Case records of the Mas-sachusetts General Hospital. Weekly clinicopathological exercises. Laboratory reference values

Department of Pathology Clinical Hematology Laboratory, Massachusetts General Hospital, USA.
New England Journal of Medicine (Impact Factor: 55.87). 11/2004; 351(15):1548-63. DOI: 10.1056/NEJMcpc049016
Source: PubMed


The following is a table of reference values for adults for laboratory tests commonly or-dered at the Massachusetts General Hospital (MGH) and recorded in the Case Records. The table revises the most recently published data (Normal Reference Laboratory Values. N Engl J Med 1998;339:1063-72). Laboratory values are expressed in the units used at the MGH and the units of the Système International d'Unités (SI units). The table is not intended to provide a comprehensive review of reference values, since this information is widely available in standard textbooks. To avoid suggesting an endorsement of com-mercial products by the hospital or the Journal, information on specific methods and instruments is not provided. Reference values are affected by many variables, including the patient population and the laboratory methods used. The ranges used at the MGH may therefore not be appropriate for other institutions and may not be optimal in some situations.

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    • "Normal ranges modified from Kratz et al. [5]. "
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    ABSTRACT: Background: A set of standard clinical chemistry and hematology parameters are usually measured during clinical studies. The major outcome of these standard tests is to control that the drug investigated does not lead to pathophysiological changes in respective organs or blood. In some cases based on scientific rationale such tests may not be needed. In this paper we report on a standard set of clinical chemistry and hematology laboratory parameters measured before and after treatment in three different immunotherapy studies, representing different routes of administration and different formulations. Methods: Thirteen hematological laboratory parameters and eight clinical chemistry parameters were evaluated from three double-blind, placebo-controlled, randomized, multi-centre, phase III studies. The three studies include one with sublingual immunotherapy (n = 185), one subcutaneous immunotherapy trial with an aluminium hydroxide-adsorbed recombinant hypoallergenic Bet v1-FV (n = 211) and one with pre-seasonal subcutaneous immunotherapy with a 6-grass pollen allergoid (n = 154). Results: Allergen specific immunotherapy with both administration forms and formulations respectively did not show any influence on any of the 21 laboratory parameters analyzed. Few patients had a change in laboratory parameters from within normal range at baseline to either below or above at end-of-treatment. No differences between active and placebo were seen with respect to number of patients with such a change. Conclusions: This study with different preparations and routes of application indicates that the value of repeated measurements of standard clinical chemistry and hematology parameters during allergen immunotherapy should be discussed further.
    05/2014; 4:18. DOI:10.1186/2045-7022-4-18
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    • "The subjects in the current study were deemed appropriate for qualification of the biomarkers in this step, based on the similarity of the study demographics, inclusion criteria, and exclusion criteria to those of typical clinical Phase I healthy volunteer studies.21 In addition, the routine kidney biomarker values in this study were similar to the Mass General Hospital reference intervals,22 assuming a urine excretion of approximately 2 L per day. "
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    ABSTRACT: Several preclinical urinary biomarkers have been qualified and accepted by the health authorities (US Food and Drug Administration, European Medicines Agency, and Pharmaceuticals and Medical Devices Agency) for detecting drug-induced kidney injury during preclinical toxicologic testing. Validated human assays for many of these biomarkers have become commercially available, and this study was designed to characterize some of the novel clinical renal biomarkers. The objective of this study was to evaluate clinical renal biomarkers in a typical Phase I healthy volunteer population to determine confidence intervals (pilot reference intervals), intersubject and intrasubject variability, effects of food intake, effect of sex, and vendor assay comparisons. Spot urine samples from 20 male and 19 female healthy volunteers collected on multiple days were analyzed using single analyte and multiplex assays. The following analytes were measured: α-1-microglobulin, β-2-microglobulin, calbindin, clusterin, connective tissue growth factor, creatinine, cystatin C, glutathione S-transferase-α, kidney injury marker-1, microalbumin, N-acetyl-β-(D) glucosaminidase, neutrophil gelatinase-associated lipocalin, osteopontin, Tamm-Horsfall urinary glycoprotein, tissue inhibitor of metalloproteinase 1, trefoil factor 3, and vascular endothelial growth factor. Confidence intervals were determined from the single analyte and multiplex assays. Intersubject and intrasubject variability ranged from 38% to 299% and from 29% to 82% for biomarker concentration, and from 24% to 331% and from 10% to 67% for biomarker concentration normalized to creatinine, respectively. There was no major effect of food intake or sex. Single analyte and multiplex assays correlated with r (2)≥0.700 for five of six biomarkers when evaluating biomarker concentration, but for only two biomarkers when evaluating concentration normalized to creatinine. Confidence intervals as well as intersubject and intrasubject variability were determined for novel clinical renal biomarkers/assays, which should be considered for evaluation in the next steps of the qualification process.
    Drug Design, Development and Therapy 02/2014; 8:227-237. DOI:10.2147/DDDT.S54956 · 3.03 Impact Factor
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    • "It is of particular importance that these differences in reference intervals be considered by clinicians in different settings. i. Red blood cell (RBC) components African RBC component values were significantly lower when compared to reference intervals obtained from the Massachusetts General Hospital [6] from a North American population, and thus a significant proportion are misclassified when the NIH DAIDS toxicity tables are applied [9] [34] [38]. Differences observed in the RBC components between African and Caucasian populations may be attributed to lower dietary iron intake, genetic polymorphisms such as thalassemia and sickle cell trait or chronic exposure to endemic parasites including helminths, malaria and schistosomiasis. "
    Blood Cell- An overview of studies in hematology, Edited by Terry E. Moschandreou, 09/2012: chapter 15; INTECH., ISBN: 978-953-51-0753-8
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