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At least 757 records · Page 42Linked to original sources
PubMed2003

A critical evaluation of enzyme immunoassay kits for detection of antinuclear autoantibodies of defined specificities. III. Comparative performance characteristics of academic and manufacturers' laboratories.

OBJECTIVE: To analyze the performance of different commercial enzyme immunoassay (EIA) kits for measuring antinuclear antibodies (ANA) specific for dsDNA, SSB/La, Sm, and Scl-70. METHODS: EIA kits for detection of ANA from 9 commercial manufacturers were evaluated. The manufacturers were advised that they would be sent coded sera containing mixtures of the Arthritis Foundation/Centers for Disease Control reference reagents, and that they were to use their own test kits to analyze the antibody specificities of these sera and to report the data, in optical density (OD) units or their equivalent. Independently, 12 investigators in academic institutions who have done research in this field agreed to participate in a parallel study. The concentration of the antibodies and the specificities were blinded to the analysts and the coefficients of variation (CV) were computed for each participant. RESULTS: There were statistically significant differences between laboratories in terms of CV for all 9 kits tested. With the exception of one kit, there were no significant CV differences between the various autoantibody kits provided by each manufacturer and, with the exception of kits from 2 manufacturers, there were no significant differences between the various antibody kits in terms of reproducibility (CV). From the point of view of interlaboratory variability, manufacturers could be separated into either a high or low performance group. CONCLUSION: We found a disconcertingly large range of performance characteristics in the various laboratories, which could be quite detrimental in routine utilization of EIA ANA kits. Clinicians should be aware of the performance issues raised in our study, and should know and be involved in how their service laboratory assesses its own performance and the performance of commercial testing systems utilized. Manufacturers and clinical laboratories need to exercise constant quality assurance and surveillance of kit performance in the hands of medical laboratory technologists involved in routine testing.

Analysis of Variance↗
PubMedDate not supplied

[Digoxin assay: results of 10 years of intralaboratory controls].

Serum digoxin measurement is often performed in medical laboratories. A professional association specialized in quality control, based in Lyon, has been organizing punctual controls of medication measurement for the past ten years. The results are analysed in term of intra and inter-technique precision, difference between methods and specificity in regard to endogenous or exogenous interfering substances. Methods have changed with a quasi disappearance of the methods used ten years ago (FPIA, EMIT) and introduction of new technologies on recent immunoanalysis automates. The results observed with the different instruments are similar. Reproductibility has not changed over ten years. Some difficulties remain in the measurement of low concentrations of digoxin. Many substances interfere in digoxin measurement : digoxigenine (inactive metabolite), endogenous digoxin-like immunoreactive factors, spironolacton, antidigoxin antibodies used for treatment of digitalic intoxications. These interferences depend on the method which is used, but it is essential to know them in order to interpret the results correctly.

Clinical Laboratory Techniques↗
PubMed1980

Future perspectives of automatization in clinical chemistry.

In planning the internal organization of central laboratories, the future needs for clinical chemistry in hospitals must be considered. For the next decade the medical laboratory will primarily be concerned with the interpretation of laboratory data and with organizational problems, such as sample identification, specimen splitting and especially the timing of its service. The consequences for instrumentation, newer technology for routine clinical chemistry, and recommendations for the future development of analytical systems are discussed.

Autoanalysis↗
PubMed1998

[Better quality of thrombotest in family practice. Results from the NOKLUS survey 1993-97].

The Norwegian centre for external quality assurance of primary health care laboratories (Norwegian abbreviation: NOKLUS) was established in 1992. In 1997 about 1,800 practices participated in NOKLUS' quality assurance schemes, and 576 of these participated in the PT survey. Participation is voluntary and free of charge. The interlaboratory variation (CV%) was 17.7% in 1993 and 13.3% in 1997, and the percentage of results classified as "poor" has decreased from 7-8% in 1993 to 4% in 1997. These data indicate that participation in the scheme has led to a widespread improvement in laboratory performance. Norwegian primary health care practices now seem to analyse PT just as accurately as the Norwegian hospital laboratories. Logistic regression showed that the two most important factors for ensuring quality analysis were having a medical laboratory technician perform the PT analyses, and using an analyzer rather than a manual procedure.

Family Practice↗
PubMed2001

[Uniform programme in caring for patients with acute hepatic porphyria].

The programme commissioned by the Ministry of Health is presented. Data basis for the years 1996-1998 were created. A booklet on diagnosis, treatment and prophylaxis of porphyrias was edited and distributed in Poland in 5000 copies to all hospitals, major laboratories, medical libraries, regional officers as well as patients. The booklet lists simple diagnostic methods which can be easily introduced to hospital laboratories for early diagnosis of porphyria. It also includes a list of the safe drugs for patients with porphyria. Several lectures for doctors and medical staff were delivered, nine publications appeared and six others were accepted for publication. Results of the work, evaluated after three years are as follows. Early clinical diagnosis of porphyria and its prophylaxis among family members has significantly improved. The frequency of severe attacks and the mortality rate due to porphyria has been reduced to singular cases. The proposed organization of small regional centers (with help of Porphyria Center), oriented at early diagnosis of porphyria appears to be impossible without further financial support.

Guidelines as Topic↗
PubMed2005

The clinical chemistry laboratory: current status, problems and diagnostic prospects.

Although increased automation, advanced analytical techniques and sophisticated information technology have greatly improved the performance and quality in medical laboratory testing, several studies show that significant amounts of errors occur. Detailed analysis revealed that most of the errors occur in the preanalytical phase, while fewer errors occur in the intra- and post-analytical phase. The majority of errors are caused by wrong sampling or occur during transport to the laboratory. This review focuses on the analytical procedures in a large central laboratory. Possible problems are described by following samples from the patient to the laboratory and back. Finally, the advantages and disadvantages of point-of-care testing versus central laboratory are compared.

Calibration↗
PubMed2001

International standards in laboratory medicine.

International standards play an important role in establishing quality systems. A considerable number of standards have been created by ISO and CEN for medical laboratories. Standards can be looked upon in a hierarchal manner but most standards are produced in similarly with iterative consultations and review by the intended users. Most standards are suggested by industry and national or international organisations whereas individuals rarely can influence the contents. An exception is illustrated by a conference arranged to influence and improve the suggested standard (ISO 15196) on quality specifications in laboratory medicine. Standards may also influence the methodological practice and the performance of reagents and kits used in analytical work. A good example is the standard on traceability of calibrators (ISO 17511) that illustrates the practical importance of concepts like 'uncertainty in measurements' and 'trueness'. Biological calibrators, e.g., 'WHO biological standards', constitute a special problem since they often cannot be traced to SI. A reference procedure should be defined and referred. This would be more advantageous than to refer to a reference material that can only be traced to a master preparation. This would reduce the uncertainty and guarantee that calibrators of different batches meet certain metrological criteria.

Clinical Chemistry Tests↗
PubMed1983

Infections in British clinical laboratories 1980-81.

This survey through the Association of Clinical Pathologists was continued and extended for 1980-81, with the help of the Institute of Medical Laboratory Sciences. Hepatitis maintained a low attack rate of 26/100 000 person-years, including only three cases of hepatitis B probably attributable to laboratory work (attack rate 9). Nineteen cases of tuberculosis (attack rate 56) included 14 of probable occupational origin (attack rate 41) half of which involved post-mortem or mortuary work. Thirteen bacterial infections of the bowel (attack rate 38, predominantly shigellosis) involved almost exclusively microbiology MLSOs, with 10 attributed to laboratory work (attack rate 29). The seven other infections included 4 of occupational sepsis in morbid anatomy and post-mortem workers. There appears to be scope for improvement in bacteriological bench techniques particularly at the faeces bench and for reduction in the hazards of tuberculosis and sepsis for morbid anatomy and mortuary workers.

Bacterial Infections↗
PubMed1996

[Seroprevalence of viral hepatitis A in at the Amiens University Hospital].

OBJECTIVES AND METHODS: The epidemiology of viral hepatitis A has been evolved in the past few years, resulting in an increasing number of people without immunity to this virus. Health care workers are usually considered to be a group at risk of contamination by hepatitis A. A sero-epidemiologic study was performed in 525 members of the Pediatry, Gastroenterology, Internal medicine, Digestive radiology, kitchen and maintenance department staffs in the Amiens University Hospital. The aim of this study was to describe the epidemiology of hepatitis A and to estimate the level of occupational hazard it represents in the hospital. RESULTS: Age, low education level, country of origin in an endemic region and more than 2 siblings or children were significantly associated with the presence of anti-HAV antibodies. The prevalence of 50% was similar to that observed in other hospitals, but lower than that found in the general population. Seroprevalence was not higher in departments exposed to stools (Pediatry, Digestive endoscopy and laboratories) than in others. A higher rate of seroprevalence was observed in kitchen and maintenance staffs than in medical, laboratory and Radiology staffs, in Internal medicine than in the Gastroenterology Department, and in the laboratory than in Radiology Department. These differences disappeared after adjustment for extraprofessional parameters which appeared to be most important for hepatitis A epidemiology. CONCLUSIONS: The hospital occupational hazard for hepatitis A virus did not seem higher than that observed in the general population.

Adult↗
PubMedDate not supplied

Proficiency testing in cytology laboratories in Ontario, Canada: a decade of experience. II. Results of initial surveys.

The results of the initial surveys in the cytology proficiency testing of the medical laboratories in the Province of Ontario, Canada, showed a high correlation between the opinions of the testing committee and the participants in the categories of "no abnormal cells," "metaplasia" and forms of "benign atypia." The proportion of times that slides were tested in the categories of dysplasia and malignancy in the surveys increased from 38% by the end of survey 3 to 46% by the end of survey 5. A progressive improvement in the diagnostic accuracy was demonstrated in the categories of malignancy and severe dysplasia while results were more variable in the categories of moderate and mild dysplasia. Several educational activities were initiated following survey 3, including development and circulation of demonstration sets of marked glass slides for repeated circulation to participants as well as copies of a slide/tape presentation describing the program and specific case material.

Cytological Techniques↗