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Value of an ELISA for mycobacterial antigen detection as a routine diagnostic test of pulmonary tuberculosis.

A double antibody sandwich ELISA was carried out with commercially available anti-BCG and peroxidase labeled anti-BCG, for the detection of mycobacterial antigens. By using purified protein derivative of tuberculin (PPD) as the antigen, the lowest detection limit of the assay was found to be 0.05 microgram/ml. At the cut off level of absorbance index (Al) greater than or equal to 5. positive results of ELISA were obtained from 24/25 sputum specimens which were positive for staining of acid fast bacilli (AFB), 5/16 specimens positive for culture of Mycobacterium tuberculosis and 67/69 specimens positive for both tests. The assay was positive in only 11/164 specimens negative for both staining of AFB and culture of M. tuberculosis. 4 of which were known to have tuberculosis. Thus, with sputum specimens, the sensitivity, specificity, efficiency, positive predictive value and negative predictive value of the ELISA were 87.27, 93.29, 90.88, 89.72 and 91.62 percent respectively. Positive results were also obtained in 2/111 sputum specimens which were positive for other bacteria but the presence of AFB in these specimens could not be ruled out. With pleural fluid specimens, positive ELISA with Al greater than 1 was found in 3/26 specimens of patients with tuberculous pleurisy and 0/11 of those with malignancy. Twenty-six sera and urine specimens of tuberculous patients and also all control specimens (138 sera and 86 urine specimens) assayed, gave negative ELISA results (Al less than 1).

Antigens, Bacterial↗

[Diagnostic value of C-reactive protein in comparison with erythrocyte sedimentation as routine admission diagnostic test].

In a prospective study the diagnostic relevance of C-reactive protein (CRP) as a screening parameter for inflammatory diseases was compared to the erythrocyte sedimentation rate (ESR). At time of hospitalization CRP, ESR and other routine laboratory tests were performed. After taking history and clinical examination, the responsible physician had to answer a first questionnaire and a second at the time of patient discharge. At the time of admission, elevation of CRP was expected by the treating physician in 40.3% of patients, and elevation of ESR in 43.2%. An unexpected elevation of CRP or ESR was found in 38/303 cases (12.5%). In 22/38 patients only CRP was elevated, but ESR only was elevated in 13/38 cases. In summary, measurement of CRP and/or ESR was felt by the treating physician to have been helpful in 25.1% of all patients. Due to the fast rise of CRP, all patients with bacterial pneumonia showed increased CRP at the time of hospitalization (23/23), but the ESR was still in normal range in some of these patients (normal ESR in 5/23). Also in patients with COPD or asthma and clinical evidence for infection, or patients with bacterial gastroenteritis, CRP turned out to be the more sensitive parameter. In conclusion, CRP is a valuable screening test in acutely ill patients, has a higher sensitivity and (as shown by other authors) higher specificity than ESR. In addition, the short half-life of CRP makes it a useful parameter for the follow-up of patients with e.g. infections under antibiotic treatment.

Acute-Phase Reaction↗

Sex-specific performance of routine TB diagnostic tests.

SETTING: City Council Chest Clinic, Nairobi, Kenya. OBJECTIVE: To determine to what extent the performance of smear microscopy is responsible for sex differences in notification rates. METHODOLOGY: Three sputum samples from TB suspects were subjected to smear microscopy with Ziehl-Neelsen (ZN) and auramine (FM) staining. Lowenstein-Jensen culture was used as the gold standard. RESULTS: Of 998 suspects, 600 (60%) were men and 398 (40%) women. The odds of detecting culture-positive patients with ZN was lower for women (OR 0.67). By examining the first spot specimen, ZN detected 35% of culture-positive males and 26% of culture-positive females. These proportions increased to respectively 63% and 53% when examining three specimens, and to 79% and 74% when using FM. The sex difference reduced and became non-significant (P = 0.19) when adjusted for HIV; however, the numbers involved for HIV stratification were low. CONCLUSION: The performance of a diagnostic tool contributes to sex differences in notification rates and influences male/female ratios. Women were less likely to be diagnosed (P = 0.08), and when ZN was used they were less likely to be labelled as smear-positive TB (P < 0.01). The application of more sensitive diagnostic tools such as FM is to the advantage of women.

Adolescent↗

[Utilization of rapid diagnostic tests for group A streptococcus and and bacteriologic and clinical correlations with acute angina in general medicine].

OBJECTIVES: A prospective study was conducted between November 1995 and May 1996 by 130 general practitioners in France to assess feasibility of a rapid routine diagnostic test for group A streptococcus infection in a general medicine setting and to search for bacteriological and clinical correlations. METHODS: A routine diagnostic test was performed in all patients presenting acute pharyngitis and cultures were ordered in case of positive tests. Among the 2,800 patients included, there were 563 children under 14 years and 2,226 adults. The routine diagnostic test was positive in 393 cases (14%). A culture was obtained in 375 case and isolated group A streptococcus in 324 (11.5% of the total population). The positive predictive value of the routine diagnostic test was 86.4% in this general medicine setting. RESULTS: Comparing clinical signs with the results of the routine diagnostic test showed that an erythematous pultaceous aspect of the pharynx, severe dysphagia and the presence of enlarged nodes were more frequent in patients with streptococcal pharyngitis. The association of these 3 clinical signs with fever > 38 degrees C was also more frequent in patients with a positive routine diagnostic test (OR = 3.3; 95% CI = 2.5-4.4). The triad hoarseness + cough + rhinorrhea was more frequent in subjects with a positive routine diagnostic test (22.7% versus 9%; OR = 2.6; 95% CI = 2.1-4.3). CONCLUSION: The general practitioners who participated in this study found the routine diagnostic test for group A streptococcal pharyngitis was easy to use and compatible with everyday practice. This diagnostic tool was seen as a progress in the management of acute pharyngitis, but only 53.7% of the practitioners were willing to use antibiotics only for cases where a highly specific routine diagnostic test performed during the consultation identifies group A streptococcus. Lack of reimbursement by the national health assurance however makes it impossible to use this test routinely in the general medicine setting.

Acute Disease↗

Screening for the risk for bleeding or thrombosis.

BACKGROUND: Numerous tests are available to assess patient risk for bleeding or thrombosis. Appropriate use of these tests must involve consideration of the clinical setting, disease prevalence, performance characteristics of the tests, cost, and consequences of false-positive and false-negative results. PURPOSE: To summarize information about coagulation testing in three common clinical settings: nonsurgical hospitalized patients, surgical patients, and patients having a first venous thromboembolic event. DATA SOURCES: All English-language studies identified in searches of MEDLINE (1966 to April 2002) and reference lists of key articles. STUDY SELECTION: All published studies of blood coagulation testing as routine diagnostic tests or in the preoperative care of patients reporting postoperative bleeding complications, and all published studies of patients with the factor V Leiden mutation reporting venous thromboembolic outcomes. DATA EXTRACTION: 5 observational studies of routine coagulation testing in nonsurgical hospitalized patients and 12 observational studies of preoperative coagulation testing, from which both sensitivity and specificity could be calculated. DATA SYNTHESIS: Test performance characteristics for the partial thromboplastin time in predicting postoperative hemorrhage were pooled by type of surgery. Likelihood ratios for positive and negative results were calculated for each group; 95% confidence intervals were calculated. Patients with prolonged partial thromboplastin times did not have a statistically significantly increased risk for postoperative complications. CONCLUSION: For nonsurgical and surgical patients without synthetic liver dysfunction or a history of oral anticoagulant use, routine testing has no benefit in assessment of bleeding risk. Routine testing after a first episode of venous thromboembolism is not recommended for most patients.

Blood Coagulation Tests↗

New screening guidelines cut hours off delays.

Screening guidelines for psychiatric patients can eliminate hours of delays due to costly, time-consuming diagnostic testing. If patients don't have to undergo extensive testing, they can be treated without delay. By eliminating routine diagnostic testing, $300 per patient can be saved. If care is delayed, a patient's condition may worsen and necessitate inpatient admission.

Diagnostic Tests, Routine↗

Completion of hemagglutination inhibition test by solid-phase radioimmunoassay test in routine diagnostic rubella serology.

A solid-phase radioimmunoassay (RIA) test for rubella virus IgG and IgM class antibodies was used for completing the hemagglutination inhibition (HI) test in routine diagnostic serology. During a six-month period 80 serum specimens from 47 patients were tested by RIA because the HI test result was either unreliable or gave insufficient information. This was approximately 5% of the total number of serum specimens tested for rubella antibodies in our laboratory during the study period. The main indications for using the RIA test were improper timing in the taking of serum specimens, which accounted for IgM determination, and nonspecific agglutinins or nonspecific serum hemaglutination inhibitors, which disturbed the HI test. In all cases an unambiguous result was obtained by the RIA test, and five recent rubella infections, not diagnosably by the HI test, were detected. Based on these findings we consider the RIA test to be a good alternative among the methods proposed for diagnostic rubella serology.

Hemagglutination Inhibition Tests↗

The impact of routine admission tests on the care of Third-World children.

To determine the clinical usefulness of routine diagnostic tests on admission of Third-World children to hospital, the records of 306 children admitted to a Ciskei hospital were examined. The tests performed were 'dipstick' urinalysis, Mantoux testing and bedside haemoglobin measurement. Of the 164 Mantoux tests performed, 16 were unexpectedly positive and 15 (94%) of these 16 patients had their treatment changed as a result. Measurement of the haemoglobin concentration revealed that 31 of 278 patients had a haemoglobin value unexpectedly below 10 g/dl, but in 28 of these 31 cases (90%) this result was ignored. Of the 3 patients followed up, 2 had their treatment changed. An unexpected abnormal result was obtained in 76 of 233 urinalyses performed, but 72 (95%) of these were ignored. Follow-up in the remaining 4 cases did not result in any change in treatment. Routine urine and haemoglobin testing had negligible impact on patient care because unexpected abnormal results were ignored. This finding is similar to those of similar studies on Western adults. The possible reasons for this, and for the striking exception of the Mantoux test, are discussed.

Child↗

[Ambulatory anesthesia: which preoperative screening tests are required].

The volume of preoperative screening investigations for outpatient anaesthesia ranges from few, selectively ordered investigations to extensive routine diagnostic procedures. It seem appropriate to reevaluate benefit and efficacy of routine preoperative assessment programs. The purpose of preoperative diagnostic is to assess the risk of anaesthesia and surgery for the patient. As shown by a number of studies, preoperative screening investigations seldom disclose new pathological findings of clinical relevance. Abnormal laboratory results in otherwise healthy patients rarely alter the anaesthetic management of the patient and are not related to perioperative complications. Extensive use of costly diagnostic procedures considerably increases health care budgets. A more selective approach to order preoperative investigations promises considerable savings. To achieve costeffective evaluation an efficient organisation of properative assessment must be established to avoid costly delay and on day-of-surgery-cancellations. There is no medicolegal obligation to perform routine diagnostic testing. The anaesthetist must be sufficiently informed in time to assess the perioperative risk of the patient and to alter anaesthetic management as necessary. According to the presented studies a clinical history and a through physical examination represent an effective method of screening for the presence of disease. Careful medical history evaluation and physical examination can avoid extensive investigations in apparently healthy individuals and the latter should only be ordered if indicated.

Ambulatory Surgical Procedures↗

[Agglutination as screening test in routine diagnostic of listeriosis].

INTRODUCTION: The persons with weakened immunity, newborn infants and pregnant women are very much sensitive on infection with bacteria Listeria monocytogenes. Listeria can readily invade the placenta and precipitate premature labor and fetal death. To confirm diagnosis is very difficult because listeriosis is disease very similar to the others acute diseases. Serum threshold values above 1: 320 confirm think about listeriosis when the relevant clinical symptoms are present. Of greater diagnostic relevance is the detection of a rise in titer. Therefore, it is always desirable to test a second sample (collected 2 to 3 weeks later) together with the first sample (stored in the deep-freeze). AIM: The aim of the study is to confirm the advance agglutination as a screening test in routine diagnostic Listeriae monocytogenes. MATERIAL AND METHODS: In testing were included 60 women in the reproductive age to divide in experimental group and control group. By agglutination serologic methods we researched if there is any antibody on Listeria monocytogenes with Listeria antigen. RESULTS AND DISCUSSION: From a total of 60 patients positive samples were 18 (60.00%) in experimental group (30) and 8 (26.70%) in control group (30). CONCLUSION: due to simple way of performing screening test of agglutination the same one are giving adequate antibiotic therapy in a case of positive serological response.

Adolescent↗

Routine low-cost pathology tests: measuring the value in use of bacteriology tests in hospital and primary care.

The introduction of a managed market in health care in the NHS will encourage managers and clinicians to examine clinical services, such as pathology, more closely. However, simple cost-minimization may not be sufficient; the recent Audit Commission report on pathology emphasises a need to measure and monitor cost-effectiveness of clinical services such as pathology. This paper presents the findings of a study to measure the cost-effectiveness of one routine pathology test; the culture and antibiotic susceptibility test performed by all microbiology laboratories. Over 2,900 requests were examined and test results tracked in hospitals and general practices served by three laboratories. The findings show that, although average test costs are low for the three main user groups (4.3-5.9 pounds), the cost of producing an effect on patient management (change to therapy) is high at 54-67 pounds. In addition to therapy changes, the one major effect recorded was that of clinician reassurance. If all measured effects are weighted by their reported clinical utility, cost-utility ratios of 27.0 pounds +/- 1.0 pounds, 45.5 pounds +/- 4.5 pounds and 44.5 pounds +/- 3.5 pounds per patient management effect are calculated for general practitioner, outpatient and inpatient use respectively. A theoretical model is presented which will allow the comparative cost-effectiveness of a range of routine diagnostic tests to be measured through the use of a test-utility index, similar to the health index which is currently used to measure the outcome of medical interventions (QALYs).

Anti-Bacterial Agents↗

Diagnostic strategies in the management of acute upper gastrointestinal bleeding: patient and physician preferences.

BACKGROUND: Routine diagnostic endoscopy is commonly obtained for low-risk patients with acute upper gastrointestinal bleeding despite evidence from controlled trials that it does not improve patient outcome. OBJECTIVE: To determine whether endoscopy is being overutilized for these patients or whether considerations not addressed in the trials could justify its widespread use. METHODS: Twenty-five patients recovering from a recent hemorrhage and 22 primary care physicians used the analytic hierarchy process to perform an individualized analysis regarding the diagnostic management of acute upper gastrointestinal bleeding. The results were used to determine whether routine endoscopy was consistent with each subject's interpretation of relevant data and judgments regarding the relative importance of five management goals. The authors then compared the proportion of subjects in each group who preferred endoscopy over two non-endoscopy strategies (upper gastrointestinal series and no routine diagnostic test) with 85%, the current rate of endoscopy at the authors' hospital. RESULTS: Endoscopy was preferred by 92% (97.5% CI: 70%-98%) of the patients and 55% (97.5% CI: 31%-77%) of the physicians. The patients ranked identifying the cause of bleeding the second most important management goal after avoiding a poor outcome from the acute bleeding episode. CONCLUSIONS: The current rate of diagnostic endoscopy is higher than would be expected based on physicians' preferences but quite consistent with patients' preferences. Patients regard knowledge of the bleeding site as important, even if this information will not affect management or prognosis. Attempts to assess the use of diagnostic endoscopy and other diagnostic tests should take both patient preferences and the pure value of diagnostic information into account.

Adult↗

Comprehensive methylation analysis in typical and atypical PWS and AS patients with normal biparental chromosomes 15.

Imprinting defects in 15q11-q13 are a rare but significant cause of Prader-Willi syndrome (PWS) and Angelman syndrome (AS). Patients with an imprinting defect have apparently normal chromosomes 15 of biparental origin, but are recognised by @parental DNA methylation at D15S63 (PW71) or SNURF-SNRPN exon 1. We have investigated the methylation status of five additional loci in 12 such patients with or without a deletion in the imprinting centre. In each patient, the imprinting defect affected all loci tested. During routine diagnostic testing we identified four patients who had a normal methylation pattern at SNURF-SNRPN exon 1, but an abnormal pattern at D15S63. In two of these patients, who were suspected of having PWS, this change was restricted to D15S63. In two patients suspected of having AS, several but not all loci were affected. Using a newly developed methylation-specific PCR test for D15S63 we found that these methylation changes are rare in patients suspected of having AS. Although we can not prove that the methylation changes in the four patients are causally related to their disease, our findings demonstrate that spatially restricted changes in methylation can occur. In some cases, these changes may reflect incomplete imprint spreading.

Angelman Syndrome↗

A practical guide to defining high-risk myeloma for clinical trials, patient counseling and choice of therapy.

Clinical outcomes for multiple myeloma (MM) are highly heterogeneous and it is now clear that pivotal genetic events are the primary harbingers of such variation. These findings have broad implications for counseling, choice of therapy and the design and interpretation of clinical investigation. Indeed, as in acute leukemias and non-hodgkins lymphoma, we believe it is no longer acceptable to consider MM a single disease entity. As such, the accurate diagnosis of MM subtypes and the adoption of common criteria for the identification and stratification of MM patients has become critical. Herein, we provide a consensus high-risk definition and offer practical guidelines for the adoption of routine diagnostic testing. Although acknowledging that more refined classifications will continue to be developed, we propose that the definition of high-risk disease (any of the t(4;14), t(14;16), t(14;20), deletion 17q13, aneuploidy or deletion chromosome 13 by metaphase cytogenetics, or plasma cell labeling index >3.0) be adopted. This classification will identify most of the 25% of MM patients for whom current therapies are inadequate and for whom investigational regimens should be vigorously pursued. Conversely, the 75% of patients remaining have more favorable outcomes using existing - albeit non-curative - therapeutic options.

Antineoplastic Agents↗