COX-2 inhibition versus gastroprotection with dual COX inhibitors: an evidence-based approach

Highly selective inhibitors of cyclooxygenase-2 (COX-2i) were introduced to minimize peptic ulcers and their complications caused by dual COX inhibitors (COXi). Co-prescribing a (generally cheap) dual COXi with a gastroprotectant is an alternative strategy, proven to reduce the incidence of NSAID-associated endoscopic ulcers. This review compares the efficacies of these two strategies and makes some estimates of their relative cost-effectiveness. In standard risk patients, endoscopic ulcers are reduced to about the same extent (around 70-80%) by either co-prescribing omeprazole or lansoprazole with a dual COXi or preferring a COX-2i alone. COX-2i reduced ulcer complications by a weighted mean of around 60% in comparative studies with dual COXi. There is little information about the influence of PPI on this endpoint, although one study using H. pylori treatment as a possible surrogate for placebo intervention found 77% protection against recurrent upper gastrointestinal bleeding by co-administered omeprazole. One direct comparison of the two strategies in high-risk patients (recent ulcer bleed) found quite high rates of re-presentation with bleeding ulcer using either strategy, and the differences between them were not significant. Drug costs in four Western countries were compared for each strategy. In one, the costs were similar, but in the others the combination of a cheap dual COXi with omeprazole was usually more expensive than using a COX-2i. The safest strategy in highest risk patients may be to co-prescribe a gastroprotectant with a COX-2i, with resulting higher drug costs but possibly offset by savings in other health costs. The efficacy and cost-benefit of this alternative approach warrants investigation.     

Evaluating the potential cost-effectiveness of stenting as a treatment for symptomatic single-vessel coronary disease. Use of a decision-analytic model

BACKGROUND: Coronary stenting appears to provide more predictable immediate results and lower rates of restenosis than conventional balloon angioplasty for selected lesion types, but its hospital costs are significantly higher. This study was designed to evaluate the potential cost-effectiveness of Palmaz-Schatz coronary stenting relative to conventional balloon angioplasty for the treatment of patients with symptomatic, single-vessel coronary disease. METHODS AND RESULTS: We developed a decision-analytic model to predict quality-adjusted life expectancy and lifetime treatment costs for patients with symptomatic, single-vessel coronary disease treated by either Palmaz-Schatz stenting (PSS) or conventional angioplasty (PTCA). Estimates of the probabilities of overall procedural success (PTCA, 97%; PSS, 98%), abrupt closure requiring emergency bypass surgery (PTCA, 1.0%; PSS, 0.6%), and angiographic restenosis (PTCA, 37%; PSS, 20%) were derived from review of the literature published as of September 1993. Procedural costs were based on the true economic (ie, variable) costs of each procedure at Boston's Beth Israel Hospital. On the basis of these data, coronary stenting was estimated to result in a higher quality-adjusted life expectancy than conventional angioplasty but to incur additional costs as well. Compared with conventional angioplasty, stenting had an estimated incremental cost-effectiveness ratio of $23,600 per quality-adjusted life year gained. Although the cost-effectiveness ratio for stenting changed with variations in assumptions about the relative costs and restenosis rates, it remained less than $40,000 per quality-adjusted year of life gained--and thus was similar to many other accepted medical treatments--unless the stent angiographic restenosis rate was > 23%, the angioplasty restenosis rate was < 34%, or the cost of stenting (including vascular complications) exceeded that of conventional angioplasty by more than $3000. The alternative strategy of secondary stenting (initial angioplasty followed by stenting only for symptomatic restenosis) was estimated to be both less effective and less cost-effective than primary stenting over a wide range of plausible assumptions and thus does not appear to be cost-effective when primary stenting is also an option. CONCLUSIONS: Decision-analytic modeling can be used to evaluate the potential cost-effectiveness of new coronary interventions. Our analysis suggests that despite its higher cost, elective coronary stenting may be a reasonably cost-effective treatment for selected patients with single-vessel coronary disease. Primary stenting is unlikely to be cost-effective for lesions with a low probability of restenosis (eg, < 30%) or for patients for whom the cost of stenting is expected to be much higher than usual (eg, because of a high risk of vascular complications). Given the sensitivity of the cost-effectiveness ratios to even modest variations in the relative restenosis rates and cost estimates, future studies will be necessary to determine more precisely the cost-effectiveness of coronary stenting for specific patient and lesion subsets.     

Increased left ventricular muscle mass after long-term altitude training in athletes

STUDY OBJECTIVES: To compare the costs and effectiveness of directly observed therapy (DOT) vs self-administered therapy (SAT) for the treatment of active tuberculosis. DESIGN: Decision analysis. SETTING: We used published rates for failure of therapy, relapse, and acquired multidrug resistance during the initial treatment of drug-susceptible tuberculosis cases using DOT or SAT. We estimated costs of tuberculosis treatment at an urban tuberculosis control program, a municipal hospital, and a hospital specializing in treating drug-resistant tuberculosis. OUTCOME MEASURES: The average cost per patient to cure drug-susceptible tuberculosis, including the cost of treating failures of initial treatment. RESULTS: The direct costs of initial therapy with DOT and SAT were similar ($1,206 vs $1,221 per patient, respectively), although DOT was more expensive when patient time costs were included. When the costs of relapse and failure were included in the model, DOT was less expensive than SAT, whether considering outpatient costs only ($1,405 vs $2,314 per patient treated), outpatient plus inpatient costs ($2,785 vs $10,529 per patient treated), or outpatient, inpatient, and patients' time costs ($3,999 vs $12,167 per patient treated). Threshold analysis demonstrated that DOT was less expensive than SAT through a wide range of cost estimates and clinical event rates. CONCLUSION: Despite its greater initial cost, DOT is a more cost-effective strategy than SAT because it achieves a higher cure rate after initial therapy, and thereby decreases treatment costs associated with failure of therapy and acquired drug resistance. This cost-effectiveness analysis supports the widespread implementation of DOT.     

Use of a 24-kilodalton Trypanosoma cruzi recombinant protein to monitor cure of human Chagas' disease

A 24-kDa recombinant protein from Trypanosoma cruzi (rTc24) was evaluated by enzyme-linked immunosorbent assay (ELISA) and Western blot (immunoblot) tests to identify treated chagasic patients considered parasitologically cured on the basis of persistently negative tests of hemocultures and lytic antibodies. Some of these patients were termed dissociated because their sera, although negative by the complement-mediated lysis test, were positive by conventional serology. The negative lysis test indicates the absence of active infection after specific treatment, but this assay requires live and infectious parasites and cannot be used easily in a laboratory routine. Here we tested rTc24 by ELISA and Western blotting as an alternative for the complement-mediated lysis test. For the group of patients with active infection despite the treatment (uncured patients), all the sera tested recognized rTc24 in both tests. For the dissociated patients, approximately 80% of the sera did not react with rTc24 in the ELISA or in Western blots, in agreement with the negative complement-mediated lysis tests. Thus, the 24-kDa T. cruzi recombinant antigen, when used for initial trials to evaluate cure of chagasic patients submitted to specific treatment, will allow the identification of most, but not all, cases.     

The human dead ringer/bright homolog, DRIL1: cDNA cloning, gene structure, and mapping to D19S886, a marker on 19p13.3 that is strictly linked to the Peutz-Jeghers syndrome

A 2-year trial was conducted to evaluate the cost-effectiveness of heliotherapy for psoriasis. The course and cost of psoriasis of 46 Finnish patients were first closely monitored for 1 year, then the patients received a 4-week supervised heliotherapy treatment in the Canary Islands, Spain, after which they continued to be followed for another year. Heliotherapy dramatically reduced the severity of psoriasis and also seemed to have favourable long-term effects on psoriasis. The mean direct cost of the 4-week heliotherapy for one patient was FIM12,289 (1 Pound = FIM7.0 in 1989). The cost of flights and half-board in Spain formed nearly 60% (FIM7033) of the total cost. In the year preceding heliotherapy, the mean direct annual cost of antipsoriasis therapy was FIM7335 and in the year after FIM5700, a reduction of 22% in annual costs; this change was not statistically significant because there were large variations in costs among patients. The costs of heliotherapy exceeded manyfold the mean monthly cost of conventional psoriasis therapy. There were no overall savings using heliotherapy in those patients suffering mainly from moderately severe psoriasis. Heliotherapy saved costs only in those patients with severe psoriasis that required expensive medication or ward treatment. Although heliotherapy cannot be regarded as an economical treatment for the average patients with psoriasis, it clears psoriasis effectively and is preferred by patients. Thus, heliotherapy constitutes an alternative for patients suffering severe psoriasis.     

Isolation of putative plant transcriptional coactivators using a modified two-hybrid system incorporating a GFP reporter gene

Liver and spleen volumes and serum concentrations of nitrate (the end-product of NO in vivo), albumin, gamma-globulin, protein, creatine and urea were measured during the course of progressive infections with Leishmania infantum MON-1 (MHOM/PR/93/CRE29) in 10 Syrian golden hamsters. Each hamster was infected by intraperitoneal injection with 4 x 10(7) promastigotes. Five of the infected animals were treated, with 6 mg liposomal amphotericin B (L-AmB)/kg given by intracardiac injection, on day 107 post-infection (p.i.). Compared with those in the uninfected hamsters used as controls, the liver volumes in the infected animals became significantly enlarged by day 40 p.i. (38% larger than the controls; P < 0.001) whereas significant enlargement of the spleen was first detected on day 72. Each infected animal had detectable serum levels of antileishmanial antibodies on day 72. There were significant elevations in gamma-globulin concentration as early as day 40 (P < 0.05) but significant falls in albumin concentrations were only detected from day 107 (P < 0.001). Nitrate, creatinine and urea concentrations remained unchanged during the course of infection, even after L-AmB treatment. Serum nitrate levels were not enhanced by L. infantum infection nor by the L-AmB treatment which induced a 98.2% decrease in parasite burden. The lack of NO production in visceral leishmaniasis, with or without L-AmB treatment, points to the unresponsiveness of inducible nitric oxide synthase in this rodent model.     

Use of alternative medicine in oncology patients

BACKGROUND AND OBJECTIVE: Up to 60% of all oncological patients use methods of alternative medicine in the course of their illness. In earlier blinded studies demographic characteristics and the patients' motives of using alternative medicine had been recorded, but a correlation with individual illnesses had not been possible. PATIENTS AND METHODS: 142 patients of a oncological outpatient clinic gave their experience with alternative medicine in interviews and non-blinded questionnaires, 103 of them (72.5%; 46 men and 57 women; median age 58 years, range 18-91 years) returning questionnaires that could be evaluated. RESULTS: 46 patients stated that they had used alternative medicine. There was no difference between users and non-users regarding sex; age, profession, education, family status or religion. 58% of all patients with advanced disease used alternative medicine, compared with only 31% with partial remission or stable disease and 41% in complete remission (P = 0.042). Vitamins and mistletoe preparations were the most commonly used substances (50 and 45%, respectively). The predominant purpose was to stimulate the immune system (77%) and strengthen general physical capacity (64.5%). As main stimulus for using alternative medicine the patients came from their family doctor (56%), followed by family and friends (41%). Alternative medicine was used largely as complementary and not an alternative to conventional medicine. Health insurance met all or some of the costs of alternative treatment in 59% of patients. CONCLUSION: A large number of patients treated with conventional oncological regimens also use alternative medicine, most of them because of a polypragmatic attitude to tumor treatment. Family doctors and health insurance companies are playing a more important role than had hitherto been assumed in spreading the use of treatment options without providing scientifically based evidence of their efficacy.     

False-positive results in premature infants with the Platelia Aspergillus sandwich enzyme-linked immunosorbent assay

The sensitivity of a sandwich enzyme-linked immunosorbent assay (ELISA) for detecting Aspergillus galactomannan was tested using 783 serum samples obtained from 247 patients (1-15 sera per patient) with severe underlying diseases (haematological malignancies or intensive care unit stay). We selected 146 serum samples from 50 patients for retesting. Serum samples were frozen after routine testing at -18 degrees C until retesting. All patients charts were checked for signs of Aspergillus infection, such as pneumonia or sinusitis. Adult patients were divided into four groups: proven (5), probable (6), suspected (8) or unlikely (25) Aspergillus infection. The results of Platelia ELISA were 100% in proven, 33% in probable and 50% in suspected Aspergillus infection. Patients with unlikely infection had no positive results with Platelia ELISA. Group 5 consists of six paediatric patients with prolonged ICU stay and a birth weight of 400-1320 g. In five out of six infants we found positive results with Platelia ELISA. All positive results in this group of patients are considered as false positive (83.3%).     

Costs and effects of microsurgery versus radiosurgery in treating acoustic neuroma

This study analyses costs and effects of treating acoustic neuroma patients by using microsurgery compared to radiosurgery. Radiosurgery is the stereotactic application of radiotherapy and an innovative medical technology. Cost and effect estimates of conventional treatment were based on a retrospective study in the Netherlands. Similar data for a comparable group of patients in Sweden were collected for radiosurgery, as this treatment option is currently not available in the Netherlands. Fifty-three acoustic neuroma patients who had been operated on the University Hospital Rotterdam between November 1990 and February 1995 were included. This group was compared with 92 acoustic neuroma patients treated with radiosurgery (Gamma Knife. Stockholm, Sweden) in the same period. Data on health care use were collected from patient files. To obtain data on production losses and quality of life, a questionnaire was sent by mail in February 1995. This booklet consisted of the Health and Labour-questionnaire (HLQ), the Short Form-36 (SF36) and the EuroQol. The response rate was 92%. Direct costs for microsurgery amounted to Dfl. 20.072,- and for radiosurgery to Dfl. 14.272,-. Indirect costs were respectively Dfl. 16.400,- and Dfl. 1.020,-. General health rating was better for radiosurgery than for microsurgery. On the whole, differences in clinical outcomes between the two patient groups were small. Assuming a reasonable occupancy rate of the expensive radiosurgery equipment, we demonstrated that for the short term treating patients with acoustic neuroma with an extra-meatal tumour diameter of less than 3 centimeters, radiosurgery is more cost-effective than microsurgery.     

血清半乳甘露聚糖检测对血液病患者侵袭性曲霉菌感染早期诊断的价值

目的 评价血清半乳甘露聚糖(GM)检测对血液病患者侵袭性曲霉菌(IA)感染早期诊断的价值.方法 前瞻性采用酶联免疫吸附试验(ELISA)每周2次测定患者的GM水平,并计算该诊断试验的各项评价指标.结果 共有来自92例患者的113例次感染进入研究,检测血清标本472份,以确诊IA感染和临床诊断IA感染为真阳性组,排除IA感染为真阴性组,0.7为阈值,连续2次GM结果阳性为真阳性,该诊断试验的敏感度为83.3%,特异度为91.1%,阳性预测值为78.9%,阴性预测值为93.1%.GM阳性结果较痰培养阳性时间提前4 d(1～7 d),比影像学改变提早7 d(1～14 d),较抗真菌治疗提前6 d(1～15 d).结论 通过ELISA方法进行血清GM检测可以快速、灵敏的为早期诊断IA感染提供有力证据.     

Acute normovolemic hemodilution can replace preoperative autologous blood donation as a standard of care for autologous blood procurement in radical prostatectomy

Predonation of autologous blood (PAD) is a standard of care for patients undergoing radical prostatectomy, but recent studies have shown that PAD is not cost-effective. Acute normovolemic hemodilution (ANH) is an alternative autologous blood procurement technique that is much less costly than PAD. We compared the efficacy and costs of ANH alone to ANH combined with PAD. Two hundred-fifty patients who predonated fewer than 3 units of autologous blood before radical prostatectomy underwent ANH to a target hematocrit of 28%. Perioperative hematocrit levels, transfusion outcomes and costs, and postoperative outcomes were compared for patients who predonated 0, 1, or 2 units of blood before surgery. A computer model was used to estimate the savings in red blood cells (RBC) associated with each autologous intervention. ANH alone resulted in a 21% allogeneic transfusion rate and contributed a mean net savings of 112 mL RBC in blood conservation (equivalent to 0.6 unit of blood). The addition of 1 or 2 units of PAD reduced allogeneic exposure rates to 6% or 0%, respectively. Overall, patients who predonated blood had a mean net loss of 198 mL of RBC (equivalent to 1 blood unit), due to both an absence in compensatory erythropoiesis and to the wastage of 60% of the blood units donated. Patients who underwent ANH alone had a 60% reduction in mean total transfusion costs ($103 +/- $102) compared with patients who predeposited 2 units of autologous blood in addition to ANH ($269 +/- $11, P < 0.05). We conclude that ANH can replace PAD as an autologous blood option because it is less costly and equally effective. A combination of ANH and PAD can further decrease allogeneic blood exposure, but it increases transfusion costs and wastage. IMPLICATIONS: A patient's own blood can be obtained for use in surgery by predonation or acute normovolemic hemodilution on the day of surgery. Both blood collection techniques decrease the need for blood bank transfusions, but acute normovolemic hemodilution is less expensive and more convenient for patients.     

A review and economic evaluation of bronchodilator delivery methods in hospitalized patients

BACKGROUND: Bronchodilator delivery by metered dose inhaler (MDI) to treat airflow obstruction is considered to be less expensive and as effective as nebulized therapy. OBJECTIVES: To document the utilization of bronchodilator delivery methods in a tertiary care Canadian university teaching hospital and to perform an economic evaluation. METHODS: A prospective 6-week audit of 4 preselected hospital wards (respiratory, thoracic surgery, general surgery, and a general internal medicine clinical teaching unit) and a cost-minimization economic evaluation were performed. Bronchodilator (salbutamol and ipratropium bromide) doses, frequency, and delivery methods, either MDI or wet nebulizer (WN), were recorded for 95 patients treated with aerosolized bronchodilators. Direct costs for medications and hourly wages including benefits and equipment were obtained. Time and motion studies identified time allocated to MDI and WN delivery. We used sensitivity analyses to test assumptions that could significantly affect treatment costs, especially assumptions about medications, labor, and spacer devices. Costs are expressed in Canadian dollars (Can$1 = US$0.75). RESULTS: Sixty-seven patients (70.5%) were treated with WN, 6 (6.3%) with MDI, and 22 (23.2%) with both WN and MDI. Self-administration of salbutamol by MDI was the least expensive: $1.27 for 200-microgram doses and $1.73 for 400-microgram doses compared with $2.62 for a 2.5-mg dose delivered by WN. The difference in cost between equivalent treatments (400-microgram MDI vs 2.5-mg WN) is only $0.89. Sensitivity analyses showed that MDI was the least expensive therapy when self-administration was possible and for all levels of supervision if more than 4 minutes was needed to administer a WN treatment. CONCLUSIONS: Bronchodilator delivery by WN is commonly prescribed for hospitalized patients despite evidence for equivalency of effect using MDI and in the absence of substitution protocols. Previous studies have estimated a far greater cost differential based on unrealistic labor estimates. We found that supervision of patients using MDIs minimized the differential cost between WN and MDI therapy and that cost savings are maximal in patients who can self-administer MDI therapy. Methodologically sound economic evaluations can better identify true cost savings and variables that need further study.     

Treatment costs in a medical intensive care unit: a comparison of 1992 and 1997

BACKGROUND AND OBJECTIVE: Treatment in an intensive care unit (ICU) is very expensive. Aim of this study was to determine the exact composition of costs and to analyse what factors are responsible for the rise in costs over the last 5 years. METHODS: In a prospective investigation all 790 patients who had been treated at the ICU of the Medical Department of Frankfurt University during 1992 were included, findings being compared with data on all 208 patients treated in the ICU in May and June 1997. All important diagnostic and therapeutic measures were quantitatively determined each day. RESULTS: The mean age of the ICU patients rose in the 5 years from 55 to 59 years (P < 0.001). Mean period of stay in the ICU remained unchanged (4.1 days), total duration of hospital stay (15 and 12 days, respectively), and treatment intensity (sum of points according to the "Therapeutic Intervention Scoring System" per ICU stay: 96 and 77, respectively). The mortality rate in the ICU fell from 16.3% to 10.6% (P = 0.02), hospital mortality rate from 23% to 14% (P = 0.01). Total cost rose from DM 797,860 to DM 1,148,945 per 100 patients (+44%). Of this total, personnel costs were DM 286,885 in 1992 and 356,091 in 1997 (+24%), costs for apparatus-based diagnostic and therapeutic tests were DM 169,743 and 245,156, respectively (+44%), DM 98,496 and 129,222 for drugs (+31%), and DM 60,399 and 186,671 (+209%) for blood and clotting products (in each category per 100 patients). Per case costs rose from DM 7970 to 11,489, per day costs from DM 1943 to 2831. 90% of cost increases were due to new strategies in the treatment of patients with myocardial infractions and those with severe clotting disorders and a rise in personnel costs. CONCLUSION: The costs of a stay in the ICU has greatly increased over the last 5 years, the main causes being a change to new forms of treatment, especially in patients with myocardial infarction and those with haemophilia.     

The cost of caring for end-stage kidney disease patients: an analysis based on hospital financial transaction records

The costs of care for end-stage renal disease patients continue to rise because of increased numbers of patients. Efforts to contain these costs have focused on the development of capitated payment schemes, in which all costs for the care of these patients are covered in a single payment. To determine the effect of a capitated reimbursement scheme on care of dialysis patients (both hemodialysis [HD] and peritoneal dialysis [PD]), complete financial records (all reimbursements for inpatient and outpatient care, as well as physician collections) of dialysis patients at a single medical center over 1 year were analyzed. For the period from July 1994 to July 1995, annualized cost per dialysis patient-year averaged $63,340, or 9.8% higher than the corrected estimate from the U.S. Renal Data Service (USRDS; $57,660). The "most expensive" 25% of patients engendered 44 to 48% of the total costs, and inpatient costs accounted for 37 to 40% of total costs. Nearly half of the inpatient costs resulted from only two categories (room charges and inpatient dialysis), whereas other categories each made up a small fraction of the inpatient costs. PD patients were far less expensive to care for than HD patients, due to reduced hospital days and lower cost of outpatient dialysis. Care for a university-based dialysis population was only slightly more expensive than estimates predicted from the USRDS. These results validate the USRDS spending data and suggest that they can be used effectively for setting capitated rates. Efforts to control costs without sacrificing quality of care must center on reducing inpatient costs, particularly room charges and the cost of inpatient dialysis.     

Metallic or absorbable fracture fixation devices. A cost minimization analysis

Absorbable polyester pins and screws for the internal fixation of small fragment fractures have been commercially available for several years. The main advantage of these devices is that no implant removal procedures are required, which could result in financial savings. The current cost analysis, which included costs of medical care plus costs of lost time from work, was based on 994 fracture patients treated with absorbable internal fixation devices and 1173 patients operated on using conventional metallic devices. The fracture types studied were uni- and trimalleolar fractures of the ankle, fractures of the olecranon, and metacarpal fractures. When the costs for an implant removal procedure after metallic fixation were included, the average cost saved per patient by using absorbable implants varied from $410 in fractures of the olecranon to $903 in unimalleolar fractures. However, hardware removals often are optional. According to the results of this cost analysis, the break even point is attained at a removal rate of 19% for metacarpal fractures, 21% for unimalleolar fractures, 46% for fractures of the olecranon, and 54% for trimalleolar fractures. Only at a higher removal rate would the use of absorbable devices, with their current prices, be a financially more favorable alternative than the use of metallic ones.     

Day hospital/crisis respite care versus inpatient care, Part II: Service utilization and costs

OBJECTIVE: The authors compared service utilization and costs for acutely ill psychiatric patients treated in a day hospital/crisis respite program or in a hospital inpatient program. METHOD: The patients (N = 197) were randomly assigned to one of the two programs and followed for 10 months after discharge. Both programs were provided by a community mental health center (CMHC) in a poor urban community. Data were collected for developing service utilization profiles and estimates of per-unit costs of the inpatient, day hospital, and outpatient services provided by the CMHC. RESULTS: On average, the day hospital/crisis respite program cost less than inpatient hospitalization. The average saving per patient was +7,100, or roughly 20% of the total direct costs. There were no significant differences between programs in service utilization or costs during the follow-up phase. Cost savings accrued in the index episode because per-unit costs were lower for day hospital/crisis respite and the average stay was shorter. Significant differences in cost were found among patient groups with psychosis, affective disorders, and dual diagnoses; psychotic patients had the highest costs in both programs. The two programs had roughly equal direct service staff and capital costs but significantly different operating costs (day hospital/crisis respite operating costs were 51% of inpatient hospital costs). CONCLUSIONS: The programs were equally effective, but day hospital/crisis respite treatment was less expensive for some patients. Potential cost savings are higher for nonpsychotic patients. Cost differences between the programs are driven by the hospital's relatively higher overhead costs. The roughly equal expenditures for direct service staff costs in the two programs may be an important clue for understanding why these programs provided equally effective acute care.     

Dynamics of antigenemia and coproantigens during a human Fasciola hepatica outbreak

In the present study the dynamics of antigenemia and coproantigens were studied in patients with Fasciola hepatica infection during an outbreak occurring in La Palma, Pinar del Río, in the West Province of Cuba. Stool and serum samples were collected from 67 patients and 40 healthy subjects. Stool samples were studied by a simple gravity sedimentation technique and an ES78 sandwich enzyme-linked immunosorbent assay (ELISA) for observation of eggs and detection of parasite coproantigens, respectively. Serum samples were also studied by the ES78 sandwich ELISA and an indirect ELISA to detect circulating antigens and antibodies, respectively. At the beginning of the study, 8 of 67 patients had patent infections and 59 had prepatent infections, which was determined by the recent consumption of lettuce contaminated with metacercariae of F. hepatica, the presence of clinical symptoms, and the absence of Fasciola eggs in their stools. Patients with prepatent infections were monitored by all techniques until patency. Circulating antigens were not detected in patients with patent infections. However, coproantigens were clearly detected in all patients with patent infections. On the other hand, 28.8% of patients with prepatent infections tested positive for circulating antigens and 81.4% tested positive for coproantigens in the first stool sample studied. Only two other coproantigen determinations were necessary to diagnose 93.2% of the patients. While circulating antigen levels diminished in all patients during the infection, coproantigen levels increased. The present study demonstrates that the ES78 sandwich ELISA is a better tool than parasitological examination for diagnosis of active early infection, since by the combination of the circulating-antigen detection assay and the coproantigen detection assay 91% of patients were able to be diagnosed at the beginning of the study. In contrast, a coprologic analysis repeated over several weeks was necessary to diagnose 100% of the patients.     

Low CSF concentration of a dopamine metabolite in tobacco smokers

We developed a monoclonal antibody-based, antigen capture sandwich enzyme-linked immunosorbent assay (ELISA) for bovine coronavirus. We compared the ELISA with electron microscopy and the hemagglutination test and found a close correlation between them. The sensitivity of the ELISA was 10(4) bovine coronavirus particles per ml of 10% fecal suspension. Compared with electron microscopy, bovine coronavirus ELISA had 96% specificity.     

Keeping abreast of new drug approvals and labeling changes

PCR technology offers alternatives to conventional diagnosis of Cryptosporidium for both clinical and environmental samples. We compared microscopic examination by a conventional acid-fast staining procedure with a recently developed PCR test that can not only detect Cryptosporidium but is also able to differentiate between what appear to be host-adapted genotypes of the parasite. Examinations were performed on 511 stool specimens referred for screening on the basis of diarrhea. PCR detected a total of 36 positives out of the 511 samples, while routine microscopy detected 29 positives. Additional positives detected by PCR were eventually confirmed to be positive by microscopy. A total of five samples that were positive by routine microscopy at Western Diagnostic Pathology but negative by PCR and by microscopy in our laboratory were treated as false positives. Microscopy therefore exhibited 83.7% sensitivity and 98.9% specificity compared to PCR. PCR was more sensitive and easier to interpret but required more hands-on time to perform and was more expensive than microscopy. PCR, however, was very adaptable to batch analysis, reducing the costs considerably. Bulk buying of reagents and modifications to the procedure would decrease the cost of the PCR test even more. An important advantage of the PCR test, its ability to directly differentiate between different Cryptosporidium genotypes, will assist in determining the source of cryptosporidial outbreaks. Sensitivity, specificity, ability to genotype, ease of use, and adaptability to batch testing make PCR a useful tool for future diagnosis and studies on the molecular epidemiology of Cryptosporidium infections.     

Cross-reactivity of ten anti-prostate-specific antigen monoclonal antibodies with human glandular kallikrein

OBJECTIVES: Prostate-specific antigen (PSA) is commonly used as a marker for prostate disease. Prostate epithelium expresses both PSA and human glandular kallikrein (hK2) proteins, which share 80% sequence homology. The immunologic cross-reactivity of these two proteins could potentially interfere with determination of PSA levels in diagnoses of prostate cancer. We set out to determine the extent of this cross-reactivity for a panel of 10 anti-PSA monoclonal antibodies (mAbs). METHODS: Enzyme-linked immunosorbent assay (ELISA), sandwich assays, and western transfer techniques were used to assess the PSA/hK2 cross-reactivity of the anti-PSA mAbs. RESULTS: We did not detect the hK2 protein with any of the 10 anti-PSA mAbs under western transfer conditions. In ELISA experiments, 8 of 10 mAbs exhibited hK2 cross-reactivity under certain conditions. However, no combination of mAbs tested in sandwich assays exhibited a signal in hK2 cross-reactivity experiments greater than 0.1% of the PSA signal. CONCLUSIONS: We have evaluated 10 anti-PSA mAbs and determined that despite the 80% homology between PSA and hK2 proteins, cross-reactivity with hK2 by these antibodies would not significantly affect the determination of PSA levels by means of sandwich assays.