Areas Of Laboratory Medicine Research Articles

Clinical Chemistry through Clinical Chemistry: A Journal Timeline

The establishment of the modern discipline of clinical chemistry was concurrent with the foundation of the journal Clinical Chemistry and that of the American Association for Clinical Chemistry in the late 1940s and early 1950s. To mark the 50th volume of this Journal, I chronicle and highlight scientific milestones, and those within the discipline, as documented in the pages of Clinical Chemistry. Amazing progress has been made in the field of laboratory diagnostics over these five decades, in many cases paralleling—as well as being bolstered by—the rapid pace in the development of computer technologies. Specific areas of laboratory medicine particularly well represented in Clinical Chemistry include lipids, endocrinology, protein markers, quality of laboratory measurements, molecular diagnostics, and general advances in methodology and instrumentation.

Anti-HIV quality assurance programs in Australia and the southeast Asian and Western Pacific regions

Anti-HIV testing is the most regulated area of laboratory medicine in Australia. These regulations have placed the National Sero-logy Reference Laboratory, Australia (NRL) in a unique position to implement a comprehensive quality assurance (QA) program for HIV testing. The elements of our QA program include pre-market evaluation of assays, external quality assessment schemes (EQAS), quality control, specificity monitoring, consultations, and training workshops. The results of the NRL EQAS for Australian laboratories were compared with those of a program developed by the NRL for reference laboratories in the Southeast Asian and Western Pacific (SEAWP) regions. For laboratories authorized to use tests for HIV in Australia, participation in the entire QA program is mandatory, whereas the SEAWP EQAS program is voluntary. While the overall percentage of discrepant results for these programs are similar, the percentage of false negatives, variation in laboratory results, and choice of assay differ. These differences have decreased with time with improvements in assays and laboratory testing practices. The educational component of both EQAS, which comprises workshops, laboratory questionnaires, consultancies, and newsletters, has had a critical impact on the testing practices of laboratories.

Signal Amplification in Time-resolved Fluorometry

A frequent question among clinical biochemists is how sensitive analytical techniques should be in the context of clinical diagnostics. Currently, the analyte concentrations usually encountered in clinical chemistry range from 10−3 to 10−12 mol/L. By far, the most sensitive nonamplification techniques used in the clinical laboratory are based on noncompetitive immunological assays. Is there any need for measuring analytes at even lower concentrations? The answer is likely yes. Once the methodologies for measuring even lower concentrations of analytes are developed and our knowledge of the many new candidate biological markers that likely will be discovered through the Human Genome Project is more complete, we may be interested in or need to measure analyte concentrations that are 1/10th to 1/100th of those currently measured. Hence, we should continually pursue the development of methodologies that can reach the ultimate sensitivity, i.e., detection of single molecules. In other areas of laboratory medicine, e.g., microbiology, single pathogen particles (e.g., viruses and bacteria) have diagnostic significance. We should not forget that the measurement of a single molecule in a very small fraction of the total blood volume may mean that the whole organism could contain relatively large numbers of such pathogenic or abnormal constituents. When the analytes are nucleic acids (DNA …

Standards of laboratory practice: guidelines for the maintaining of a modern therapeutic drug monitoring service

On Saturday, June 19, 1997 the National Academy of Clinical Biochemistry held a meeting to publicly review a draft document containing recommendations on the provision of basic therapeutic drug monitoring (TDM) services. This was the third in a continuing series of meetings on Standards of Laboratory Practice (SOLP), which was established to provide practice guidelines for laboratory scientists in a focused area of laboratory medicine. The manuscripts and summaries of two earlier SOLPs, on Thyroid Disease (1) and on Support of the Newborn (2), were published in this Journal, and the monographs are available from the NACB. By facilitating discussion between clinical laboratory analysts and physicians during the …

The Laboratory Test Handbook with Key Word Index, 4th ed. David S. Jacobs, Wayne R. DeMott, Harold J. Grady, Rebecca T. Horvat, Douglas W. Huestis, and Bernard L. Kasten, Jr., eds. Hudson, OH: Lexi-Comp, 1996, 823 pp., $54.75. ISBN 0-916589-36-6.

This comprehensive handbook is a valuable addition to the reference library of today’s clinical laboratorian, physician, or other healthcare worker. This enlarged edition is updated and expanded from the 1994 edition. Although written by 27 contributors from all areas of laboratory medicine, each section is similarly formatted, which contributes to value and ease of use. The book begins with a general overview of selected topics. The first section includes a discussion of the factors affecting laboratory values, normal ranges, and a review of statistics. The second section focuses on the regulations, hazard communication, and record-keeping involved in …

Laboratory support for transplantation

The clinical laboratory plays a major role in support of transplantation. Depending on the spectrum and number of transplants performed, such programs can consume up to 35% of all laboratory testing. This testing can be transplantation-nonspecific or -specific. The former constitutes routine laboratory procedures in various areas of laboratory medicine that are common to other categories of patients. Transplantation-specific testing includes tissue typing, procedures for assessment of graft viability/rejection, and measurement of immunosuppressive drugs. Because of the development of new immunosuppressive drugs such as FK506, cyclosporin G, and rapamycin, an increased burden will be placed on laboratories to establish new therapeutic monitoring programs. Preliminary guidelines for monitoring these drugs, similar to those previously established for cyclosporin A, are proposed herein. With the use of an increasing spectrum of immunosuppressive drug combinations, and the possible use of xenotransplantation on the horizon, new demands will be placed on the laboratory for the support of transplant programs.

NHS research and development: a research strategy for nuclear medicine.

The objective of the National Health Service (NHS) research and development strategy is to ensure that the content and delivery of care in the NHS is based on high quality research relevant to improving the health of the nation. In 1991 Professor Michael Peckham was appointed Director of Research and Development, with a target of 1.5% of the NHS budget to be spent on research and development by 1997/98. The Standing Group on Health Technology (SGHT) was formed to advise on the need for health technology assessment in the NHS. Health technology assessment (HTA) can be defined as the assessment of the effectiveness, costs and impact of a health technology on health care. The SGHT is aided by five advisory panels, one of which is the Diagnostics and Imaging Panel, covering all areas of Laboratory Medicine and Imaging. In 1993 the panel was asked by the SGHT to identify new and existing technologies in need of assessment, to identify technologies with insufficient evidence of value and in need of assessment prior to diffusion throughout the NHS, and to identify emerging technologies which may have a major impact on the NHS in the future. Formal consultation processes at both regional and national level were used to obtain recommendations for HTA from the NHS, patient and professional organizations, including the British Nuclear Medicine Society and European Association of Nuclear Medicine (BNMS and the EANM). Of the 197 recommendations received, 16 were considered a high priority and forwarded to the SGHT in October 1993.(ABSTRACT TRUNCATED AT 250 WORDS)

Improving the Quality of Plasma Cholesterol Measurements in Primary Care

During the last 2 years an external quality assessment (EQA) scheme has been developed for plasma cholesterol measurements made in primary care. The scheme, which is supported by the UK Department of Health and by the instrument manufacturers, now has over 300 participants, most of whom use the Boehringer Reflotron. Operators are mostly nurses, with little or no laboratory experience. To avoid matrix effects, fresh plasma specimens collected from normal volunteers and those attending a hospital lipid clinic are used. Three specimens, mostly with cholesterol concentrations in the range 5-9 mmol/L, are distributed every 2 months. The mean plasma cholesterol results show good agreement with those from 'reference' laboratories, and efforts are now being made to link these laboratories with the CDC-based reference system. The scheme uses a predominantly graphical presentation of results, with a greater element of interpretation by the organisers than is usually provided for laboratory-based participants. The distribution of results shows a higher proportion of outliers than in the UK national EQA scheme for laboratory cholesterol measurements. At present about 10% of participants in primary care obtain results which could be clinically misleading, and new approaches are needed in dealing with these 'poor performers'. This scheme could serve as a model for other assays in primary care. It illustrates the importance of training, quality assurance and education, and the need for laboratory staff to become more involved in this growing and important area of laboratory medicine.

Microbiology: Microbial Antigen Detection

While other areas of laboratory medicine have been undergoing great growth and innovation, standard approaches remain the norm in clinical microbiology. Immunologic methods currently available for the detection of microbial antigens are assessed, and a brief discussion of chemical methods of detection reveals a valuable area for future research.

Todd-Sanford Clinical Diagnosis by Laboratory Methods

This, the 15th edition of Todd and Sanford , is the second edited by Israel Davidsohn and John Bernard Henry. Davidsohn and Henry had expanded the scope of the book, previously limited, by obtaining authors whose chapters have covered almost all areas of laboratory medicine. This new edition maintains the place of this book as the best reference in modern laboratory medicine. The book as a whole is a compendium of methodologies, but each chapter provides good discussion of basic mechanisms, clinical relevance, and the basis for clinical interpretations of the laboratory tests. It will be particularly useful to residents and laboratory directors who can read it prior to their consultations with the clinicians. It will be useful to clinicians to provide the basis for their clinical interpretations. Students of medicine and technology will generally find it too lengthy and detailed for everyday use but will find it a useful reference.

Implementation of the inspection and accreditation program of the American Association of Blood Banks: experiences in Pennsylvania.

The circumstances which have led to the establishment of an Inspection and Accreditation Program by the American Association of Blood Banks are outlined. The need for such a program has been greater in this field of clinical laboratory practice than in other fields because of the awareness of the Public of the medical consequences from the transfusion of incompatible blood. In Pennsylvania there has been widespread cooperation in implementing inspection and accreditation of individual hospital blood banks on the part of pathologists and hospital administrators. Some of the deficiencies encountered on inspection are listed. It is possible that this voluntary program in blood banking may be extended to other areas of laboratory medicine.