|Comprehensive Comparison of the Capacity of Functionalized Sepharose, Magnetic Core, and Polystyrene Nanoparticles to Immuno-Precipitate Procalcitonin from Human Material for the Subsequent Quantification by LC-MS/MS.
Masetto T, Matzenbach K, Reuschel T, Tölke SA, Schneider K, Esser LM, Reinhart M, Bindila L, Peter C, Grimmler M
|National external quality assessment and direct method comparison reflect crucial deviations of Procalcitonin measurements in Germany.
Masetto T, Eidizadeh A, Peter C, Grimmler M.
|Characterization of the Diagnostic Performance of a Novel COVID-19 PETIA in Comparison to Four Routine N-, S- and RBD-Antigen Based Immunoassays.
Spaeth A, Masetto T, Brehm J, Wey L, Kochem C, Brehm M, Peter C, Grimmler M.
|Letter to the Editor regarding “Development of an antibody-free ID-LC MS method for the quantification of procalcitonin in human serum at sub-microgram per liter level using a peptide-based calibration”.
Tölke SA, Masetto T, Grimmler M, Bindila L, Schneider K.
|An essential role of the autophagy activating kinase ULK1 in snRNP biogenesis.
Schmitz K, Cox J, Esser LM, Voss M, Sander K, Löffler A, Hillebrand F, Erkelenz S, Schaal H, Kähne T, Klinker S, Zhang T, Nagel-Steger L, Willbold D, Seggewiß S, Schlütermann D, Stork B, Grimmler M, Wesselborg S, Peter C.
|IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals.
Bohn MK, Lippi G, Horvath AR, Erasmus R, Grimmler M, Gramegna M, Mancini N, Mueller R, Rawlinson WD, Menezes ME, Patru MM, Rota F, Sethi S, Singh K, Yuen KY, Wang CB, Adeli K; IFCC Taskforce on COVID-19.
|Evaluation of the necessity and the feasibility of the standardization of procalcitonin measurements: Activities of IFCC WG-PCT with involvement of all stakeholders.
Huynh HH, Bœuf A, Vinh J, Delatour V; IFCC Working Group on Standardization of Procalcitonin assays (WG-PCT).
|Bioanalytical Performance of a New Particle-Enhanced Method for Measuring Procalcitonin
Dupuy AM, Bargnoux AS, Larcher R, Merindol A, Masetto T, Badiou S, Cristol JP
|IFCC Interim Guidelines on Biochemical/ Hematological Monitoring of COVID-19 Patients.
Thompson S, Bohn MK, Mancini N, Loh TP, Wang CB, Grimmler M, Yuen KY, Mueller R, Koch D, Sethi S, Rawlinson WD, Clementi M, Erasmus R, Leportier M, Kwon GC, Menezes ME, Patru MM, Gramegna M, Singh K, Najjar O, Ferrari M, Lippi G, Adeli K, Horvath AR; IFCC Taskforce on COVID-19.
|IFCC Interim Guidelines on Serological Testing of Antibodies against SARS-CoV-2.
Bohn MK, Loh TP, Wang CB, Mueller R, Koch D, Sethi S, Rawlinson WD, Clementi M, Erasmus R, Leportier M, Grimmler M, Yuen KY, Mancini N, Kwon GC, Menezes ME, Patru MM, Gramegna M, Singh K, Najjar O, Ferrari M, Horvath AR, Lippi G, Adeli K; and the IFCC Taskforce on COVID-19.
|IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection.
Bohn MK, Mancini N, Loh TP, Wang CB, Grimmler M, Gramegna M, Yuen KY, Mueller R, Koch D, Sethi S, Rawlinson WD, Clementi M, Erasmus R, Leportier M, Kwon GC, Menezes ME, Patru MM, Singh K, Ferrari M, Najjar O, Horvath AR, Adeli K, Lippi G.
|PLAC1 is essential for FGF7/FGFRIIIb-induced Akt-mediated cancer cell proliferation.
Roldán DB, Grimmler M, Hartmann C, Hubich-Rau S, Beißert T, Paret C, Cagna G, Rohde C, Wöll S, Koslowski M, Türeci Ö, Sahin U.
|Direct glucosone-based synthesis and HILIC-ESI-MS/MS characterization of N-terminal fructosylated valine and valylhistidine for validation of enzymatic HbA1c assays in the diagnosis of diabetes mellitus.
Gerke C, Buchholz M, Müller H, Meusinger R, Grimmler M, Metzmann E.
An All-Purpose Particle Enhanced Immunoturbidimetric Assay for the Comparable, Instrument-Independent Monitoring of Procalcitonin in the Management of Sepsis
Procalcitonin (PCT) revealed to be an indispensable parameter for the management of sepsis. However, recent analysis of EQA survey results suggested crucial deviations of PCT measurements in Germany and studies by the IFCC Working Group on standardization of PCT stated the need for a higher-order reference measurement procedure. Here we present the evaluation of the all-purpose particle enhanced immunoturbidimetric assay (PETIA) of DiaSys, which can be easily applied to every high-throughput clinical chemistry analyzer. The high diversity of applications and datasets match current diagnostic and regulatory needs (IVDR). In addition, the high comparability between the seven analyzers enables the reliable and instrument-independent monitoring of PCT in the management of sepsis, thus offering a solution to the current landscape of deviating PCT measurement results.
Total bile acids 21 FS – now available for human stool samples
Total bile acids (TBA) determination in human stool plays an increasing role to diagnose bile acid malabsorption (BAM). DiaSys Total bile acids 21 FS has been developed to determine TBA in human stool specimens on DiaSys’ clinical chemistry analyzer respons®910. The DiaSys study performed clearly proves that Total bile acids 21 FS displays highly precise recovery values of clinically relevant bile acids. The assay shows a very good repeatability, good precision and good correlation in comparison against a co-evaluated competitor test.
Evaluation of a new accurate and reliable particle enhanced immunoturbidimetric assay for the detection of Procalcitonin in the management of sepsis
The Third International Consensus Definitions for Sepsis and Septic Shock redefined sepsis as the life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is considered as a major public healthcare issue affecting more than 30 million people worldwide, associated with a mortality of potentially 6 million people and accounts for almost $24 billion in health care expenditures only in the US, annually. As the quick and accurate sepsis management reduces a possible negative clinical course and the economic burden, a multiplicity of plasma biomarker have been developed to overcome the long turn-around time of the blood culture. [...]
New DiaSys Enzymatic Method for Determination of Total Bile Acids in Serum on BioMajesty® JCA-BM6010/C Clinical Chemistry Analyzer
Total bile acid ( content is a sensitive marker of liver function for diagnosis and monitoring of various liver diseases 1 Increased TBA levels are associated with acute and chronic hepatitis, intrahepatic cholestasis of pregnancy (ICP 2 liver sclerosis, cirrhosis and cancer Commercially available assays show limitations regarding the detection of clinically relevant primary and secondary bile acids DiaSys introduces a new liquid stable, ready to use reagent for assessment of all relevant bile acids in a sample offering the possibility to precisely cover all stages of liver diseases.
A New Direct Enzymatic Assay for Determination of β-Hydroxybutyrate on Clinical Chemistry Analyzer Platforms
Determination of β-hydroxybutyrate [HBUT] in serum or plasma can be used for the diagnosis and prognosis of diabetic ketoacidosis, alcoholic ketoacidosis and hypoglycemia. Recently the determination of β-hydroxybutyrate is also used in neurodegenerative diseases, inhibition of adipocyte lipolysis or tumor progression. Identification of ketones [β-hydroxybutyrate (78%), acetone (2%) and acetoacetat (20%)] in serum is exempt from FDA 510(k) premarket notification procedures. The objective of this study was to evaluate CLSI performance of DiaSys β-Hydroxybutyrate 21 FS reagent on Architect c8000TM clinical chemistry analyzer.
Urinary Cystatin-C: A new automated particle-enhanced immune turbidimetric test for the routine evaluation of kidney tubular function
In an independent study, researchers from the University of Pécs, Hungary, adapted DiaSys’ Cystatin C FS to detect the concentration of this analyte in urine. The urinary cystatin C levels sensitively reflect the tubular damage in acute kidney injury. The results, indicating the great quality and flexibility of Cystatin C FS, were presented in a poster at the EuroMedLab 2017 in Athens.
A New Enzymatic Cycling Method for Determination of Total Bile Acids in Serum
DiaSys Bile Acids 21 FS is a new enzymatic assay for the sensitive diagnosis and prognosis of various liver diseases. Initial data, summarized in the poster, show excellent performance. The poster attracted many participants of the EuroMedLab 2017 in Athens. Bile Acids 21 FS…Coming soon.
A new high sensitive and specific kinetic assay for the determination of ß-Hydroxybutyrate on clinical chemistry analyzers
DiaSys ß-Hydroxybutyrate 21 FS is a new improved assay for the determination of ß-hydroxybutyrate. The main performance data of the new assay are summarized in this poster. The poster was presented during the Asia–Pacific Federation for Clinical Biochemistry and Laboratory Medicine Congress (APFCB) in Taiwan in 2016.
Evaluation of an Advanced Cystatin C Assay on DiaSys Automated Analyzer respons®920
Cystatin C is an endogenously expressed, non-glycosylated protein that represents an excellent biomarker for moderate impairment of kidney function. Increased Cystatin C levels indicate an even slightly reduced glomerular filtration rate (GFR) compared to conventional parameters like Creatinine.
Cholesterol efflux to high density lipoproteins (HDL) in plasma does not reflect cardiovascular risk
A study at the University of Münster included DiaSys Lp-PLA2 FS test as an independent coronary risk marker. Data indicate that determination of Lp-PLA2 in patients with moderate or high cardiovascular might improve cardiovascular risk prediction. The poster was presented during EuroMedLab 2015 which just took place in Paris.
An enzymatic Lp-PLA2 assay for fully automated analysis: A valuable supplementation to currently used cardiovascular risk assessment
Lipoprotein-associated phospholipase A2 (Lp-PLA2 ) is a Ca2+ -independent serine lipase. The enzyme is produced by macrophages and is mainly expressed in atherosclerotic lesions. Lp-PLA2 is primarily associated with low-density lipoprotein (LDL) and responsible for the hydrolysis of oxidized phospholipids, resulting in the production of pro-inflammatory and proatherogenic mediators. Lp-PLA2 is a useful plasma biomarker associated with cardiovascular disease and enables a more pecise identification of vulnerable plaques.
Development of an easy-to-use C-reactive protein (CRP) point-of-care test (POCT) for analysis from easily accessible capillary whole blood samples
C-reactive protein (CRP) has been extensively studied and compared for its efficacy as a marker of inflammation and bacterial infection. In a point-of-care setting, a serial monitoring of patients' CRP values is vital to patient outcomes. The optionally battery-assisted DiaSys InnovaStar ® setup allows access to CRP values through a convenient and minimally-invasive capillary puncture even in remote settings.
New liquid stable Na+, K+ and Cl- assays for the fast and easy assessment of electrolytes on clinical chemistry analyzers
The results presented in this poster demonstrate, that the DiaSys Na+, K+ and Cl- reagent panel offers a great opportunity for small and mid-sized labs to automate routine electrolyte diagnosis. The reagents can be used manually as well as on CCAs with a comparable performance to ISE or FES.
Reagent on-board stability study on the new economic respons®910 clinical analyser
To demonstrate the long-term on-board stability a panel of 28 clinical IVD reagents was evaluated. The panel included tests sensitive to environmental factors, like atmospheric oxygene, carbon-dioxide, temperature or evaporation.
The New respons 920®System - Adaptation of a Panel of Kidney Disease Markers
Assay adaptation and performance verification of the important markers Creatinine, Cystatin C, Total Protein, Urea und Urinary Albumin on respons®920. The analytical performance of this benchtop analyzer compares well to established floor stand analyzers.