Clinical/diagnostic, laboratory operation

Mobile Medical units with Clinic for First aid treatment Laboratory Diagnostic units operating theater hospital, specifications for treatment of patients affected by chemical agents (indication, decontamination). 

The design and operation of a molecular diagnostics laboratory have much in common v ith other areas of the clinical laboratories. The purpose of this chapter is to highlight specific issues that are unique to a molecular diagnostics laboratory, both in design and operation. 

Out-of-laboratory measurements are undertaken across a broad range of industrial and analytical sectors for a variety of reasons in clinical and medical diagnostics for the control of chemical and petrochemical production processes and to monitor emissions and discharges to the environment. The validity of data derived from such measurements is clearly of vital importance, for example to demonstrate compliance with environmental legislation. However, it is particularly difficult to obtain valid and reliable measurements outside the laboratory. The inability to control the environment in which the measurements are made and the use of untrained operators both have potential to impact significantly on the reliability of data. The situation is made worse because of the lack of adequate QA and QC procedures, the shortage of reference materials and calibration standards, and... 

Heterogeneous immunoassays may be used with conventional microtiter systems in clinical laboratories, but have also been adapted for doctor s office and home diagnostic test devices. For example, a device for detecting antibodies to the human immunodeficiency virus (HIV), operates as shown in Figure 6.10.19... 

Several organizations have developed and implemented quahty initiatives to ensure that clinical laboratories and manufacturers and providers of diagnostic products mcor-porate the principles of quality management and assurance in their daily operations. Examples include (1) Joint Committee for Traceability in Clinical Laboratories (http //www.bipm.fr/en/committees/jc/jctlm/), (2) International Organization for Standardization (http //www.iso.ch), and (3) National Institute of Standards and Technology (http //www,nist.gov). 

The ISO 9000 standards represent an international consensus on the essential features of a quality system to ensure the effective operation of any business, whether a manufacturer or service provider or other type of organization, whether in the public or private sector. Many major diagnostic companies have received ISO 9000 certification, and in 1996, the Excel Bestview Medical Laboratories of Mississauga, Ontario, Canada became the world s first clinical laboratory to receive ISO 9002 certification. (Note that an organization apphes for certification under the section that most closely represents its structure.) Elements of ISO 9002 certification (http //www.revereelectric.com/eleISO.html)... 

Point-of-care tests (POCT) are clinical laboratory tests performed in a self-contained analytical platform that can be operated by non-laboratory healthcare professionals. POCT allow quicker results than centralized laboratory services due to reduced assay time and because the analysis is performed at the site where the sample is drawn or clinical care must be delivered. The recent technology improvements with the possibility to achieve high detectability (down to the micro- and nanomolar levels) for a wide number of analytes allows one to envisage a new generation of diagnostic POCT devices for the detection in biological fluids (blood, serum, saliva) of a panel of biomarkers of a given disease. 

One of the major developments in analytical chemistiy during the last few decades has been the appearance of commercial automated analytical sterns, which provide analytical and control information with a minimum of operator intervention. Automated systems first appeared in clinical laboratories, where thirty or more specie,t are routinely determined for diagnostic and screening purposes. Laboratory automation soon spread to industrial process control and later to pharmaceutical, environmental, forensic, governmental, and university research laboratories. Today, many routine determinations as well as many of the most demanding analyses are made with totally or partially automated systems. 

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