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Variability in the levels of PML-RAR alpha fusion transcripts detected by the laboratories participating in an external quality control program using several reverse transcription polymerase chain reaction protocols.

BACKGROUND AND OBJECTIVES: The detection of PML-RAR by reverse transcription (RT) polymerase chain reaction (PCR) in acute promyelocytic leukemia (APL) patients who are in hematologic remission influences therapeutic decision making in several trials. In the light of this, the Spanish group has recently designed an external quality assessment program (EQAP) of RT-PCR detection of PML-RAR, which includes a study of sensitivity of the participating laboratories. DESIGN AND METHODS: Eighteen laboratories were involved in the program. Ten laboratories followed the method of Biondi et al., 5 employed that of Borrow et al. and the 3 remaining used other protocols. The sensitivity was studied in five rounds of quality control. The first two shipments consisted of dilutions of NB4 RNA into non-APL RNA. The third round consisted of serial dilutions of the NB4 cell line into HL60 cells. The fourth and five rounds consisted of plasmid dilutions containing the bcr1 and bcr3 PML-RAR isoforms. RESULTS: The results showed that the distinct methods allow detection of the PML-RAR hybrid up to a dilution of 10(-4), and exceptionally, up to 10(-5). The laboratories following the method of Biondi et al. usually detected the 10(-3) dilution and less frequently the 10(-4) one, whereas those using other methods usually detected PML-RAR transcript in the 10(-4) dilution, and less commonly in the 10(-5) dilution. However, each of the PCR methods used by EQAP participating laboratories successfully detected at least 50 copies of PML-RAR alpha fusion transcript in plasmid dilution controls. INTERPRETATION AND CONCLUSIONS: The results point to heterogeneous sensitivity amongst participating laboratories. This may reflect differences in methodology, although variations in sample quality may also account for discrepant findings.

Humans↗

Evaluation of western fence lizards (Sceloporus occidentalis) and eastern fence lizards (Sceloporus undulatus) as laboratory reptile models for toxicological investigations.

A need is recognized for one or more laboratory reptile models for use in ecotoxicological studies and risk assessments. Maintenance of breeding populations of most reptile species under laboratory conditions is not practical because of their size and slow maturation rate. However, a number of species of spiny lizards (Sceloporus sp.) are small, mature quickly, and reproduce under laboratory conditions. We evaluated three populations of western fence lizards (S. occidentalis) and four populations of eastern fence lizards (S. undulatus) for their performance under laboratory conditions. We reared an F1 generation of each population and compared their performance relative to survival, growth, maturation rate, and reproductive output. A population from the San Joaquin Valley (CA. USA) performed especially well under laboratory conditions and is a good candidate for a laboratory model. We also examined the sensitivity of developing fence lizard embryos to an estrogenic chemical to determine if male secondary sex characteristics were affected. Microinjecting eggs with an estrogenic chemical (17alpha-ethinylestradiol) feminized males and prevented development of embryonic secondary sex characteristics. Therefore, embryonic fence lizards may be useful for studying the effects of endocrine-disrupting chemicals.

Animals↗

Laboratory surveillance for wild poliovirus and vaccine-derived poliovirus, 2000-2001.

After the 1988 World Health Assembly resolution to eradicate poliomyelitis, the Global Laboratory Network for Poliomyelitis Eradication (the laboratory network) was established by the World Health Organization (WHO). The laboratory network is one component of the international surveillance system for detecting polio through notification of cases of acute flaccid paralysis (AFP). As progress is made in eradicating polio worldwide, the laboratory network provides critical virologic evidence about where poliovirus is circulating as a guide to supplementary vaccination activities aimed at interrupting transmission. This report summarizes the laboratory data for documenting the decline in wild poliovirus transmission and the occurrence of vaccine-derived polioviruses and highlights the expanding role of the laboratory network in global polio eradication.

Clinical Laboratory Techniques↗

[Evaluation of the system for controlling the quality of the HBsAg detection in the system of screening laboratories].

The two-stage control system, ensuring the high quality of serological investigations in the network of screening laboratories in Moscow was developed and introduced into practice. At the first stage the entry control of the quality of the test system for the detection of HbsAg, coming to the screening laboratories, is made in the reference laboratory with the use of specially developed "representative" panels, as well as the test systems for comparison ("reference" test systems). Then "minipanels" are formed from specimens included into the "representative" panels, which are used for the evaluation of the quality of laboratory investigations made in the screening laboratories. The high quality of such system for controlling the quality of the detection of HBsAg in the screening laboratories of Moscow is shown.

Evaluation Studies as Topic↗

[Comparison of plasma total homocysteine determinations in 9 French hospital laboratories by using 6 different methods].

A lot of methods are now available for total plasma homocysteine (tHcy) determination. Commercial kits using immunoassay, easier to use, begin to supplant in-house laboratory methods. Our aim is to evaluate the interchangeability of tHcy measurements in 9 French hospital laboratories. Six different method types were used: 2 gas chromatography-mass spectrometry (GC-MS), 2 HPLC with fluorescence detection subdivided in one in-house method and one commercial kit (Bio-Rad ), 3 fluorescence polarization immunoassays (FPIA), 1 enzyme immunoassay, 1 amino acid analyser, 1 capillary electrophoresis coupled with laser-induced fluorescence detection (EC-LIF). Each laboratory analysed 41 patient's plasma samples in which 8 samples contained added homocystine. Results were analysed for imprecision, recovery, and methodological differences. The mean among-laboratory imprecision (CV) ranged from 12.5 to 18% in function of plasma sample type and was identical to the mean among-method variation. In terms of recovery, we obtained underestimated results with immunoassays. The bias relative to the GC-MS method was less than 12.5% except for two laboratories, one using FPIA assay and the other EC-LIF. In conclusion, the interchangeability of tHcy results between laboratories is not satisfactory and does not allow us to evaluate cardiovascular risk linked to moderate increases of tHcy.

Blood Chemical Analysis↗

Biochemical and microscopic urinalysis: time and cost in a nephrology laboratory.

BACKGROUND: Urinalysis is a fundamental test in internal medicine and nephrology. Figures for costs are available in the general laboratory, where biochemical and microscopic urinalysis are commonly performed as semiautomated screening tests. Information on costs is lacking in the nephrology laboratory, where a time-consuming morphological analysis is usually preferred. This study analyses the costs of urinalysis in a nephrology laboratory. METHODS: In the nephrology laboratory at the University of Turin - Italy, biochemical urinalysis consists of multi-property strip and proteinuria/creatininuria, done by laboratory technicians. Phase-contrast microscopy is done by a nephrologist or biologist. Time dedicated to the tests was recorded by the same operator over 20 working days, during which 350 urine samples were processed (median 19/day, range 842). The production costs were calculated with the logic bottom-up technique. RESULTS: Overall time needed was 11.9 minutes/sample. Biochemical urinalysis required 6.6 minutes/sample; time required and samples processed were inversely related (< or =19 samples: 7.95 minutes/sample; >19 samples: 5.6 minutes/sample, p=0.01). Microscopic urinalysis took 5.3 minutes/slide; the best time-to-samples ratio was at 18-22 samples per day (with peak efficiency at 21 samples: 4.6 minutes). Cost of reagents and disposables was Euro1.06/sample. Time accounted for euro 5.32/sample (technicians, nephrologist-biologist), with total direct cost of euro 6.38/sample. CONCLUSION: In a nephrology laboratory, microscopic urinalysis is a time-consuming, expensive test. Analysis of cost and modalities may be useful, in a time of budget constrains, to maintain a role for this precious semeiotic art.

Chemistry, Clinical↗

[Postgraduate training program in laboratory medicine at a clinical teaching hospital].

The Tenri Hospital resident system was introduced in 1976 and the training program for laboratory medicine began in 1982. Thus, the author proposes goals for the the future on the basis of experience. It is appropriate that trainees study emergency tests, blood transfusion and microbiology(particularly Gram's stain and sputum culture) as practical matters, and in addition to these, learn how to reply to consultations from physicians, learn the laboratory flow(so-called laboratory system), and announce interpretations of laboratory data at reversed clinical pathological conference(R-CPC). The objectives of these training programs are to gain skills for appropriate laboratory utilization and interpretation, and develop communications and consultations with clinical pathologists and medical technologists. The key points of success in the training are close cooperation of the laboratory and teaching divisions. Particularly, cooperation with medical technologists is necessary, and it is essential medical practice for trainees because they will have to work with them in future. Finally it should be emphasized that there training has a limited effect because of the short duration. It is thus important to communicate and discuss clinical matters regularly in medicine.

Education, Medical, Graduate↗

Challenges, benefits and pitfalls of the independent laboratory process.

During 1998 Sydney's drinking water supply system experienced three contamination events in quick succession. These events were revealed by routine monitoring, which indicated the presence of large numbers of Cryptosporidium and Giardia in raw and treated water. Questions were raised regarding the validity of the results produced by Sydney Water's laboratory, Australian Water Technology. In response to the incident a NSW Government Inquiry was carried out which made a range of recommendations, one of which was that "A suitably qualified independent laboratory should be established to provide accurate data for regulatory authorities." The NSW Department of Health (DOH) was given the responsibilty for interpretation and implementation of this recommendation. The role of Independent Laboratory was awarded to the Australian Water Quality Centre (AWQC) and monthly program of duplicate sample analysis was established. The implementation of the program and interpretation of the results have provided a challenge for all parties involved. A protocol was developed which defined conditions under which differences in results from the two laboratories were to be investigated. Over the time period of the Independent Laboratory process there has been only one occasion where a difference between results, as defined by the protocol, has been seen. The process has provided additional assurance of quality control procedures for the laboratories. The future role of the process will need to be readdressed in light of the results of the previous 18 months and as changes in the area of testing methodologies occur.

Animals↗

[Symposium: the role of laboratory medicine in modern medical care--chairman's remarks].

Recent developments in laboratory techniques have brought dramatic changes in medical diagnosis, that is, a change from physical diagnosis to laboratory diagnosis. It is imperative that laboratory medicine develop further to meet the continuously growing needs of medical care. Major progress in medical care is classified into two categories, (A) treatment of severe disorders by modern technology and (B) health maintenance to prevent disease and achieve a higher quality of life. In this symposium, category (A) is subdivided in to (A-1) development of new drugs and (A-2) organ transplantation. In (A-1) the field of new drugs, "Recent Trends in Granulocyte Colony Stimulating Factor Therapy and its Relation to Clinical Laboratory Tests" is reviewed as an example of applying recombinant peptides to treatment. In (A-2) transplantation, two papers (A-2a) "Effect of HLA Matching in Renal Transplantation" and (A-2b) "Liver Transplantation and Function of the Graft Liver" are reported. In category (B), health maintenance, (B-1) exercise and (B-2) nutrition are important subjects. (B-1a) "The Role of Clinical Laboratory Examinations During Physical Exercise Therapy for Diabetes Mellitus" and (B-1b) "Exercise Loading Test for Evaluating Cardio-Pulmonary Functions" are given attention. In (B-2) nutrition, artificial feeding, such as intravenous hyperalimentation (IVH) is a current issue. The role of laboratory medicine in modern medical care will be discussed under each of these subjects.

Clinical Laboratory Techniques↗

[Hemostasis screening in the emergency laboratory].

PURPOSE: While automation of laboratories is of great value for analysts, as it makes technical work easier, and for clinicians, as the results are available in a shorter time, the requests increase strikingly bringing about higher costs. The emergency laboratory is an example of what happens in the general laboratory. In order to make an estimate of this subject, the haemostasis screening was chosen since it is a recently automated technique in that laboratory, attention being paid to the aim and indication of the screening and its economical burden. MATERIAL AND METHODS: A study of the haemostasis screening performed during July 1990 was carried out of considering the 24 hours per day work. The requests were classified, in accordance with their indication, as diagnostic, pre-surgical, therapeutic or unknown; the justification and purpose of those requests was also examined. RESULTS: The total number of studies performed in that month was 1,273, with a daily mean of 41, as opposed to 2,095 performed in the haemostasis laboratory in the same period. According to the American Medical Association criteria only 48% of the requests could be warranted, and abnormal findings appeared in only 10% of them. CONCLUSIONS: The cost per isolated parameter is low, but it increases greatly when compared with the benefit that it reports to the patient because, as those biological tests indirectly measure the concentration of clotting factors, they are subjected to error when performed by non-specialized personnel; on the other hand, the most valuable information for detecting haemorrhagic troubles comes from the patient's history. The economical burden in the month studied amounted to 985,879 PTA; one year later, the same laboratory, in the same month, had a 50% increase of studies.

Blood Coagulation Disorders↗

Targeted laboratory screening for sexually transmitted and bloodborne infections in Wisconsin.

Public health laboratories play an important role in screening programs for asymptomatic diseases of public health importance in high-risk and underserved populations. The implementation of targeted screening strategies for communicable diseases requires thorough planning and evaluation. The Wisconsin State Laboratory of Hygiene (WSLH) systematically selects and evaluates laboratory tests used in communicable disease control programs coordinated by the Wisconsin Division of Public Health. To do this, the epidemiologic features of the disease in potential target populations are carefully assessed, with the choice of laboratory tests based on performance as well as practical and cost considerations. Laboratory testing at WSLH plays a crucial role in screening programs for sexually transmitted and bloodborne infections. Hallmarks of these programs are cross-sector collaboration, empirical selection of laboratory testing methods, and the use of epidemiologic data to develop and evaluate targeted screening strategies.

Blood-Borne Pathogens↗

Is the provision of laboratory results via the Internet acceptable to patients? A survey of private patients in a large, specialist gynaecology practice.

AIM: The purpose of this research project was to ascertain patients' views as to the acceptability of having their laboratory results communicated via the Internet. A database was designed to hold laboratory results on a web site. METHODS: A survey was then prepared for patients of a private, specialist gynaecology practice, at whom the site was targeted. RESULTS: Two hundred and thirty five patients responded to the questionnaire, which canvassed their views on the provision of results through this new modality. Of the 235 respondents, 190 professed to be users of the Internet in general. Of this group almost 60% used the laboratory results web site. Feedback was highly favourable with 87% of those who used the site stating that they would use it again in the future. The respondents as a whole rated the Internet as their preferred method for gaining their laboratory results, even if they had not used it in this instance. The number of patients who held concerns about the security of the site, or the PIN system used to access it, was significantly small. Neither of these possible problems seemed to be a barrier to patients' utilisation of the site. CONCLUSIONS: The Internet-based laboratory results were well received by those who accessed them and the figures for those who would use the system again in the future suggest that once converted patients were more than likely to use the site again. With the increasing use of the Internet for the dissemination of all sorts of information, laboratory results hosted in this way can only become more and more favourably accepted by patients.

Adult↗

Laboratory staff qualifications and accuracy of proficiency test results. A national study.

In the last quarter of 1988, laboratories from across the country that participated in the College of American Pathologists (Northbrook, Ill) proficiency testing program were asked to complete a questionnaire describing their staffing pattern and submit it with their test results. Laboratories were then divided into two groups, those employing 100% American Society of Clinical Pathologists (Chicago, Ill) certified technologists and those employing 0% American Society of Clinical Pathologists certified technologists. The nonparametric Wilcoxon significance test was used to determine differences in accuracy of test results for laboratories in each group. Significant differences were found for the basic laboratory survey, comprehensive diagnostic immunology, comprehensive blood banking, comprehensive hematology, and comprehensive chemistry. chi 2 Analysis revealed that laboratories employing 100% American Society of Clinical Pathologists certified technologists had a significantly higher probability of achieving 80% accuracy across all surveys. These results present a strong argument that staffing with qualified technologists contributes to maximizing the quality of laboratory services offered to the public.

Allergy and Immunology↗

Points for consideration: transferring and changing hospital clinical laboratories.

BACKGROUND: The laboratories of Carmel Medical Centre were located in the main hospital building since its establishment (1977). Due to expansion of the clinical wards, the laboratories were relocated to a nearby building. The project was utilized for reorganization of the laboratories. METHODS: The basic design addressed the existing hospital needs based mainly on the original organization of the laboratories. The project allowed for the prospective organizational changes. The planning, design, and erection were performed by teams of the hospital and by outside parties, headed by the hospital management and the laboratories' director. The laboratories' staff was involved in all phases of the project. RESULTS: The project laid the foundations for future consolidation, i.e., establishment of a central reception station and merging of chemistry, endocrinology, pharmacology, and segments of immunology. The merging involved performance but not validation of tests. Separation between research and routine work was achieved. By-products attained were as follows: simplification of tube handling, reduction in volume of blood needed, improvements in safety, employees' amenities, general atmosphere, and communication within personnel. CONCLUSION: The successful transfer resulted from appropriate design, close cooperation between management and personnel, and the ability to pinpoint problems at early stages with ad hoc solutions.

Hospital Design and Construction↗

Laboratory exposure to Burkholderia pseudomallei--Los Angeles, California, 2003.

On July 26, 2003, the Los Angeles County Department of Health Services (LACDHS) received a report that a local clinical laboratory had isolated from specimens Burkholderia pseudomallei, a category B biologic terrorism agent and the causative organism for melioidosis, which is endemic to certain tropical areas. Because laboratory workers had manipulated cultures of the organism, CDC was asked to assist in the subsequent investigation. This report summarizes the results of that investigation, which included assessment of laboratory exposures, postexposure chemoprophylaxis, and serologic testing of exposed laboratory workers. The findings underscore the need to reinforce proper laboratory practices and the potential benefits of chemoprophylaxis after laboratory exposures.

Adult↗

Prevalence and associated factors of job-related depression in laboratory technicians in Hospital Universiti Sains Malaysia (HUSM) and Ministry of Health Malaysia (MOH) Hospitals in Kelantan.

Karasek's job strain model postulates that workers chronically exposed to adverse psychosocial work environment (high strain job)--high psychological job demands and low job control, including poor social support, increased physical demand and hazardous work condition--will eventually develop both physical illnesses such as cardiovascular diseases and psychological disorders such as depression. In order to determine the prevalence and associated factors of job-related depression, a cross-sectional study was conducted among laboratory technicians in Hospital Universiti Sains Malaysia (HUSM) and Kementerian Kesihatan Malaysia (KKM) Hospitals in Kelantan between September 2001 and February 2002. One hundred and two laboratory technicians in HUSM and 79 laboratory technicians in 7 KKM Hospitals were selected; 84/102 (82.4%) in HUSM and 71/79 (89.9%) in KKM Hospitals responded. Data was collected using self-administered questionnaires of the validated Malay version of the Job Content Questionnaire (JCQ) originally developed by Robert Karasek. Results indicated that the prevalence of high job strain in laboratory technicians in HUSM and KKM hospitals was 33.3% (28/84) and 26.8% (19/71), respectively (p>0.05). Significantly higher proportion (59.5%) (50/84) of laboratory technicians in HUSM compared to those in KKM Hospitals (39.4%) (28/71) (p = 0.016) experienced job-related depression. Significant associated factors of job-related depression were low social support (HUSM: adjusted OR 4.7, 95% CI 1.2-18.8; KKM: adjusted OR 14.8, 95%CI 2.4-89.3), high psychological demand (HUSM: adjusted OR 3.0, 95%CI 1.0-8.8), and low decision authority (KKM: adjusted OR 9.7, 95%CI 1.0-91.1). We conclude that strengthening the social support network (supervisors' and coworkers' support), reducing psychological job demand, and increasing decision-making authority of laboratory technicians may go a long way towards reducing job-related depression.

Adult↗

[More and faster notification of infectious disease if notification is carried out by the laboratories instead of the diagnosing physician].

OBJECTIVE: To investigate if notification by the laboratories of a number of Group B diseases (meningococcal disease, whooping cough and hepatitis A) which according to the Communicable Disease Law of 999 must be reported to the local public health authority, would increase the number of reports and the speed at which the reports were made. DESIGN: Comparative study. METHOD: In the participating regions (Den Bosch and north-east Brabant) it was decided that the laboratories would notify the authorities of cases ofmeningococcal disease, whooping cough and hepatitis A. The notifications were compared with those from the middle-Brabant region which was used as a control. This took place in 1997/'98, prior to the start of the notification project and in 2000/'02 when it was running. The number of positive cases of infectious disease confirmed by the laboratories that were reported to the local health authorities and to the Inspectorate of Public Health Services was examined - this is known as the degree of notification. The number of days from diagnosis to notification of the local health authorities was also examined - this is known as the speed of notification. RESULTS: The degree of notification for these three diseases improved from 6I-89% to 87-95% if the authorities were notified by the laboratories. In the control region the degree of notification improved from 29-4I% to 54-60%. The speed of notification increased significantly if notification was done by the laboratories. CONCLUSION: Based on these results it is recommended that the Communicable Disease Law be adapted to allow the laboratories to notify the authorities of cases of infectious disease.

Communicable Disease Control↗

Factors contributing to the retention of clinical laboratory personnel.

OBJECTIVE: To identify factors contributing to retention of clinical laboratory practitioners. DESIGN: A paper survey addressing retention was distributed to a potential of 4000 clinical laboratory professionals. SETTING: The survey was distributed to subjects by their laboratory manager to be completed at the worksite or home. PATIENTS OR OTHER PARTICIPANTS: 599 usable surveys were received from non-supervisory individuals employed in clinical laboratory science (CLS) for five years or more. INTERVENTIONS: Surveys were mailed to laboratory managers in March 2003 with directions to distribute to practitioners with five or more years of work experience. MAIN OUTCOME MEASURES: Percentages of respondents agreeing and disagreeing with Lickert-type opinion items were determined. The means, ranges, and standard deviations were calculated for the number of hours of continuing education, years of experience, percentage of time spent on tasks, and years in the current job. The means for job satisfaction were calculated and compared statistically based on respondents' job function, satisfaction with salary, job independence, sense of appreciation, and responsibility for continuing education. Open-ended responses were tabulated and categorized. RESULTS: Committed practitioners believe their work is important and find it challenging. Those who are most satisfied with their jobs believe they make a good salary (p = 0.000), have work independence (p = 0.000), and feel that their work is appreciated (p = 0.000). Job satisfaction does not differ for CLTs vs. CLSs. Salaries comparable to nurses and appreciation from physicians, nurses, and hospital administrators are cited by respondents as the most important factors to retaining laboratory staff. CONCLUSION: Committed practitioners believe that salaries comparable to nurses are needed to improve retention of staff. Respondents said that being appreciated by hospital administrators, nurses, and physicians would also contribute to improved retention.

Career Choice↗