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At least 1,045 records · Page 58Linked to original sources
PubMed1997

Laboratory techniques for semen analysis: a Scottish survey.

OBJECTIVE: To survey the techniques used by Scottish laboratories to undertake semen analysis in the context of the investigation of infertility. DESIGN: A telephone survey. SETTING/SUBJECTS: Laboratories in Scotland performing semen analysis. RESULTS: Thirty-one laboratories reported performing semen analysis for infertility. There was a lack of consistency in the instructions given to patients in several areas, including the period of abstinence prior to producing the specimen and the delivery of the specimen to the laboratory within an appropriate time after ejaculation. Only 19% of laboratories reported using a positive displacement pipette in the dilution of semen and only 26% used phase contrast microscopy for routine semen analysis. The minimum normal values quoted by laboratories for sperm concentration ranged from 20 x 10(6)/ml to greater than 50 x 10(6)/ml. The normal values quoted for sperm morphology ranged from at least 30% normal forms to at least 88% normal forms. Only 13% of laboratories participated in any form of internal or external quality control for semen analysis. CONCLUSIONS: Semen analysis is fundamental to the clinical work up of the infertile couple but, unlike most other laboratory investigations, it is not a standardised test in Scotland. Factors which are known to influence the results such as the advice given to patients about collecting specimens and the methods and equipment used by technicians vary widely. There is not even a consensus on the normal values quoted. This has implications for clinical decisions based on semen analysis and for future accreditation of laboratories.

Clinical Laboratory Techniques↗
PubMed1998

Supporting pharmaceutical studies for FDA submissions: diversifying the drug monitoring laboratory.

Well-founded pharmacokinetic information is one of the cornerstones of a New Drug Application (NDA) to the Food and Drug Administration (FDA) required to introduce a new drug or a generic equivalent (ANDA) to the marketplace. The service that laboratories engaged in therapeutic drug monitoring provide to support clinical activities is also needed by the pharmaceutical industry during the evaluation and introduction of drugs to the marketplace. In considering this alternative service activity, one must be aware of and compliant with rules established by the FDA for performance of such studies. As specified in CFR 21, Parts 58, 211, and 320, good clinical and laboratory practice indicates that the laboratory should employ a Lab Study Director, who is responsible for the validation of all procedures implemented to support a study protocol, ensures that the laboratory carries out the study following these defined procedures, and personally reviews the results of all testing. The laboratory must validate each procedure by demonstrating and documenting that the procedure does what it is designed to do while meeting the analytical performance specifications required by the study. Laboratory records of all activities must be maintained and available for inspection by the FDA on request. The FDA has authority over all activities related to NDA and ANDA submissions and can bring criminal charges if results of a study are changed because a laboratory deviates from standard procedure. Competent drug monitoring laboratories are fully capable of participating in clinical trials testing activities. Laboratory staff should be fully versed in the FDA rules governing these activities, validate all procedures, and establish systems to verify the procedures are carried out as specified.

Clinical Trials as Topic↗
PubMed1998

Clinical laboratory test menu changes in the Pacific Northwest: 1994 to 1996.

Laboratory testing services are presently undergoing dynamic changes in response to a wide range of external factors. Government regulations, reimbursement, and managed care are only a few of the influences affecting the availability of testing services and on-site testing capabilities in hospital, independent, and physician office laboratories. Medical practice changes, marketplace influences, test technologies, and costs also play a role in determining where testing is being performed. To better understand the factors influencing clinical laboratory test volumes and menus and to identify on-site testing deemed essential in physician office laboratories, we gathered information from a network of clinical laboratories in the Pacific Northwest. Questionnaires were sent to 257 Laboratory Medicine Sentinel Monitoring Network participants in March 1996. In the past 2 years, changes in on-site test volumes and test menus have been primarily due to medical practice changes and marketplace influences. When laboratories had a decrease in test volumes or test menu choices, the size of the patient workload and the volumes of test orders have had the greatest impact. Laboratory regulations and managed care contracts have played a role in shifting on-site testing to outside sources; however, these factors did not appear to be primary influences. Only 5% of physician office laboratories identified tests that they believed were essential for optimal patient care but did not perform on-site.

Alaska↗
PubMed1998

Assessment of the impact of a CD4+ T-cell testing laboratory improvement program.

OBJECTIVE: To evaluate the effectiveness of the Centers for Disease Control and Prevention's CD4+ T-cell laboratory testing improvement program and the influence of other laboratory improvement programs on CD4+ T-cell testing practices. DESIGN: Surveys asking for practice changes and factors that influenced the changes, a survey of clinicians' perceptions of laboratory quality in CD4 testing, and analysis of data from the Model Performance Evaluation Program. INTERVENTIONS: Centers for Disease Control and Prevention interventions included a series of 3-day workshops on flow cytometry, CD4+ T-cell testing guidelines published in the Morbidity and Mortality Weekly Report, the Clinical Laboratory Improvement Amendments of 1988, and the Model Performance Evaluation Program. PARTICIPANTS: All known laboratories in the United States that perform clinical CD4+ T-cell testing, workshop participants, and a sample of clinicians that treat patients infected with the human immunodeficiency virus. MAIN OUTCOME MEASURES: Changes in practices, factors most influential in effecting change, and performance on samples mailed to laboratories by the Model Performance Evaluation Program; knowledge before and after presentation of material in workshops; and practicing clinicians' observations of any effects of changes in laboratory practices. RESULTS: Many existing laboratories changed practices as a result of both governmental and nongovernmental CD4+ T-cell testing improvement programs. Sources of influence varied with each testing practice. Perceptions that test results were more reproducible seemed to offset presumed increases in the time and cost of testing. Clinicians who had ordered CD4+ T-cell testing for more than 10 years noted some improvements in results reported. CONCLUSIONS: As new complex testing methodologies are introduced into clinical and public health laboratories, the users seem to seek guidance in appropriate application of preanalytic, analytic, and postanalytic phases of the testing process. Testing improvement programs from a variety of sources were credited with changing practices and should continue to provide this guidance.

CD4 Lymphocyte Count↗
PubMed1998

The role and importance of veterinary laboratories in the prevention and control of infectious diseases of animals.

Veterinary laboratories which deal with infectious diseases form three groups according to the tasks for which they are responsible. The first group includes central or national veterinary laboratories, national or international reference laboratories, high-security laboratories, district regional or state veterinary diagnostic laboratories. The major role of these laboratories is to assist national Veterinary Services in diagnosing infectious animal diseases. The second group comprises laboratories that produce veterinary diagnostic kits and those that produce veterinary vaccines. The third group is composed of veterinary research laboratories, which generally concentrate on basic research and do not contribute directly to the diagnosis and control of infectious animal diseases. The author describes the objectives of each of the three groups of laboratories.

Animals↗
PubMed2001

International external quality assessment scheme for the laboratory diagnosis of diphtheria.

An international external quality assessment (EQA) scheme has been established so as to evaluate the proficiency of specialist, national diphtheria reference laboratories in the laboratory diagnosis of diphtheria. Six simulated clinical specimens were freeze-dried and distributed to 23 participants in 20 countries. Participants were asked to isolate, identify and perform toxigenicity testing on any corynebacteria present and to complete a simple questionnaire describing the procedures and reagents used. Only three laboratories obtained correct biochemical and toxigenicity results for all six specimens. The majority of laboratories performed better with toxigenicity testing than with the biochemical identification. Of concern were the results from three laboratories that failed to isolate any corynebacteria from four or more of the specimens. In one centre this was shown to be due to lack of availability of 'in-date' media and, in the other two, was presumed to be due to lack of experience in primary laboratory diagnostics for this organism. It is essential that countries, globally, maintain awareness and laboratory capabilities in this specialised area of microbiology. EQA is an invaluable process, which enables laboratories to monitor, evaluate and improve their own performance in such areas.

Clinical Laboratory Techniques↗
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↗
PubMedDate not supplied

The deployment of information technology in clinical laboratories and its impact on professional roles.

New information technology is deployed in hospital clinical laboratories to increase both the quality and efficiency of laboratory operations. Although total laboratory expenses may rise as a result of technology deployment, the average cost per test may decline. S-curves can be used to illustrate the effects of new information technology--such as a laboratory information system (LIS)--on the useful output and use of resources in laboratories. Major changes are now occurring as a result of the deployment of information technology, most notably in the area of automated information management. The role of laboratory professionals must be modified in response to this new information environment. The generation of information within clinical laboratories should be considered as the beginning--not the end--of the responsibility of laboratory professionals.

Clinical Laboratory Information Systems↗
PubMedDate not supplied

Factors influencing relative financial performance of hospital laboratories. Economic comparisons to measure performance.

When factors that drive hospital laboratory costs are clearly understood, administrators and laboratory directors can make more informed, comprehensive decisions about the laboratory's future. If internal laboratory operations cause higher-than-average relative costs, department managers can work toward improving productivity, efficiency, and decisions about purchased products/services. If, however, external factors, such as unusually high laboratory utilization and service-level expectations of the medical staff cause higher-than-average relative laboratory costs, hospital administration and laboratory managers can determine whether those external factors can be modified to reduce laboratory costs without adversely affecting patient care.

Clinical Laboratory Information Systems↗
PubMed1997

[Clinical laboratory consultation in the general hospital].

The future of laboratory medicine depends not only on quality assurance but also on appropriate use of laboratory tests. The clinical laboratory consultation system is effective tool for clarifying purpose. As an active laboratory-initiated consultation, we report patient-oriented "Laboratory Comment" on important or abnormal test results of each patient. About one thousand laboratory comments have been accumulated over the past eight years. From these comments, we discussed the requirements of laboratory consultation skills, establish standards for laboratory data check, and a database of reported and accumulated consultations or comments.

Clinical Laboratory Information Systems↗
PubMed1994

The relationship between 24-hour ambulatory blood pressures and laboratory measures of cardiovascular reactivity.

The relationship between 24-hour ambulatory blood pressures (ABP) and blood pressures (BP) obtained during laboratory stressors was examined. Thirty normotensives (equal males and females) underwent ABP monitoring on three occasions separated by a week. They also underwent a laboratory assessment which included standard stressors (i.e., mental arithmetic, cold pressor, orthostatic response, treadmill exercise). Correlational analyses found laboratory pressures to be significantly correlated with ambulatory pressures, with laboratory baseline BPs showing higher correlations to the ambulatory BPs than the BPs obtained during laboratory stressors. In addition, gender effects were examined. In the correlational analyses between ABPs and laboratory BPs, males and females did not differ significantly in the strength of the correlations. In terms of absolute values, males were found to have significantly higher SBP during ambulatory monitoring, random-zero recordings, calibration readings, and during baselines of the laboratory assessment. There were no gender effects for these measures with respect to diastolic blood pressure or heart rate. There were also no gender effects on reactivity to laboratory stressors as measured by change scores. Exploratory analyses found no significant effect of history of familial hypertension on either the ABPs or the laboratory pressures.

Adult↗
PubMed2002

Enhanced laboratory-based surveillance of Shiga-toxin-producing Escherichia coli O157 in The Netherlands.

The aim of this study was to analyse the results of a programme in the Netherlands for enhanced surveillance of Shiga-toxin-producing Escherichia coli (STEC) O157. In this programme, implemented in January 1999, all laboratories report positive cases to the public health services and submit isolates for typing to the reference laboratory. Public health services collect clinical and risk factor information of patients, using a standardised questionnaire. Results were analysed for the first two and a half years of the programme. In February 2000, a questionnaire was sent to all laboratories to assess (i) the criteria for testing faecal samples for STEC O157, (ii) the diagnostic tools used, and (iii) the level of participation in the surveillance programme. Between January 1999 and June 2001, 93 cases of symptomatic STEC O157 infection were reported, 25% of which occurred in children aged 0-4 years. Serotyping for O, H and stx types showed that two types dominated, O157:H7, s tx2 positive (48%) and O157:H-, stx1 and stx2 positive (24%). Analysis of the 93 isolates by pulsed-field gel electrophoresis showed 17 clusters of isolates with at least 95% fragments in common, including isolates with unknown epidemiological links. Of the patients for whom questionnaire information was reported, 38% were hospitalised, 15% developed haemolytic uraemic syndrome, and 52% reported a known risk factor, such as contact with farm animals or manure, consumption of raw or undercooked beef, consumption of raw milk or cheese made from raw milk, or contact with a symptomatic individual. Response to the laboratory survey was high (97%). Only 6% of the laboratories carried out testing for non-O157 STEC, although 95% performed testing for STEC O157. The majority (88%) used culture on sorbitol MacConkey agar or sorbitol MacConkey agar with cefixime and tellurite as the method of detection of STEC O157. The identity of the strains was confirmed primarily with commercially available latex agglutination assays (95% of laboratories) and biochemical characterisation with the API 20E test (bioMérieux, France) (42% of laboratories). Most laboratories (92%) used selection criteria for testing, especially bloody diarrhoea and other clinical information (81% of laboratories) and young age (10%). It is concluded that STEC O157 is a limited public health problem in the Netherlands, although the selective testing policy and the low sensitivity of the culture techniques used probably caused the incidence of STEC O157 infection to be underestimated.

Adolescent↗
PubMed1993

Long-term oral antibiotics for acne: is laboratory monitoring necessary?

BACKGROUND: The role of laboratory monitoring in patients receiving long-term oral antibiotics for acne vulgaris has not been clearly defined. OBJECTIVE: The purpose of our study was (1) to evaluate the literature for objective evidence on the value of routine laboratory monitoring of the asymptomatic patient receiving oral antibiotics for acne and (2) to determine the utilization of laboratory monitoring of these patients by Connecticut dermatologists. METHODS: We surveyed Connecticut dermatologists by phone and inquired about the laboratory monitoring performed in patients receiving long-term oral tetracycline, minocycline, or erythromycin for acne. RESULTS: Eight published studies reported a total of 777 patients who had laboratory monitoring at various frequencies while receiving oral antibiotics for acne. Only one adverse drug reaction (ADR) was detected in a patient in whom mild hyperbilirubinemia developed. Of the 75 Connecticut dermatologists who participated in our survey, 48 (64%) perform some laboratory monitoring; 29% do so routinely, and 35% under special circumstances. CONCLUSION: Our literature review does not support routine laboratory monitoring in all patients who receive long-term oral antibiotics for acne; rarely does such screening detect an ADR and thus does not justify the cost of such testing. A relatively small proportion of Connecticut dermatologists check laboratory tests more frequently than appears necessary; in our opinion, laboratory monitoring should be limited to patients who may be at higher risk for an ADR.

Acne Vulgaris↗
PubMed2006

Applying adult emergence as an endpoint in a post-exposure laboratory test using two midge species (Diptera: Chironomidae).

Several approaches have been used to evaluate biological impairment in aquatic ecosystems which can be categorized as either laboratory or field. In the recent years, the laboratory toxicity test approach has been extended to field exposures where ambient factors are allowed to influence the test response. Field exposures of laboratory test organisms require method modifications. In this paper, a novel in situ method is described which measures growth, survival and emergence of sediment inhabiting insects (Diptera: Chironomidae) that are used in standardized laboratory toxicity testing. Two standard chironomid species (Chironomus riparius and Chironomus tentans) were used to test the suitability of the approach and to compare the performance of the species. The larvae were transferred to the laboratory for emergence after 7 days in situ exposure which was compared to laboratory responses. Growth, survival and emergence were significantly lower in the in situ pre-exposure than in the laboratory. Also, emergence success was significantly lower in one reference sediment (LMR) than in the other test sediments in both in situ and the laboratory treatment. These lower response levels likely resulted from sediment characteristics and artifacts related to the exposure in the in situ chamber. Feeding and water quality within the exposure chamber appear to be factors that may differ markedly from the laboratory exposure and may affect organism responses. C. riparius developed (growth, emergence time) faster than C. tentans in all treatments, otherwise the species responded similarly. C. riparius may be a better alternative for the chronic in situ exposures because of shorter exposure times and reduced feeding requirements.

Analysis of Variance↗
PubMed2002

Ultraviolet protection factor of fabrics: comparison of laboratory and field-based measurements.

BACKGROUND/PURPOSE: Spectrophotometry has become an accepted laboratory-based method for the determination of the ultraviolet protection factor (UPF) of fabrics. However, the validity of the UPF determined in the laboratory has been a controversial issue with regard to its significance in the field. To compare UPF values obtained by spectrophotometry, determination of the minimal erythema dose (MED), and biological dosimetry, we conducted laboratory and field-based measurements on various fabric materials. METHODS: One cotton, two viscose, and two polyester fabrics were enrolled into the study. Spectrophotometric (SP) testing was performed in accordance with the European standard. In vivo "on skin" (IV) testing on human subjects was performed with and without fabric protection. For determination of MED, a solar-simulator was used. In another part of the study, biological dosimetry (BD) testing was employed for laboratory testing with solar-simulated radiation (laboratory BD testing) as well as field-based measurements with natural sunlight in stationary (stationary BD testing) and "real life" exposure situations (mobile subject BD testing). For field-based measurements one light-weight polyester fabric was selected. RESULTS: The differences of the mean UPF values obtained by the laboratory-based methods were significant (MANOVA; P = 0.05), except for fabric no. 2 (MANOVA; P = 0.097). In 4 of the 5 fabrics tested, UPF values obtained by IV testing were significantly lower than those obtained by SP testing (t-test; P = 0.05). In 3 fabrics, SP testing revealed significantly higher UPF values in comparison to laboratory BD testing (t-test; P = 0.05). The differences of UPF values obtained by the laboratory and field-based measurements employed for the light-weight polyester fabric were significant (ANOVA; P = 0.05). In comparison to SP testing (UPF 3.8), stationary BD testing resulted in significantly lower (UPF 3.5) and mobile subject BD testing in a significantly higher UPF of 4.4 (t-test; P = 0.05). The UPF obtained by mobile subject BD testing differed significantly from the UPF obtained by stationary BD testing (t-test; P = 0.05). CONCLUSIONS: Comparison of the presented methods indicates that IV testing generally results in lower UPF values. By contrast BD testing in "real life" exposure situations reveals relatively high UPF values. Although an overestimation of the spectrophotometrically measured UPF has been observed in comparative laboratory testing, UPF values obtained by field-based measurements are in relatively good agreement, or even surpass UPF values obtained by spectrophotometry. It is, therefore, suggested that SP testing provides "safe" UPF values which may be also valid in extreme real exposure situations. Biological UV dosimetry is, however, a promising alternative method for UPF testing: the test is easily performed in realistic exposure situations, the test is relatively inexpensive, and the measurements are valid.

Analysis of Variance↗
PubMed2002

Methicillin-resistant Staphylococcus aureus: laboratory detection methods in use in the Republic of Ireland and Northern Ireland.

There is no universally agreed laboratory protocol for the detection of methicillin-resistant Staphylococcus aureus (MRSA) and hence a variety of approaches are used. As part of an all-island survey of MRSA in the Republic of Ireland (the South) and Northern Ireland (the North), a questionnaire was circulated to 14 participating laboratories in the North and 49 in the South, to determine the methods used to isolate MRSA from clinical specimens, identify S. aureus and test for susceptibility to methicillin. Almost two-thirds (64%) of laboratories in the North but only 16% of laboratories in the South use enrichment culture. There is heavy reliance on commercial kits to confirm the identification of S. aureus in the South but all laboratories in the North use the staphylocoagulase test. More than 90% of all laboratories use a disc method for susceptibility testing and 71% of laboratories in the North supplement this with the E-test; however, a range of methicillin disk concentrations are in use. There is a need to review current laboratory methods used to detect MRSA, with follow-up audit on their implementation. Additional resources may be needed in some laboratories to comply with revised guidelines, and reference facilities are required to assess new commercially available techniques and to confirm the identification of unusual or difficult strains.

Bacterial Typing Techniques↗
PubMed1999

Laboratory testing, diagnosis, and management of von Willebrand disease. Current practice in Australasia. RCPA Quality Assurance Program in Haematology Scientific Haemostasis Advisory Panel.

We report an evaluation of current laboratory and clinical practice for the diagnosis and management of von Willebrand disease (VWD) for a wide geographic area including Australia, New Zealand, and parts of Southeast Asia. This assessment has been undertaken in conjunction with the RCPA Quality Assurance Program (QAP) in Haematology. This external QAP currently comprises around 550 participating laboratories, of which some 450 perform coagulation testing, and from which 32 laboratories were identified to be actively involved in testing for VWD. These laboratories were targeted and their current laboratory and clinical practice evaluated by using various questionnaires. Our overall findings indicate a wide variation in laboratory test practice for VWD-based investigations. There was considerable variation among laboratories in the tests and test methods used, the control and calibration material used, the reported test reference intervals and units used, and the composite test panels used to diagnose VWD. However, substantial consensus in the clinical evaluation process, as undertaken by hematologists, also was identified. Despite the observed variations, most laboratory professionals seemed to understand the complexities involved in the diagnosis and subclassification of VWD, and the laboratories can provide an effective diagnostic service.

Asia, Southeastern↗
PubMed2026

Comprehensive Genomic Profiling Timeliness Beyond Laboratory Turnaround Time: A Patient-Facing Pathway Analysis.

AIM: We evaluated the timeliness of the patient-facing comprehensive genomic profiling (CGP) pathway by separating laboratory and post-laboratory intervals within an expert panel-mediated process, using direct disclosure of results to patients as the endpoint. METHODS: This single-center retrospective study included adult CGP test episodes performed under government-funded cancer genomic medicine at a Japanese university hospital between October 2019 and November 2025. The primary outcome was patient-centered turnaround time (TAT), defined as the interval from informed consent to direct disclosure of the CGP result to the patient. Laboratory TAT and pathway intervals were summarized descriptively, and laboratory TAT was compared across assays. RESULTS: Among 882 CGP test episodes, median laboratory TAT was 14 days (interquartile range [IQR], 12-16) among 871 evaluable episodes. Among 828 evaluable episodes, median patient-centered TAT was 41 days (IQR 35-45). The laboratory analysis retained observed long intervals, including a maximum of 72 days; no episode was excluded solely because laboratory TAT exceeded 56 days. These findings indicate that laboratory TAT was only one component of the longer consent-to-disclosure pathway. CONCLUSION: In this routine-care CGP pathway, patient-facing timeliness depended on the full process from consent to direct patient disclosure. Patient-centered TAT should be monitored alongside laboratory TAT as a care-delivery measure.

comprehensive genomic profiling↗