One of the most crucial requirements for a Hospital based emergency service is an efficient laboratory back up. The laboratory must provide reliable, efficient, timely services to the emergency ...patient care. A major problem experienced in many hospitals, centres around, the inappropriate ordering of tests. Objective was to identify the test parameters most frequently requested during the emergency hours, to review the turnaround time (TAT) of the emergency laboratory services and to reduce the inappropriate use of laboratory services during emergency hours. A retrospective analysis of all the test requests received for the month of May-June 2013 during the emergency hours was carried out. Areas most prone to inappropriate use of the services were detected. Following intervention by discussing with the clinicians and reviewing of test which are really emergency, a prospective analysis was done for the requests received for the next six months July-December 2013. A total of 1532 (Biochemistry), 1169 (Haematology) samples were studied between May-December 2013. Following the intervention, decrease in the requests observed was 19.33% (Biochemistry) & 17.61% Haematology. Turnaround time (TAT) for all the samples was maintained as per laboratory protocol. Our findings correlate with those of other centres around the world regarding inappropriate use of emergency laboratory facilities. Periodic analysis of the requests received, which is also one of the quality indicators, should be carried out.
Various factors may affect the accuracy of haemoglobin (Hb) A1c measurements that are widely used to monitor glycaemic control in diabetic patients. Glycosylated haemoglobin levels were estimated on ...two different biochemistry analysers. The values obtained were compared statistically. This study aims at the possibility of using either analyser interchangeably. Measurements of HbA1c were carried out in blood samples from 67 patients using two different analysers SIEMENS DIMENSION EXL-LM and BECKMAN COULTER AU5800 based on the turbidometric inhibition immunoassay (TINIA). The data was statistically analysed using Linear regression, Passing Bablok Bland-Altman plot. Linear-regression analysis showed r2 as 0.9245, Passing Bablok Regression showed 95% confidence interval between 0.95 and 1.12. Bland-Altman showed bias of -0.11. There was good correlation between Blood Glycosylated Haemoglobin (HbA1C) levels obtained by two different analysers having same principle and methodology. This suggests that either of the analysers may be used for HbA1C analysis. KEYWORDS: HbA1C, Biochemistry analysers, statistical correlation
Background: This in vitro study compared physical parameters and the dissolution profile of innovator itraconazole capsule formulation, i-Tyza, and 5 other generic capsule formulations available in ...the Indian market.
Methods: The number of pellets and size distribution were determined using naked eye examination and sieving method, respectively. Dissolution profile of formulations was done at 15, 30, 45, and 60 minutes, using a United States Pharmacopeia type II Paddle apparatus in simulated gastric fluid (SGF, pH 1.2) without enzymes, acetate buffer (pH 4.5) with 0.5% sodium lauryl sulfate (SLS), and phosphate buffer (pH 6.8) with 0.5% SLS.
Results: All formulations had capsule size 0. Capsule fill weight (~335 to ~510 mg) and total pellet number (127 to 810) varied across formulation, with the innovator brand having the highest number of pellets. Innovator product and i-Tyza had similar fill weight (~460 mg). Pellet size distribution of the innovator product, brand 2, brand 3, and i-Tyza was relatively narrow. In SGF, except brand 1 (84% dissolved) and brand 5 (80% dissolved), all the formulations had near-complete (>85% drug dissolved) or complete dissolution (>90% drug dissolved) at 60 minutes. In acetate buffer, pH 4.5 with 0.5% SLS and phosphate buffer, pH 6.8 with 0.5% SLS, only the innovator product and i-Tyza demonstrated near-complete to complete dissolution at 60 minutes (96% and 90% dissolved).
Conclusions: Across all the itraconazole generic formulations evaluated, i-Tyza had comparable physical characteristics and dissolution profile to the innovator product. The in vitro dissolution profile of i-Tyza may indicate adequate in vivo performance.
Follicular Lymphoma (FL) is the most common indolent lymphoma derived from light zone germinal center B cells and characterized by a t(14;18) translocation resulting in upregulation of BCL2 in over ...80% of cases. This translocation alone is not sufficient for tumorogenesis, and must be combined with additional genetic mutations to transform B cells. FL is incurable and the disease course can be highly varied, with survival ranging from a few months to decades following diagnosis and treatment with standard chemoimmunotherapy. The heterogeneity of FL poses major challenges to identifying the association of genetic alterations and clinical outcome.
Current WHO guidelines recommend establishing grade for each FL case with grade 3 thought to be more aggressive than 1 and 2. The genetic basis and clinical implications of grade in FL are unclear. Recent sequencing studies have identified many genes found to be recurrently mutated in FL including KMT2D and CREBBP. However, the degree to which genetic alterations cooperate with each other or contribute to clinical outcome is unclear. Based on the observed mutational rates in follicular lymphoma, we estimated 900 cases were needed to comprehensively delineate the genetic alterations that underlie histologic grade and clinical outcome.
Accordingly, we enrolled a cohort of 1042 patients with newly diagnosed FL. All treated patients received rituximab-containing standard regimens. To go beyond the identification of gene-coding events, we developed a very large panel of 110 Mbp covering exonic (~40Mbp) and non-exonic regions (~70Mbp) of interest to enable a wide range of genomic analysis including mutation calling in both coding and non-coding regions, rearrangement detection, viral identification, and copy number analysis. In addition to the whole exome, we extended coverage to include introns, promoters, and untranslated regions of all known driver genes in cancer. We included the entirety of the immunoglobulin loci, T-cell receptor loci and CD3 loci to detect clonotypes and rearrangements. We also included lymphoma-relevant long non-coding RNAs, microRNAs, enhancers, and breakpoint-prone regions. For viral detection, we targeted the genomes of eight cancer-related viruses: Epstein-Barr virus, human papillomavirus, human immunodeficiency virus, hepatitis B, hepatitis C, Kaposi's sarcoma-associated herpesvirus, human T-lymphotropic virus, and Merkel cell polyomavirus. In addition, to enable high resolution identification of copy number variation (CNV) calls, the entire genome was tiled with probes spaced 10kb apart.
DNA and RNA were extracted from all tumors and their paired normal samples, prepared into DNA and RNA sequencing libraries and subjected to sequencing on the Illumina platform to a targeted coverage of 150X. Somatic events were identified and further filtered to identify driver events in both coding and non-coding regions.
FLs demonstrated a significant degree of genetic heterogeneity with over 100 genes mutated with a frequency of at least 2%. Nearly 100% of FL cases had a mutation in at least one chromatin-modifying gene. The most frequently mutated genes in follicular lymphoma were KMT2D, BCL2, IGLL5 and CREBBP. In addition, we identified frequent mutations in SPEN, BIRC6 and SETD2. To our knowledge, this is the first description of alterations in these genes in FL. Transcriptome analysis indicated a strong correlation between BIRC6 mutations and the previously described immune response 2 signature that is associated with a poor prognosis. We further performed unbiased clustering of genetic alterations in these FL cases. We identified a cluster that was specifically enriched in BCL6 and TP53 alterations and was strongly associated with grade 3 FLs which are predicted to have poorer outcomes with low intensity therapies. We further examined the genetic profiles of 1001 DLBCLs in comparison to this cohort of FLs. Our data indicate a continuum of highly overlapping genetic alterations with DLBCL displaying more complex patterns that included alterations in MYC, TP53 and CDKN2A (mainly copy number losses), indicating shared pathogenetic mechanisms underlying FL and DLBCL, particularly those germinal center B cell origin.
Koff:Burroughs Wellcome Fund: Research Funding; V Foundation: Research Funding; Lymphoma Research Foundation: Research Funding; American Association for Cancer Research: Research Funding. Leppä:Roche: Honoraria, Research Funding; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bayer: Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen-Cilag: Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees. Gang:ROCHE: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Hsi:Abbvie: Research Funding; Eli Lilly: Research Funding; Cleveland Clinic&Abbvie Biotherapeutics Inc: Patents & Royalties: US8,603,477 B2; Jazz: Consultancy. Flowers:AbbVie: Consultancy, Research Funding; Denovo Biopharma: Consultancy; BeiGene: Consultancy, Research Funding; Burroughs Wellcome Fund: Research Funding; Eastern Cooperative Oncology Group: Research Funding; National Cancer Institute: Research Funding; V Foundation: Research Funding; Optimum Rx: Consultancy; Millenium/Takeda: Research Funding; TG Therapeutics: Research Funding; Gilead: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Karyopharm: Consultancy; AstraZeneca: Consultancy; Pharmacyclics/Janssen: Consultancy, Research Funding; Spectrum: Consultancy; Bayer: Consultancy; Acerta: Research Funding; Genentech, Inc./F. Hoffmann-La Roche Ltd: Consultancy, Research Funding. Neff:Enzyvant: Consultancy; EUSA Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees. Fedoriw:Alexion Pharmaceuticals: Other: Consultant and Speaker. Reddy:Genentech: Research Funding; BMS: Consultancy, Research Funding; Celgene: Consultancy; KITE Pharma: Consultancy; Abbvie: Consultancy. Mason:Sysmex: Honoraria. Behdad:Loxo-Bayer: Membership on an entity's Board of Directors or advisory committees; Thermo Fisher: Membership on an entity's Board of Directors or advisory committees; Pfizer: Other: Speaker. Burton:Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel; Celgene: Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees. Dave:Data Driven Bioscience: Equity Ownership.
Heterogenous megaspores recovered from the Upper Permian sediments of Kuraloi Area, Ib-River coalfield, have been systematically described. The megaspore assemblage includes seven genera with ...seventeen species viz.
Bokarosporites rotundus, Banksisporites indicus, B. utkalensis, Biharisporites spinosus, Biharisporites
sp.A,
Biharisporites
sp.B,
Jhariatriletes baculosus, J. srivastavae, J. damudicus, Manumisporites distinctus, Singhisporites baculatus, S. radialis, S. surangei, Ramispinatispora indica, R. nautiyalii
and
Ramispinatispora
sp. Additionally, a new species of
Ramispinatispora viz. R.mahanadiensis
has been identified. Associated spore pollen assemblages are suggestive of a Late Permian age corresponding to Raniganj/Kamthi Formation. Raniganj megaspores are known from Damodar and Godavari Basins. The newly recorded megaspore assemblage from the Ib-River coalfield is comparable to that of Raniganj/Kamthi Formation of Godavari Graben. The diversity in exosporium ornamentations indicates structural diversity. Moreover, their prolific presence ultimately points towards occurrence of heterosporous source vegetation in the area.
Abstract
While the
90
Sr/
90
Y generator is the exclusive source of obtaining `no carrier added'
90
Y for
targeted therapy, the presence of trace metals in the radiolabeling solutions poses a serious ...challenge owing to their ability to
diminish the
90
Y complexation yields with bifunctional chelators (BFCs). p-SCN-Bn-PCTA is a novel ligand having faster
complexation kinetics with a number of radiometals. In this work, a systematic investigation was performed to evaluate the chelating
ability of p-SCN-Bn-PCTA for
90
Y and the influence of trace metal ions on it's complexation with
90
Y in
comparison to p-SCN-Bn-DTPA and p-SCN-Bn-DOTA using
90
YCl
3
obtained from an electrochemical generator. Results from our
study indicate that while p-SCN-Bn-PCTA gave very good radiolabeling yields with
90
Y when the reaction was carried out by
heating for few minutes, it was most sensitive to the presence of trace metals, especially Fe(III). An independent and useful
observation is that p-SCN-Bn-PCTA could be considered as the ligand of choice for assessing the chemical purity of generator derived
90
Y.
While the
Sr/
Y generator is the exclusive source of obtaining `no carrier added'
Y for
targeted therapy, the presence of trace metals in the radiolabeling solutions poses a serious challenge owing ...to their ability to
diminish the
Y complexation yields with bifunctional chelators (BFCs). p-SCN-Bn-PCTA is a novel ligand having faster
complexation kinetics with a number of radiometals. In this work, a systematic investigation was performed to evaluate the chelating
ability of p-SCN-Bn-PCTA for
Y and the influence of trace metal ions on it's complexation with
Y in
comparison to p-SCN-Bn-DTPA and p-SCN-Bn-DOTA using
YCl
obtained from an electrochemical generator. Results from our
study indicate that while p-SCN-Bn-PCTA gave very good radiolabeling yields with
Y when the reaction was carried out by
heating for few minutes, it was most sensitive to the presence of trace metals, especially Fe(III). An independent and useful
observation is that p-SCN-Bn-PCTA could be considered as the ligand of choice for assessing the chemical purity of generator derived
Y.
Introduction: Quality indicators are measurable, objective, quantitative measures of key system performance. They can indicate the quality of the key, strategic and support processes. It is important ...that quality indicators address all three key processes in the laboratory: preanalytical, analytical and postanalytical. Aims and Objectives: To capture information about quality indicators in the biochemistry laboratory and to evaluate laboratory quality performance over time as a strategy for continuous quality improvement effort. Materials and Methods: A retrospective analysis of the following quality indicators for the period of March 2015-March 2016 was carried out: a) Sample Rejection, b) Equipment Breakdown, c) Critical Alerts Reporting, d) Turn around Time (TAT), e) External Quality Assurance Scheme (EQAS) and f) Internal Quality Assurance Scheme (IQAS). Results: A total of 36861 biochemistry samples were received. Thirty samples were rejected based on rejection criteria viz. haemolysis, sample mismatch, unlabeled etc. Equipment breakdown occurred 39 times, 99.9% critical alerts were informed immediately telephonically; in addition system generated short message service (sms) was sent to patients. Two percent of the reports were reported beyond the given TAT.EQAS results from 12 challenges which included 252 parameters, showed 10 outliers, for which necessary corrective actions were taken. Internal quality control was performed routinely, which were within the laboratory defined ranges. Conclusion: Use of quality indicators to assess and monitor the quality system of the laboratory services is an valuable tool in keeping the total testing process under control in a systematic and transparent way.