当前位置： SCI文献检索 > JOURNAL OF MEDICAL MICROBIOLOGY期刊下所有文献 > Verification of the Roche cobas® 6800 PCR 200 µl and 500 µl protocols for the quantification of HIV-1 RNA, HBV DNA and HCV RNA and evaluation with COBAS® Ampliprep/COBAS® TaqMan® assays.

Verification of the Roche cobas® 6800 PCR 200 µl and 500 µl protocols for the quantification of HIV-1 RNA, HBV DNA and HCV RNA and evaluation with COBAS® Ampliprep/COBAS® TaqMan® assays.

Abstract：

PURPOSE:The analytical performance of the cobas 6800 HIV-1, HBV and HCV assays was verified and evaluated to the COBAS Ampliprep/COBAS TaqMan assays. METHODOLOGY:The precision, limit of detection (LoD), limit of quantification (LoQ) and linearity were verified using pooled residual clinical samples. The analytical specificity was verified with negative plasma. HIV-1 analytical reactivity was verified with WHO reference preparations. Accuracy was verified using EQA plasma panels. Evaluation of the equipment was performed using prospectively collected clinical whole blood samples. RESULTS:Excellent precision was demonstrated using both testing protocols (coefficient of variation ≤15 %). The LoDs using the 500 and 200 µl protocols were 20 and 50 cp ml-1 for HIV-1, 10 and 20 IU ml-1 for HBV and 15 and 40 IU ml-1 for HCV, respectively. The LoQs were 40 and 100 cp ml-1 for HIV-1, 20 and 25 IU ml-1 for HBV and 30 and 80 IU ml-1 for HCV, respectively. Assays demonstrated good linearity (R2 ≥0.96). The analytical specificity of the assays was 100 %. There was excellent agreement between the cobas 6800 and CAP/CTM assays (kappa>0.94). The sensitivity, specificity, positive predictive value and negative predictive value for each of the assays were ≥99 %. The cobas HIV-1 and HCV mean quantifications were 0.03 log10 cp ml-1 and 0.17 log10 IU ml-1 higher than the CAP/CTM. The cobas HBV mean quantification was 0.17 log10 IU ml-1 lower than the CAP/CTM. Subtype/genotype specific differences were not observed. CONCLUSION:Cobas 6800 equipment and assays demonstrated excellent performance and correlated well with CAP/CTM assay results.

journal_name

J Med Microbiol

journal_title

Journal of medical microbiology

authors

Tan NK,Carrington D,Pope CF

doi

10.1099/jmm.0.000838

subject

Has Abstract

pub_date

2018-12-01 00:00:00

pages

1711-1717

issue

12

eissn

0022-2615

issn

1473-5644

journal_volume

67

pub_type

杂志文章

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