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An outbreak of leptospirosis, Thailand--the importance of the laboratory.

The reported incidence of leptospirosis increased 30-fold in Thailand between 1995 and 2000. Despite many hypotheses to explain the increase, the true etiology remains unknown. We conducted a review of the national surveillance system for leptospirosis, examining the reporting practices, system attributes, and utilization of laboratory confirmation in two northeastern provinces. Using standard guidelines for evaluation of public health surveillance systems, we assessed the timeliness, completeness, and accuracy of data; the sensitivity and specificity of case ascertainment; and the overall usefulness of the Thai leptospirosis surveillance system. Physicians were interviewed to assess compliance and understanding of the case definition. Capacity for confirmation of leptospirosis by a Thai latex agglutination test was assessed. Completeness for variables critical for linking epidemiologic and laboratory data for leptospirosis was 69%. Twenty-eight percent of 208 provincial surveillance reports were considered timely. Interviewed physicians indicated that the national case definition was difficult to understand and apply, and that laboratory confirmation was infrequently used. Compared to a standardized microscopic agglutination test (MAT) panel, the Thai test was specific, but relatively insensitive. We found that a lack of a standardized case definition for leptospirosis, the infrequent use of confirmatory laboratory testing, and the inability to link clinical, epidemiologic, and laboratory data hindered system utility. This surveillance system for leptospirosis highlights difficulties with surveillance of febrile illnesses in general, and the importance of laboratory confirmation for infections that are difficult to diagnose clinically.

Centers for Disease Control and Prevention, U.S.↗

Attitudes and concerns amongst laboratory staff regarding handling of HIV positive biological specimens.

AIMS: to ascertain attitudes and concerns of laboratory staff towards handling of HIV positive biological samples. METHOD: an anonymous questionnaire regarding various aspects of biological sample handling was distributed to laboratory staff from the Wellington Area Health Board laboratories. RESULTS: of a total of 133 laboratory staff (response rate: 56.4%), five were seriously considering leaving, and another ten would have chosen another career if given prior information in regard to handling HIV positive biological samples. Of the responders, 22.8% and 38.3% considered that their employer does not provide adequate safety measures and education respectively in regard to HIV. CONCLUSIONS: handling of HIV positive biological samples does not greatly contribute to attrition amongst laboratory staff. Given the concern of laboratory staff for safety and education in regard to HIV, a continuous in-service educational programme would be desirable.

Attitude of Health Personnel↗

Variability in a commercially available enzyme-linked immunosorbent assay system. II. Laboratory variability.

An experiment was conducted to determine the amount of variability that occurred in enzyme-linked immunosorbent assays when samples from common serum pools were assayed in five different labs on three consecutive days. Low- (approximately 1:2000), medium- (approximately 1:4000), and high-titered (approximately 1:8000) serum pools were distributed to five poultry industry laboratories that cooperated in the study. Results varied significantly among different laboratories and among different days in the same lab. Variation among days within the same laboratory and among laboratories were large. The greatest variability occurred among labs. Correlations between mean daily titer and laboratory ambient temperature were small and not significant. The amount of variability within and among different laboratories that were observed indicate that single determinations on individual serum samples are not likely to give a reliable estimate of antibody titer. The large variability within labs further indicates the need for standard reference pools of positive serum to be included in assays in order to substantiate assay results.

Animals↗

[Preoperative laboratory testing].

The preoperative laboratory screening is commonplace in clinical practice and is traditionally defined as the practice of prescribing laboratory testing before surgery on patients undergoing a given procedure. The wide heterogeneity of the solutions prospected over the past decades emphasizes the objective difficulty at issuing definitive guidelines and recommendations. Despite its widespread use, a systematic evaluation of the clinical and cost-effectiveness of routine laboratory testing demonstrates that several approaches are as yet unsuitable, as inappropriate investigations may lead to evaluation of borderline or false-positive laboratory abnormalities. Three major difficulties can be identified when issuing reliable recommendations: articulation and appropriateness of diagnostic protocols, contestualization, in terms of surgical procedures and suitable clinical contests that might achieve the greatest advantages from results of laboratory testing, and impact of these tests on clinical management and outcome. This article aims to provide a comprehensive review of the current literature on this topic, attempting to suggest a suitable approach to the puzzling issue of preoperative laboratory testing.

Clinical Laboratory Techniques↗

Field evaluation of the chessboard modification for serotyping of Streptococcus pneumoniae in a small laboratory in Bangladesh.

The chessboard modification of the quellung method for serotyping Streptococcus pneumoniae (Pneumococcus) was introduced in the Gonoshasthaya Vaccine Research Laboratory, a small laboratory in Bangladesh. We applied initial bench-side training and subsequent continuous surveillance and quality assurance as approaches for good laboratory practice. Results obtained a this laboratory on 1,101 consecutive isolates had satisfactory sensitivity (85.1-100%) and specificity (97.9-99.9%) for serotyping the 10 most common serogroups/types of pneumococci when compared with the results obtained in the Finnish reference laboratory for pneumococcal serotyping at the National Public Health Institute. We conclude that serotyping of pneumococci by the chessboard method can be introduced into a small laboratory by providing basic bacteriologic skills, adequate initial training, and continuous external support.

Adult↗

Evaluation of laboratory monitoring alerts within a computerized physician order entry system for medication orders.

BACKGROUND: Errors involving medication use are common. Computerized physician order entry (CPOE) can improve prescribing practices. Few studies have examined the effect of CPOE in combination with decision support tools on prescribing practices in the outpatient setting. Less is known about prescribers' adherence to laboratory monitoring recommendations. OBJECTIVE: To evaluate if reminders presented during CPOE for medications would increase physicians' compliance with guidelines for laboratory monitoring at initiation of therapy. STUDY DESIGN: Randomized prospective intervention study. METHODS: Two hundred seven primary care physicians in a group-model managed care organization were randomized to receive or not receive drug laboratory monitoring alerts within the CPOE system. Adherence to laboratory monitoring recommendations for patients prescribed selected medications was compared between physician groups. RESULTS: There was no significant difference between the control and intervention group physicians in the overall rate of compliance with ordering the recommended laboratory monitoring for patients prescribed study medications. Laboratory monitoring was performed as recommended 56.6% of the time in the intervention group compared with 57.1% of the time in the control group (P = .31). In cases in which a statistically significant difference was demonstrated, improved compliance favored the intervention group (eg, 71.2% vs 62.3% [P = .003] for gemfibrozil and 75.7% vs 73.9% [P = .05] for statins). CONCLUSIONS: As CPOE becomes more prevalent, additional research is needed to determine effective decision support tools. These findings then should be communicated to the developers and users of computerized medical record systems.

Adolescent↗

Improving the laboratory diagnosis of TB in Ghana: the impact of a quality assurance system.

SETTING: Greater Accra region, Ghana. OBJECTIVE: To establish a pilot quality assurance (QA) system in sputum smear microscopy and to evaluate its impact. DESIGN: Quarterly supporting visits were paid to participating laboratories between 2000 and 2002. Fifteen examined slides were selected randomly from each laboratory during the visits and blindly re-assessed. Feedback was given promptly to the various laboratories. Training and stakeholder workshops were organised whenever necessary. RESULTS: General improvements in smear preparation and staining as well as the reading ability of the laboratory personnel included in the study were observed. The average marks for specimen quality, staining ability, smear cleanness, thickness, size and evenness increased from 64%, 79%, 69%, 46%, 67% and 60% in the last quarter of 2000 to 81%, 90%, 86%, 79%, 80% and 74%, respectively, 24 months after the establishment of the QA system. Within the same period, the rate of false-positives and -negatives decreased from respectively 14.8% and 20.5% to 0%, and agreements in positivity grade increased from 74% to 95%. The performance of the participating laboratories in keeping the laboratory registers up to date also improved. CONCLUSION: The QA system needs to be extended to the rest of the country.

Clinical Laboratory Techniques↗

[Harmonization of laboratory medicine in Croatia].

In order to harmonize laboratory results in the field of general medical biochemistry at the national level, analytical methods and analytical quality goals based on biological criteria together with common reference intervals were recommended. The following parameters are included: general biochemical parameters (metabolites and substrates, enzymes, electrolytes, microelements, proteins, lipids), routine urine and stool analysis and laboratory haematology and coagulation. The main purpose of external quality control in medical biochemical laboratories is to ensure independent and objective evaluation of laboratory test results in order to promote harmonization and achieve a high degree of interlaboratory comparability. The recommended reference intervals were produced on a representative sample group of urban population in Croatia for school children, adolescents and adults. For pediatric population, reference intervals were recommended according to the literature data. The recommended laboratory methods and corresponding reference intervals in the field of general medical biochemistry have to be used in all medical biochemical laboratories in Croatia since January 1, 2005.

Clinical Laboratory Techniques↗

[Elements of NOT (Scientific Organization of Labor) in a clinical diagnostic laboratory].

The suggested graphic variants of laboratory forms permit a rapid and accurate assessment of laboratory data, help detect organ abnormalities and relationships between shifts in laboratory characteristics of various systems of the body. These forms are convenient for dynamic assessment of changes in laboratory parameters, they permit a further mathematical processing of the data. Use of such forms will help reduce the number of laboratory analyses at the expense of purposeful laboratory tests, much more rapidly interpreted, thus saving the clinician's time.

Efficiency↗

Performance goals for the laboratory testing of antithrombin, protein C and protein S.

To achieve a reliable analytical quality for both monitoring and diagnostic testing, laboratories need to fulfil the widely accepted analytical performance goals based on the biological variation of the analytes of testing. Not only is the short-term analytical performance, which regularly is assessed by internal quality control procedures, of importance, but also the long-term analytical performance. To assess the long-term analytical performance, data obtained from an external quality assessment programme can be used. In this study we have used the evaluation model designed by the ECAT Foundation for the assessment of the longterm analytical performance, including imprecision, bias and total analytical error. The model was applied to the data from 136 different laboratories for the assay of antithrombin (activity), protein C (activity and antigen) and protein S (activity, total and free antigen). The imprecision (median; range), reflected by the long-term analytical coefficient of variation (LCV (A) ), was the lowest for antithrombin (7.6%; 2.6 - 43.8%) and the highest for protein S activity (17.2%; 4.3 - 88.6%). For bias and total error the same pattern was observed (antithrombin: 3.8%; 0.3 - 17.1% and 9.1%; 3.4 - 34.3%, respectively; protein S activity: 12.8%; 3.1 - 34.8% and 24.5%; 9.9 - 87.0%, respectively). For the majority of the laboratories (70 - 85%) the imprecision contributes considerably more to the total error than the bias. However the effect of the bias on the analytical quality is not negligible. Assays for antithrombin, protein C and protein S are mainly used for diagnostic testing. About 70 - 100% of the laboratories can fulfil the desirable performance goal for imprecision. The desirable performance goal for bias was reached by 50 - 95% of the laboratories. In all cases the highest numbers of laboratories fulfilling performance goals was obtained for the protein C variables. To improve the analytical quality in assays of antithrombin, protein C and protein S it is highly recommended that primarily imprecision (non-systematic failures) be suppressed. However the effect of the bias (systematic failures) on the analytical quality should not be neglected. A useful tool for determining the imprecision (LCV (A) ) and bias is the long-term analytical performance evaluation model as used by the ECAT Foundation.

Antithrombin III↗

Laboratory-confirmed non-O157 Shiga toxin-producing Escherichia coli--Connecticut, 2000-2005.

Shiga toxin-producing Escherichia coli (STEC) infection causes diarrhea that is often bloody and can result in potentially life-threatening hemolytic uremic syndrome (HUS). Escherichia coli O157:H7 is the most common cause of STEC infection in the United States, producing 73,000 illnesses annually, according to the last estimate in 1999. Unlike O157, however, little is known about the incidence of non-O157 strains. Because STEC other than O157 are not commonly identified, the incidence, trends, and epidemiology of non-O157 STEC are not well understood. To assess trends in Shiga toxin enzyme immunoassay (Stx EIA) testing by local clinical laboratories, the Connecticut Department of Public Health (CTDPH) analyzed results of confirmatory testing conducted in the state laboratory during 2000--2005. The findings indicated that a total of 403 STEC infections were reported by clinical laboratories in Connecticut, including 207 identified as STEC by Stx EIA testing alone, and that the use of Stx EIA increased from 2000 to 2005. Use of Stx EIA without prompt culture confirmation can delay or prevent serotyping and subtyping of isolates and detection of both O157 and non-O157 STEC outbreaks. Public health authorities in all states should ensure that clinical laboratories forward Stx EIA-positive specimens to the state laboratory for isolation and identification of STEC, as recommended by the Association of Public Health Laboratories and CDC.

Clinical Laboratory Techniques↗

Dientamoeba fragilis detection methods and prevalence: a survey of state public health laboratories.

Dientamoeba fragilis is a pathogenic protozoan parasite that has no cyst stage. Because of the lack of a cyst stage, the laboratory detection of D. fragilis in stool specimens is dependent on the stool processing and examination methods employed. Failure to use recommended stool fixation and permanent staining techniques almost precludes identification of D. fragilis, which is associated with gastrointestinal illness in humans. In this survey, questionnaires were mailed to all State and territorial public health laboratories requesting information on the number of ova and parasite examinations, methods of processing and examining stools, and the number of D. fragilis positive stools for 1985. Forty-three of 54 (80 percent) laboratories responded. Results showed that those laboratories which reported D. fragilis detection examined more stools using recommended stool fixation methods and were more likely to stain permanently all stools examined. Permanent staining of all stools, as compared to loose and watery stools only, resulted in a fivefold greater detection of D. fragilis. More State and territorial public health laboratories reported finding D. fragilis infections in 1985 than in a 1978 survey performed by the Centers for Disease Control. However, in 1985 only six laboratories reported 82 percent of all D. fragilis detections. To increase the probability of detecting D. fragilis in stool specimens, the findings suggest that all stools should be submitted fixed in polyvinyl alcohol fixative, sodium acetate-acetic acid-formalin fixative, or Schaudinn's fixative. Further, all specimens, regardless of consistency, should be permanently stained prior to microscopic examination.

Animals↗

Laboratory findings: structure, validity and significance for medical cognitive processes.

Modern medicine employs laboratory findings to a great extent in medical cognitive and decision processes. As supposedly "hard" data, the value of such findings is frequently incorrectly assessed. So far, no comprehensive general theory of laboratory findings has been available, although various subproblems have been dealt with. Firstly, the structure of a laboratory finding will be investigated in detail, proceeding from an analysis of the scientific language used for laboratory findings. The part played by laboratory findings in medical cognitive processes in making a diagnosis or prognosis will then be shown. Finally, attempts at characterizing the validity of a laboratory finding with the aid of statistical methods and information theory, as well as appropriate steps for checking the validity will be discussed.

Clinical Laboratory Techniques↗

The impact of sequential quality assessment exercises on laboratory performance: the multicentre ECAT Angina Pectoris Study. Report from the European Concerted Action on Thrombosis and Disabilities (ECAT).

As an adjunct to a European multicentre prospective study, five quality assessment (QA) exercises, spanning a period of 2.5 years, were undertaken. In these, fifteen laboratories from eight countries each performed ten haemostatic factor assays. The design of the QA exercises allowed the between-duplicate, between-day and between-laboratory coefficients of variation (CVs) to be calculated. The between-duplicate CV decreased by a factor of one quarter, and the between-day CV by a factor of one third, over the five exercises. The activated partial thromboplastin time (APTT) assay consistently showed the lowest CVs, while there was notable improvement in the between-day CVs for von Willebrand factor related antigen (vWF R:Ag) and factor VIII clotting activity (VIII:C). However, the between-laboratory CV, assessing extent of agreement between the different laboratories, did not apparently improve over the five exercises. Thus, while QA exercises may be very useful in improving the performance of haemostatic assays according to criteria which an individual laboratory can assess, improving agreement on haemostatic assay results between laboratories may be more difficult to achieve.

Angina Pectoris↗

Laboratory standardizatin in an international study: the Kaunas--Rotterdam intervention study (KRIS).

Laboratory results obtained in different laboratories over lengthy periods of time usually are difficult to compare. In cooperative long-term studies where such results must be pooled, thorough standardization of methods is vital. We describe a program in which comparable plasma cholesterol and glucose analyses have been obtained, by simple methods. In the Netherlands and the Soviet Union in close collaboration with the Center for Disease Control, Atlanta, Ga., U.S.A. The two laboratories produced glucose values (direct o-toluidine reaction) within 2% of the target reference values and cholesterol results (direct Liebermann-Burchard reaction) with a consistent 6-8% positive bias over the reference method values. Intralaboratory precision was subject to preset acceptance limits. The use of common control materials, exchange of patient samples, and on-site comparison of all details of laboratory procedures are vital tools in standardization efforts. A laboratory protocol that included quality requirements and rejection criteria was developed and proved to be indispensable. The experience gained should be useful in standardizing inter-laboratory results in similar studies.

Blood Glucose↗

Bacteriological proficiency testing in Hungarian clinical microbiology laboratories.

In course of a proficiency testing programme carried out in 1989, a total of 47 clinical microbiology laboratories of public health stations and of hospitals received freeze-dried cultures for isolation, identification and antimicrobial susceptibility testing. The specimens contained bacteria that occur in everyday work, including those that require improved methods of cultivation and identification. Nine public health laboratories and one hospital laboratory achieved excellent results. Good results were attained by 11 public health and 6 hospital laboratories. Four public health and 10 hospital laboratories were on the medium level and 4 hospital laboratories did not reach even this degree. The main failures were due to an insufficient anaerobic cultivation, unreliable identification and negligation of controls for drug susceptibility tests.

Bacteriological Techniques↗

CDC's Model Performance Evaluation Program: assessment of the quality of laboratory performance for HIV-1 antibody testing.

In 1986, the Centers for Disease Control (CDC) implemented the Model Performance Evaluation Program (MPEP) to evaluate the performance of laboratories that test for antibody directed against human immunodeficiency virus type 1 (HIV-1). The impetus for developing this program came from the recognition of a need to assess the quality of existing and changing laboratory technology and to ensure that the quality of testing was sufficient to meet medical and public health needs. To develop the program, CDC chose HIV-1 antibody testing as the first specific application for assessing the quality of laboratory performance because (a) of the importance of accurate and reproducible test results for acquired immunodeficiency syndrome (AIDS) surveillance, prevention, and treatment programs; (b) HIV-1 testing technology is new to many laboratories; and (c) HIV-1 testing practices and applications continue to evolve. Unlike proficiency testing programs, the MPEP is not limited to assessing quality in the analytical step, alone. It will also assess quality in the preanalytical and postanalytical steps of the testing process, that is, from the time a test is requested until the clinician who ordered the test takes an action based on the test result. The participating laboratories furnish the information needed for the performance evaluation program by (a) completing questionnaires designed to describe HIV-1 testing laboratories and their testing practices, (b) analyzing specially prepared sample panels for HIV-1 antibody reactivity, and (c) reporting results to CDC.

AIDS Serodiagnosis↗

Robotics in the medical laboratory.

Robotic systems specifically designed for the automation of laboratory tasks are now available commercially. Equipped with computer, analytical hardware, and supporting software, these devices may soon revolutionize the concept of the clinical laboratory and usher in a new era in laboratory testing. We review the types of robots and motion-control software currently available and discuss examples of their applications that extend across many analytical areas. Several ongoing projects are concerned with the systematic integration of robotic devices with other laboratory automation. The integrated robotic laboratories emerging from this work portend a bright future for robotic automation. Many challenges remain, however, in training the individuals needed to develop and manage robotic laboratories, and in making this new technology cost-efficient.

Laboratories, Hospital↗