For in vitro diagnostic use. Others cobas DPX 6800 8800 IVD cobas® DPX PID00000370 Duplex HAV & parvovirus B19 nucleic acid test 09 171 126 190 9 171 126 190 09171126190 9171126190 09171126190 KIT COBAS 58/68/8800 DPX 192T CE-IVD KIT COBAS 58/68/8800 DPX 192T CE-IVD 00875197006698 Reagents, kits 1 kit 192 tests true 09 040 714 190 9 040 714 190 09040714190 9040714190 09040714190 KIT COBAS 58/68/8800 DPX 480T US KIT COBAS 58/68/8800 DPX 480T US 00875197007138 Reagents, kits 1 kit 480 tests true Indication for useThe cobas® DPX for use on cobas® 6800 and cobas® 8800 Systems is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (HAV) genotypes I, II, and III RNA in human plasma.This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV infection. en The cobas® DPX test for use on the cobas® 5800/6800/8800 systems is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (HAV) genotypes I, II, and III RNA in human plasma. This test is intended for use as an in vitro test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors may be tested as individual samples or in pools comprised of aliquots of individual samples. This test is not intended for use on samples of cord blood. This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV. en The cobas® DPX test is based on real time PCR technology on a fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection system. The cobas® 6800/8800 Systems consists of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 6800/8800 software which assigns test results for a quantitative value (in IU/mL) for the B19 parvovirus through the use of a Quantitation Standard (QS), directly traceable to the WHO International Standard for Parvovirus B19. 47 The cobas® 6800/8800 software also assigns test results for presence of HAV as non-reactive, reactive, or invalid. Results can be reviewed directly on the system screen, and printed as a report or sent to a Laboratory Information Management System (LIMS) or other result management system.Samples can either be tested individually or, optionally, can be tested in pools consisting of multiple samples. The cobas® Synergy software with the Hamilton MICROLAB® STAR IVD may optionally be used in a pre-analytical step if pooling is to be performed.Nucleic acid from the sample, added armored RNA internal control (IC) and DNA QS (which serves as the sample preparation and amplification/detection process control) are simultaneously extracted. In addition the test utilizes three kit controls: a dual positive, a high positive and a negative control. Viral nucleic acids are released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris, and potential PCR inhibitors (such as hemoglobin) are removed with subsequent wash reagent steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature.Selective amplification of target nucleic acid from the sample is achieved by the use of virus-specific forward and reverse primers which are selected from highly conserved regions of the viral nucleic acid. A thermostable DNA polymerase enzyme is used for both reverse-transcription and amplification. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). 50-52 Any contaminating amplicon from previous PCR runs are destroyed by the AmpErase enzyme [uracil-N-glycosylase], which is included in the PCR master mix, when heated in the first thermal cycling step. However, newly formed amplicon are not destroyed since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C.The cobas® DPX master mix contains detection probes which are specific for B19, HAV, QS and IC nucleic acid. The specific B19, HAV, IC, and QS detection probes are each labeled with one of four unique fluorescent dyes which act as a reporter. Each probe also has a fifth dye which acts as a quencher. The four reporter dyes are measured at defined wavelengths, thus permitting simultaneous detection and discrimination of the amplified B19, HAV, IC, and QS targets. 53,54 The fluorescent signal of the intact probes is suppressed by the quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage by the 5' to 3' nuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye is concomitantly increased. Since the four specific reporter dyes are measured at defined wavelengths, simultaneous detection and discrimination of the amplified B19 , HAV, and the QS and IC is possible.47. U.S. Food and Drug Administration. Guidance for industry: nucleic acid testing (NAT) to reduce the possible risk of human parvovirus B19 transmission by plasma-derived products. 2009 July. http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/blood/ucmblood/ucmblood/ucm071592.htm50. Longo MC, Berninger MS, Hartley JL. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene. 1990; 93:125- 128.51. Savva R, McAuley-Hecht K, Brown T, Pearl L. The structural basis of specific base-excision repair by uracil-DNA glycosylase. Nature. 1995; 373:487-493.52. Mol CD, Arvai AS, Slupphaug G, et al. Crystal structure and mutational analysis of human uracil-DNA glycosylase: structural basis for specificity and catalysis. Cell. 1995;80:869-878.53. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Biotechnology (NY). 1992;10:413-417.54. Heid CA, Stevens J, Livak JK, Williams PM. Real time quantitative PCR. Genome Res. 1996;6:986-994. en The cobas® DPX test is based on real time PCR technology on a fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 system consists of a single, integrated instrument. The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 5800 or 6800/8800 software which assigns test results for a quantitative value (in IU/mL) for the parvovirus B19 through the use of a Quantitation Standard (QS), directly traceable to the WHO B19 International Standard. 47 The cobas® 5800/6800/8800 software also assigns test results for presence of hepatitis A virus as non-reactive, reactive, or invalid. When using the cobas® 5800/6800/8800 systems, results can be reviewed directly on the system screen, and printed as a report, or sent to a Laboratory Information Management System (LIMS) or other result management system. Samples can either be tested individually or, optionally, can be tested in pools consisting of multiple samples. If pooling is to be performed, the cobas® p 680 instrument, or cobas® Synergy software with the Hamilton Microlab® STAR/STARlet IVD, may optionally be used in a pre-analytical step. Nucleic acid from the sample and added armored RNA internal control (IC) (which serves as a full process control from sample preparation through amplification/detection) is simultaneously extracted. The IC monitors for interference that could cause negative results. Potentially affected samples are invalidated. The DNA QS molecules also serve as a sample preparation and amplification/detection process control, and are simultaneously extracted. Viral nucleic acids are released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris, and potential PCR inhibitors (such as hemoglobin) are removed with subsequent wash reagent steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. Selective amplification of target nucleic acid from the donor sample is achieved by the use of virus-specific forward and reverse primers which are selected from highly conserved regions of the viral nucleic acid. A thermostable DNA polymerase enzyme is used for both reverse-transcription and amplification. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). 50-52 Any contaminating amplicon from previous PCR runs are destroyed by the AmpErase enzyme [uracil-N-glycosylase], which is included in the PCR master mix, when heated in the first thermal cycling step. However, newly formed amplicon are not destroyed since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. The cobas® DPX master mix contains detection probes which are specific for B19 and HAV as well as QS and IC nucleic acid. The specific B19, HAV, IC, and QS detection probes are each labeled with one of four unique fluorescent dyes which act as a reporter. Each probe also has a fifth dye which acts as a quencher. The four reporter dyes are measured at defined wavelengths, thus permitting simultaneous detection and discrimination of the amplified B19, HAV targets, IC, and QS. 53,54 The fluorescent signal of the intact probes is suppressed by the quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage by the 5' to 3' nuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye is concomitantly increased. Since the four specific reporter dyes are measured at defined wavelengths, simultaneous detection and discrimination of the amplified B19 and HAV target and the QS and IC is possible. 47. U.S. Food and Drug Administration. Guidance for industry: nucleic acid testing (NAT) to reduce the possible risk of human parvovirus B19 transmission by plasma-derived products. Updated July 2009; Accessed: 09 September 2022. https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Guidance-for-Industry--- Nucleic-Acid-Testing--to-Reduce-the-Possible-Risk-of-Parvovirus-B19-Transmission-by-Plasma-Derived- Products.pdf. 50. Longo MC, Berninger MS, Hartley JL. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene. 1990;93:125-8. 51. Savva R, McAuley-Hecht K, Brown T, Pearl L. The structural basis of specific base-excision repair by uracil-DNA glycosylase. Nature. 1995;373:487-93. 52. Mol CD, Arvai AS, Slupphaug G, et al. Crystal structure and mutational analysis of human uracil-DNA glycosylase: structural basis for specificity and catalysis. Cell. 1995;80:869-78. 53. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Biotechnology (N Y). 1992;10:413-7. 54. Heid CA, Stevens J, Livak KJ, Williams PM. Real time quantitative PCR. Genome Res. 1996;6:986-94. en

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