Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Mandatory Testing”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,243 records · Page 69Linked to original sources
PubMed2006

Food for thought in women's health. The gynecologist: the new European gatekeeper in Chlamydia trachomatis infection.

Genital Chlamydia trachomatis infection is the principal cause of bacterial sexually transmitted disease in industrialized countries. A wide spectrum of pathologic conditions has been associated with the disease ranging from urethritis, cervicitis, to pelvic inflammatory disease, ectopic pregnancy, tubal infertility and cervical neoplasia. Screening for genital Chlamydia infection may prevent its serious complications. The need of a comprehensive European screening policy has been recently underlined by PACMeR's scientific committee. Anyhow invitational screening programs are only at the beginning. Chlamydia trachomatis control ''orphan'' and women's health at risk. Until organized programs are developed, implementation of opportunistic screening is mandatory. Since the infection is more commonly observed among juvenile females proper testing of the young women is recommended. As asymptomatic young women in reproductive age are more eager to visit gynaecologists for periodical gynaecological examination and councelling (cervical cytology, breast examination, contraception and family planning), gynaecologist represents the only specialist able to provide early diagnosis of Chlamydia trachomatis. Gynaecologists are called to play a new role in public healthcare, being ''gatekeepers'' for the early detection of the disease, emphasizing their crucial part in young women's health.

Adolescent↗
PubMed1993

[Initial experiences using SPECT cameras with multiple detector heads].

User acceptance testing of newly installed gamma cameras is mandatory in order to verify manufacturers' specifications and to ensure optimal image quality. Acceptance test procedures are widely standardized today and are carried out following commonly accepted test protocols. Two new triple head gamma cameras have been installed during the last year at the Department of Nuclear Medicine of the Vienna University Hospital. For acceptance testing of these cameras a modified and expanded version of the commonly used test protocol for single head SPECT systems has been employed. Details of the tests that have been carried out and a comparison of the results obtained for both cameras are presented. Furthermore, some specific problems that are encountered during acceptance testing of multiple head systems are discussed. In particular it has been noted that some important tests of intrinsic camera parameters cannot be carried out, which makes a complete verification of vendors' specifications impossible. In spite of these problems the acceptance test system for multiple head cameras presented in this work was sufficient for establishing proper working conditions for clinical use.

Equipment Design↗
PubMed1998

Evaluation of the performance of Brazilian blood banks in testing for Chagas' disease.

BACKGROUND AND OBJECTIVES: Due to the low sensitivity and reproducibility of available tests, in 1989 it became mandatory for all Brazilian blood donors to be screened for Chagas' disease by at least two serological techniques. In 1994 the Brazilian Ministry of health launched a program to systematically evaluate the quality of serological screening for the detection of blood-transmissible diseases as performed by public blood banks. METHODS: A blind panel containing positive samples for blood-transmissible disease was distributed to 57 major public blood banks in four sequential programs. RESULTS: The ELISA test was chosen by the majority of the blood banks. There were 64 (3.7%) false-negative results, 49 produced by banks using indirect hemagglutination. Since most blood banks screened with more than one test for Chagas, only 8 samples were actually missed, of which 3 were by banks using only one test. CONCLUSION: Our data show a clear improvement in performance of Brazilian blood banks testing for Chagas' disease.

Animals↗
PubMed2006

[Anonymous STD counselling versus mandatory checks for prostitutes--what is effective in STD prevention?].

BACKGROUND: When in 2001 in Germany the new act for control of infectious diseases came into force, mandatory checks for prostitutes were abolished. The consequences of this paradigm shift in STD prevention are being judged controversially even today. The public health department of the city of Cologne, like others, adapted its programme, staff, equipment, and diagnostic procedures to the new requirements. The department for venereal disease control was converted into a walk-in-clinic for STD and now forms part of a comprehensive STD and Aids prevention unit. The present article illustrates the changes by comparing the clients and the STD numbers of the years 1994 and 2004. METHOD: The following data were compared: number of consultations, number of clients regarding sex, occupation in sex business, health insurance, national or ethnic background, frequency of consultation, number of STD. RESULTS: In 1994, almost all clients of the department for venereal disease control were female prostitutes. 74% of them worked in established sex business venues with a high grade of professionalism, few STD cases were diagnosed. In 2004, the STD clinic was open for anybody considered to be at risk and not having access to the regular health care system. Only 49% of the patients were prostitutes, either female or male. 25% of the clients were male. 68% of the patients were migrants, many of them without any legal status and without any access to regular health care. A high number of acute STD and subsequent disorders that required treatment was registered. Besides the STD-related services, a great need for gynaecological and urological differential diagnostics as well as a high demand for counselling and provision of other problems of sexual health were observed. DISCUSSION: The data show that an STD department providing comprehensive services anonymously and free of charge will reach a broader range of highly vulnerable persons in comparison with an obligatory VD check of prostitutes. The high numbers of STD and STD-related disorders demonstrate the improved effectiveness of the new service.

Adolescent↗
PubMed2000

Coarctation of the aorta in adults: surgical results and long-term follow-up.

BACKGROUND: The aim of this retrospective study was to determine the impact of coarctation surgical repair on arterial blood pressure in adults more than 20 years of age. METHODS: Thirty-five adults (23 men), mean age 28.1 +/- 5.7 years (range, 21 to 52 years), underwent coarctation surgical repair between 1977 and 1997. All patients had preoperative hypertension. Mean systolic blood pressure was 178 +/- 37 mm Hg (range, 110 to 230 mm Hg). Thirty-three patients were taking at least one hypertension medication at the time of operation. All patients had preoperative catheterization and angiography (mean gradient across the coarctation was 62 +/- 27 mm Hg [range, 32 to 130 mm Hg]). Operative technique was resection and end-to-end anastomosis for 30 patients, resection with Dacron (C. R. Bard, Haverhill, MA) graft for 4 patients, and a prosthetic bypass graft for 1 patient. There were no hospital deaths and no late morbidity. RESULTS: All patients were reviewed. Follow-up was 165 +/- 56 months (range, 25 to 240 months). Of the 35 patients with preoperative hypertension, 23 were normotensive (systolic blood pressure < or = 140 mm Hg, diastolic blood pressure < or = 90 mm Hg) with no medication. Twelve patients were receiving medication: 6 required single-drug therapy and 6 patients required two drugs. Exercise testing was performed at an average of 6 +/- 4 months after repair and revealed hypertensive response to exercise in 8 of the 23 patients who were normotensive at rest and without medication. There were no recoarctation or repeat operations. Six aortic valve diseases were observed: three aortic incompetences (two bicuspid valves) treated by two valve replacements and one Bentall procedure, and three aortic stenoses (two valve replacements). No patient had evidence of a cerebrovascular accident. CONCLUSIONS: Surgical repair of coarctation in adults has proved to be an effective procedure and significantly reduces arterial hypertension. However, long-term surveillance is mandatory and should include exercise testing to identify patients with potential hypertension.

Adult↗
PubMedDate not supplied

How (who?) and when to test or retest for H. pylori.

Several direct/invasive and indirect/non-invasive diagnostic tests are available for the diagnosis of H. pylori infection. Invasive tests require biopsy sampling of the gastric mucosa and include rapid urease test, histology, bacterial culture and polymerase chain reaction technique. Non-invasive tests include the urea breath test and serological assays. This review gives a critical comparative analysis of accuracy, advantages and limitations of the different diagnostic tests including current cost and availability in Belgium. Rapid urease testing (RUT) of gastric biopsy specimens is probably the initial test of choice in patients undergoing endoscopy because of its low cost, rapid availability of results, simplicity and accuracy. Histological examination of gastric biopsy samples should be mandatory at the initial presentation of the patient because it also gives insight on the status of the gastric mucosa (inflammation & premalignant changes). Although not mandatory for primary diagnosis, a biopsy for culture and sensitivity testing should always be obtained when it is available and when endoscopy is undertaken as part of the patient's management. Among the non-invasive tests, the place of serology remains questionable for other than epidemiological purposes. How is H. pylori infection best diagnosed? How many tests are needed in routine clinical practice? The answer will depends on the clinical setting and local availability of the tests. For primary diagnosis in dyspeptic patients--where endoscopy is an important tool--a biopsy-based detection system is appropriate an we recommend the use of at least two diagnostic tests based on different principles, like RUT (with 1 or 2 biopsy specimen/test) and histology (including antrum & corpus biopsies) which are widely available. Alternatively a urea breath test may also be recommended when endoscopy is not required. Post-treatment monitoring seems to be justified in most cases and must always be performed at least 4-6 weeks after completion of therapy. The urea breath test is probably the method of choice for non-invasive testing in this clinical setting. When endoscopy is required, multiple biopsy specimens both from the antrum and the corpus and the use of at least two different diagnostic methods must be performed. Whenever possible, culture should always be done as it is very specific and allows testing of antimicrobial susceptibility which is mandatory in case of treatment failures. Neither the "Test and Treat" nor the "Test and Scope" strategies have been investigated in terms of effectiveness of symptoms relief and cost in Belgium and cannot therefore be recommended at this time.

Bacteriological Techniques↗
PubMed2004

Basic problems of serological laboratory diagnosis.

Serological laboratory diagnosis of infectious diseases is inflicted with several kinds of basic problems. One difficulty relates to the fact that the serological diagnosis of infectious diseases is double indirect: The first indirect aim in diagnosing an infectious disease is to identify the microbial agent that caused the disease. The second indirect aim is to identify this infectious agent by measuring the patient's immune response to the potential agent. Thus, the serological test is neither measuring directly disease nor the cause of the disease, but the patient's immune system. The latter poses another type of problem, because each person's immune system is unique. The immune response to an infectious agent is usually of polyclonal nature, and the exact physicochemical properties of antibodies are unique for each clone of antibody. The clonal makeup and composition and, therefore, the way an individual's immune system sees an infectious agent, depends not only on the genetic background of the person but also on the individual experience from former encounters with various infectious agents. In consequence, the reaction of a patient's serum in an analytical system is not precisely predictable. Also, the antigenic makeup of an infectious agent is not always foreseeable. Antigenic variations leading to different serotypes is a quite common phenomenon. Altogether, these biological problems lead to complexities in selecting the appropriate tests and strategies for testing, in interpreting the results, and in standardizing serological test systems. For that reason, a close collaboration of the laboratory with the clinic is mandatory to avoid erroneous conclusions from serological test results, which might lead to wrong decisions in patient care.

Antibody Affinity↗
PubMed1985

[Effects of the addition of serum albumin on penetration of human spermatozoa into zona-free hamster eggs].

Since Yanagimachi et al. (1976) suggested that human spermatozoa were capable of penetrating into zona-free hamster eggs, this in vitro assay has been used to analyse the fertilizing ability of human spermatozoa. Serum albumin is an important constituent of the medium used for the assay. However, a great variation in the rate of sperm penetration was observed in the use of different albumin preparations at different concentrations. Therefore we examined the effects of three different kinds of albumin preparations on the rate of human sperm penetration into zona-free hamster eggs. The results obtained were as follows. The percentages of eggs being penetrated by spermatozoa from three fertile donors A,B, and C, were assessed. When Fraction V, Globulin Free and Fatty Acid Free albumin preparations were tested at a concentration of 3.5% (W/V) by the assay using sperm from donor A, penetration rates were 13.3%, 97.4%, and 8.7% respectively. Dilution of the albumin concentration to 0.3% considerably changed the penetration rates to 64.4%, 78.8% and 12.1% in that order. In cases B and C, penetration rates showed the same tendency as in case A. alpha 1 and alpha 2 globulin fractions contaminated in the Fraction V preparation possibly inhibit the human sperm penetration into zona-free hamster eggs. An appropriate quantity of fatty acid is necessary for human spermatozoa to penetrate into zona-free hamster eggs, because penetration rates were low in the percentage of Fatty Acid Free albumin regardless of the concentration added. It is concluded that use of the same preparation of good quality is mandatory for human sperm penetration tests using zona-free hamster eggs to evaluate the results with reproducibility and accuracy.

Animals↗
PubMed2002

Clinical relevance of electrophysiological tests in the assessment of patients with Huntington's disease.

Assessment programs recently designed to follow-up patients with Huntington's disease (HD) in therapeutic trials have not included electrophysiological testing in the list of mandatory examinations. This omission is likely due to the current lack of data establishing a clear correlation between the electrophysiological results and those of clinical assessment. We address this issue in a cohort of 36 patients at relatively early stages of the disease (I and II). Electrophysiological studies comprised the recording of palmar sympathetic skin responses (SSRs), blink reflexes (BRs), thenar long latency reflexes (LLRs), cortical somatosensory evoked potentials (SEPs), and electromyographic silent periods evoked by transcranial magnetic stimulation (SPs). Results were analyzed with reference to disease duration and staging and to specific cognitive, psychiatric, and motor alteration. SEPs were the most and very sensitive markers, because they were abnormal in 94% of patients. Except for LLRs, alteration of electrophysiological results increased in parallel to the evolution of the disease. Except for LLRs and SSR latency, electrophysiological results correlated with those of specific clinical examinations. In particular, an increased BR latency or a reduced amplitude of the N20 component of SEPs correlated with the extent of bradykinesia, whereas a reduced amplitude of SSRs or of the N30 component of SEPs correlated with hyperkinesia. Overall, electrophysiological tests, in particular SEPs and BRs, appeared sensitive and interesting in the follow-up of HD patients and correlated with various clinical parameters, suggesting that these easy to perform and noninvasive repeatable examinations could be added fruitfully to the assessment programs for HD.

Adult↗
PubMed2006

The ICH S8 immunotoxicity guidance. Immune function assessment and toxicological pathology: autonomous or synergistic methods to predict immunotoxicity?

The new ICH S8 guideline on Immunotoxicology Studies for Human Pharmaceuticals indicates that additional, functional testing of pharmaceuticals is not mandatory to screen for unintended immunotoxicity. The usefulness of conventional parameters like clinical pathology, organ weights and histopathology as measured in Standard Toxicity Studies (STS) to screen for potential unintended immunotoxicity was investigated in an ICH survey. Data of this survey appear to support the notion that properly evaluated STS endpoints would be sufficient for the detection of the majority of unintended immunosuppression by investigational pharmaceutical compounds. Thus the ICH S8 guideline was based on a cause for concern approach using a weight of evidence review of various factors like: findings from STS, pharmacological properties of the drug, intended patient population, structural similarities to known immunomodulators, drug disposition and/or clinical information. Overall the S8 guideline allows for more flexible approaches, and requires a weight of evidence review for which there is no given set of rules. For a proper use this asks for a sensible, realistic and above all a responsible approach both from Industry and Regulators. Some examples regarding the use of clinical pathology parameters like immunoglobulin levels and lymphocyte phenotyping have been included to illustrate this. In conclusion, to detect and evaluate potential immunotoxic effects of human pharmaceuticals the ICH S8 guideline allows for a more flexible, scientifically sound approach. For a proper evaluation of potential immunotoxic effects integration of data from standard toxicological parameters like clinical pathology, histopathology and functional assays are important.

Animals↗
PubMed1999

Prevalence and factors associated with tuberculosis infection among new school entrants, New York City, 1991-1993.

SETTING: New York City public (or state-run) and private schools-elementary and secondary. OBJECTIVE: To describe the prevalence and determine factors associated with positive tuberculin skin tests (TSTs) in school children. DESIGN: Mandatory TST surveys among cohorts of new school entrants for the 1991, 1992 and 1993 school years, of whom birthplace was known for 81%. A positive tuberculin skin test defined as > or =10 mm induration. RESULTS: Of the 298506 new school entrants, 2.1% (6326) were tuberculin test positive. The proportion that was tuberculin test positive was 0.5% (931/199 728) among US-born and 9.2% (3794/41 346) among foreign-born students. Foreign-born (FB) students with a history of BCG vaccination were much more likely to have a positive tuberculin test than US-born students (13.6% vs. 0.5%, odds ratio [OR] = 33.6, 95% confidence interval [CI] 31.7, 35.6), and were more likely to have a positive tuberculin test than FB students with no history of BCG (13.6% vs. 4.4%, OR = 3.4, 95% CI 2.5, 4.6). Older age was independently associated with tuberculin test positivity, except among foreign-born BCG-vaccinated children, in whom the youngest were more likely to have a positive tuberculin test. CONCLUSIONS: Even in the midst of a tuberculosis resurgence such as that experienced by New York City, where tuberculosis cases nearly tripled from 1978 to 1992, the risk of tuberculosis infection among school children remained quite low. Given the reduced predictive value of the tuberculin test among low risk children and the effects of BCG vaccination, many children (especially younger children) with positive tuberculin test results are probably not infected with Mycobacterium tuberculosis. To reduce unnecessary evaluation and treatment, routine tuberculin tests should be administered only to high risk groups such as older children from countries with high rates of tuberculosis.

Adolescent↗
PubMed2004

Video assisted prophylactic thyroidectomy and central compartment nodes clearance in two RET gene mutation adult carriers.

Activating point mutations of RET gene have been demonstrated to be causative of the familial form of medullary thyroid cancer (MTC), both isolated (FMTC) and associated to other endocrine neoplasia [multiple endocrine neoplasia (MEN) 2A and 2B]. In RET gene mutation carriers, who are prone to developing MTC, prophylactic thyroidectomy is recommended to obtain their definitive cure. The simultaneous excision of the central node compartment is mandatory when the stimulation pentagastrin test for serum calcitonin is positive. Although the minimally invasive video assisted thyroidectomy (MIVAT) is nowadays currently adopted in many centers, it has never been employed for the prophylactic thyroidectomy of RET gene mutation carriers. The fear of obtaining an incomplete lymphadenectomy of the central compartment was the main reason for this reluctance. Since RET gene mutation carriers have often normal thyroid volume and, if involved, small lymph nodes, they indeed represent the best candidates to this approach especially when considering that they are usually young and concerned about the cosmetic results and the period of hospitalization. The excellent results obtained by MIVAT in the last few years induced us to propose this procedure together with a central compartment lymphadenectomy to 2 RET gene mutation carriers recently found by genetic screening. As assessed by a negative pentagastrin stimulation test performed after 6 months from the MIVAT, they were definitively cured without any surgical complication with the exception of a transient hypoparathyroidism. They showed a great satisfaction for both the cosmetic results and the very short period of hospitalization, thus supporting the idea that MIVAT can be used in association with the central node dissection for the prophylactic treatment of RET mutation gene carriers whose thyroid volume is still normal.

Adult↗
PubMed1991

Outcome of patients who were admitted to a new short-stay unit to "rule-out" myocardial infarction.

For emergency room patients with a low probability of acute myocardial infarction, we established a new short-stay coronary observation unit, a 2-bed nonintensive care unit with telemetry monitoring adjacent to the emergency room. Of 512 consecutive admissions to the coronary observation unit, 425 (83%) were discharged home without evidence of acute myocardial infarction or serious complications (mean length of stay, 1.2 days; median length of stay, 1 day); 87 (17%) were transferred to other hospital beds. The rate of acute myocardial infarction was 3%. No deaths and only 1 serious complication occurred in the coronary observation unit. At 6 month follow-up, the cardiac survival rate was 99% for patients sent home directly from this unit. It is concluded that the coronary observation unit is safe and adequate for ruling out acute myocardial infarction in a defined subset of patients. Short-stay units, however, encourage early discharges which, when premature, may miss patients who are at risk of having complications shortly thereafter. Strategies such as mandatory but expeditious predischarge stress testing to encourage early but not premature discharge may augment the efficiency of coronary observation units.

Coronary Care Units↗
PubMed2004

Biological qualification of blood units: considerations about the effects of sample's handling and storage on stability of nucleic acids.

BACKGROUND: In transfusional setting introduction of nucleic amplification technique (NAT) for HBV-DNA, HCV-RNA and HIV-RNA in biological qualification of blood units suggest some problems. At first the opportunity to operate on mini-pool, at second the need to store the samples at +4 degrees C. The authors therefore have tried to estimate the impact of these conditions on the operativity of NAT testing in the transfusional setting. METHODS: The following parameters has been estimated: distribution of viral-load in untreated subjects, stability of nucleic acids during storage at +4 degrees C, stability of nucleic acids after repeated cycles of freezing and defrosting, robustness of the test to the cross-contamination, definition of the detection-limit (95%). Quantitative tests has been performed by using the following kits: Cobas Amplicor HBV Monitor, Cobas Amplicor HCV Monitor, Cobas Amplicor HIV Monitor; the qualitative tests has been performed by using the following kits: Ampliscreen HBV, Ampliscreen HCV 2,0, Ampliscreen HIV 1,5 all supplied by Roche Molecular System (Brancburg, NJ). RESULTS: Viral load in untreated subjects showed wide variation for HBV, HCV and HIV. HBV has been demonstrated much stable to the conservation +4 degrees C also until 168 h while for HCV and HIV a greater decrease of the viral-load was observed. For all and three virus the conservation to +4 degrees C until 72 h does not seem to involve meaningful fall in the viral-load. A remarkable reduction of the viral-load has been observed after five cycles of freezing and defrosting. All the tests showed a good robustness to cross-contamination. The detection-limit (95%) was 8 U/ml for HBV, 21 U/ml for HCV and 27 copy/ml for HIV. CONCLUSIONS: Samples for NAT testing, can be stored until 72 h to +4 degrees C without appreciable lowering of the viral-load. Repeated cycles of changes of state should be avoided. The tests showed a good robustness to cross-contamination. NAT tests for biological qualification of blood units had a minimal sensibility around 50 (copy/unit/ml). In our experience the detection-limit (95%) was 21 U/ml for HCV, 27 copies/ml for HIV, 8 U/ml for HBV. The availability of NAT test for HBV-DNA, HCV-RNA e HIV-RNA, sensitive and reliable, together with epidemiological data, suggest the opportunity to place side by side, in the biological qualification of the blood units, to add the tests for HBV-DNA and HIV-RNA to the test for HCV-RNA mandatory by low, in Italy in the biological qualification of blood units.

Blood Preservation↗
PubMed2001

Cholecystokinin cholescintigraphy: clinical indications and proper methodology.

Cholecystokinin is a useful diagnostic adjunct to cholescintigraphy. Clinical indications include contracting the gallbladder before cholescintigraphy in patients fasting greater than 24 hours, during cholescintigraphy to diagnose sphincter of Oddi dysfunction, and after cholescintigraphy to exclude acute acalculous cholecystitis, differentiate common duct obstruction from normal variation, and to confirm the diagnosis of chronic acalculous cholecystitis. Proper methodology is mandatory for a diagnostically useful test. Data presented shows that a 3-minute infusion of 0.01 or 0.02 microg/kg is nonphysiologic and often results in ineffective contraction similar to that seen with a bolus infusion. Normal gallbladder ejection (GBEF) values cannot be established using a 3-minute infusion because of the wide variability in response. Instead, infusions of 30 or 60 minutes are required. Normal GBEF values have been established for these methods and are 30% and 40%, respectively.

Biliary Tract↗
PubMed1999

Stroke and seizures as the presenting signs of pediatric HIV infection.

The authors report two pediatric patients with definite human immunodeficiency virus infection whose initial presentation was stroke and seizure. The first patient was a 3-year-old female who developed acute hemiparesis as the first manifestation. The other, a 2-month-old infant, had focal seizures secondary to cerebral infarction. Investigations revealed ischemic infarction of the thalamus, hypothalamus, and internal capsule in the first patient and cerebral cortex in the second. Further investigations failed to demonstrate any other causes of these cerebral infarctions. Opportunistic infection of the central nervous system was not documented. The authors emphasize that cerebrovascular accident may be the initial presentation in human immunodeficiency virus infection in children. Human immunodeficiency virus infection must be included in the differential diagnosis, and testing for the disease is mandatory in the investigation of stroke in any child who is at risk of having this infection.

Cerebrovascular Disorders↗