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11:05 EST 28th January 2020 | BioPortfolio

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Showing "Roche Tecentriq gets another" PubMed Articles 1–25 of 40

ANNALS EXPRESS: Multicenter evaluation of the Roche Elecsys® Active B12 (holotranscobalamin) electro-chemiluminesence immunoassay.

Background Vitamin B12 deficiency is a common disorder. In circulation, vitamin B12 is bound to transcobalamin (holotranscobalamin), which is considered the active form of cobalamin. The objective of this study was to evaluate the analytical performance of the Roche Elecsys Active B12 immunoassay. Methods Limit of quantification and linearity were assessed according to CLSI EP17-A2 and EP-6A guidelines. Precision and bias of Roche Active B12 test against Architect ci8200 (Abbott) were performed according to...

Optimizing the u411 automated urinalysis instrument for veterinary use.

The Cobas u411 Analyzer (Roche Diagnostics) is an automated, reflectance photometry-based urinalysis instrument designed for use with Roche's CHEMSTRIP 10UA technology and human urine samples.

Response to Van Domelen and Bandeen-Roche.

Response to van Domelen and Bandeen-Roche's Commentary.

Two-center comparison of 10 fully-automated commercial procalcitonin (PCT) immunoassays.

Background This two-center study was designed to verify comparability of procalcitonin (PCT) values among 10 different commercial immunoassays. Methods A total number of 176 routine lithium-heparin plasma samples were divided in identical aliquots and simultaneously analyzed with 10 different PCT immunoassays, including Kryptor BRAHMS PCT sensitive, Abbott Architect BRAHMS PCT, Beckman Coulter Access PCT (on Access and DXI), BioMérieux Vidas BRAHMS PCT, Diasorin Liaison BRAHMS PCT, Fujirebio Lumipulse G BR...

Interferences in free thyroxine concentration using the Roche analytical platform: improvement of the third generation?

Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents.

Background The diagnostic utility of laboratory tests in paediatric medicine relies heavily on the availability of appropriate reference intervals (RIs). The Canadian Laboratory Initiative on Paediatric Reference Intervals (CALIPER) has established a comprehensive database of covariate-stratified RIs for many paediatric laboratory tests using a large, healthy reference population. Several automated analysers in widespread use in clinical laboratories have already been studied. Here, we extend the testing to...

Agreement Between Two Procalcitonin Assays in Hospitalized Children.

Agreement between available procalcitonin (PCT) assays is unclear. We sought to compare concordance between Roche and bioMérieux PCT assays using pediatric samples.

Performance of the ResistancePlus MG diagnostic test for using samples collected with Hologic Aptima Specimen Collection kits.

 is a sexually transmitted organism with high levels of resistance to the recommended first-line therapy, azithromycin. The ResistancePlus MG test concurrently detects and the presence of macrolide-resistance mutations (MRM). European, UK and Australian guidelines recommend a diagnostic test that reports MRM to optimize treatment through resistance-guided therapy. Hence, for samples collected for use on other platforms, reflex testing using the ResistancePlus MG test would be beneficial. To validate the...

A study on reference interval transference via linear regression.

Background Reference intervals (RIs) transference can expand the applicability of established RIs. However, the study on transference methodology is insufficient, and RIs validation based on small samples cannot adequately identify transferred risk under complex situations. This study aimed to find appropriate conditions to ensure the effect of transference. Methods We established the RIs of Roche and Beckman systems for 27 analytes based on 681 healthy individuals. Roche RIs were converted into the Beckman...

Evaluation of the 25-hydroxy vitamin D assay on a fully automated liquid chromatography mass spectrometry system, the Thermo Scientific Cascadion SM Clinical Analyzer with the Cascadion 25-hydroxy vitamin D assay in a routine clinical laboratory.

Background Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers advantages over immunoassay due to its increased specificity and ability to multiplex metabolites within a single run. Wide scale adoption of LC-MS/MS in routine clinical laboratories is restricted in part due to the high level of technical expertise required. The Thermo Scientific™ Cascadion™ SM Clinical Analyzer is the first fully automated, random access clinical analyser that utilises LC-MS/MS technology. We report an analyt...

Comparison of the diagnostic performance of two automated urine sediment analyzers with manual phase-contrast microscopy.

Background Recently, several manufacturers have launched automated urinalysis platforms. This study aimed to compare the diagnostic performance of the UF-5000 (Sysmex Corporation, Kobe, Japan) and the cobas® u 701 (Roche Diagnostics, Rotkreuz, Switzerland) urine sediment analyzers with manual phase-contrast microscopy as the reference method. Methods A total of 195 urine samples were analyzed on both automated platforms and subjected to manual microscopic examination. Agreement was assessed by Cohen's kapp...

Rise and fall of the new variant of in Sweden: mathematical modelling study.

A new variant of (nvCT) was discovered in Sweden in 2006. The nvCT has a plasmid deletion, which escaped detection by two nucleic acid amplification tests (Abbott-Roche, AR), which were used in 14 of 21 Swedish counties. The objectives of this study were to assess when and where nvCT emerged in Sweden, the proportion of nvCT in each county and the role of a potential fitness difference between nvCT and co-circulating wild-type strains (wtCT).

Pitfalls of commercially available HPV tests in HPV68a detection.

Human papillomavirus 68 (HPV68) is a probable carcinogenic HPV genotype which is included in almost all HPV screening assays and exists as two genetically variable subtypes (HPV68a and HPV68b). Routine HPV sample testing has shown that the cobas 4800 HPV Test (Roche) provides higher false-negative rates for HPV68 status than PapilloCheck HPV-Screening (Greiner Bio-One). The aim of our study was to evaluate the efficacy of cobas 4800 in HPV68 detection.

Interference From High-Dose Biotin Intake in Immunoassays for Potentially Time-Critical Analytes by Roche: Evaluation of a Countermeasure for Worst-Case Scenarios.

Immunoassays using the interaction between streptavidin and biotin are used for clinical chemical analytes on platforms by many different manufacturers. The design can be susceptible to interference from high-dose biotin intake in patients, which remains an often-overlooked confounder despite recently increased awareness.

Vortioxetine use may cause false positive immunoassay results for urine methadone.

Urine immunoassays are frequently employed for methadone screening because they are relatively inexpensive and widely available. However, immunoassays are notoriously prone to false positives. We report that the use of vortioxetine (Trintellix® in the USA and Canada, Brintellix® worldwide) could cause false positives in the Roche KIMS Methadone II Urine immunoassay (MDN2).

Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma.

We sought to compare the pharmacokinetics (PKs) of DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP]) in patients with diffuse large B-cell lymphoma (DLBCL). Efficacy, pharmacodynamics (PDs), safety, and immunogenicity were also compared.

Heterophile antibody interference affecting multiple Roche immunoassays: A case study.

Analysis of many clinically important analytes is dependent on antibody-based assays. However, depending on the design, these assays are vulnerable to interference from endogenous molecules including circulating antibodies and free biotin. In this case report, we describe a patient whose laboratory findings from immunoassay based methodologies, are inconsistent with the clinical presentation.

Analytical Differences in Intraoperative Parathyroid Hormone Assays.

We compared the rates of intraoperative parathyroid hormone (PTH) decline using the Siemens Immulite Turbo PTH and Roche Elecsys short turnaround time PTH assays in 95 consecutive surgical patients to investigate analytical and turnaround time (TAT) differences between the tests performed in the operating room (OR) vs the central clinical chemistry laboratory (CCL).

A Randomized, Single-dose, Two-sequence, Two-period, Crossover Study to assess the Bioequivalence between Two Formulations of Clonazepam Tablet in Healthy Subjects.

Clonazepam is a benzodiazepine commonly prescribed to treat panic disorder, epilepsy, anxiety, depression and certain types of seizures. This study aimed to evaluate the bioequivalence between two formulations of clonazepam tablets in order to meet regulatory requirements for marketing in Colombia and others countries in Latin America. An open-label, randomized, single-dose, two-period, two-sequence, two-treatment crossover study was conducted in 36 healthy subjects of both genders. Subjects received a sing...

Genotyping Neisseria gonorrhoeae gyrA and penA antimicrobial genes from remnant Neisseria gonorrhoeae positive Cepheid Xpert® clinical specimens - A feasibility study.

Neisseria gonorrhoeae (NG) has developed resistance to most antibiotics, making it increasingly difficult to treat. Previous studies have predicted antimicrobial NG susceptibility based on the antimicrobial gene target DNA gyrase subunit A (gyrA) codon serine 91 and the penicillin-binding protein 2 (penA) using Roche Cobas® and Hologic APTIMA™ clinical specimens. We studied whether similar methods could be used on remnant NG-positive Cepheid Xpert® specimens.

The effect of Benznidazole dose among the efficacy outcome in the murine animal model. A quantitative integration of the literature.

Despite more than 100 years since it was firstly described Chagas disease, only two drugs are available to treat Chagas disease: Nifurtimox launched by Bayer in 1965 and benznidazole launched by Roche in 1971. Drug discovery initiatives have been looking for new compounds as an alternative to these old drugs. Although new platforms have been used with the latest technologies, a critical step on that process still relies on the in vivo model. Unfortunately, to date, available animal models have limited predi...


Pemphigus is a chronic autoimmune bullous disease. To date there is no curative treatment for the disease. The standard treatment has been based on systemic corticosteroids and immune-suppressants. Rituximab is a monoclonal antibody against CD20 cells which leads to B cell depletion, resulting in decreased antibody production. In recent years increasing evidence on promising efficacy and safety of rituximab in the treatment of pemphigus has emerged. This review presents the key publications and the Israeli ...

Clinical evaluation of capillary B-type natriuretic peptide testing.

Background Capillary B-type natriuretic peptide (BNP) testing is attractive in outpatient and emergency settings. The aim of this study was to perform an evaluation of the clinical performances of capillary BNP testing as compared with venous whole blood and plasma point-of-care (POC) BNP as well as plasma N-terminal (NT) proBNP central laboratory testing. Methods BNP was measured with a novel single epitope POC assay (Minicare® BV, Eindhoven, The Netherlands) and NT-proBNP with a central laboratory assay ...

Actions of Trace Amines in the Brain-Gut-Microbiome Axis via Trace Amine-Associated Receptor-1 (TAAR1).

Trace amines and their primary receptor, Trace Amine-Associated Receptor-1 (TAAR1) are widely studied for their involvement in the pathogenesis of neuropsychiatric disorders despite being found in the gastrointestinal tract at physiological levels. With the emergence of the "brain-gut-microbiome axis," we take the opportunity to review what is known about trace amines in the brain, the defined sources of trace amines in the gut, and emerging understandings on the levels of trace amines in various gastrointe...

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