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Cobas 6800 8800 system

Manufactured by Roche
Sourced in United States, Germany, Switzerland

The Cobas 6800/8800 Systems are automated, high-throughput molecular testing platforms designed for clinical laboratories. They are capable of performing a variety of nucleic acid tests, including real-time PCR (polymerase chain reaction) assays. The systems are engineered to provide efficient sample processing, accurate results, and increased workflow productivity.

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16 protocols using cobas 6800 8800 system

1

Quantifying HIV Viral Load Inhibition

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MT4 cells were incubated for 3 hours with HIVIIIB, at multiplicity of infection (MOI) 0.01, washed thrice with PBS to remove the initial inoculum and then plated at 3×105 cells/mL (200 µL per well with RPMI 1640 medium and 10% FBS). Wells were treated in triplicate with 25 µL of AZT, dendrimer alone, dendriplex with control RNA or dendriplex with Ψ RNA.58 (link) The concentration of the dendrimer was kept constant. A total of 25 µL of RPMI 1640 medium was added to untreated control wells. After 3 or 5 days of incubation, 100 µL was aspirated from each well, inactivated by exposure to acidified Triton X (in isopropanol) for 1 hour,53 (link) washed twice (by centrifugation and resuspension in PBS) and finally resuspended in 3 mL PBS for viral load quantification. The dilution factor (104) introduced because of the aforementioned procedures was taken into account when calculating the final viral load. Viral load was quantified by the automated Roche Cobas® 6800/8800 System (Roche Diagnostics, Mannheim, Germany) as per the manufacturer’s instructions. This is a fully automated polymerase chain reaction (PCR)-based system with a linear range of 20–10,000,000 copies/mL.
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2

SARS-CoV-2 Detection from Post-Mortem Samples

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Fresh paired post-mortem conjunctival, bronchial, and vitreous samples from 20 different donors were analyzed using the fully automated Roche cobas® 6800/8800 system (Roche Diagnostics, Penzberg, Germany). For quantification, standard curves were generated in multiple replicates using a commercially available standard for calibration (Instand e.V., Düsseldorf, Germany). Viral loads of samples were calculated as SARS-CoV-2 ORF1ab copy numbers per 1 ml of swab medium or vitreous fluid, respectively. Positive and negative control samples were included in each run. These measurements were performed at the fully accredited diagnostic laboratory of the Department of Virology at the Pettenkofer Institute.
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3

SARS-CoV-2 RNA Quantification via Automated Roche System

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Samples were quantified for SARS-CoV-2 RNA using the fully-automated Roche cobas® 6800/8800 system (Roche, Mannheim, Germany). For quantification, standard curves were generated in multiple replicates using a commercially available standard for calibration (Instand e.V.) as described previously [14 (link)]. Viral loads of samples were calculated as SARS-CoV-2 nucleocapsid gene copy numbers per 1 ml of oropharyngeal gargle.
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4

COVID-19 Screening of Occupational Groups

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Basic demographic data, e.g. age, sex, occupation, and PCR test results were collected. Because of a decentralised implementation approach of the screening, only two testing sites (A and E) collected further data. At Site A, a web app-based questionnaire collected information on symptoms, previous contacts and IPC measures (Supplementary Table S3: Questionnaire for the screening of special occupational/population groups). At Site E, a paper-based questionnaire collected information on symptoms and previous contacts.
From each participant, a nasopharyngeal, oropharyngeal or combined swab was taken by a healthcare professional; SARS-CoV-2 infection was assessed. The samples from Sites A-D were analysed by RT-PCR using the cobas 6800/8800 system (Roche Diagnostics, Mannheim, Germany), and the samples from site E, by RT-PCR using AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 RUO (Altona Diagnostics, Hamburg, Germany). According to German infection prevention laws, all positive test results must be reported to the local health authority.
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5

SARS-CoV-2 PCR Testing of Symptomatic Patients

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Polymerase chain reaction (PCR) testing of nose and throat swabs was performed in case of symptoms suggesting respiratory infection. Only a fraction of the patients (Sana Hospital Offenbach, n = 11) was tested weekly using SARS-CoV-2 PCR.
The SARS-CoV-2 PCR test was performed as dual target PCR for ORF1 and E genes on a Cobas® 6800/8800 system (ROCHE Diagnostics, Mannheim, Germany).
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6

SARS-CoV-2 IVD Dual-Target Test

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The SARS-CoV-2 IVD dual-target test for the cobas6800/8800 system was obtained from Roche and used according to instructions issued by the manufacturer. Target-1 (ORF1ab) and Target-2 (E gene) properties were analysed separately, though the entire assay was deemed positive as long as one Target returned a positive result. Apart from loading the ready-to-use SARS-CoV-2 IVD-test cartridges onto the device, there are no manual steps required in the assay setup.
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7

Longitudinal HBV DNA Monitoring During TAF

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The day TAF was started was used as reference point, and HBV DNA levels were measured every 3 months during 2 years before (during ETV) and after the reference point (during TAF). Quantitative measurement of HBV DNA was done using real‐time PCR (COBAS 6800/8800 system, TaqMan HBV assay; Roche). The serum HBV DNA was measured by real‐time PCR with a detection range of 1.0–9.0 log IU/mL. The lower limit was 10 IU/mL.
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8

Virological Outcomes of Long-Acting Injectable HIV Therapy

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Virological outcomes were evaluated at the start of OLI, at the start of injectable CAB plus RPV LA, and at 1, 3, 5, 7, 9, 11, and 13 months after injectable CAB plus RPV initiation, that is, ∼14 months after the start of OLI. One who was dosed every month was analyzed in the same way. HIV-RNA was measured at BML, Inc. (Tokyo, Japan), using cobas® 6800/8800 System (Roche diagnostics, Tokyo, Japan); HIV-RNA ≥20 copies/mL was measured quantitatively and HIV-RNA <20 copies/mL was evaluated for qualitative detection. “Undetectable HIV-RNA” means that the virus is qualitatively undetectable, which is synonymous with “Target not detected.”
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9

COVID-19 Epidemiology in Austrian Patients

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This retrospective study included 338 Caucasian patients, over the age of 18, admitted to the Department of Internal Medicine at the University Hospital Graz and to Landeskrankenhaus Graz II, with a diagnosis of COVID‐19, between March and May 2020 during the first wave of coronavirus infection in Austria. All study participants tested positive for SARS‐CoV‐2 RNA by real‐time PCR (qPCR). After extraction using the EMAG® platform (bioMérieux S.A., Marcy l'Etoile, France), nucleic acids were amplified using the RIDA® GENE SARS‐CoV‐2 (r‐biopharm, Darmstadt, Germany) with the LightCycler® 480 II (Roche Molecular Diagnostics, Rotkreuz, Switzerland). Additionally, the Cobas® SARS‐CoV‐2 test (Roche Molecular Systems, Branchburg, NJ) was applied on the Cobas® 6800/8800 system (Roche Molecular Diagnostics).49 (link)
The diagnosis of COVID‐19 was established based on the national guidelines published by the Austrian Ministry of Health.50 Admission referred to COVID‐19‐related hospitalization, and mortality was defined as all‐cause mortality in SARS‐CoV‐2 infected patients.51 (link), 52 (link)
Demographic information and concurrent diagnoses, based on the International Classification of Diseases (ICD‐10), were obtained from the electronic health records of patients.
The study was approved by the local Ethics Committee at the Medical University of Graz (32‐436 ex 19/20).
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10

Comparative Evaluation of Roche cobas HBV Assays

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All experiments were performed in International Standard Organization (ISO) 9001:2008-certified or ISO 17,025:2005-accredited laboratories.
The following four generations of the Roche cobas HBV assay were utilized: cobas 6800/8800 HBV (cobas HBV test for use on the cobas 6800/8800 Systems; Roche Diagnostics, Pleasanton, CA, USA), cobas 4800 HBV (cobas HBV test for use on the cobas 4800 Systems; Roche Diagnostics, Pleasanton, CA, USA), CAP/CTM HBV v2 (COBAS AmpliPrep/COBAS TaqMan HBV v2 test; Roche Diagnostics, Pleasanton, CA, USA), and HPS/CTM HBV v2 (COBAS TaqMan HBV test; Roche Diagnostics, Pleasanton, CA, USA for use with the High Pure System).21 24 (no links found)All four cobas HBV assays are quantitative nucleic acid tests that enable the detection and quantification of HBV DNA in EDTA plasma or serum of HBV-infected patients. Assays (cobas 6800 HBV, cobas 4800 HBV, CAP/CTM HBV v2, and HPS/CTM v2) were used according to the manufacturer’s instructions.21 24 (no links found) Assay and system characteristics are described in Table 1. All assays are calibrated to the World Health Organization (WHO) International Standard for HBV DNA, and results are reported in IU/ml.
Assay performance was evaluated using the following two approaches.
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