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At least 271 records · Page 15Linked to original sources
PubMed1997

Approach to maintaining comparability of biochemical data during long-term clinical trials.

Our objective was to design a structured approach to maintaining comparability of biochemical data during a long clinical trial. Maintaining the comparability of clinical and biochemical data obtained in long-term studies is essential, even though analytical methods in the laboratory may be changed, conventions on specimen handling and storage revised, calibration procedures updated, quality-control systems replaced, and secular changes may occur. The United Kingdom Prospective Diabetes Study (UKPDS), a large randomized control trial investigating therapy for type 2 diabetes, was the setting for the study. Data were collected from 5102 subjects randomized since 1977. Our techniques included quality control, external quality assurance, direct comparison of laboratory methods when updating assays and statistical techniques for the detection of unsuspected changes in assay bias, laboratory comparisons of new with old assay methodologies, the realigning of data to current methods, the use of a suitable reference population for long-term monitoring, and rules to aid decision-making about clinical vs statistical significance. Procedures by which comparability of data is assured should be specified for all long-term trials and, where possible, comparison with reference methods should be detailed to allow results from different laboratories to be compared.

Diabetes Mellitus, Type 2↗
PubMed1997

Quality assessment of blood glucose testing in general practitioners' offices improves quality.

Measurement of blood glucose is a frequent test in Danish physicians' offices. We describe here a new design of external quality assessment wherein fresh, unstabilized whole-blood samples were analyzed by the physicians' office methods and by a hospital laboratory comparison method (glucose dehydrogenase assay, calibrated against NIST 909a). This approach was used in the offices of 171 general practitioners in our county during a 5-year period. The first survey, in 1992, revealed unsatisfactory performance in terms of our criterion that no difference between the physician's office and the hospital laboratory's single result should exceed +/-20% of the laboratory result. After initiation of a program of consultation and assistance, the proficiency testing rounds of 1994 and 1996 showed considerable improvement. Thus, whereas in 1992 12% of the values were outside the acceptance limits, in 1994 and 1996 the respective values were 4% and 3%. We believe the effect was mainly related to improvements in choice of technology, procedures, and handling of specimens. We conclude that the use of bedside instruments should be restricted to diagnosis of only severe hypo- or hyperglycemia and to monitoring glucose >5 mmo/L in already diagnosed diabetics. Our program differs from previous approaches to quality assessment and could also be useful for large hospitals' in-house proficiency testing.

Blood Glucose↗
PubMed1998

A comparison of diagnostic methods for the detection of bovine respiratory syncytial virus in experimental clinical specimens.

Virus shedding was monitored in nasal secretions of 12 calves experimentally infected with bovine respiratory syncytial virus (BRSV) using an antigen capture enzyme-linked immunosorbent assay (ELISA) detecting the nucleoprotein (NP) antigen of BRSV, by a polymerase chain reaction (PCR) amplifying the fusion protein of BRSV, and by a microisolation assay combined with immunoperoxidase staining for the F protein of BRSV. Under the conditions of this study, similar limits of detection and quantitative results were obtained from all three assays. BRSV was detected in nasal secretions of all calves for a minimum of 4 d. Virus shedding began on Day 2 after infection, peaked on Days 3-5, and was cleared in most calves by Day 8. The PCR, and to a lesser extent the ELISA, may detect virus shedding for a longer period after infection than virus isolation, possibly due to neutralization of the virus by rising mucosal antibody. Simulated environmental conditions likely to be experienced during transport of clinical field specimens markedly reduced the sensitivity of virus isolation but had a minimal effect on the results of the NP ELISA. Actual field transport conditions (overnight on ice) had minimal apparent effect on the results of the PCR assay. The less stringent specimen handling requirements, combined with low limits of detection, of both the nucleoprotein ELISA and PCR, indicate either of these assays are more suitable for diagnostic applications than virus isolation.

Animals↗
PubMed1998

[Actual situation and problems in the information office of clinical laboratories; questionnaire surveys of central laboratories of university hospitals].

The laboratory tests supplied by clinical laboratory comprise an increasing volume in most hospitals. Consultation and effective utilization of laboratory data are important aspects of evidence-based medicine. Effective utilization of laboratory data will also contribute to the efficiency of hospital practice. Questionnaire surveys were conducted to investigate the actual situation in the information office of clinical laboratories in national, public and private facilities of 80 medical universities in Japan. Few facilities demonstrated efficient functioning, although information offices had been opened in six national, one public, and four private universities. The office staff received many questions on specimen handling and analytical methods. In the future, the office will be expected to be actively involved in mutual communications with clinical physicians and an information system such as computerized web is anticipated. Furthermore, a full-time laboratory physician and technicians are expected to provide support as experts in patient diagnosis.

Clinical Laboratory Information Systems↗
PubMed2005

HUPO Plasma Proteome Project specimen collection and handling: towards the standardization of parameters for plasma proteome samples.

There is a substantial list of pre-analytical variables that can alter the analysis of blood-derived samples. We have undertaken studies on some of these issues including choice of sample type, stability during storage, use of protease inhibitors, and clinical standardization. As there is a wide range of sample variables and a broad spectrum of analytical techniques in the HUPO PPP effort, it is not possible to define a single list of pre-analytical standards for samples or their processing. We present here a compendium of observations, drawing on actual results and sound clinical theories and practices. Based on our data, we find that (1) platelet-depleted plasma is preferable to serum for certain peptidomic studies; (2) samples should be aliquoted and stored preferably in liquid nitrogen; (3) the addition of protease inhibitors is recommended, but should be incorporated early and used judiciously, as some form non specific protein adducts and others interfere with peptide studies. Further, (4) the diligent tracking of pre-analytical variables and (5) the use of reference materials for quality control and quality assurance, are recommended. These findings help provide guidance on sample handling issues, with the overall suggestion being to be conscious of all possible pre-analytical variables as a prerequisite of any proteomic study.

Blood Platelets↗
PubMed2005

Assessment of physical conditions and current practice in laboratories carrying out sputum smear microscopy in Northwest Ethiopia.

A cross-sectional study was conducted in Northwestern Ethiopia involving 18 health-care institutes in August 2003 to assess the physical conditions and current laboratory practice, pertaining to handling sputum specimens in the health-care laboratories carrying out sputum smear microscopy. A structured and pre-tested questionnaire was used to collect information. The laboratories had an area of less than 25 m(2). None of them had separate rooms or safety cabinets for sputum smear preparation. Only three laboratories used facemasks. QJ;Decontamination of sputum specimens prior to disposal was reported in only two. Incineration as a means of sputum specimen disposal was used in only six laboratories. The physical conditions of the laboratories were found below the standard set by the International Union Against Tuberculoses and Lung Diseases. A large number of sputum specimens continue to be handled, despite the poor conditions and procedures in all the healthcare laboratories. Laboratory safety standards need to be improved, to minimize the risk of infection. In addition, there is an urgent need for education, training and supervision of the staff involved in sputum microscopy.

Clinical Laboratory Techniques↗
PubMed1992

Evaluation of a soft-handling computerized pneumatic tube specimen delivery system. Effects on analytical results and turnaround time.

A computerized pneumatic tube specimen delivery system with system-wide air cushion soft handling features was evaluated. There were no significant differences in values (largely normal) for components of a standard chemical profile or complete blood count in specimens delivered from the outpatient center or neonatal intensive care unit by pneumatic tube compared to couriers. The pneumatic tube system also did not affect values for pO2, pCO2, and pH over a wide range (pO2, 25 to 438 mmHg) in specimens sent from the operating room during cardiac surgery. The pneumatic tube system decreased the median turnaround time for potassium and hemoglobin results on specimens from the emergency department by 25%. The system evaluated is a rapid, efficient mechanism for sending specimens to the clinical laboratory that produces no significant effects on analytical results and has the ability to decrease turnaround time.

Blood Cell Count↗