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Practical Laboratory Medicine

Mayu Onozato, Yuriko Tanaka, Michitsune Arita, Tatsuya Sakamoto, Hideaki Ichiba, Kiyomi Sadamoto, Motonari Kondo, Takeshi Fukushima
Objectives: Amino acid levels in serum or plasma are used for early detection and diagnosis of several diseases. The objective of this study was to analyze amino acid levels in serum exosomes, which have not been previously reported. Design and methods: We investigated the amino acid composition of exosomes from human serum using HPLC with fluorescence detection. Results: The composition ratios of His, Arg, Glu, Cys-Cys, Lys, and Tyr were significantly increased in the exosomes compared with those in the corresponding native serum...
November 2018: Practical Laboratory Medicine
Sheng Feng, Oneka Cummings, Gregory McIntire
Scheidweiler and colleagues have clinically tested and identified a reporting cutoff (10 ng/mL) of nicotine and cotinine in oral fluid that could reliably determine active smoking in patients. The results from that study were reevaluated using a large data set of oral fluid nicotine and cotinine results available from pain medication monitoring. Additionally, test results from patients using a nicotine transdermal patch delivery device are compared with those from smokers. Finally, oral fluid test results collected over a 2-year period were normalized and transformed to yield a near Gaussian distribution for nicotine...
November 2018: Practical Laboratory Medicine
Yuji Mano
Cross validation studies for bioanalytical methods are important to ensure that assay data from all study sites where sample analysis is performed can be compared throughout clinical trials. To support global clinical studies of lenvatinib, a novel multi-targeted tyrosine kinase inhibitor, seven bioanalytical methods by liquid chromatography with tandem mass spectrometry (LC-MS/MS) were developed at five laboratories. In this study, methods were initially validated at each laboratory according to bioanalytical guidelines...
November 2018: Practical Laboratory Medicine
Talita T Rocchetti, Suzane Silbert, Alicia Gostnell, Carly Kubasek, Robert Jerris, Jennifer Vong, Raymond Widen
The aim of this study was to develop a multiplex PCR test to detect Achromobacter xylosoxidans (AX), Burkholderia cepacia (BC), Pseudomonas aeruginosa (PSA) and Stenotrophomonas maltophilia (SM) directly from CF patient's respiratory samples using the open mode of the BD MAX™ System. A total of 402 CF respiratory samples were evaluated by culture and PCR. Specific sets of primers and probes for each target were designed in-house. Out of 402 samples tested, 196 were identified as negative and 206 as positive by culture for AX, PSA, BC and SM...
November 2018: Practical Laboratory Medicine
Rie Saito, Hisayuki Yokoyama, Kuniaki Meguro, Yusuke Ohba, Yoshihiko Izumi, Shinichiro Takahashi
A 38-year-old woman was suffering from back, right arm, and ankle joint pain, and visited our emergency department. Upon admission, the white blood cell (WBC) count was high (11,700/µL), and low numbers of red blood cells (2.21 × 106 /µL) and platelets (PLTs) (42,000/µL) were observed. A PLT histogram showed an abnormally shaped peak at around 20-30 fL, suggesting the presence of giant PLTs or PLT aggregation. The WBC histogram showed abnormal elevation at 35 fL and around 100 fL, suggesting abnormal cells including nucleated red blood cells...
November 2018: Practical Laboratory Medicine
Jeffrey Petersen, Darshana Jhala
Anti-A1 antibodies can be found as a usually clinically insignificant naturally occurring cold IgM antibody in A-subgroup patients. It is known from multiple prior case reports that warm-reactive anti-A1 that reacts at 37 °C can be clinically significant, and it has been previously reported that it could form after alloimmunization with donor A1 red blood cell (RBC) transfusion. In addition, the development of anti-A1 , often as an autoantibody, have been described in the setting of various malignancies, perhaps due to expressed subtle alterations of the ABO antigens provoking an immune response...
November 2018: Practical Laboratory Medicine
Aly Bernard Khalil, Bashir Taha Salih, Onismos Chinengo, Ma Remy D Bardies, Andrew Turner, Laila O Abdel Wareth
Background: The American Thyroid Association (ATA) recommended the establishment of population specific reference ranges for thyroid hormones during pregnancy. Initial studies conducted in the United Arab Emirates (UAE) in 2003 and 2004 on pregnant women published a considerably higher upper limit for thyroid stimulating hormone (TSH) than that proposed by ATA. The UAE was classified as a country with mild iodine deficiency at the time of this initial study. After the implementation of aggressive strategies to address iodine deficiency over the last decade, the UAE was recently declared as iodine sufficient...
November 2018: Practical Laboratory Medicine
Camille Chenevier-Gobeaux, Louis Deweerdt, Anne-Valérie Cantero, Bertrand Renaud, Bruno Desmaizières, Sandrine Charpentier, Aline Leroy, Emmanuelle Adelaïde, Delphine Collin-Chavagnac, Eric Bonnefoy-Cudraz, Laurence Estepa, Akli Chekroune, Sylvie Basco, Stéphane Andrieu, Stéphane Bourgeois, Marie-Agnès Costa, Christine Vallejo, Tiphaine Robert, Siham Ouahabi, Bruno Baudin, Benedicte Beneteau-Burnat, Anne-Marie Gorce-Dupuy, Patrick Ray, Claire Gast, Monique Dehoux, Guillaume Lefèvre
Objectives: We aimed to compare the use of nine different cardiac troponin (cTn) assays (2 cTnT and 7 cTnI) for the diagnosis of NSTEMI in a single multi-centre population. Design and methods: One hundred and fifty-eight patients were included (mean age 60 years, SD 17 years), including 23 patients (14%) with NSTEMI. Results: The analytical comparison highlighted a large heterogeneity of cTn assays, as reflected by percentages of patients with detectable cTn, correlation coefficients, Passing-Bablok comparisons and concordance coefficients...
July 2018: Practical Laboratory Medicine
Shiro Mawatari, Seira Hazeyama, Tomomi Morisaki, Takehiko Fujino
Objectives: Ethanolamine ether phospholipids (ePE) and choline ether phospholipid (ePC) are present in human serum or plasma. Decreases in ether phospholipids (plasmalogens) in serum (plasma) have been reported in several diseases such as Alzheimer's disease, Parkinson's disease, metabolic syndrome, schizophrenia. Therefore, need for assay of ether phospholipids in plasma may increase in the future. Nowadays, measurement of the ether phospholipids in human plasma seem to depend on tandem mass spectrometry (LC/MS/MS), but a system for LC/MS/MS is too expensive for most of ordinary clinical laboratories, moreover, use and maintenance of the system are time consuming...
March 2018: Practical Laboratory Medicine
Charlotte Oris, Yoan Clavel, Matthieu Jabaudon, Annick Pialat, Hadj Abdelkader Mohamed, Frédérique Lioret, Vincent Sapin, Damien Bouvier
Background: Blood gas analyzers are o0.ften integrated into point-of-care testing provisions. International standards (ISO 22870 and 15189) as adapted to French COFRAC regulations make accreditation of point-ofta-care testintag obligatory. We installed and assessed 12 GEM PREMIER 4000 analyzers for pH, p CO2 , p O2 , Na+ , K+ , Cl- , Ca2+ , lactate, hemoglobin and oxyhemoglobin (O2 Hb) at Clermont-Ferrand Hospital. These instruments were distributed across 11 care sites in the hospital...
March 2018: Practical Laboratory Medicine
Ruth Natali, Cara Wand, Kelly Doyle, Jaime H Noguez
Objectives: Blood collections from peripheral intravenous catheters offer several benefits to patients, including reduced needle punctures and patient discomfort, but they risk reducing the quality of blood specimens analyzed by the laboratory. In an effort to balance analytical quality of test results with patient-centered care initiatives, a needle-less blood collection device called PIVO™ was evaluated at two institutions. The primary objective of this study was to assess the ability of the PIVO™ device to provide high-quality blood specimens for laboratory testing compared to current blood collection methods...
March 2018: Practical Laboratory Medicine
Jayson V Pagaduan, Mahesheema Ali, Michael Dowlin, Liye Suo, Tabitha Ward, Fadel Ruiz, Sridevi Devaraj
Objectives: Recent sweat chloride guidelines published by the Cystic Fibrosis Foundation changed the intermediate sweat chloride concentration range from 40-59 mmol/L to 30-59 mmol/L for age > 6 months. We wanted to know how this new guideline would impact detection of cystic fibrosis among patients who previously had sweat tests done at Texas Children's Hospital. Methods: We revisited sweat chloride test results (n = 3012) in the last 5 years at Texas Children's Hospital based on the new guidelines on diagnosis of cystic fibrosis from the Cystic Fibrosis Foundation...
March 2018: Practical Laboratory Medicine
Susan Mohamed, Carmina Candela, Roberto Riva, Manuela Contin
We present a simple and fast high-performance liquid chromatography method with fluorescence detection for the determination of the antiepileptic drug perampanel in human plasma. The chromatographic separation was performed on a Kinetex PFP (100 × 2.6 mm, 4.6 µm) column, using a mobile phase of sodium acetate 0.03 M pH 3.7 and acetonitrile (40/60, v/v), at a flow rate of 0.8 mL/min. Total chromatography time for each run was 5 min. Sample preparation (250 µL) involved only one simple precipitation step by acetonitrile spiked with mirtazapine as internal standard...
March 2018: Practical Laboratory Medicine
Julie Hejl, Klaus Theede, Brian Møllgren, Kirsten Vikkelsø Madsen, Ashraf Heidari, Anna Á Steig, Mogens Fenger
Objectives: Fecal calprotectin (FC) is widely used to monitor the activity of inflammatory bowel disease (IBD) and to tailor medical treatment to disease activity. Laboratory testing of fecal samples may have a turnaround time of 1-2 weeks, whereas FC home testing allows results within hours and thus enables a rapid response to clinical deterioration. Design and methods: Fifty-five stool samples were analyzed by the IB Doc ® Calprotectin Home Testing kit and the BÜHLMANN fCAL® turbo assay on a Roche Cobas 6000 c501...
March 2018: Practical Laboratory Medicine
G Forzy, L Peyrodie, S Boudet, Z Wang, A Vinclair, V Chieux
Background: IgG concentrations in cerebrospinal fluid generally range from 20 to 45 mg/L. In multiple sclerosis immune reactions lead to intrathecal synthesis of specific IgGs that can be detected in biological fluid samples both quantitatively and qualitatively by isoelectric focusing of supplementary oligoclonal IgG bands. Method: A simple tool, using the MATLAB application, to facilitate and improve isoelectric focusing profile analysis is presented and evaluated in terms of its sensitivity, repeatability and reproducibility...
March 2018: Practical Laboratory Medicine
Philip M Hemken, Nicolette M Jeanblanc, Tracey Rae, Susan E Brophy, Maria J Datwyler, Ying Xu, T Scott Manetz, Inna Vainshtein, Meina Liang, Xiaodong Xiao, Partha S Chowdhury, Chien-Ying Chang, Katie Streicher, Lydia Greenlees, Koustubh Ranade, Gerard J Davis
Background: Dipeptidyl peptidase-4 (DPP-4) may be a suitable biomarker to identify people with severe asthma who have greater activation of the interleukin-13 (IL-13) pathway and may therefore benefit from IL-13-targeted treatments. We report the analytical performance of an Investigational Use Only immunoassay and provide data on the biological range of DPP-4 concentrations. Methods: We assessed assay performance, utilising analyses of precision, linearity and sensitivity; interference from common endogenous assay interferents, and from asthma and anti-diabetic medications, were also assessed...
December 2017: Practical Laboratory Medicine
Krishna Sumanth Nallagangula, K N Shashidhar, V Lakshmaiah, C Muninarayana
Background: Cirrhosis of liver is a pathological condition, wherein functions of liver are impaired by chronic liver exploitations. Due to decrease in synthetic capacity, expressions of plasma proteins tend to decrease in blood stream. Serpins (Serine protease inhibitors) are class of plasma proteins expressed from liver with structural similarities and diverse functions. SERPINA4 (Kallistatin) is a multifunctional serpin clade A protein expressed from liver and concentration in serum is the reflection of extent of liver dysfunction...
December 2017: Practical Laboratory Medicine
Nicola S Pether, Jessica L Brothwood, Cornelis van Berkel, Elaine H Dunwoodie, Robert L Blake, Christopher P Price, Richard G Jones, Karl S Baker, Geoff Hall
Objectives: Use of point-of-care testing is increasing, however many haematology analysers can only determine granulocyte count without further differentiation into neutrophils, eosinophils and basophils. Since the diagnosis of life-threatening neutropenia in cancer patients requires a distinct neutrophil count, this study aimed to determine the comparative performance between the neutrophil and granulocyte count. Design and methods: A database of 508 646 venous full blood count results measured on a laboratory reference analyser was mined from a large oncology unit...
December 2017: Practical Laboratory Medicine
Karin Malíčková, Irena Francová, Milan Lukáš, Martin Kolář, Eva Králíková, Martin Bortlík, Dana Ďuricová, Lenka Štěpánková, Kamila Zvolská, Alexandra Pánková, Tomáš Zima
OBJECTIVES: Human zonulin is a protein that increases permeability in the epithelial layer of the small intestine by reversibly modulating the intercellular tight junctions. There is not sufficient information available about zonulin's participation in inflammatory bowel diseases (IBD). The aim of this study was therefore to investigate fecal and serum zonulin in IBD patients and its relation to the disease localization, behavior and smoking status. DESIGN AND METHODS: Forty IBD patients and forty healthy persons were examined for fecal and serum zonulin concentrations by competitive ELISA (DRG International Inc)...
December 2017: Practical Laboratory Medicine
J Schaefer, B B Burckhardt, J Tins, A Bartel, S Laeer
INTRODUCTION: Heart failure is well investigated in adults, but data in children is lacking. To overcome this shortage of reliable data, appropriate bioanalytical assays are required. OBJECTIVES: Development and validation of a bioanalytical assay for the determination of aldosterone concentrations in small sample volumes applicable to clinical studies under Good Clinical Laboratory Practice. METHODS: An immunoassay was developed based on a commercially available enzyme-linked immunosorbent assay and validated according to current bioanalytical guidelines of the EMA and FDA...
December 2017: Practical Laboratory Medicine
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