ICSH guidance for INR and D-dimer testing using point of care testing in primary care.

This guideline has been written on behalf of the International Council for Standardisation in Haematology (ICSH) and focuses on two point of care haematology tests used within primary care, namely International Normalised Ratio (INR) and D-dimer. Primary care covers out of hospital settings and can include General Practice (GP), Pharmacy and other non-hospital settings (although these guidelines would also be applicable to hospital out-patient settings). The recommendations are based on published data in peer reviewed literature and expert opinion; they should supplement regional requirements, regulations or standards.

Guidelines for the laboratory investigation of heritable disorders of platelet function.

The guideline writing group was selected to be representative of UK-based medical experts. MEDLINE was systematically searched for publications in English up to the Summer of 2010 using key words platelet, platelet function testing and platelet aggregometry. Relevant references generated from initial papers and published guidelines/reviews were also examined. Meeting abstracts were not included. The writing group produced the draft guideline, which was subsequently revised and agreed by consensus. Further comment was made by members of the Haemostasis and Thrombosis Task Force of the British Committee for Standards in Haematology. The guideline was then reviewed by a sounding board of approximately 40 UK haematologists, the British Committee for Standards in Haematology (BCSH) and the British Society for Haematology Committee and comments incorporated where appropriate. Criteria used to quote levels and grades of evidence are as outlined in appendix 7 of the Procedure for Guidelines Commissioned by the BCSH [http://www.bcshguidelines.com/BCSH_PROCESS/EVIDENCE_LEVELS_AND_GRADES_OF_RECOMMENDATION/43_GRADE.html]. The objective of this guideline is to provide healthcare professionals with clear guidance on platelet function testing in patients with suspected bleeding disorders. The guidance may not be appropriate to patients receiving antiplatelet therapy and in all cases individual patient circumstances may dictate an alternative approach.

Clinical practice guidelines for the management of atypical haemolytic uraemic syndrome in the United Kingdom.

Atypical haemolytic uraemic syndrome (aHUS) is associated with a poor prognosis with regard to survival at presentation, recovery of renal function and transplantation. It is now established that aHUS is a disease of complement dysregulation with mutations in the genes encoding both complement regulators and activators, and autoantibodies against the complement regulator factor H. Identification of the underlying molecular abnormality in an individual patient can now help to guide their future management. In these guidelines we make recommendations for the investigation and management of aHUS patients both at presentation and in the long-term. We particularly address the role of renal transplantation alone and combined liver-kidney transplantation.

International Council for Standardization in Haematology (ICSH) recommendations for laboratory measurement of ADAMTS13.

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH), by the ADAMTS13 Assay Working Group, which comprises an international group of both clinical and laboratory experts. The document provides recommendations on best practice for the performance of ADAMTS13 assays in clinical laboratories. ADAMTS13 assays support the differential diagnosis of thrombotic microangiopathies and have utility in the management of thrombotic thrombocytopenic purpura (TTP). There are three types of assay: activity, antigen and autoantibody/inhibitor assays. Methods for activity assays differ in terms of sensitivity, specificity, precision and turnaround time. The most widely used assays involve VWF peptide substrates and either chromogenic ELISA or FRET techniques, although chemiluminescence assays and rapid screening tests have recently become available. Tests for autoantibodies and inhibitors allow confirmation of acquired, immune-mediated TTP, while antigen assays may be useful in congenital TTP and as prognostic markers. In this document, we have attempted to describe ADAMTS13 assays and the conditions that affect them, as well as: blood collection, sample processing, quality control, standardization and clinical utility; recognizing that laboratories in different parts of the world have varying levels of sophistication. The recommendations are based on expert opinion, published literature and good clinical laboratory practice.

Digital morphology analyzers in hematology: ICSH review and recommendations.

INTRODUCTION: Morphological assessment of the blood smear has been performed by conventional manual microscopy for many decades. Recently, rapid progress in digital imaging and information technology has led to the development of automated methods of digital morphological analysis of blood smears. METHODS: A panel of experts in laboratory hematology reviewed the literature on the use of digital imaging and other strategies for the morphological analysis of blood smears. The strengths and weaknesses of digital imaging were determined, and recommendations on improvement were proposed. RESULTS: By preclassifying cells using artificial intelligence algorithms, digital image analysis automates the blood smear review process and enables faster slide reviews. Digital image analyzers also allow remote networked laboratories to transfer images rapidly to a central laboratory for review, and facilitate a variety of essential work functions in laboratory hematology such as consultations, digital image archival, libraries, quality assurance, competency assessment, education, and training. Different instruments from several manufacturers are available, but there is a lack of standardization of staining methods, optical magnifications, color and display characteristics, hardware, software, and file formats. CONCLUSION: In order to realize the full potential of Digital Morphology Hematology Analyzers, pre-analytic, analytic, and postanalytic parameters should be standardized. Manufacturers of new instruments should focus on improving the accuracy of cell preclassifications, and the automated recognition and classification of pathological cell types. Cutoffs for grading morphological abnormalities should depend on clinical significance. With all current devices, a skilled morphologist remains essential for cell reclassification and diagnostic interpretation of the blood smear.

Hydroxyethyl starch in balanced electrolyte solution (Hextend)--pharmacokinetic and pharmacodynamic profiles in healthy volunteers.

UNLABELLED: Hextend is a new plasma volume expander containing 6% hydroxyethyl starch (HES) in a physiologically balanced medium of electrolytes, glucose, and lactate (weight average, molecular weight 670 kDa, molar substitution 0.75). This open-label study was designed to investigate the pharmacokinetic and pharmacodynamic profiles of Hextend in 21 healthy volunteers. We infused Hextend 10 ml/kg IV over 20 min and determined serum concentrations of HES at selected intervals over a 7-day period. Serum concentration-time curves indicated mixed pharmacokinetic behavior reflecting a two-compartment model in most subjects. The median serum half-life over 7 days was 38.2 h. The balanced formulation of the suspension medium did not seem to affect distribution, metabolism, or excretion of Hextend when compared with similar HES. Pharmacodynamic analysis demonstrated decreases in some plasma components compatible with the infusion of that volume of fluid and the duration of plasma volume expansion. Other plasma components remained unchanged, reflecting the benefit of a balanced electrolyte solution. Hemodilution was observed for 24--48 h after short-term infusion of Hextend. Some hemostatic indices showed moderate changes, and serum amylase demonstrated a temporary increase. Our study suggested that Hextend has pharmacokinetic and pharmacodynamic profiles that are similar to those of other HES. IMPLICATIONS: Hextend is a new plasma volume expander containing 6% hydroxyethyl starch in a physiologically balanced medium. This open-label volunteer study demonstrated that it has pharmacokinetic and pharmacodynamic profiles similar to those of established HES.