European interlaboratory comparison of breath 13CO2 analysis.
The BIOMED I programme Stable Isotopes in Gastroenterology and Nutrition (SIGN) has focused upon evaluation and standardisation of stable isotope breath tests using 13C labelled substrates. The programme dealt with comparison of 13C substrates, test meals, test conditions, analysis techniques, and calculation procedures. Analytical techniques applied for 13CO2 analysis were evaluated by taking an inventory of instrumentation, calibration protocols, and analysis procedures. Two ring tests were initiated measuring 13C abundances of carbonate materials. Evaluating the data it was found that seven different models of isotope ratio mass spectrometers (IRMS) were used by the participants applying both the dual inlet system and the continuous flow configuration. Eight different brands of certified 13C reference materials were used with a 13C abundance varying from delta 13CPDB -37.2 to +2.0/1000. CO2 was liberated from certified material by three techniques and different working standards were used varying from -47.4 to +0.4/1000 in their delta 13CPDB value. The standard deviations (SDs) found for all measurements by all participants were 0.25/1000 and 0.50/1000 for two carbonates used in the ring tests. The individual variation for the single participants varied from 0.02 /1000 (dual inlet system) to 0.14/1000 (continuous flow system). The measurement of the difference between two carbonates showed a SD of 0.33/1000 calculated for all participants. Internal precision of IRMS as indicated by the specifications of the different instrument suppliers is < 0.3/1000 for continuous flow systems. In this respect it can be concluded that all participants are working well within the instrument specifications even including sample preparation. Increased overall interlaboratory variation is therefore likely to be due to non-instrumental conditions. It is possible that consistent differences in sample handling leading to isotope fractionation are the causes for interlaboratory variation. Breath analysis does not require sample preparation. As such, interlaboratory variation will be less than observed for the carbonate samples and within the range indicated as internal precision for continuous flow instruments. From this it is concluded that pure analytical interlaboratory variation is acceptable despite the many differences in instrumentation and analytical protocols. Coordinated metabolic studies appear possible, in which different European laboratories perform 13CO2 analysis. Evaluation of compatibility of the analytical systems remains advisable, however. (+info)
Analyte comparisons between 2 clinical chemistry analyzers.
The purpose of this study was to assess agreement between a wet reagent and a dry reagent analyzer. Thirteen analytes (albumin, globulin, alkaline phosphatase, alanine aminotransferase, amylase, urea nitrogen, calcium, cholesterol, creatinine, glucose, potassium, total bilirubin, and total protein) for both canine and feline serum were evaluated. Concordance correlations, linear regression, and plots of difference against mean were used to analyze the data. Concordance correlations were excellent for 8 of 13 analytes (r > or = 0.90); the correlations for albumin, potassium, and calcium were clinically unreliable. The linear regression analysis revealed that several analytes had slopes significantly different from unity, which was likely related to methodological differences. Compared to the wet reagent analyzer, the dry reagent analyzer showed excellent agreement for alkaline phosphatase, alanine aminotransferase, amylase (feline), urea nitrogen, cholesterol, creatinine, glucose, total bilirubin (canine), and total protein. However, it showed only slight to substantial agreement for amylase (canine), calcium, albumin, potassium, and total bilirubin (feline). (+info)
Pseudoepidemic of Aspergillus niger infections traced to specimen contamination in the microbiology laboratory.
We report a pseudo-outbreak of Aspergillus niger that followed building construction in our clinical microbiology laboratory. Because outbreaks of invasive aspergillosis have been linked to hospital construction, strategies to minimize dust in patient care areas are common practice. We illustrate that the impact of false-positive cultures on patient care should compel laboratories to prevent specimen contamination during construction. (+info)
Preliminary external quality assessment for the biological monitoring of carbon disulfide with urinary 2-thiothiazolidine-4-carboxylic acid.
Four laboratories have participated in an external quality control assessment for the determination of 2-thiothiazolidine-4-carboxylic acid (TTCA). TTCA is used as a biomarker for exposure to CS2. Thirteen different urine samples were analyzed by each laboratory. Ten of these were spiked with known amounts of TTCA, and had either a high or intermediate creatinine content. Two samples without any TTCA were used as controls and one sample was a pool of samples of urine from five employees occupationally exposed to CS2. The latter had unknown TTCA content. For each sample, TTCA and creatinine concentration were determined. The samples were supplied in three consecutive deliveries. Several samples were offered more than once. Thus, within-laboratory variability could be established for creatinine and TTCA determination and accuracy could be determined for TTCA analysis. Within-laboratory variability was low for all laboratories for creatinine, although laboratory D seemed to have a slight downward bias. Accuracy for TTCA was good for all laboratories. No significant mean deviation from the expected TTCA value was encountered. There does not seem to be any clear influence of the TTCA concentration level of the samples on the accuracy and within-laboratory variability. Two of the four laboratories (A and C) showed lower within-laboratory variability than the other two for TTCA, although coefficients of variation between replicated samples are high for these two laboratories as well. The laboratory giving the best accuracy, gave the highest within-laboratory variability. A non-systematic, random error is probably the source of this. The results of this preliminary study indicate that analysis of TTCA, although regarded as an established biomarker, can give biases and thus negatively interfere with inferred dose-effect or dose-response relationships in occupational epidemiology. (+info)
Experience with external quality control in spermatology.
Results are presented from participation in an external quality control (EQC) programme for semen analysis (UK NEQAS). Formalin-fixed semen samples and videotapes of motile spermatozoa were distributed four times a year over a 3-4 year period. Over the entire period there was close agreement for sperm concentration with, initially, the average of values from the other groups participating in the scheme, and later, values designated as reference values obtained from six laboratories of several chosen that consistently agreed with each other. The initial underestimation of the percentage of normal forms was abolished at the time of change in derivation of designated values and this largely eliminated the difference to establish closer agreement with the designated values. A consistent bias in the assessment of different categories of progressive sperm motility appeared to be resolved by a conscious decision to consider most spermatozoa as grade b and the exceptions as grade a, rather than the converse. Feedback of results to the technicians of the laboratory participating in an external quality control programme leads to reappraisal of subjective evaluation and to harmonization of results between laboratories. (+info)
emm typing and validation of provisional M types for group A streptococci.
This report discusses the following issues related to typing of group A streptococci (GAS): The development and use of the 5' emm variable region sequencing (emm typing) in relation to the existing serologic typing system; the designation of emm types in relation to M types; a system for validation of new emm types; criteria for validation of provisional M types to new M-types; a list of reference type cultures for each of the M-type or emm-type strains of GAS; the results of the first culture exchange program for a quality control testing system among the national and World Health Organization collaborating centers for streptococci; and dissemination of new approaches to typing of GAS to the international streptococcal community. (+info)
A national survey of practice patterns in the noninvasive diagnosis of deep venous thrombosis.
PURPOSE: Recent studies have recommended unilateral venous duplex scanning for the diagnosis of deep venous thrombosis (DVT) in patients who are unilaterally symptomatic. Vascular laboratory accreditation standards, however, imply that bilateral leg scanning should be performed. We examined whether actual practice patterns have evolved toward limited unilateral scanning in such patients. METHODS: A questionnaire was mailed to all 808 vascular laboratories in the United States that were accredited by the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL). To encourage candid responses, the questionnaires were numerically coded and confidentiality was assured. RESULTS: A total of 608 questionnaires (75%) were completed and returned. Most of the respondents (442; 73%) were either community-hospital or office-based laboratories, and the remaining 163 (27%) were university or affiliated-hospital laboratories. Most of the laboratories (460; 76%) had been in existence for 9 years or more, and 65% had been ICAVL-accredited in venous studies for 3 years or more. Board-certified vascular surgeons were the medical directors in 54% of the laboratories. Duplex ultrasound scanning was the diagnostic method used by 98% of the laboratories. In patients with unilateral symptoms, 75% of the laboratories did not routinely scan both legs for DVT. A large majority (75%) believe that bilateral scanning is not clinically indicated. Only 57 laboratories (14%) recalled having patients return with a DVT in the previously unscanned leg, with 93% of these laboratories reporting between one and five such patients. This observation correlated with larger volumes of venous studies performed by those laboratories (P <.05). Similarly, only 52 laboratories (12%) recalled having patients return with subsequent pulmonary emboli. Of these laboratories, only five reported proximal DVT in the previously unscanned legs of such patients. Of all these laboratories, therefore, only 1% (5 of 443) have potentially missed the diagnosis of a DVT that caused a preventable pulmonary embolus with such a policy. Among those laboratories that always perform bilateral examinations, 41% do so because of habit. Most (61%) of the laboratories that perform bilateral scanning would do unilateral scanning if it were specifically approved by ICAVL. CONCLUSION: Three quarters of the ICAVL-accredited vascular laboratories perform limited single-extremity scanning for the diagnosis of DVT in patients with unilateral symptoms. This broad clinical experience suggests that this practice is widespread in selected patients. Clinical protocols should be established to provide guidelines for local laboratory implementation. (+info)
The Calgary Biofilm Device: new technology for rapid determination of antibiotic susceptibilities of bacterial biofilms.
Determination of the MIC, based on the activities of antibiotics against planktonic bacteria, is the standard assay for antibiotic susceptibility testing. Adherent bacterial populations (biofilms) present with an innate lack of antibiotic susceptibility not seen in the same bacteria grown as planktonic populations. The Calgary Biofilm Device (CBD) is described as a new technology for the rapid and reproducible assay of biofilm susceptibilities to antibiotics. The CBD produces 96 equivalent biofilms for the assay of antibiotic susceptibilities by the standard 96-well technology. Biofilm formation was followed by quantitative microbiology and scanning electron microscopy. Susceptibility to a standard group of antibiotics was determined for National Committee for Clinical Laboratory Standards (NCCLS) reference strains: Escherichia coli ATCC 25922, Pseudomonas aeruginosa ATCC 27853, and Staphylococcus aureus ATCC 29213. Growth curves demonstrated that biofilms of a predetermined size could be formed on the CBD at specific time points and, furthermore, that no significant difference (P > 0.1) was seen between biofilms formed on each of the 96 pegs. The antibiotic susceptibilities for planktonic populations obtained by the NCCLS method or from the CBD were similar. Minimal biofilm eradication concentrations, derived by using the CBD, demonstrated that for biofilms of the same organisms, 100 to 1,000 times the concentration of a certain antibiotic were often required for the antibiotic to be effective, while other antibiotics were found to be effective at the MICs. The CBD offers a new technology for the rational selection of antibiotics effective against microbial biofilms and for the screening of new effective antibiotic compounds. (+info)