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Cobas e411 analyser

Manufactured by Roche
Sourced in Switzerland, Germany

The Cobas e411 analyser is a fully automated immunoassay analyser designed for clinical laboratories. It performs a variety of immunoassay tests, including those for hormones, proteins, and other analytes. The Cobas e411 analyser is capable of processing a high volume of samples efficiently and accurately.

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34 protocols using cobas e411 analyser

1

Assessing Body Composition and Biomarkers

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Body composition was analysed with means of a bio-impedance device (Tanita BC 41 MA, Tanita Inc, Tokyo, Japan). To assess hs-TnT and hs-CRP levels an electrochemiluminescence immunoassay method (ECLIA) on Roche Cobas e411 analyser (Roche Diagnostics, Mannheim, Germany) was used. Reference values for this fourth-generation hs-TnT assay were < 14 ng/L and < 5 mg/dL for hs-CRP assay. Fingertip capillary L and Glu assessment were performed with Biosen C-Line Glucose and Lactate analyser (EKF Diagnostics, Cardiff, United Kingdom).
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2

Serological Screening for SARS-CoV-2 Antibodies

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Samples were analysed for antibodies against the spike (S) protein RBD and the nucleocapsid (N) antigen by Elecsys® Anti‐SARS‐CoV‐2 S (Roche S) and Elecsys® Anti‐SARS‐CoV‐2 (Roche N; Roche, Basel, Switzerland) immunoassays, respectively, using Roche Cobas e411 Analyser (Roche, Basel, Switzerland), following the manufacturer's instructions. For Roche S assay (Roche, Basel, Switzerland), the electro‐chemiluminescent signal representing the level of antibodies in titrated samples was measured and assigned a value. Samples with antibody levels ≥ 0.8 U mL−1 were considered positive. For Roche N assay, the cut‐off index (COI) was derived from the measured signal, where samples with COI ≥ 1.0 were considered reactive.
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3

Blood Sampling and Biomarker Analysis Protocol

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Approximately 9 ml of blood was collected from an antecubital vein into a plasma separator tube just before and within 30 min after the race. The sample was kept at room temperature for 30 min prior to centrifugation at 1,500 × g for 15 min at 18–25°C. Plasma was aliquoted into 500 μl volumes and stored in −80°C freezer. In order to determine hs-CRP and hs-TnT, an electrochemiluminescence immunoassay method (ECLIA) Roche Cobas e411 analyser (Roche Diagnostics, Mannheim, Germany) was used. Reference values were set to <5 mg/dL and <14 ng/L, for hs-CRP and hs-TnT, respectively. Glucose and lactate assessment was carried out in intervals during the run through a fingertip capillary test with Biosen C-Line analyser (EKF Diagnostics, Cardiff, United Kingdom), as described previously (Małek et al., 2020 (link)).
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4

Measurement of ERFE and NT-proBNP in Samples

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Human ERFE was measured using a commercially available ELISA kit (SKU# ERF-001, Intrinsic Lifesciences) and performed following the manufacturers’ instructions. All ERFE measurements were conducted at the Christchurch Heart Institute, New Zealand. The inter-assay coefficient of variation (CV) of low (5 ng/ml, 37%) and high (35 ng/ml, 36%) quality control samples, with intra-assay CVs at 28% and 25% were derived over 16 and 29 assays, respectively. NT-proBNP measurements were assessed using the commercially available Elecsys proBNP II assay, a chemiluminescent two-site assay conducted on the Roche Cobas e411 analyser (Roche Diagnostics GmbH, Mannheim, Germany). NT-proBNP had an inter-assay CV of 5.5% and 5.7% for the low (845 pg/ml) and high (4860 pg/ml) quality control samples, respectively. Haemoglobin measurements were determined at the core biochemistry laboratories of the respective institutions.
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5

Quantifying SARS-CoV-2 Spike Protein Antibodies

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Total antibodies to the spike protein (RBD) were quantified with the Elecsys® Anti-SARS-CoV-2 S assay on the Cobas e411 analyser (Roche Diagnostics, Rotkreuz, Switzerland)32 . The assay reports results in U/mL, whereby 1 U/mL = 1 binding antibody unit (BAU)/mL33 (link). Samples initially showing results above the upper limit of quantification (250 U/mL) were diluted in the assay diluent to obtain a quantified value. According to the manufacturer’s instructions, a cut-off of 0.8 U/mL indicates the presence of RBD-specific antibodies, whereas a cut-off of 15 U/mL is proposed to offer optimal correlation with the detection of neutralisation by PRNT (as determined with convalescent plasma from donors with SARS-CoV-2 infection)32 . Total anti-nucleocapsid (anti-N) antibodies were detected qualitatively with the Elecsys® Anti-SARS-CoV-2 assay on the Cobas e411 analyser (Roche Diagnostics) according to the manufacturer’s instructions; a cut-off index (COI) ≥ 1.0 identified positive results.
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6

Biomarker Measurement Protocols

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High-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) were measured in baseline serum samples using the CardioPhase® hs-CRP assay (Siemens Healthcare, Erlangen, Germany) on a Dimension Vista® 1500 system and the Elecsys® IL-6 assay (Roche Diagnostics, Rotkreuz, Switzerland) on a cobas® e 411 analyser, respectively.
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7

SARS-CoV-2 Antibody Detection in DBS

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DBS specimens were tested using the Elecsys Anti-SARS-CoV-2 (nucleocapsid) and Elecsys Anti-SARS-CoV-2 S (RBD) assays (Roche Diagnostics, Basel, Switzerland) at the National Microbiology Laboratory (NML; Public Health Agency of Canada, Winnipeg, Canada) according to the manufacturer’s instructions. DBS samples were punched (4 × 6 mm) using a semi-automated BSD600 Ascent puncher (BSD Robotics) into 2 mL 96-well polypropylene plates (ThermoFisher Scientific). DBS punches were eluted in 370 μL of DPBS containing 0.5% BSA and 0.05% Tween 20 overnight at 4 °C with agitation (400 RPM). Afterwards, plates were incubated at room temperature for 30 min with agitation (400 RPM) and 250 μL of DBS eluate was transferred into 2 mL microtubes for direct loading onto a cobas e 411 analyser (Roche Diagnostics). A result of <0.8 U/mL and ≥0.8 U/mL was interpreted as negative and positive respectively with the Elecsys Anti-SARS-CoV-2 S. A cutoff index <1.0 and ≥1.0 was interpreted as negative and positive respectively with the Elecsys Anti-SARS-CoV-2 assay. DBS punching and elution protocols were validated using an earlier DBS panel [9 ].
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8

Quantification of HBsAg and HBeAg

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Quantification of serum HBsAg and HBeAg were performed using electrochemiluminescence on the Cobas e411 analyser (Roche) as according to the manufacturer’s protocols through the Public Health Reference and Diagnostic Testing Laboratory Service at the Victorian Infectious Disease Reference Laboratory (VIDRL), Peter Doherty Institute for Infection and Immunity.
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9

Hormonal Ratio and Liver Enzyme Analysis

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They were measured in blood plasma using immunoassay analysers based on electrochemical luminescence detection technology. Prolactin was measured using the Immulite 2000 Immunoassay System (Siemens Healthcare GmbH, Erlangen, Germany) while testosterone was measured using the Cobas e 411 analyser (Roche Diagnostics GmbH, Mannheim, Germany). For each rat the prolactin to testosterone ratio was calculated. Activities of ALT and AST in the plasma were measured by COBAS INTEGRA 400 plus (Roche Diagnostic GmbH, Mannheim, Germany) automated analyser (Roche Diagnostics, Mannheim, Germany).
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10

SARS-CoV-2 Antibody Detection Assay

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All serum samples were analysed in the clinical biology unit of the Georges-Francois Leclerc cancer centre, using the same tests as in the first study [12 ], in order to enable comparison and paired testing since a majority of HCWs participating in the present study had already participated in the first study.
SARS-CoV-2 total antibodies were measured on the fully-automated cobas e411 analyser (Roche Diagnostics) using Elecsys® Anti-SARS-CoV-2 electrochemiluminescence immunoassay (Roche Diagnostics) for the qualitative detection of SARS-CoV-2 antibodies in human serum and plasma. The IVD CE-marked Elecsys® assay uses a modified double-antigen sandwich immunoassay using recombinant nucleocapsid protein (N), which is geared towards the detection of late, mature, high-affinity antibodies independent of the subclass. It is a total SARS-CoV-2 antibody assay (IgA, IgM and IgG) detecting predominantly but not exclusively, IgG. This test was validated (amongst others) by the French national reference centre on 21st May 2020 [38 ]. Measurement of anti-SARS-CoV-2 antibodies was performed following the manufacturer's instructions. Results are reported as numeric values in the form of a cutoff index (COI; signal sample/cutoff) and as a qualitative result, i.e. non-reactive (COI <1.0; negative) or reactive (COI ≥1.0; positive).
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