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PubMed2001

Screening of blood donations by hepatitis C virus polymerase chain reaction (HCV-PCR) improves safety of blood products by window period reduction.

Introduction of the nucleic acid amplification technique (NAT) as a screening test for blood donors to detect HCV RNA became mandatory on 1 April 1999. Few automated commercial systems are available for HCV RNA detection at the moment. The Cobas Amplicor HCV 2.0 System is able to perform fully automated amplification and detection of nucleic acids. A concentration of 98 IU HCV RNA/ml can be detected by the Cobas Amplicor HCV 2.0 System (n = 233, in 100% of the cases). With a pool size of 40 donor samples, the guidelines of the Paul-Ehrlich-Institute concerning sensitivity (5,000 IU HCV RNA per mL in a single donation) were followed. One whole blood donation was identified as HCV-RNA positive (anti-HCV IgG negative, GPT < 30 U/L) during a period of 5 months. No false positive test results could be observed. The internal control and the run control are primarily helpful to monitor methodological problems.

Autoanalysis↗
PubMed1998

Cushing's syndrome: a ten year experience at Tikur Anbassa Hospital.

A retrospective analysis of Cushing's syndrome from the retrieved records of 24 out of a total of 27 referred cases over a period of 10 years (January 1985-January 1995) showed confirmation in 16 cases. Fourteen (88%) were females, 9 (56%) were in their third decade. Duration of symptoms before admission was one year or less in eleven (69%) patients. Among symptoms weakness, fatigue and weight gain and among signs moon face, truncal obesity and buffalo hump were found in all patients. Amenorrhea occurred in all the women of childbearing age. Basal urinary 17-hydroxycorticoid (17-OHCS) values were elevated in 9/12 patients and low dose dexamethasone suppression test favoured Cushing's syndrome in 8/9 patients. Definitive treatment consisted of bilateral adrenalectomy in 7 and transfrontal pituitary adenomectomy in 3. Two patients declined surgery; 4 patients were lost to follow up before definitive treatment. Two patients who had bilateral adrenalectomy and two who had transfrontal adenomectomy died subsequently while three remained in good health on corticosteroid replacement therapy. Three of the 7 patients who had bilateral adrenalectomy developed Nelson's syndrome. It is concluded that Cushing's disease is the most frequent cause of Cushing's syndrome in our series. The patients presented with the well-known clinical manifestations of hypercortisolism. However, our laboratory facilities require considerable improvement to serve as a reliable adjunct to clinical evaluation. Since Cushing's syndrome, whatever the cause, is eventually fatal if left untreated, surgical intervention is mandatory after confirmation of the cause with appropriate laboratory tests.

Adolescent↗
PubMed2003

An improved serodiagnostic test for Chagas' disease employing a mixture of Trypanosoma cruzi recombinant antigens.

BACKGROUND: Blood transfusion is one of the most important transmission routes of Chagas' disease, a major parasitic infection in Latin America. Therefore, screening for antibodies to Trypanosoma cruzi is mandatory in blood banks in South America. Most of the commercial serologic tests employ epimastigote antigens and show a high number of inconclusive and false-positive results, with high economic and social costs. STUDY DESIGN AND METHODS: An ELISA using a mixture of three T. cruzi recombinant antigens, B13, 1F8, and H49 (mix-ELISA), was evaluated, first with a panel of well-characterized sera from 617 patients with Chagas' disease and 277 nonchagasic individuals, living in nine countries of South and Central America. Subsequently, the mix-ELISA was evaluated with 451 samples, from an endemic area of Brazil (Goiás), that were rejected from several blood banks because they presented discrepant results by two commercially available kits (indirect immunofluorescence assay, indirect hemagglutination assay, and/or ELISA). RESULTS: The mix-ELISA exhibited 99.7 percent sensitivity and 98.6 percent specificity in the first evaluation with the 894 samples. In the second evaluation, 451 sera that had discrepant results in the first screening for Chagas' disease were further analyzed with the mix-ELISA. Upon consideration of the consensus results obtained with the trypomastigote excreted-secreted antigens blot test, a confirmatory test for Chagas' disease, the mix-ELISA led to a reduction in 99.6 percent in the number of discordant sera. CONCLUSION: The combination of three T. cruzi recombinant antigens in a multiantigen immunoassay was highly sensitive and specific for Chagas' disease diagnosis. It is proposed that it can be applicable in blood bank screening in conjunction with the conventional serologic tests.

Animals↗
PubMed2006

[Comparison of Preferential Hyperacuity Perimeter (PHP) test and Amsler grid test in the diagnosis of different stages of age-related macular degeneration].

BACKGROUND: Age-related macular degeneration (ARMD) is the leading cause of blindness in people over 65 years of age. A rapid loss of vision occurs especially in cases with choroidal neovascularisation. Early detection of ARMD and timely treatment are mandatory. We have prospectively studied the results of two diagnostic self tests for the early detection of metamorphopsia and scotoma, the PHP test and the Amsler grid test, in different stages of ARMD. PATIENTS AND METHODS: Patients with ARMD and best corrected visual acuity of 6/30 or better (Snellen charts) were examined with a standardised protocol, including supervised Amsler grid examination and PHP, a new device for metamorphopsia or scotoma measurement, based on the hyperacuity phenomenon in the central 14 degrees of the visual field. The stages of ARMD were independently graded in a masked fashion by stereoscopic ophthalmoscopy, stereoscopic fundus colour photographs, fluorescein angiography, and OCT. The patients were subdivided into 3 non-neovascular groups [early, late (RPE atrophy > 175 microm) and geographic atrophy], a neovascular group (classic and occult CNV) and an age-matched control group (healthy volunteers). RESULTS: 140 patients, with ages ranging from 50 to 90 years (median 68 years), were included in the study. Best corrected visual acuity ranged from 6/30 to 6/6 with a median of 6/12. 95 patients were diagnosed as non-neovascular ARMD. Thirty eyes had early ARMD (9 were tested positive by the PHP test and 9 by the Amsler grid test), and 50 late ARMD (positive: PHP test 23, Amsler grid test 26). The group with geographic atrophy consisted of 15 eyes (positive: PHP test 13, Amsler grid test 10). Forty-five patients presented with neovascular ARMD (positive: PHP test 38, Amsler grid test 36), 34 volunteers served as control group (positive: PHP test 1, Amsler grid test 5). CONCLUSIONS: The PHP and Amsler grid tests revealed comparable results detecting metamorphopsia and scotoma in early ARMD (30 vs. 30 %) and late ARMD (46 vs. 52 %). However, the PHP test more often revealed disease-related functional changes in the groups of geographic atrophy (87 vs. 67 %) and neovascular ARMD (84 vs. 80 %). This implies that the PHP and Amsler grid self tests are useful tools for detection of ARMD and that the PHP test has a greater sensitivity in the groups of geographic atrophy and neovascular AMD.

Aged↗
PubMed2001

Dose intensive chemotherapy in small cell lung cancer.

The rationale for treatment intensification is to overcome the occurrence of drug resistance and to improve the outcome in SCLC. Several different approaches have been tested in the past two decades. Increasing the dose of conventional chemotherapy has failed to improve survival in extensive stage. In limited stage patients one randomized trial demonstrated a significant survival advantage by a 20% increase of the dose of cisplatin and cyclophosphamide given during the first cycle of chemotherapy. Shortening treatment intervals is achievable by weekly chemotherapy or by use of hematopoietic growth factors. Neither weekly chemotherapy, tested in four randomized trials, nor the application of hematopoietic growth factors significantly improved survival. However, two studies described a better survival for patients receiving chemotherapy in shorter treatment intervals. In one trial a 3-week interval was superior to a 4-week interval, and in a second one a 2-week interval superior to a 3-week interval. One smaller study, comparing a 4-week interval with a 2-week interval with stem cell augmentation by whole blood, revealed no difference in survival between both groups. A randomized trial comparing chemotherapy in intervals as short as possible with or without growth factor application showed no difference for the two groups. Thus, growth factor application seems not to be essential for treatment in short intervals and was not associated with superior survival in randomized trials. To achieve a more than two-fold increase in dose intensity some kind of stem cell support is mandatory. Several phase II trials with small patient numbers tested the concept of late intensification with bone marrow support in the 1980s. These trials did not show any convincing benefit. There is one randomized trial available testing the late intensification approach in which a superior progression free survival and a trend for better survival was demonstrated, but this difference was not statistically significant due to a high mortality rate and a substantial number of local relapses in the high dose arm. Newer concepts involving high dose therapy are combining high dose strategies with approaches for better local tumor control, administer high dose regimens earlier in the treatment course, or use multiple sequential high dose cycles. With these approaches 3-year survival rates of up to 40% have been reported. So up to date, the superiority of an intensified treatment strategy has not been demonstrated in a convincing way and further controlled trials will be necessary to clarify the role of dose intense chemotherapy in SCLC.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1998

[Trends in HIV prenatal screening from 1992 to 1994 in South Eastern France].

BACKGROUND: To study trends in HIV testing among pregnant women before and after the introduction of mandatory screening in January 1993. METHODS: The study was based on data from the Prevagest surveys which were carried out in the Provence-Alpes-Côte d'Azur region in samples of pregnant women who just delivered in 1992 (n = 2,775) and 1994 (n = 2,701). RESULTS: The proportion of women declaring that they had been tested during pregnancy increased from 63% in 1992 to 73% in 1994 (p < 0.001). The percentage of women who believe they were tested without consent decreased from 14% in 1992 to 6% in 1994 (p < 0.001). In 1994, 86% nevertheless declared that they received no information on AIDS and its prevention during their pregnancy. After adjustment by a logistic model, type of prenatal care and educational level longer appeared in 1994 to be associated with a lower probability of declaring having been tested. On the contrary, women originating from North Africa, those younger than 25 years and married women had a lower probability of declaring that they have been tested in 1994 as well as 1992. CONCLUSIONS: This study stresses the need for improved communication between public health professionals and practitioners and the establishment of effective training programs in HIV preventive counselling for health professionals in charge of prenatal care.

Adult↗
PubMedDate not supplied

Pseudohypoparathyroidism type IA and II with severe neuropsychic manifestations.

Pseudohypoparathyroidism (PHP) is characterized by unresponsiveness of target tissues to the biological actions of the parathyroid hormone (PTH), with resulting hypocalcemia and hyperphosphatemia, despite the elevated serum levels of PTH. PHP is divided into types Ia, b, c and II, depending on the presence of Albright's hereditary osteodystrophy (AHO), defective urinary excretion of phosphate (U-P) and response in urinary excretion of cyclic adenosine monophosphate (U-cAMP) after the administration of exogenous PTH. Patients with PHP might exhibit various manifestations of neuropsychic disturbances. We present two boys, aged 14 and 16 years, both with paresthesia, anxiety and epilepsy; the former patient also suffered from mild mental retardation. In both patients, hypocalcemia and hyperphosphatemia together with increased serum levels of PTH suggested the diagnosis of PHP. After administration of exogenous PTH (Ellsworth-Howard test), there was a drop in U-P in both patients, while U-cAMP was decreased in the first patient and increased in the second one, thus confirming the diagnoses of PHP Ia and II, respectively. Neuropsychic disturbances and epilepsy resolved completely in both patients after treatment with calcium and dihydrotachysterol. Evaluation of calcemia and phosphatemia should be mandatory in all patients with neuropsychic disorders. Ellsworth-Howard test remains a useful tool in the differential diagnosis of PHP.

Adolescent↗
PubMed2004

[The pathologist and EGFR in 2004: I like you, nor do it].

Epithelial growth factor receptor (EGFR) appears as a key element in carcinogenesis. It displays high levels of expression in some tumor types. Its activation induces cell proliferation, angiogenesis, cell mobility and inhibition of apoptosis. EGFR inhibitors such as monoclonal antibodies or small molecules tyrosine kinase inhibitors have been developed. For EGFR, the diversity of the activation means (amplification, mutation, enhanced transcription, ligands...) leads to technical caveats. Immunohistochemistry appears to be the most appropriate test for clinical use, but standardized assays and scoring systems are mandatory. Pathologists are involved in the selection of patients for a monoclonal antibody based targeted treatment, Erbitux, and numerous standardization efforts are provided. No consensus has been reached, to date, for a scoring system. Whether the EGFR status has to be tested for the selection of patients is a non answered question. The selection of the "right patient for the right treatment" might be through the evaluation of other putative markers involved in resistance. EGFR testing may be required before targeted treatment. An exciting endpoint might be the functional and dynamic evaluation of EGFR and downstream proteins, for patients, before and during treatment. The exact role of the pathologist still have to be accurately determined.

Antibodies, Monoclonal↗
PubMed2003

Feedback for general practice trainers: developing and testing a standardised instrument using the importance-quality-score method.

INTRODUCTION: Although general practice vocational training has been mandatory in Germany since 1993, a service philosophy still prevails. To help general practice trainers develop their identity and skills as trainers we developed and tested a standardised instrument. The questionnaire is to be filled in by registrars after their attachment to a given practice and handed to the trainer as personal feedback on the training provided. METHODS: Items were collected by asking experts in the field to name content that should be covered. The resulting items were reduced using the importance-quality method derived from health-related quality of life research. Reliability was tested by registrars rating their training twice 3 weeks apart. They also provided free text comments that were coded and analysed to establish criterion validity. RESULTS: A total of 121 items were collected. Eighty registrars provided importance and quality ratings to reduce these to 43 items. Test-re-test reliability and criterion validity were also established. CONCLUSION: The importance-quality method proved to be useful for item reduction according to the objective of the questionnaire. Instruments evaluating the quality of vocational training must be context-sensitive.

Education, Medical, Continuing↗
PubMed1996

Nurses' body fluid exposure reporting, HIV testing, and hepatitis B vaccination rates: before and after implementing universal precautions regulations.

The purpose of this study was to investigate whether mandatory universal precautions changed nurses' body fluid exposure and reporting rates, hepatitis B vaccination rates, and human immunodeficiency virus (HIV) testing rates. Random cross-sectional surveys of nurses in Tennessee were conducted in 1991 and 1993 (n = 145 in 1991; n = 143 in 1993). The questionnaire in both surveys included frequency of body fluid exposures and reporting in the past year, and whether or not the respondent had received the hepatitis B vaccine or had been HIV tested. Findings indicated that self reported needlestick injuries decreased by 69%, and other sharps injuries decreased by 81%. Only 4.1% of all exposure incidents reported on this anonymous survey were reported to employee health officials, as required. Body fluid exposure incidents were the most common form of exposure (81%) and the most underreported. Hepatitis B vaccinations significantly increased (61.4% to 82.5%), with a nonsignificant increased in HIV testing (47.2% to 55.6%) from 1991 to 1993. Findings of this study suggest that the universal precautions regulatory mandate has been effective in increasing nurses' compliance to universal precautions. Body fluid contacts were significantly underreported and showed no decrease between 1991 and 1993.

AIDS Serodiagnosis↗
PubMed2003

[Epidermal growth factor receptors: status evaluation methods and tumor expression].

The development of targeted antitumor agent aiming the HER family of tyrosine kinase transmembrane receptors, focused on the issue of target detection. For HER2, the techniques used to detect an overexpression are well established and none has, to date, shown its superiority. These are immunohistochemistry (protein) and in situ fluorescent hybridization (DNA). For EGFR, the diversity of the activation means (amplification, mutation, enhanced transcription, ligands...) leads to technical caveats. Immunohistochemistry appears to be the most appropriate test for clinical use but standardized assays and scoring systems are mandatory. The EGFR levels of expression are very high in some normal tissues such as oral mucosae. In tumors, EGFR levels are variable. The highest expression is found in head and neck epithelial tumors. EGFR expression is also elevated in oral and lung dysplasia. EGFR testing may be required before targeted treatment. An exciting endpoint would be the functional and dynamic evaluation of EGFR and downstream proteins for patients, before and during treatment.

ErbB Receptors↗
PubMed1997

Standardisation of allergens in Europe.

A general monograph for allergen products has now been adopted by the European Pharmacopoeia Commission. It is based on the use of an In-House Reference Preparation (IHRP), which shall be used in the control of every production batch after appropriate characterization. This characterization will depend on the intended use of the product. When possible, the biological potency should be established by skin testing and expressed in biological units. The monograph is the first mandatory regulation in Europe for allergen products and will guarantee the consistent composition and potency of the products on the market.

Allergens↗
PubMed1998

The millennium criteria for the diagnosis of atopic dermatitis.

Atopic dermatitis forms an active area of basic and clinical research, where important new knowledge about genetics and immunopathogenesis has surfaced over the past years, and where simultaneous development of new and innovative therapies is under way. However, the inclusion of any patient in an atopic dermatitis study, whether it is on its genetics, pathogenesis or therapy, requires a diagnosis which is irrefutable. Since there is no simple and also no complicated laboratory procedure to reach a diagnosis of atopic dermatitis, different sets of clinical criteria have been developed for the purpose of making the diagnosis uniformly in different studies as well as in different study centers. The most commonly used are Hanifin and Rajka's set of diagnostic features, which have major and minor clinical criteria to be fulfilled in order to establish a diagnosis of atopic dermatitis. Recent developments in the immunology of atopy have clearly established the major abnormality in this syndrome, the preferential production of allergen-specific IgE. In this contribution, it is suggested that the presence of such antibodies in a given patient should be a mandatory criterium for the diagnosis of atopic dermatitis. Such a diagnostic test however establishes a diagnosis of atopic syndrome, not atopic dermatitis. Thus, for atopic dermatitis we have to rely, for the time being, on additional clinical criteria. The clinical features described in the literature are critically evaluated, and it is suggested that in addition to the mandatory presence of allergen-specific IgE, 2 of 3 principal criteria (pruritus, typical morphology and distribution, chronic or chronically relapsing) should be present for such a diagnosis. Finally, the minor features originally described by Hanifin and Rajka and later evaluated by others are revised and divided over 4 subcategories; a) related to subclinical eczema; b) related to dry skin; c) extra skin folds; and d) ophthalmological pathology. They are suggested to be used as additional criteria only, needed when clinical suspicion is high but the new mandatory and principal diagnostic criteria described here are inconclusive. For study purposes, we suggest that the mandatory and principal criteria are sufficient. They are now evaluated and validated in ongoing atopic dermatitis treatment studies.

Animals↗
PubMed1991

Penetrating wounds of the neck.

The management of penetrating wounds of the neck provides several decision-making steps that remain controversial. The two basic concepts of management include the idea that all wounds deep to the platysma should be explored and (the more conservative concept) that selective neck exploration should be based on a battery of tests to identify traumatic injuries. The areas of agreement within these two schools of thought include exploration of wounds with obvious injury, exploration of wounds in which patients cannot be stabilized satisfactorily for further testing, and the idea that all patients with wounds deep to the platysma should be admitted to the hospital. The remaining issues, including the need for angiography, barium swallow, or endoscopy, still are contested. Mandatory exploration of neck wounds became popular during World War II. The weapons used, the lack of accurate testing, and delays in treatment caused by transport problems played significant roles in the development of this policy. Proponents of mandatory exploration of neck wounds contend that delays in treatment result in increased mortality rates. Also delays caused by lengthy diagnostic testing have resulted in rapid exsanguination of patients who might otherwise have been surgically salvageable. These factors, along with the potential for undetected injuries and the associated complications (including false aneurysms and mediastinitis) favor mandatory exploration. Advocates of routine neck explorations also note the low morbidity rates associated with a neck exploration. Reported rates of negative exploration are high, however, approaching 45%, and mortality rates vary from 2% to 9%. Selective neck exploration has gained popularity in some centers because of the lower negative exploration rates associated with this treatment, while comparable mortality rates are achieved. May found a negative exploration rate of 12% in his series of selective neck explorations and a mortality rate of approximately 3%. Furthermore, Noyes found that the hospital stay for patients with selective observation management not requiring a neck exploration was 2.8 days, compared with 4.2 days for patients with mandatory but negative neck explorations. A summary of diagnostic techniques and their indications in selecting patients with penetrating neck wounds for surgery is presented in Table 5. It has become apparent that both selective and mandatory explorations of neck wounds play important roles in treatment.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1984

Cerebral toxoplasmosis in acquired immune deficiency syndrome.

The clinical course of and pathologic findings in a patient with cerebral toxoplasmosis and acquired immune deficiency syndrome were evaluated. The nonspecificity of CNS signs, symptoms, and laboratory features were noted. Appropriate serologic tests and a biopsy of suspicious cerebral lesions were mandatory for confirmation of the diagnosis and administration of appropriate therapy. The importance of recognizing the nature of this infectious process and of instituting vigorous therapy as promptly as possible was emphasized.

Acquired Immunodeficiency Syndrome↗
PubMed1989

Computed tomography and diagnostic peritoneal lavage in blunt abdominal trauma. Their combined role.

We reviewed medical records and films of all 196 trauma patients who underwent computed tomography (CT) between June 1982 and October 1986 to see whether CT achieved the level of accuracy attributed to it, whether diagnostic peritoneal lavage (DPL) performed in conjunction with CT was a useful diagnostic test for blunt abdominal trauma, and whether laparotomy was mandatory when pelvic fluid collections were seen by CT after blunt trauma. A total of 36 patients underwent DPL, 29 before and seven after CT. There were seven false-negative CTs that were clinically significant. Diagnostic peritoneal lavage was positive in three patients who had false-negative CTs. Although overall accuracy was excellent, CT was not reliable in detecting bowel injury. Diagnostic peritoneal lavage was helpful in detecting injuries missed by CT. Most stable patients with moderate or large intraperitoneal fluid collections on CT accompanying solid viscus injury were treated successfully without laparotomy.

Abdominal Injuries↗