for diagnosis. Harmony test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmatory fetal diagnostic testing, parental evaluation, clinical genetic evaluation, and counseling, as appropriate. Reporting of results is intended to be performed by a clinical laboratory director and provided directly to the ordering healthcare provider for consideration with other clinical assessments. Note: Because the fetal sex determination test option does not have a medical purpose, it does not meet the definition of an IVD device and therefore is not a CE marked product. *The 22q11.2 test option is not available for those customers in Germany and the UK using the AMB protocol. en The Harmony® prenatal test is a qualitative assay intended to assess the probability of fetal chromosome 13, 18, and 21 trisomy; the probability of fetal 22q11.2 deletion, the probability of aneuploidy of fetal sex chromosomes; and to determine fetal sex by analysis of plasma-derived cell-free DNA (cfDNA) from a pregnant woman. The results are intended for prenatal screening and are not intended to be the sole basis for diagnosis. Harmony test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmatory fetal diagnostic testing, parental evaluation, clinical genetic evaluation, and counseling, as appropriate. Reporting of results is intended to be performed by a clinical laboratory director and provided directly to the ordering healthcare provider for consideration with other clinical assessments. Note: Because the fetal sex determination test option does not have a medical purpose, it does not meet the definition of an IVD device and therefore, is not a CE marked product or included in the Health Canada approved options. en The Harmony test is intended for use in analysis of cfDNA samples isolated from plasma from pregnant women who meet the following criteria: Maternal age ≥ 18 years Gestational age ≥ 10 weeks Number of fetuses ≤ 2 The Harmony test requires cfDNA that has been isolated using a commercially available cfDNA extraction kit from approximately 4mL of plasma collected using a cell-free DNA collection tube (Roche PN 07785666001 or equivalent). The QiaSymphony SP/AS nucleic acid extraction platform, MagNA Pure 24 platform, and MagNA Pure 96 platform are validated for use with the Harmony test on AcfS.18 The Harmony test includes the following components: the Harmony IVD Kit (P/N 08011281001) and the Ariosa cell-free DNA System (AcfS) Software (P/N 07831773001), including the FORTE_R.DLL and FORTE algorithm. The Harmony test is designed tobe used with a set of required equipment and AcfS Software, collectively termed the Ariosa cell-free DNA System. The Harmony test enables execution of 3 sequential processes on sets of 48-96 samples which includes 48-95 cfDNA samples prepared from plasma of pregnant women and 1 Assay Performance Control (APC). First, the Harmony IVD Kit implements the DANSR assay process to amplify a set of universal polymerase chain reaction (UPCR) products from genomic intervals on chromosomes 1-12, 13, 18, 21, 22, X, and Y in each sample, and to quantify the amount of each UPCR product in each sample by hybridization to a custom oligonucleotide microarray. Next, the FORTE_R.DLL and FORTE algorithm evaluate the microarray fluorescence intensity data to compute the probability of trisomy of fetal chromosomes13, 18, and 21; the probabilityof fetal 22q11.2 deletion; the probability of aneuploidy of fetal sex chromosomes (Monosomy X, XXX, XXY, XYY, XXYY); and to determine fetal sex in each specimen. The Sex Chromosome Aneuploidy Panel and the 22q11.2 test option are only validated in singleton pregnancies. 18.Stokowski R, Ong F, Bellare P, et al. Evaluation of automated cell-free DNA extraction methods with the Harmony prenatal test. White Paper. Pleasanton, CA: 2018.http://sequencing.roche.com/en/products-solutions/by- application/clinical/nipt/ar iosa-cellfree-dna-system.html en The Harmony test is intended for use in analysis of cfDNA samples isolated from plasma from pregnant women who meet the following criteria: Maternal age ≥ 18 years Gestational age ≥ 10 weeks Number of fetuses ≤ 2 The Harmony test requires cfDNA that has been isolated using a commercially available cfDNA extraction kit from approximately 4mL of plasma collected using a cell-free DNA collection tube (Roche PN 07785666001 or equivalent). The QiaSymphony SP/AS nucleic acid extraction platform, MagNA Pure 24 platform, and MagNA Pure 96 platform are validated for use with the Harmony test on AcfS.18 The Harmony test includes the following components: the Harmony IVD Kit (P/N 08011281001) and the Ariosa cell-free DNA System (AcfS) Software (P/N 07831773001), including the FORTE_R.DLL and FORTE algorithm. The Harmony test is designed tobe used with a set of required equipment and AcfS Software, collectively termed the Ariosa cell-free DNA System. The Harmony test enables execution of 3 sequential processes on sets of 48-96 samples which includes 48-95 cfDNA samples prepared from plasma of pregnant women and 1 Assay Performance Control (APC). First, the Harmony IVD Kit implements the DANSR assay process to amplify a set of universal polymerase chain reaction (UPCR) products from genomic intervals on chromosomes 1-12, 13, 18, 21, 22, X, and Y in each sample, and to quantify the amount of each UPCR product in each sample by hybridization to a custom oligonucleotide microarray. Next, the FORTE_R.DLL and FORTE algorithm evaluate the microarray fluorescence intensity data to compute the probability of trisomy of fetal chromosomes 13, 18, and 21; the probabilityof fetal 22q11.2 deletion; the probability of aneuploidy of fetal sex chromosomes (Monosomy X, XXX, XXY, XYY, XXYY); and to determine fetal sex in each specimen. The Sex Chromosome Aneuploidy Panel and the 22q11.2 test option are only validated in singleton pregnancies. 18. Stokowski R, Ong F, Bellare P, et al. Evaluation of automated cell-free DNA extraction methods with the Harmony prenatal test. White Paper. Pleasanton, CA: 2018. http://sequencing.roche.com/en/products-solutions/by-application/clinical/nipt/ariosa-cellfree-dna-system.html en

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