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13 protocols using cobas h232

1

Comparative Evaluation of cTnI and cTnT POC Assays

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Five POC cTnI assays—Alere Triage Cardio3TnI (Alere International), BioMerieux Vidas Troponin I Ultra (Biomerieux), Mitsubishi Pathfast cTnI (LSI Medience Corporation), ReLIA TZ‐301 cTnI (Ruilai Biological Engineering), and Radiometer AQT90 TnI (Radiometer Medical), were evaluated against the central laboratory cTnI assay (Access II Accu TnI, Beckman Coulter). Two POC cTnT assays—Radiometer AQT90 cTnT (Radiometer Medical) and Roche Cobas h232 (Roche Diagnostics), were compared to a central laboratory hs‐cTnT assay—Roche Cobas e601 (Roche Diagnostics).
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2

Myoglobin and Troponin T Measurement by POCT

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Myoglobin and troponin T levels were measured in whole blood by POCT using the Roche Cobas® h 232 immunoassay analyzer (Roche Diagnostics, Mannheim, Germany). The range of detection was 0.1 to 3 μg/l for troponin T and 30 to 700 μg/l for myoglobin (7 (link), 8 (link)).
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3

Point-of-Care Troponin T Assay

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Troponin T was measured on the POCT instrument Cobas h232 (Roche Diagnostics, Mannheim, Germany). The detection limit was 0.03 µg/L (30 ng/L) and all values >0.03 µg/L (>30 ng/L) were regarded as positive according to the manufacturer’s recommendations. Further details about the method for POCT-cTnT are described elsewhere [11 (link)].
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4

NT-proBNP POC Test in HF Diagnosis

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An NT‐proBNP POC test (Cobas h232, Roche Diagnostics Switzerland) was offered to each intervention practice. This test is reliable and easy to use.17, 18 All GPs had to follow an educational meeting on the value of NPs in HF diagnosis, the interpretation of test results, and the use of the device but were free to use the test at their own discretion. GPs were encouraged to use it to objectify uncertain HF diagnoses of the OSCAR‐HF study population, in addition to its diagnostic use in new patients. GPs had to perform a weekly quality check of the device. A POC coordinator affiliated with the clinical laboratory of Ziekenhuis Oost‐Limburg (ZOL) acted as a point of contact and supervised the qualitative use of the POC device. We advised GPs to use age‐dependent cut‐offs for referral [N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) value ≥ 125 pg/mL for patients younger than 75 years or ≥400 pg/mL for patients 75 years or older].19
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5

Cardiac Biomarkers in Animal Models

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cTnI and cTnT levels were measured in rats, dogs and cynomolgus monkeys. CK and LDH levels were also measured in dogs and monkeys to monitor the effect by strenuous movement. The measurement methods are as follows.

cTnI: For rats, plasma samples were measured with Cardiac Injury Panel 3 (rat) Assay Kit and SECTOR® Imager 6000 (Meso Scale Discovery, MD, USA). For dogs and cynomolgus monkeys, serum samples were measured with Multiskan Ascent (Thermo Fischer Scientific, MA, USA).

cTnT: For rats, plasma samples were measured with Cardiac Injury Panel 3 (rat) Assay Kit and SECTOR® Imager 6000 (Meso Scale Discovery, MD, USA). For dogs and cynomolgus monkeys, blood samples were measured with Cobas h 232 (Roche Diagnostics GmbH, Mannheim, Germany).

CK and LDH: Serum samples were measured with JCA-BM6070 (Nihon Denshi, Tokyo, Japan) in both dogs and cynomolgus monkeys.

Note that all the testing methods were validated for their intra-assay precision, inter-assay precision, and frozen stability.
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6

Comprehensive Evaluation of Acute Decompensated Heart Failure

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All enrolled subjects were subjected to a nasopharyngeal or pharyngeal test for SARS-CoV-2 with all the appropriate precautions. A detailed medical history was obtained including all medications received, family history, patients’ habits and lifestyle. Afterwards, a thorough physical examination was performed. Blood samples were collected with standard venipuncture procedures for routine laboratory investigations. NT-proBNP was measured using a POC device (Cobas h 232, Roche Diagnostics, GmbH, Mannheim, Germany). After blood sampling, saliva sample collection followed as described in detail below. Subsequently, a 12-lead electrocardiogram and a transthoracic echocardiogram were recorded. A 6 min walk test was performed for all patients who were able to walk in the corridor. All patients were studied in the morning after an overnight fasting. ADHF patients were studied as early as their medical condition allowed within the first 24 h of their admission.
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7

Biomarkers for Renal Function Assessment

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Blood samples were collected under fasting conditions and immediately sent to the local laboratory. Estimated glomerular filtration rate (eGFR) was assessed by the Modified Diet for Renal Disease Study equation. NT-proBNP determination was performed directly using the cobas h 232 point-of-care analyzer by Roche (Roche Diagnostics, Basel, Switzerland) with a lower detection limit of 59 pg/ml. Within-series coefficients of variation ranged from 4.8 to 14.8% as previously determined by Bertsch et al. [25 (link)] Urine albumin/creatinine ratio was assessed quantitively in fresh spot urine samples according to the local laboratory standards.
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8

SARS-CoV-2 Positive Patients: Clinical and Laboratory Evaluation

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This retrospective study was carried out on 118 patients (59 males, 59 females) who were diagnosed as SARS-CoV-2 positive. We retrospectively collected the data from patient records in COVID-19 isolation hospitals in Sohag governorate and the isolation department in Sohag university hospitals during the period from the start of June 2020 to the end of July 2020. The inclusion criteria were patients with positive PCR for SARS-CoV-2, while the exclusion criteria were patients with chronic hepatic disorders (liver cirrhosis, hepatitis B surface antigen-positive, or patients who were anti-HCV antibody positive and HCV RNA positive) and patients with a history of alcohol intake.
The study protocol was accepted by the Ethical Committee of Scientific Research, Faculty of Medicine, Sohag University. The researchers retrospectively collected data about clinical manifestations including fever, cough, dyspnea, fatigue, and diarrhea, and laboratory investigation: complete blood count (CBC) by ABX Micros 60 (Horriba-ABX, France), total and direct bilirubin, AST, ALT, albumin, C-reactive protein (CRP) by Vitros-350 autoanalyzer (Ortho-Clinical Diagnostics, USA), prothrombin time and concentration by STA-Satellite (Diagnostic STAGO, France), D-dimer by Cobas h232 from Roche Diagnostic (Germany) and serum ferritin by TOSOH AIA-360 from Tosoh Corporation, Japan.
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9

Heart Failure Telemonitoring Protocol

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Research personnel in each centre are responsible for the screening and selection of eligible participants. Baseline data are collected by trained researchers using a structured electronic case report form including sociodemographic and clinical data, health‐related quality of life according to the Kansas City Cardiomyopathy Questionnaire (KCCQ),20 satisfaction and acceptability of SMS text messaging, HF self‐care assessed by the European Heart Failure Self‐Care Behaviour Scale,21, 22 and HF knowledge evaluated by the Heart Failure Knowledge Questionnaire.23, 24 All applied scales have been adequately validated for the Portuguese language.20, 22, 24 N‐terminal pro‐brain natriuretic peptide (NT‐proBNP) levels are measured using point‐of‐care equipment according to the manufacturer's recommendations (Cobas® h 232, Roche Inc., Switzerland).
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10

Multidisciplinary Heart Failure Evaluation

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With the help of two junior researchers, the nursing home physicians will review residents’ history and perform a clinical examination to identify clinical signs of heart failure. They will have full access to residents’ medical records and will be able to assess multimorbidity. Trained nursing home staff will record ECG and collect blood samples for measurement of the NT-proBNP marker. NT-proBNP will be measured using a Roche Cobas h 232 point-of-care system on site. The ECG will be interpreted by a nursing home physician. A qualified cardiologist will perform the echocardiography exam using a GE Vivid 7 ultrasound system. While performing echocardiography, the cardiologist will be blinded for NT-proBNP value and will perform echocardiography on an additional 10% of NT-proBNP negative patients as a control measure. A predefined ultrasonography protocol will be followed and images and clips recorded.
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