![]() Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS, Jr., Bzowej NH, Wong JB. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. EASL recommendations on treatment of hepatitis C 2018. ![]() This fulfills an unmet need for low- to mid-throughout laboratories seeking to optimize efficiency of their viral molecular testing.ĭNA HBV HCV HIV-1 PCR RNA viral load.Įuropean Association for the Study of the Liver. IMPORTANCE These are the first published data that demonstrate equivalent performance of the new cobas 5800 system compared with cobas 6800. This establishes cobas 5800 as a new option for low- to mid-throughout laboratories seeking to optimize efficiency of their viral molecular testing. This multisite comparison study demonstrates equivalent performance of the new cobas 5800 system compared with cobas 6800. Between 98.6% and 100% of results fell within the allowable total difference zone that defines expected variability on the existing 6800/8800 system. In general, variability was higher at lower VL. The standard deviation values ranged from 0.04 to 0.19 log 10 IU/mL for HBV, 0.06 to 0.33 log 10 IU/mL for HCV, and 0.05 to 0.34 log 10 copies/mL for HIV-1. The slope of the Deming regression line ranged from 0.994 (HBV, site 3) to 1.025 (HIV-1, site 1). The correlation between VL measurements generated using cobas 5800 versus 6800 was extremely high, with r 2 correlation coefficients between 0.990 and 0.999 for the three targets at the different sites. We also assessed cobas 5800 assay reproducibility by repetitive testing of specimens with VL close to values used as thresholds for patient management or classification. We compared HBV, HCV, and HIV-1 VL results from cobas 5800 in three different laboratories to those from the same specimens tested on a cobas 6800 system. cobas 5800 shares numerous design elements and technical characteristics with the existing cobas 6800/8800 Systems. The cobas 5800 System ("cobas 5800") is a new low- to mid-throughput PCR-based nucleic acid testing system which performs both qualitative and quantitative testing, including viral load (VL) determination. ![]()
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