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clinical chemistry assay

Leontine Mulder, Renate van der Molen, Carin Koelman, Ester van Leeuwen, Anja Roos, Jan Damoiseaux
ISO 15189:2012 requires validation of methods used in the medical laboratory, and lists a series of performance parameters for consideration to include. Although these performance parameters are feasible for clinical chemistry analytes, application in the validation of autoimmunity tests is a challenge. Lack of gold standards or reference methods in combination with the scarcity of well-defined diagnostic samples of patients with rare diseases make validation of new assays difficult. The present manuscript describes the initiative of Dutch medical immunology laboratory specialists to combine efforts and perform multi-center validation studies of new assays in the field of autoimmunity...
March 12, 2018: Autoimmunity Reviews
Irfanullah Khan, Amer Hayat Khan, Azreen Syazril Adnan, Syed Azhar Syed Sulaiman, Azhar Bin Amir Hamzah, Nafees Ahmed, Amjad Khan
PURPOSE: Creatinine is normally used to evaluate kidney function among elderly patients in clinical practice, which has been reported to be affected by socio-demographic factors like BMI and age. Cystatin C a newly introduced biomarker may be more efficient in identifying kidney function in obese and aged CKD patients. The aim of the current study was to assess the effect of BMI on endogenous biomarkers (cystatin C and creatinine) among elderly CKD patients in Malaysia, a first such study in the country...
March 13, 2018: International Urology and Nephrology
Andrea Tesija Kuna, Kristina Dukic, Nora Nikolac Gabaj, Marijana Miler, Ines Vukasovic, Sanja Langer, Ana-Maria Simundic, Nada Vrkic
Objective: To compare the analytical performances of the enzymatic method (EM) and capillary electrophoresis (CE) for hemoglobin A1c (HbA1c) measurement. Methods: Imprecision, carryover, stability, linearity, method comparison, and interferences were evaluated for HbA1c via EM (Abbott Laboratories, Inc) and CE (Sebia). Results: Both methods have shown overall within-laboratory imprecision of less than 3% for International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) units (<2% National Glycohemoglobin Standardization Program [NGSP] units)...
March 8, 2018: Laboratory Medicine
Wenshu Zheng, Huiling Li, Wenwen Chen, Jiangjiang Zhang, Nuoxin Wang, Xuefeng Guo, Xingyu Jiang
A fast (1 min), straightforward but efficient, click chemistry-based system that enables the rapid detection of free copper (Cu) ions in either biological fluids or living cells without tedious pretreatment is provided. Cu can quickly induce the conjugation between graphene oxide (GO) and a fluorescent dye via click reaction. On the basis of the high specificity of bioorthogonal reaction and the effective quenching ability of GO, the assay studied in this paper can respond to Cu ions in less than 1 min with excellent selectivity and sensitivity, which is the fastest sensor for Cu as far as it is known...
March 1, 2018: Small
Xingyu Jiang, Yunlei Xianyu, Jing Wu, Yiping Chen, Wenshu Zheng, Mengxia Xie
Multiplexed analysis of molecules with different concentrations requires assays with a tunable detection range. Herein, we outline a strategy that uses click chemistry to controllably assemble horseradish peroxidase to generate enzyme assemblies as probes for multiplexed bioassays. This controllable assembly of enzymes on detection antibodies allows for lab-on-a-chip immunoassays with a tunable detection range from pg/mL to µg/mL. Simultaneous, multiplexed bioassays of clinically relevant inflammatory biomarkers in serum are demonstrated in one lab-on-a-chip format, with a limit of detection of 0...
February 26, 2018: Angewandte Chemie
Chang-Lin Wu, Jian-An He, Da-Yong Gu, Chao-Peng Shao, Yi Zhu, Xin-Tang Dang
BACKGROUND: This study was aimed to establish a novel strategy based on the surface plasmon resonance (SPR) technology for platelet compatibility testing. METHODS: A novel surface matrix was prepared based on poly (OEGMA-co-HEMA) via surface-initiated polymerization as a biosensor surface platform. Type O universal platelets and donor platelets were immobilized on these novel matrices via amine-coupling reaction and worked as a capturing ligand for binding the platelet antibody...
January 1, 2018: Clinical Laboratory
Marie Joncquel-Chevalier Curt, Marie-Adélaïde Bout, Monique Fontaine, Isabelle Kim, Guillemette Huet, Soumeya Bekri, Gilles Morin, Stéphanie Moortgat, Alexandre Moerman, Jean-Marie Cuisset, David Cheillan, Joseph Vamecq
Creatine transporter is currently the focus of renewed interest with emerging roles in brain neurotransmission and physiology, and the bioenergetics of cancer metastases. We here report on amendments of a standard creatine uptake assay which might help clinical chemistry laboratories to extend their current range of measurements of creatine and metabolites in body fluids to functional enzyme explorations. In this respect, short incubation times and the use of a stable-isotope-labeled substrate (D3 -creatine) preceded by a creatine wash-out step from cultured fibroblast cells by removal of fetal bovine serum (rich in creatine) from the incubation medium are recommended...
February 16, 2018: Molecular Genetics and Metabolism
Hassan Noorbazargan, Seyed Alireza Nadji, Siamak Mirab Samiee, Mahdi Paryan, Samira Mohammadi-Yeganeh
Background Viral load measurement is commonly applicable to monitor HIV infection in patients to determine the number of HIV-RNA in serum samples of individuals. The aim of the present study was to set up a highly specific, sensitive, and reproducible home-brewed Real-time PCR assay based on TaqMan chemistry to quantify HIV-1 RNA genome. Methods In this study, three sets of primer pairs and a TaqMan probe were designed for HIV subtypes conserved sequences. An internal control was included in this assay to evaluate the presence of inhibition...
February 23, 2018: HIV Clinical Trials
Zilei Liu, Jie Li, Suhua Li, Gencheng Li, K Barry Sharpless, Peng Wu
Sulfur(VI) Fluoride Exchange (SuFEx) is a new family of click chemistry transformations which relies on readily available materials to produce compounds bearing the S VI -F motif. The potential of SuFEx in drug discovery has just started to be explored. We report the first method of SuFEx chemistry for the conversion of phenolic compounds to their respective arylfluorosulfate derivatives in situ in 96-well plates. This method is compatible with automated synthesis and screening to quickly assess the biological activities of the in situ generated, crude products...
February 16, 2018: Journal of the American Chemical Society
Janne Cadamuro, Martin Gaksch, Helmut Wiedemann, Giuseppe Lippi, Alexander von Meyer, Astrid Pertersmann, Simon Auer, Cornelia Mrazek, Ulrike Kipman, Thomas K Felder, Hannes Oberkofler, Elisabeth Haschke-Becher
BACKGROUND: Inappropriate utilization of laboratory resources is an increasing concern especially in high-throughput facilities. Until now, no reliable information has been published addressing to which extent laboratory results are actually used for clinical decision-making. Therefore, we aimed to close this gap using a novel retrospective approach including a survey of clinicians and nurses. METHODS: We retrospectively evaluated the number of re-orders for potassium (K), lactate dehydrogenase (LD), aspartate-aminotransferase (AST), activated partial thromboplastin-time (APTT) and prothrombin-time/INR (PT/INR), after the initial order had to be cancelled due to preanalytical non-conformities...
February 2, 2018: Clinical Biochemistry
Ru Bao Sun, Shuai Shang, Wei Zhang, Ben Cheng Lin, Qiang Wang, Yun Shi, Zhu Ge Xi
OBJECTIVE: This study aimed to evaluate the hepatotoxicity, metabolic disturbance activity and endocrine disrupting activity of mice treated by Decabromodiphenyl ethane (DBDPE). METHODS: In this study, Balb/C mice were treated orally by gavage with various doses of DBDPE. After 30 days of treatment, mice were sacrificed; blood, livers and thyroid glands were obtained, and hepatic microsomes were isolated. Biochemical parameters including 8 clinical chemistry parameters, blood glucose and hormone levels including insulin and thyroid hormone were assayed...
January 2018: Biomedical and Environmental Sciences: BES
Ernest S Fung, Kenneth M Unice, Dennis J Paustenbach, Brent L Finley, Michael Kovochich
Engineered or incidental particles may contain endotoxin from contaminated environments associated with generation, production, or handling activities. Endotoxins are ubiquitous contaminants that may yield false positive responses in immunological assays if present. The purpose of this study was to develop a sterilization method for removal of endotoxin from clinically relevant wear particles isolated from metal-on-metal (MoM) hip implant lubricant. In this case, the goal of particle sterilization was to sufficiently reduce endotoxin levels to acceptable levels for sensitive biological assays while retaining the physical and chemical characteristics of the original particles...
February 5, 2018: Scientific Reports
Nicholas K H Khoo, Lihua Li, Sonia R Salvatore, Francisco J Schopfer, Bruce A Freeman
Fatty acid nitroalkene derivatives (NO2-FA) activate Nrf2-regulated antioxidant gene expression and inhibit NF-κB-dependent cytokine expression. To better define NO2-FA structure-function relationships, a series of 22 new chemical entities (NCEs) containing an electrophilic nitroalkene functional group were synthesized and screened for both Nrf2- and NF-κB activities using luciferase-based assays. The structural variables were acyl chain length (11 to 24 carbons) and position of the electrophilic nitroalkene group...
February 2, 2018: Scientific Reports
Marianne Demarteau, Piet Cammaert, Nathalie M Vandevelde, Nico Callewaert, Wim Coucke, Bernard China, Alain G Verstraete
BACKGROUND: Harmonization of units is an important step to improve the comparability of clinical chemistry results, but few examples exist of successful harmonization efforts. We present the results of a pragmatic approach that was implemented in Belgium from 2012. METHODS: After a large consultation and information of stakeholders, preferred units were proposed for 140 assays, including the 23 immunoassays discussed in more detail here. The change occurred in two phases, first involving assays for which there was no change in the numerical result, then changes involving a change in numerical results...
January 30, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Marilyn B Nourse, Kate Engel, Samartha G Anekal, Jocelyn A Bailey, Pradeep Bhatta, Devayani P Bhave, Shekar Chandrasekaran, Yutao Chen, Steven Chow, Ushati Das, Erez Galil, Xinwei Gong, Steven F Gessert, Kevin D Ha, Ran Hu, Laura Hyland, Arvind Jammalamadaka, Karthik Jayasurya, Timothy M Kemp, Andrew N Kim, Lucie S Lee, Yang Lily Liu, Alphonso Nguyen, Jared O'Leary, Chinmay H Pangarkar, Paul J Patel, Ken Quon, Pradeep L Ramachandran, Amy R Rappaport, Joy Roy, Jerald F Sapida, Nikolay V Sergeev, Chandan Shee, Renuka Shenoy, Sharada Sivaraman, Bernardo Sosa-Padilla, Lorraine Tran, Amanda Trent, Thomas C Waggoner, Dariusz Wodziak, Amy Yuan, Peter Zhao, Daniel L Young, Channing R Robertson, Elizabeth A Holmes
The ability to perform laboratory testing near the patient and with smaller blood volumes would benefit patients and physicians alike. We describe our design of a miniaturized clinical laboratory system with three components: a hardware platform (ie, the miniLab) that performs preanalytical and analytical processing steps using miniaturized sample manipulation and detection modules, an assay-configurable cartridge that provides consumable materials and assay reagents, and a server that communicates bidirectionally with the miniLab to manage assay-specific protocols and analyze, store, and report results (i...
January 2018: Bioengineering & Translational Medicine
Christof Bernemann, Julie Steinestel, Verena Humberg, Martin Bögemann, Andres Jan Schrader, Jochen K Lennerz
OBJECTIVES: To compare the performance of two established androgen receptor splice variant 7 (AR-V7) mRNA detection systems, as paradoxical responses to next-generation androgen-deprivation therapy in AR-V7 mRNA-positive circulating tumour cells (CTC) of patients with castration-resistant prostate cancer (CRPC) could be related to false-positive classification using detection systems with different sensitivities. MATERIALS AND METHODS: We compared the performance of two established mRNA-based AR-V7 detection technologies using either SYBR Green or TaqMan chemistries...
January 23, 2018: BJU International
Frank Lovering, Paul Morgan, Christophe Allais, Ann Aulabaugh, Joanne Brodfuehrer, Jeanne Chang, Jotham Coe, WeiDong Ding, Heather Dowty, Margaret Fleming, Richard Frisbie, Julia Guzova, David Hepworth, Jayasankar Jasti, Steve Kortum, Ravi Kurumbail, Shashi Mohan, Nikolaos Papaioannou, Joseph W Strohbach, Fabien Vincent, Katherine Lee, Christoph W Zapf
Many diseases are believed to be driven by pathological levels of reactive oxygen species (ROS) and oxidative stress has long been recognized as a driver for inflammatory disorders. Apoptosis signal-regulating kinase 1 (ASK1) has been reported to be activated by intracellular ROS and its inhibition leads to a down regulation of p38-and JNK-dependent signaling. Consequently, ASK1 inhibitors may have the potential to treat clinically important inflammatory pathologies including renal, pulmonary and liver diseases...
December 15, 2017: European Journal of Medicinal Chemistry
Sei Harada, Akiyoshi Hirayama, Queenie Chan, Ayako Kurihara, Kota Fukai, Miho Iida, Suzuka Kato, Daisuke Sugiyama, Kazuyo Kuwabara, Ayano Takeuchi, Miki Akiyama, Tomonori Okamura, Timothy M D Ebbels, Paul Elliott, Masaru Tomita, Asako Sato, Chizuru Suzuki, Masahiro Sugimoto, Tomoyoshi Soga, Toru Takebayashi
BACKGROUND: Cohort studies with metabolomics data are becoming more widespread, however, large-scale studies involving 10,000s of participants are still limited, especially in Asian populations. Therefore, we started the Tsuruoka Metabolomics Cohort Study enrolling 11,002 community-dwelling adults in Japan, and using capillary electrophoresis-mass spectrometry (CE-MS) and liquid chromatography-mass spectrometry. The CE-MS method is highly amenable to absolute quantification of polar metabolites, however, its reliability for large-scale measurement is unclear...
2018: PloS One
Alan H B Wu, Robert H Christenson, Dina N Greene, Allan S Jaffe, Peter A Kavsak, Jordi Ordonez-Llanos, Fred S Apple
This document is an essential companion to the third iteration of the National Academy of Clinical Biochemistry [NACB,8 now the American Association for Clinical Chemistry (AACC) Academy] Laboratory Medicine Practice Guidelines (LMPG) on cardiac markers. The expert consensus recommendations were drafted in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on Clinical Applications of Bio-Markers (IFCC TF-CB). We determined that there is sufficient clinical guidance on the use of cardiac troponin (cTn) testing from clinical practice groups...
January 17, 2018: Clinical Chemistry
John Randolph, A Chris Krueger, Pamela Donner, John K Pratt, Dachun Liu, Christopher E Motter, Todd W Rockway, Mike D Tufano, Rolf Wagner, Hock B Lim, Jill M Beyer, Rubina Mondal, Neeta S Panchal, Lynn Colletti, Yaya Liu, Gennadiy Koev, Warren M Kati, Lisa E Hernandez, David W A Beno, Kenton L Longenecker, Kent D Stewart, Emily O Dumas, Akhteruzzaman Molla, Clarence Maring
ABT-072 is a non-nucleoside HCV NS5B polymerase inhibitor that was discovered as part of a program to identify new direct-acting antivirals (DAAs) for the treatment of HCV infection. This compound was identified during a medicinal chemistry effort to improve on an original lead, inhibitor 1, which we described in a previous publication. Replacement of the amide linkage in 1 with a trans-olefin resulted in improved compound permeability and solubility, and provided much better pharmacokinetic properties in preclinical species...
January 17, 2018: Journal of Medicinal Chemistry
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