SummaryThis guideline provides a framework for the arrangement of point-of-care testing (POCT) services, previously known as near patient testing (patient self-testing not covered). POCT is defined as any analytical test performed outside the laboratory. Primary users are often non-laboratory healthcare workers. The guidance applies to units within hospitals as well as general practioner surgeries, community clinics and pharmacies. The head of the haematology laboratory or a point of care coordinator must take responsibility for all aspects of the POCT service, including quality and training. Depending on the size and nature of the POCT practice, a local POCT manager may also be required. Equipment selected should have received a successful independent performance evaluation. If an independent evaluation has not been performed the purchaser should assess the device according to the protocol in this document. POCT devices should generate results that are comparable to those of the local laboratory. An accredited external quality assessment programme and internal quality control system must be established. Manufacturers promoting POCT devices designed for non-laboratory sites, e.g. pharmacies, should undertake training and annual competency assessment, perhaps using a web-based system. A diagram to illustrate the stages for the implementation of a POCT service is illustrated.Keywords: point-of-care testing, point-of-care committee, accreditation, external quality assurance, instrument evaluation.The purpose of these guidelines is to provide a framework for the provision of appropriate local arrangements for pointof-care testing (POCT) and to protect patients and staff. The guideline provides information and suggestions for good laboratory practice and for producing reliable results, regardless of where the test is performed. POCT may be defined as any analytical test performed for a patient by a healthcare worker outside the laboratory setting. This document is an update to the British Committee for Standards in Haematology (BCSH) guideline for Near Patient Testing: haematology (England et al, 1995) and embodies the philosophy agreed by the Joint Working Group (JWG) (1999) on Quality Assurance, the national standards required for clinical pathology accreditation (Clinical Pathology Accreditation (CPA) (UK) Ltd, 2007, revised Burnett et al, 2002 and the International Standards Organisation (ISO) POCT requirements for quality and competence (International Standard organisation, ISO, 2004a). There have been several evaluations carried out on the views of general practioners (GPs) to POCT and quality control procedures (England et al, 1995;Murray & Fitzmaurice, 1998). GPs do not always find POCT a useful addition to their resources and the challenges presented by community environments may mean that it is more difficult to adequately address all quality control issues (Department of Health, 1987;Hilton et al, 1994). Other important factors for consideration are the efficacy of the procedures being undertaken, medicol...
Objective. To investigate the contributions of the major histocompatibility complex (MHC) and C4 alleles to systemic sclerosis (SSc), and to pulmonary fibrosis and autoantibody expression in SSc, by analysis at the DNA level.Methods. One hundred fifteen patients with SSc were tested serologically for alleles of the class I MHC loci, and were tested for class I1 alleles (DRB, DQA, and DPB) by a combination of restriction fragment length polymorphism (RFLP) analysis and oligonucleotide probes with polymerase chain reaction amplification. C4 was studied by protein phenotyping and RFLP analysis in 80 patients. Correlations were made between disease status, pulmonary fibrosis, and expression of anticentromere antibodies (ACA) and antScl-70.Results. The C4A-null phenotype was found to provide the strongest disease association factor of the Conclusion. Of all the potential markers of disease susceptibility analyzed, the C4A locus was the strongest. C4AQO and DQAZ are independent susceptibility factors for SSc. The development of pulmonary fibrosis in SSc patients can be predicted using combined MHC and autoantibody analysis. The MHC alleles associated with the expression of disease-specific autoantibodies are not markers for disease susceptibility. Scleroderma (systemic sclerosis; SSc) and related disorders comprise a spectrum of acquired diseases characterized by fibrosis and vasculopathy . The spectrum ranges from localized scleroderma (morphea), where the emphasis is on dermal fibrotic disease, to diffuse cutaneous SSc (dcSSc) and limited cutaneous SSc (1cSSc) ( l ) , in which, to varying degrees, both the fibrotic and vascular elements are present and internal organ involvement is common.SSc is not considered to be an inherited disease, but there is a genetic association with the major histocompatibility complex (MHC) (see below). The human MHC comprises a discontinuous set of loci determining cell surface glycoproteins, which are spe-
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