The required number of cycles is preprogrammed into the cobas taqman analyzer or cobas taqman 48 analyzer. It uses real time pcr to detect hiv type 1 group m. Cobas taqman hbv assay for hbv dna detection and quantification. Pdf comparison of the cobas ampliprepcobas taqman hbv test. Association between negative results from tests for hbv dna and. Cobas ampliprepcobas taqman hbv tests for the quantification of. It offers realtime detection and identification of hiv, hcv and hbv, eliminating both the need for discriminatory testing and the potential for discrepant results. Comparison of the cobas taqman hbv test with the cobas. Cobas taqmat ampliprepcobas taqman hcv test is an in vitro nucleic acid amplification test for the quantitation of hepatitis c viral hcv rna in human plasma or serum of hcvinfected individuals using the cobas ampliprep instrument for automated specimen processing and the.
The qs is a noninfectious construct containing fragments of hbv sequences with primer binding regions identical to those of. Cobas ampliprepcobas taqman hiv1 test, summary of safety. It offers realtime detection and identification of hiv, hcv and hbv, eliminating both the need for discriminatory testing. Cobas ampliprepcobas taqman hiv1 qualitative test instructions. The precision, limit of detection lod, limit of quantification loq and linearity were verified using pooled residual clinical samples. Hepatitis b virus hbv genotype determination by the. Patients were considered to be negative for hbv rna if it was not detected by. Hepatitis b virus hbv taqman pcr kit product insert product. As shown in figure 1, the cobas ampliprepcobas taqman hiv1 test was found to give a linear response from 48 hiv1 rna cpml to 10,000,000 hiv1 rna cpml applying the. Pdf cobas ampliprepcobas taqman hepatitis b virus hbv. The test is a nucleic acid amplification of hiv type 1, rna in human plasma. It was unclear whether daan realtime polymerase chain reaction test daan test or cobas taqman hbv dna test cobas taqman was. Amplification occurs only in the region of the hcv genome between the. The system involves a manual dna extraction from 100.
Cobas amplicor hbv monitor 4e7 copiesml cobas amplicor hbv monitor 300200,000 copiesml high pure systemcobas taqman hbv 1706. The analytical performance of the cobas 6800 hiv1, hbv and hcv assays was verified and evaluated to the cobas ampliprep cobas taqman assays. This study aimed to standardise an inhouse realtime polymerase chain reaction rtpcr to allow quantification of hepatitis b virus hbv dna in serum or plasma samples, and to compare this method with two commercial assays, the cobas amplicor hbv monitor and the cobas ampliprepcobas taqman hbv test. Hepatitis b virus hbv pcr test procedure using cobas taqman by roche is based on the two major processes. Taqman real time polymerase chain reaction hepatitis c. Enter any desired search criteria in the specimen search section and click find specimens. Evaluation of the abbott realtime hbv dna assay and. Number of days stated is based on rdc installation guidelines as outlined in implementation binder for each platform. Cobas taqman hbv test for use with the high pure system for in vitro diagnostic use.
The test is used to measure changes in hiv1 rna levels. Supporting documents older than three years cobas ampliscreen hbv test. Hepatitis b virus hbv taqman pcr kit product insert. Hepatitis b virus hbv pcr test procedure cobas taqman by. Fda approved hiv, hav, hbv, hcv, and std diagnostic or.
Hbvdna was detected and quantified in the donor plasma by a fully automated highsensitivity system, the cobas ampliprepcobas taqman hbv test ver 2. Comparison of transcriptionmediated amplification and. This test is intended for use as an aid in the management of patients with chronic hbv infection undergoing antiviral therapy. Pdf comparison of the cobas taqman hbv test with the cobas. Quantification of hepatitis b virus hbv dna with a taqman hbv. Here, we report the performance characteristics of a realtime pcr hepatitis b dna quantitative assay, the cobas taqman ctm hbv test roche diagnostics, meylan, france, in combination with an automated dna extraction on the cobas ampliprep. The cahbm is an endpoint pcr test for hbv dna quantification. A heminested pcr procedure was used to amplify a 492. Capctm hbv dna assay is sensitive, specific and reproducible, and accurately. Comparison between abbott realtime hbv assay and cobas taqman hbv assay measurements using the realtime assay, hbv dna was detected in 216 of 220 chb patients, with a sensitivity of 98.
High pure is a manual sample preparation method configured specifically for. May 21, 2008 quest diagnostics will offer roches cobas ampliprepcobas taqman hiv1 test for hiv viral load testing under a multiyear agreement announced this week. The cobas taqman hbv test for use with the high pure system hps is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus hbv dna in human serum or plasma, using the high pure system viral nucleic acid kit for manual specimen preparation and the cobas taqman 48 analyzer for automated amplification and detection. Individual viral target identification test procedures for hiv1 group o and hiv2 are not available from roche. Claim cobas 4800 cobas 4800 ctng cobas ampliprep cobas ampliprepcobas taqman hiv. Hepatitis b cobas ampliprepcobas taqman hbv test, v2. Hepatitis b virus hbv genotype determination by the cobas. The new abbott realtime hepatitis b virus hbv assay was compared to the cobas ampliprep cobas taqman assay with 128 serum samples from patients with chronic hepatitis b. Cobas ampliprepcobas taqman hcv quantitative test, version. The cobas ampliprepcobas taqman hcv test is a nucleic acid amplification test for the quantitation of hcv rna in human serum or plasma. The specimens found grid loads with specimens that match the search criteria and have the cobas. Sample preparation purified dna is the starting material for norgens hepatitis b virus hbv taqman pcr kit.
The high pure system viral nucleic acid kit allows for manual specimen preparation and the cobas taqman analyzer for automated amplification and. Cobas ampliprepcobas taqman hepatitis b virus hbv test. Laboratory procedure manual centers for disease control. Realtime pcr assays for hepatitis b virus dna quantification. For every 6 samples, a nontemplate control nucleasefree water and a positive control must be included. Cobas ampliprep cobas taqman hepatitis b virus hbv test. Performance of the cobas hepatitis b virus hbv test using. Hbv taqman pcr detection kit is designed to test 24 samples. Fiftytwo samples were from patients who were human im. The cobas hbv test using the cobas 4800 is a reliable method for quantifying hbv dna levels in the clinical setting.
The new abbott realtime hepatitis b virus hbv assay was compared to the cobas ampliprepcobas taqman assay with 128 serum samples from patients with chronic hepatitis b. Hepatitis b virus hbv pcr test procedure cobas taqman. The cobas ampliprepcobas taqman hcv test is an in vitro nucleic acid amplification test for the quantitation of hepatitis c viral hcv rna in human plasma or serum of hcvinfected individuals using the cobas ampliprep instrument for automated specimen processing and the. Roche launches nextgeneration viral load assay for hbv in. A novel automated realtime pcr assay for quantification of hbv dna in plasma. The specimens found grid loads with specimens that match the search criteria and have the cobas taqman hiv1 qual test. Hepatitis b virus, quantification, cobas taqman hbv. The taqman test used 500 microl of specimen, 700 microl of wash buffer and 75 microl of elution buffer.
Specimen preparation is automated using the cobas ampliprep instrument with. Inclusivity was shown by reliable quantification of hbv genotypes a to h at different concentration levels. Through our unrivalled investment in research and development. Scangel reverscan a1, b 86790 2 x 5 ml reverscan a1, a2, b, o 86795 4 x 5 ml.
These data indicate that the taqman test is an excellent tool for hbv dna quantitation. Two alternative tests for the measurement of hepatitis b virus hbv dna in serum were examined. An inhouse realtime polymerase chain reaction bioline international. The cobas taqman hbv test for research use only taqman hbv ruo.
Dynamic comparison between daan realtime pcr and cobas. Allice t1, cerutti f, pittaluga f, varetto s, gabella s, marzano a, franchello a, colucci g, ghisetti v. Performance of the cobas hepatitis b virus hbv test. Norgens hepatitis b virus hbv taqman pcr kit is designed for the detection of hbv specific. Cobas ampliprep instrument manual for use with the cobas taqman analyzer or. The test can be used to measure hbv dna levels at baseline and during treatment to aid in. Specimens found grid loads with specimens that match the search criteria and have the cobas ampliprep cobas taqman hiv1 test assigned. Samples from 397 patients from the state of sao paulo were analysed by all three methods.
The aptima assay runs on the panther system hologic inc. Cobas ampliprepcobas taqman hcv test package insert. Hiv1 group m, hiv1 group o, hiv2, hcv and hbv, from a single sample. The quality of the dna template will have a major impact on the performance of the hbv detection test.
Principles of the procedure the cobas taqscreen mpx test used. Cobas amplicor hbv monitor 4e7 copiesml cobas amplicor hbv monitor 300200,000 copiesml high pure system cobas taqman hbv 1706. Roche diagnostics, meylan, france is a recent commercial nucleic acid ampli. Quantitative detection of hepatitis b virus hbv in serum or plasma has become the most direct and reliable method for monitoring chronic hepatitis b. Evaluation of the cobas amplipreptotal nucleic acid. Evaluation of the cobas taqman mtb test for the detection of mycobacterium tuberculosis complex according to acidfastbacillus smear grades in respiratory specimens. The analytical performance of the cobas 6800 hiv1, hbv and hcv assays was verified and evaluated to the cobas ampliprepcobas taqman assays. Jan 17, 2007 cobas ampliprep cobas taqman hepatitis b virus hbv test. Due to an increasing demand for molecular tests and for taking advantage of realtime pcr, a fully automated extraction system is. It is preferable to collect and test 6 samples at a time. Inclusivity was shown by reliable quantification of hbv genotypes a to h at different. Compared to the amplicor test, the taqman test had a higher sensitivity 50 vs.
Verification of the roche cobas 6800 pcr 200 l and 500 l. Pdf comparison of the cobas ampliprepcobas taqman hbv. Cobas ampliprepcobas taqman hcv test package insert fda. Analyzer or cobas taqman 48 analyzer automatically repeats this process for a designated number of cycles, with each cycle intended to double the amount of amplicon dna. As shown in figure 1, the cobas ampliprep cobas taqman hiv1 test was found to give a linear response from 48 hiv1 rna cpml to 10,000,000 hiv1 rna cpml applying the. Molecular diagnostics realtime pcr virology womens. Cobas taqmat cobas ampliprep cobas taqman hepatitis b virus hbv test. Comparison of the cobas taqman hbv test with the cobas amplicor monitor test for measurement of hepatitis b virus dna in serum. Roche, as global leader in diagnostics, is pioneering this shift in the healthcare landscape. An automated test developed to test hiv in a single multiplex assay. Pdf comparison of the cobas taqman hbv test with the.
The analytical specificity was verified with negative plasma. A duplex realtime pcr assay based on the s and c regions could solve this problem to some extent. The hbv dna level could be undervalued when using the cobas taqman hbv test version 2 for chinese hbv infections owing to a mismatch with the primerprobe. After hbv dna extraction with the cobas ampliprep instrument, a realtime pcr test is performed by the cobas taqman 48 analyzer with a multiplex taqman assay. The roche cobas ampliprepcobas taqman hbv test, v2. This study aimed to standardise an inhouse realtime polymerase chain reaction rtpcr to allow quantification of hepatitis b virus hbv dna in serum or plasma samples, and to compare this method with two commercial assays, the cobas amplicor hbv monitor and the cobas ampliprep cobas taqman hbv test. Hepatitis c virus rna centers for disease control and. Reagents cobas ampliprep cobas taqman hiv1 test pn. One was the cobas taqman hbv test taqman test and the other was the cobas amplicor hbv monitor test amplicor test. The cobas hbv test showed good correlation with capctm v2.
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