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