Clostridium difficile, a causative agent of intestinal infections (CDI) of varying severity, is an important nosocomial pathogen. Microbiological diagnosis, including an appropriate test algorithm and the corresponding interpretation of the results, is crucial for CDI confirmation. This update is based on the European guidance document for CDI laboratory diagnosis, taking into account the current CDI epidemiology and laboratory diagnostic approaches in the Czech Republic. Any diarrhoeal patient should be tested for CDI. The rectal swabs can only be used for testing in patients with paralytic ileus. Currently, a two-step test algorithm is recommended for CDI diagnosis. Due to a low positive predictive value, a single commercial test is not recommended as a stand-alone test for diagnosing CDI. Samples with a positive screening test (glutamate dehydrogenase or toxigenic strain nucleic acid) and a subsequent negative EIA (enzyme immunoassay) test for the presence of free toxins are diagnostically inconclusive. An option is to use a third confirmatory test; however, the current clinical status of the patient along with other laboratory findings should be considered in order to differentiate between ongoing CDI, carriage of a toxigenic strain of C. difficile, and other causes of diarrhoea. In general, when implementing a new diagnostic test, its sensitivity and specificity should be compared against the reference method. Diagnostic tests should refer to the data from published comparative studies and should not rely solely on information provided by the manufacturer. Currently, there is no commercial test available for detection of free C. difficile toxins in stool samples with 100 % sensitivity. Moreover, the pre-analytical conditions (storage and transport temperature of stool samples) and/or the initiation of an empirical therapy prior to the sampling may decrease the sensitivity of the assay.

BACKGROUND: The 2014 guidelines endorsed by Society of Surgical Oncology, the American Society of Breast Surgeons, and the American Society for Radiation Oncology advocate \"no ink on tumor\" as the new margin requirement for breast-conserving therapy (BCT). We used our lumpectomy margins database from 2004 to 2006 to predict the effect of these new guidelines on BCT.
METHODS: Patients with neoadjuvant therapy, pure ductal carcinoma-in situ, or incomplete margin data were excluded. We applied new (\"no ink on tumor\") and old (≥2 mm) margin guidelines and compared rates of positive margins, reexcision, and rates of residual disease found at reexcision.
RESULTS: A total of 437 lumpectomy surgeries met the eligibility criteria. Eighty-six percent had invasive ductal carcinoma, 12% invasive lobular carcinoma, and 2% invasive ductal carcinoma and invasive lobular carcinoma. Using a ≥2 mm margin standard, 36% of lumpectomies had positive margins compared to 18% using new guidelines (p < 0.0001). Seventy-seven percent of patients with \"ink on tumor\" had residual disease found at reexcision. Fifty percent of subjects with margins <2 mm had residual disease (p = 0.0013) but would not have undergone reexcision under the new guidelines. With margins of ≥2 mm, residual tumor was seen in the shaved margins of 14% of lumpectomies. Residual tumor was more common in reexcisions for ductal carcinoma-in situ <2 mm from a margin than for invasive cancer (53 vs. 40%), although this was not statistically significant.
CONCLUSIONS: Use of new lumpectomy margin guidelines would have reduced reoperation for BCT by half in our patient cohort. However, residual disease was present in many patients who would not have been reexcised with the new guidelines. Long-term follow-up of local recurrence rates is needed to determine if this increase in residual disease is clinically significant.

BACKGROUND: This study aimed to evaluate the impact that the release of consensus guidelines for margins in breast-conserving surgery (BCS) had on re-excision rates.
METHODS: A retrospective review examined a prospectively maintained database of patients who had operable invasive breast cancer treated with BCS at the authors\' institution. The patients were divided into two groups: (1) those with a diagnosis determined from 1 July 2011 to 31 July 2013 (before release of the guidelines) and (2) those with a diagnosis determined from 1 February 2014 to 31 July 2014 (after release of the guidelines). The groups were evaluated with respect to patient and tumor characteristics, re-excision rates, and reasons for re-excision.
RESULTS: A total of 846 cases of BCS were managed: 597 in group 1 and 249 in group 2. Re-excision rates were significantly reduced after release of the consensus guidelines (p = 0.03). Re-excisions were performed for 115 (19 %) of 597 patients in group 1 and 32 (13 %) of 249 patients in group 2. After release of the guidelines, re-excisions were performed for positive margins, as defined by the consensus statement, in 25 (78 %) of 32 cases. The two groups did not differ significantly in terms of age, tumor size, grade, nodal status, estrogen receptor status, progesterone receptor status, or human epidermal growth factor receptor 2 status. Group 1 had more tumors of mixed ductal and lobular histology than group 2, and group 2 had more lobular tumors than group 1 (p = 0.02).
CONCLUSIONS: The consensus guidelines on margins for BCS were applied for 78 % of the patients who underwent re-excision and resulted in a significant reduction in re-excision rates.

The purpose of this study was to compare guideline recommendations and day-to-day practice of serological testing for Lyme borreliosis (LB) in a laboratory located in Amsterdam, the Netherlands, serving both regional hospitals and primary care physicians. By telephone interview, we obtained clinical information regarding 488 requests for LB serology. Screening for LB was performed with a C6-peptide EIA and confirmed by recombinant immunoblot. A total of 82 % of the requests were not supported by guideline\'s recommendations and either originated from patients with atypical symptoms and a low a priori chance for LB or from patients for which testing on LB was not recommended for other reasons. C6-EIA screening was positive in 5 % of patients with atypical symptoms, comparable to the seroprevalence in the Dutch population. Interestingly, 10 % of the requests were from patients with atypical skin lesions, of which 20 % was positive, suggesting that serological testing is of additional value in a selection of such patients. Strikingly, only 9 % of the requests were supported by recommendations by guidelines. The percentage of positive confirmatory IgM and/or IgG immunoblots did not differ substantially between the groups and ranged from 56 to 75 %. Guidelines for testing for LB are not adequately followed in the Netherlands. Better education and adherence to the guidelines by physicians could prevent unnecessary diagnostics and antibiotic treatment of supposed LB patients.

Clostridium difficile infection (CDI) is a leading cause of hospital-associated gastrointestinal illness and places a high burden on our health-care system. Patients with CDI typically have extended lengths-of-stay in hospitals, and CDI is a frequent cause of large hospital outbreaks of disease. This guideline provides recommendations for the diagnosis and management of patients with CDI as well as for the prevention and control of outbreaks while supplementing previously published guidelines. New molecular diagnostic stool tests will likely replace current enzyme immunoassay tests. We suggest treatment of patients be stratified depending on whether they have mild-to-moderate, severe, or complicated disease. Therapy with metronidazole remains the choice for mild-to-moderate disease but may not be adequate for patients with severe or complicated disease. We propose a classification of disease severity to guide therapy that is useful for clinicians. We review current treatment options for patients with recurrent CDI and recommendations for the control and prevention of outbreaks of CDI.

The performance of the previously validated LUCIO(®)-Direct-enzyme linked immunosorbent assay (direct ELISA) screening tests according to forensic guidelines is compared to that of cloned enzyme donor immunoassays (CEDIA) test for drugs of abuse in urine as defined in the new re-licensing German medical and psychological assessment (MPA) guidelines. The MPA screening cut-offs correspond to 10 ng/ml 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic acid (THC-COOH), 50 ng/ml amphetamine and designer amphetamines, 25 ng/ml morphine, codeine and dihydrocodeine, 30 ng/ml benzoylecgonine, 50 ng/ml methadone metabolite, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) and metabolites of diazepam, oxazepam, bromazepam, alprazolam, flunitrazepam and lorazepam at 50 ng/ml. Average relative sensitivities and relative specificities were 99.7 % and 98.4 % for direct ELISA and 66 % and 91.4 % for CEDIA, respectively.

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Commission Decision (CD) 2002/657/EC describes detailed rules for method validation within the framework of residue monitoring programmes. The approach described in this CD is based on criteria. For (qualitative) screening methods, the most important criteria is that the CCβ has to be below any regulatory limit. Especially when microbiological or immunochemical methods are involved, the approach described in the CD is not easily applied. For example, by those methods, a large number of analytes (all antibiotics) within several different matrices (meat, milk, fish, eggs, etc.) are detected. It is not completely clear whether all those analytes and all matrices have to be taken into account during method validation. To clarify this, a working group - from EU Reference Laboratories - came up with a practical approach to validate multi-analyte multi-matrix screening methods. It describes how many analyte/matrix combinations have to be tested and how these combinations are selected. Furthermore it describes how to determine CCβ for screening methods in relation to a large list of compounds and maximum residue limits (MRLs). First for each analyte/matrix combination the \'cut-off\' level - i.e. the level at which the method separates blanks from contaminated samples - is established. The validation is preferably at the concentration of 50% of the regulatory limit. A minimum set of 20 different samples has to be tested. From the experiences with applying these guidelines it was concluded that the validation approach is very \'practical\'; however, there are some remarks. One has to be careful with selecting \'representative\' analytes and matrices and it is strongly recommended to collect additional validation data during the routine application of the method.

We evaluated HER-2/neu status in 100 consecutive ductal breast carcinomas by using the Food and Drug Administration (FDA) and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) scoring systems. With the FDA system, scores were 3+ in 23.0%, 2+ in 25.0%, and 0 or 1+ in 52.0% of cases. With the ASCO/CAP system, scores were 3+ in 16.0%, 2+ in 34.0%, and 0 or 1+ in 50.0%. With the FDA and ASCO/CAP systems, respectively, 3+ cases (n = 23 and 16, respectively) showed high-grade, granular HER-2/neu amplification in 15 (65%) and 14 (88%); low-grade, borderline amplification in 7 (30%) and 1 (6%); and chromosome 17 polysomy without amplification in 1 (4%) and 1 (6%). Concordance between schemes was higher for cases with high-grade, granular HER-2/neu amplification (concordance coefficient, 0.74). Cases with low-grade, borderline HER-2/neu amplification showed poor concordance (concordance coefficient, 0.20). The FDA and ASCO/CAP schemes for HER-2/neu evaluation select patients differently for trastuzumab therapy. Major discordance is present for low-grade, borderline HER-2/neu amplification. FDA low-grade, borderline tumors would be reclassified as without HER-2/neu amplification or as polysomic. The ASCO/CAP scheme has a great concordance coefficient between strong 3+ immunohistochemical cases and cases with high-grade, granular HER-2/neu amplification.

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