For in vitro diagnostic use. Others cobas HIV-1 HIV-2 Test cobas 5800-6800-8800 IVD cobas® HIV-1/HIV-2 Qualitative RMD-58-68-88-HIVqual Nucleic acid test for use on the cobas® 5800/6800/8800 systems 09 040 528 190 9 040 528 190 09040528190 9040528190 09040528190 KIT C58/68/88 HIV-1/HIV-2 QUAL 192T IVD cobas HIV-1/HIV-2 Qualitative 00875197006384 Reagents, kits 1 kit 192 tests true cobas® HIV-1/HIV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. The cobas® HIV-1/HIV-2 Qualitative may also be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women.This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV. en cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus (HIV) type 1 (HIV-1) and type 2 (HIV-2) in human serum, plasma, and dried blood spots (DBS). The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV -1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV -1 or HIV-2 is indicative of acute or primary infection. In infants born to HIV-infected mothers and who have maternal antibodies to HIV -1 or HIV-2, the presence of HIV nucleic acid is indicative of active infection. cobas® HIV-1/HIV-2 Qualitative may also be used to confirm HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. en cobas® HIV-1/HIV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. The cobas® HIV-1/HIV-2 Qualitative may also be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women.This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV. en cobas® HIV-1/HIV-2 Qualitative is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 System is designed as one 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 System or cobas® 6800/8800 Systems software, which assigns test results for all tests as non-reactive, reactive, or invalid. Results can be reviewed directly on the system screen, exported, or printed as a report.Nucleic acid from patient samples and added armored ribonucleic acid (RNA) internal control (IC) molecules (which serve as the sample preparation and amplification/detection process control) is simultaneously extracted. In addition, the test utilizes three external controls: two positive and one negative control. In summary, viral nucleic acid is 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 are removed with subsequent wash 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 target virus -specific forward and reverse primers which are selected from highly conserved regions of the HIV-1 and HIV-2 genomes. The HIV-1 gag gene, HIV-1 LTR region (dual target for HIV-1), and HIV-2 LTR region are amplified by cobas® HIV-1/HIV-2 Qualitative.Selective amplification of IC is achieved by the use of sequence-specific forward and reverse primers, which are selected to have no homology with the HIV-1 or HIV-2 genomes. A thermostable deoxyribonucleic acid (DNA) polymerase enzyme is used for both reverse-transcription and PCR amplification. The target and IC sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon).13,14,15 Any contaminating amplicons from previous PCR runs are eliminated by the AmpErase enzyme, which is included in the PCR master mix, during the first thermal cycling step. However, newly formed amplicons are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C.cobas® HIV-1/HIV-2 Qualitative master mix contains two detection probes specific for the HIV-1 target sequences, one for HIV-2 target sequences and one for the IC. The probes are labeled with target specific fluorescent reporter dyes allowing simultaneous detection of HIV-1 target, HIV-2 target and IC in three different target channels.16,17 When not bound to the target sequence, the fluorescent signal of the intact probes is suppressed by a quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease 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 increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the viral targets and IC, respectively.13. 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. PMID: 2227421.14. 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. PMID: 7845459.15. 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. PMID: 7697717.16. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Biotechnology (N Y). 1992;10:413-7. PMID: 1368485.17. Heid CA, Stevens J, Livak KJ, Williams PM. Real time quantitative PCR. Genome Res. 1996;6:986-94. PMID: 8908518. en cobas® HIV-1/HIV-2 Qualitative is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 system is designed as one 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 cobas® 6800/8800 systems software which assigns test results for all tests as non-reactive, reactive, or invalid. Results can be reviewed directly on the system screen, exported, or printed as a PDF report. Nucleic acid from patient samples and added armored RNA internal control (IC) molecules (which serve as the sample preparation and amplification/detection process control) is simultaneously extracted. In addition, the test utilizes three external controls: two positive and a negative control. In summary, viral nucleic acid is 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 are removed with subsequent wash 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 target virus-specific forward and reverse primers which are selected from highly conserved regions of the HIV-1 and HIV-2 genomes. The HIV-1 gag gene, the HIV-1 LTR region (dual target for HIV-1) and the HIV-2 LTR region are amplified by cobas® HIV-1/HIV-2 Qualitative. Selective amplification of IC is achieved by the use of sequence-specific forward and reverse primers which are selected to have no homology with the HIV-1 or HIV-2 genomes. A thermostable DNA polymerase enzyme is used for both reverse-transcription and PCR amplification. The target and IC sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon).13,14,15 Any contaminating amplicons from previous PCR runs are eliminated by the AmpErase enzyme, which is included in the PCR master mix, during the first thermal cycling step. However, newly formed amplicons are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. cobas® HIV-1/HIV-2 Qualitative master mix contains two detection probes specific for the HIV-1 target sequences, one for HIV-2 target sequences and one for the IC. The probes are labeled with target specific fluorescent reporter dyes allowing simultaneous detection of HIV-1 target, HIV-2 target and IC in three different target channels.16,17 When not bound to the target sequence, the fluorescent signal of the intact probes is suppressed by a quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease 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 increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the viral targets and IC, respectively. 13. 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. PMID: 2227421. 14. 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. PMID: 7845459. 15. 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. PMID: 7697717. 16. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Biotechnology (N Y). 1992;10:413-7. PMID: 1368485. 17. Heid CA, Stevens J, Livak KJ, Williams PM. Real time quantitative PCR. Genome Res. 1996;6:986-94. PMID: 8908518. en cobas® HIV-1/HIV-2 Qualitative is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 System is designed as one 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 cobas® 6800/8800 System software, which assigns test results for all tests as non-reactive, reactive, or invalid. Results can be reviewed directly on the system screen, exported, or printed as a report.Nucleic acid from patient samples and added armored ribonucleic acid (RNA) internal control (IC) molecules (which serve as the sample preparation and amplification/detection process control) is simultaneously extracted. In addition, the test utilizes three external controls: two positive and one negative control. In summary, viral nucleic acid is 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 are removed with subsequent wash 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 target virus -specific forward and reverse primers which are selected from highly conserved regions of the HIV-1 and HIV-2 genomes. The HIV-1 gag gene, HIV-1 LTR region (dual target for HIV-1), and HIV-2 LTR region are amplified by cobas® HIV-1/HIV-2 Qualitative.Selective amplification of IC is achieved by the use of sequence-specific forward and reverse primers, which are selected to have no homology with the HIV-1 or HIV-2 genomes. A thermostable deoxyribonucleic acid (DNA) polymerase enzyme is used for both reverse-transcription and PCR amplification. The target and IC sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon).13-15 Any contaminating amplicons from previous PCR runs are eliminated by the AmpErase enzyme, which is included in the PCR master mix, during the first thermal cycling step. However, newly formed amplicons are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C.cobas® HIV-1/HIV-2 Qualitative master mix contains two detection probes specific for the HIV-1 target sequences, one for HIV-2 target sequences and one for the IC. The probes are labeled with target specific fluorescent reporter dyes allowing simultaneous detection of HIV-1 target, HIV-2 target and IC in three different target channels.16,17 When not bound to the target sequence, the fluorescent signal of the intact probes is suppressed by a quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease 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 increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the viral targets and IC, respectively.13. 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. PMID: 2227421.14. 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. PMID: 7845459.15. 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. PMID: 7697717.16. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Biotechnology (N Y). 1992;10:413-7. PMID: 1368485.17. Heid CA, Stevens J, Livak KJ, Williams PM. Real time quantitative PCR. Genome Res. 1996;6:986-94. PMID: 8908518. en

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