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Cobas e801 module

Manufactured by Roche
Sourced in Switzerland, Germany

The Cobas e801 module is a fully automated, high-throughput laboratory instrument designed for immunoassay testing. It is part of the Cobas e series platform from Roche Diagnostics. The Cobas e801 module is capable of performing a wide range of immunoassay tests, including those for hormones, infectious diseases, and other analytes. It features advanced automation and processing capabilities to ensure accurate and efficient laboratory workflows.

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16 protocols using cobas e801 module

1

Quantification of Urinary PSA

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Urinary PSA levels were determined using the same method (Elecsys total PSA, 08791732500) used to determine serum PSA levels. This electrochemiluminescence assay is used in the clinical routine of IPO Porto. It quantifies total PSA (free + complexed PSA) using a Cobas e 801 module, a member of Roche Cobas 8000 Modular Analyzer (Roche, Woerden, The Netherlands).
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2

Serum Biomarker Quantification Assays

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AFP serum concentrations were determined by electrochemiluminescence immunoassay (ECLIA) using the Cobas e801 module (Roche Diagnostics, Basel, Switzerland). Aspartate aminotransferase (AST) and alanine transaminase (ALT) activities were determined using a spectrophotometric method, and serum concentrations of albumin were determined using a bromocresol green colorimetry method. All assays were performed on a Cobas c501 biochemistry analyzer (Roche Diagnostics).
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3

SARS-CoV-2 Antibody Quantification

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Roche Elecsys Anti-SARS-CoV-2 S electrochemiluminescence immunoassay (ECLIA) for the in vitro quantitative determination of antibodies (including IgG) against spike RBD of SARS-CoV-2 in human serum was performed on Roche Cobas e 801 module. According to the manufacturer, the correlation test between Roche Elecsys Anti-SARS-CoV-2 S units per mL and WHO International Standards for anti-SARS-CoV-2 immunoglobulins showed an excellent correlation (r2 = 0.9992, slope = 0.972, intercept = 0.0072), thus allowing to consider specific Roche Elecsys Anti-SARS-CoV-2 S U/mL units equivalent to WHO International Standard BAU/mL (Binding Arbitrary Units per mL). Measuring range spanned from 0.4 BAU/mL to 250.0 BAU/mL, requiring a 1:10 dilution for samples with concentrations > 250.0 BAU/mL, extending the measuring range until to 2500.0 BAU/mL; values higher than 0.8 BAU/mL were considered positive. Serum samples with antibody titers > 2500.0 BAU/mL, from the selected subgroups above specified, were further diluted in order to obtain the exact quantitative concentration.
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4

Serum Thyroid Hormone Quantification

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Blood samples were collected via retro‐orbital collection and allowed to coagulate at room temperature. The samples were centrifuged at 3,500 ×g for 15 min to obtain serum. The obtained serum samples were stored at −20 °C until further analysis for hormonal measurements.
The concentrations of Total T3 (nmol L−1) and Total T4 (nmol L−1) were determined using the Electrochemiluminescence (ECL) technology. Specifically, the Cobas e 801 Module by Roche Diagnostics was used for the measurement of these hormone levels.
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5

SARS-CoV-2 Nucleocapsid Antibody Assessment

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SARS-CoV-2 nucleocapsid antibodies were measured in sera using the Elecsys Anti-SARS-CoV-2 sandwich assay on a Cobas e801 module (Roche Diagnostics, Mannheim, Germany) and the analysis was conducted according to the manufacturer’s instructions. The assay employs a SARS-CoV-2 specific recombinant antigen representing the nucleocapsid protein. The electrochemiluminescent signal obtained was compared to the cut-off signal value previously generated by two calibrators. The results were expressed as cut-off index, negative COI <1.0 or positive COI ≥1.0, for anti-SARS-CoV-2 total antibodies.
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6

SARS-CoV-2 Antibody Detection by ECLIA

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An electrochemiluminescence immunoassay (ECLIA) using the Elecsys Anti-SARS-CoV-2 assay and the cobas e801 module (Roche Diagnostics, Rotkreuz, Switzerland) is a double-antigen sandwich assay for the qualitative detection of different types of antibodies against SARS-CoV-2 nucleocapsid (N) proteins, primarily IgG4. This ECLIA was carried out according to the manufacturer’s instructions, and a cut-off index (COI) ≥1.0 indicates a positive diagnosis. The reagents for 5,000 samples were obtained in collaboration with Roche, and the reagents for the other samples were purchased from Roche.
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7

SARS-CoV-2 Antibody Detection by ECLIA

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An electrochemiluminescence immunoassay (ECLIA) was conducted using the cobas e801 module (Roche Diagnostics, Rotkreuz, Switzerland) as in our previous study [18 (link)]. The Elecsys Anti-SARS-CoV-2 assay kit (Roche Diagnostics) was used for the detection of antibodies against the SARS-CoV-2 nucleocapsid (N). The measurement of anti-N antibody was performed according to the manufacturer’s instructions, and samples with a cut-off index (COI) >1.0 were diagnosed as positive.
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8

SARS-CoV-2 Spike Protein Antibody Assay

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For the analysis of humoral responses, serum was collected from all participants. IgG antibodies specific for the receptor binding domain (RBD) of the SARS-CoV-2 spike protein were measured by means of electrochemiluminescence immunoassay on a COBAS e801 module (Roche, Basel, Switzerland). Values above 0.8 U/mL were considered positive as suggested in the manufacturer’s instructions. Values below the lower detection limit of 0.4 U/mL were set to 0.2 U/mL, values above the upper detection limit of 25,000 U/mL were set to 25,001 U/mL. The unit U/mL is equivalent to the WHO international standard BAU/mL and does not require conversion [31 (link)].
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9

Measurement of Cardiac Biomarkers

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The assays of CK and its isoenzyme CK-MB were performed in the central laboratory of the Institute of Clinical Chemistry and Pharmacology at the University Hospital of Bonn. CK was determined with VIS-photometry using the cobas c702 module (Roche Diagnostics, Basel, Switzerland). Measurements were in units per liter “U/L” with cut-off values of 190 U/L for males and 170 U/L for females. CK-MB was measured via the electrochemiluminescence immunoassay method using the Elecsys® CK-MB reagent and the cobas® e801 module (Roche Diagnostics, Basel, Switzerland). Measurements were expressed in ng/mL with cut-off values of 4.87 [ng/mL] for males and 3.61 [ng/mL] for females. Troponin T was determined using the immunoluminometric assay. The measurement of pNfH from CSF was performed at the University Hospital of Ulm. Other laboratory parameters were also performed at the Institute for Clinical Chemistry and Pharmacology, University Hospital Bonn.
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10

Measurement of PCT and Presepsin Levels

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Residual EDTA plasma samples were aliquoted to avoid repeated freezing and thawing and were stored at –70°C until use. Frozen samples were thawed at room temperature and gently mixed immediately before measuring the PCT and presepsin levels. PCT level was measured using the Elecsys BRAHMS PCT assay (Roche Diagnostics GmbH, Mannheim, Germany) on a cobas e801 module (Roche Diagnostics GmbH) based on a electrochemiluminescence immunoassay. The manufacturer-suggested reference range for PCT was up to 0.046 ng/mL. Presepsin level was measured using the HISCL Presepsin assay (Sysmex, Kobe, Japan) in an HISCL 5000 automated analyzer (Sysmex) based on a delayed one-step sandwich chemiluminescence enzyme immunoassay. The manufacturer-suggested reference range for presepsin was up to 333.0 pg/mL. Both assays were performed according to the manufacturers’ instructions.
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