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PubMed2005

Biochemical analysis of serum pancreatic amylase and lipase enzymes in patients with type 1 and type 2 diabetes mellitus.

OBJECTIVE: To examine the pancreatic exocrine insufficiency in patient with diabetes mellitus by estimating serum pancreatic amylase and lipase enzymes in healthy subjects and in type 1 and type 2 diabetic patients. METHODS: The study was conducted on 20 normal healthy volunteers and 39 diabetic patients referred to Al-Isra Medical Laboratory, Amman, Jordan during the period from April - November 2003 after recording their age and gender. The age of onset of diabetes and the type of treatment were determined and the patients were categorized into type 1 and type 2 diabetics. Blood samples were collected and analyzed for fasting blood sugar (FBS), glycosylated hemoglobin (HbA1C), serum insulin, and serum pancreatic amylase and lipase enzymes. All biochemical tests were carried out in the medical laboratories of Islamic Hospital, Amman, Jordan. All estimates were presented as means +/- SD, and statistical treatment of data were performed using student t-test. RESULTS: The FBS and HbA1C estimates were consistently higher in type 1 and type 2 diabetic patients, while no significant changes were observed in the estimates of serum insulin between the normal and diabetic patients. The reduction in serum pancreatic amylase was recorded in both types of diabetes, which amounted to 71% for type 1 diabetics and 49% for type 2 diabetics. On the other hand, reduction in serum lipase was only detected in type 1 diabetics amounting to 31%. Correlation of the reduction in serum amylase and lipase levels with the duration of disease revealed a remarkable decrease in both enzymes in patients with long-standing disease (76% and 39%) in type 1 diabetic patients. Whereas, patients with very low serum insulin estimates the reduction in serum amylase was 77% while serum lipase level was reduced by 42%. Similarly, the reduction in serum amylase in type 2 diabetes was higher in patients with longer duration of illness (59%) and in patients with low serum insulin value (79%), while reduction in serum lipase was only detected in patients with very low serum insulin (34%). No differences in all measured parameters between males and females were recorded in type 1 and type 2 diabetics. CONCLUSION: Although most of diabetic research has been focused on dyslipidemia as a major risk factor for cardiac, cerebral and renal complications, the present study clearly illustrates an impairment of pancreatic exocrine function in type 1 and type 2 diabetes. We suggest that analysis of serum pancreatic enzymes could be an additional informative parameter for the assessment of chronicity and progress of the illness as well as the response to therapy.

Adult↗
PubMed1986

Serum thyrotropin as measured with a one-step monoclonal-antibody radioimmunometric assay compared with two commercial radioimmunoassay kits.

We compared results obtained with a commercial immunoradiometric assay kit for human thyrotropin in which monoclonal antibodies are used (Tandem -R TSH (ONE STEP) ImmunoRadioMetricAssay; Hybritech Inc.) with those obtained with two commercial radioimmunoassay methods: GAMMA-DAB [125I]HS-hTSH RIA (Clinical Assays) and Thyro-SHure TSH Diagnostic Kit (Nuclear Medical Laboratories). The correlation of all results obtained in the Hybritech assay with those of the two commercial RIAs exceeded 95%. Mean values for 100 euthyroid samples measured in the Hybritech assay were lower than for the other two methods. The separation between hyperthyroid and euthyroid patients was much clearer with the Hybritech assay than with the RIA methods. The Hybritech assay was far more sensitive than the Clinical Assays or the Nuclear Medical Laboratories assay.

Antibodies, Monoclonal↗
PubMed1986

The Aerospace Medical Research Laboratory: a leader in the development of life support.

The progress in the development of life support for the crewman parallels the changing flight envelope of the airplane and spacecraft. A constant in this history is man. In spite of elaborate attempts to refine the selection of the crew, the basic lists of requirements has not changed. Only the urgency and the need for providing the entire list of requirements have been seen. Generally, progress in the flight envelope has demanded more reliable and often more complex provisions to support the crew. The debate as to how this should be done has often centered on the argument about having man wear or carry the life support elements versus integration of these provisions into the vehicle. This debate initiated the concept of risks/benefits, a debate that has now reached all aspects of man's endeavors, including his medical care. This paper will discuss the major milestones of providing life support, some of the key contributors (a role that General Armstrong played in a great way), and how this has provided the base for the next steps in aviation and space operations.

Aerospace Medicine↗
PubMed1999

A new approach for clinical biological assay comparison and standardization: application of principal component analysis to a multicenter study of twenty-one carcinoembryonic antigen immunoassay kits.

BACKGROUND: Principal component analysis (PCA) is a powerful mathematical method able to analyze data sets containing a large number of variables. To our knowledge, this method is applied here for the first time in the field of medical laboratory analysis. METHODS: PCA was used to evaluate the results of a blind comparative study of 21 carcinoembryonic antigen (CEA) reagent kits used to determine CEA concentration in a panel of sera from 80 patients. RESULTS: The mathematical technique first eliminated the variations attributable to the use of different calibrators. The PCA representation then gave a global view of the dispersion of the kits and allowed the identification of a main homogeneous group and of some discrepant kits. CONCLUSIONS: PCA applied to the in vitro diagnostic reagent field could contribute to the standardization process and improve the quality of medical laboratory analyses. A standardization method using a panel of patient sera is proposed.

Biomarkers, Tumor↗
PubMed2000

The costs of HIV/AIDS care at government hospitals in Zimbabwe.

According to official figures, HIV infection in Zimbabwe stood at 700 000-1 000 000 in 1995, representing 7-10% of the population, with even higher expected numbers in 2000. Such high numbers will have far reaching effects on the economy and the health care sector. Information on costs of treatment and care of HIV/AIDS patients in health facilities is necessary in order to have an idea of the likely costs of the increasing number of HIV/AIDS patients. Therefore, the present study estimated the costs per in-patient day as well as per in-patient stay for patients in government health facilities in Zimbabwe with special emphasis on HIV/AIDS patients. Data collection and costing was done in seven hospitals representing various levels of the referral system. The costs per in-patient day and per in-patient stay were estimated through a combination of two methods: bottom-up costing methodology (through an in-patient note review) to identify the direct treatment and diagnostic costs such as medication, laboratory tests and X-rays, and the standard step-down costing methodology to capture all the remaining resources used such as hospital administration, meals, housekeeping, laundry, etc. The findings of the study indicate that hospital care for HIV/AIDS patients was considerably higher than for non-HIV/AIDS patients. In five of the seven hospitals visited, the average costs of an in-patient stay for an HIV/AIDS patient were found to be as much as twice as high as a non-HIV/AIDS patient. This difference could be attributed to higher direct costs per in-patient day (medication, laboratory tests and X-rays) as well as longer average lengths of stay in hospital for HIV/AIDS patients compared with non-infected patients. Therefore, the impact on hospital services of increasing number of HIV/AIDS patients will be enormous.

Cost Allocation↗
PubMed1996

Comparison of three immunoassay kits for serum thyroglobulin in patients with thyroid cancer.

OBJECTIVES: This study describes the evaluation of performance of three immunoassay kits [Sanofi-Pasteur, IRMA, with five monoclonal antibodies; Wallac-Delfia, FIA, with double monoclonal antibodies; and Diagnostic Products Corporation (DPC), RIA, with polyclonal antibodies] for serum thyroglobulin in patients with thyroid cancer. Specific aims were (a) to recognize a method with minimal interference, by comparing analyte recoveries, from thyroglobulin autoantibodies (TgAb) that can be present in some thyroid cancer patient samples, (b) to correlate individual results with those from Mayo Medical Laboratories (MML) (current referred out assay service used by our institute), and (c) to compare assay precision. METHODS: In evaluating performance of the three immunoassays, procedures were followed as recommended by the respective manufacturers. Parallel comparison of the three immunoassays with the MML procedure was performed with thyroid cancer patient sera. Recovery studies utilized sera from 15 thyroid cancer patients, 4 Hashimoto's thyroiditis patients, and 1 Grave's disease patient. TgAb were also measured directly by an IRMA thyroglobulin antibody kit (Sanofi-Pasteur). RESULTS: Among the randomly selected 20 samples assayed in parallel studies, low recoveries (< 80%) were present in 2 samples by IRMA assay (Sanofi-Pasteur), 8 samples by FIA assay (Wallac-Delfia), and 10 samples by RIA assay (DPC). The majority of the low recovery samples contained high titers of TgAb. All three kits correlated well with the Mayo method. At the control-1 level (approximately 9.9 microgram/L by Delfia determination), both the IRMA kit (CV = 1.96%, n = 10) and FIA Kit (CV = 2.16%, n = 10) showed good within-run precision. CONCLUSIONS: In our hands, the IRMA Kit (Sanofi-Pasteur) demonstrated excellent precision, analyte recoveries, the least interference from TgAb, and good correlation with the Mayo Medical Laboratories procedure.

Autoantibodies↗
PubMed2001

Assessment of hypercholesterolemia control in a managed care organization.

To determine the extent of achievement of goal low-density lipoprotein cholesterol (LDL) as defined by National Cholesterol Education Program-Adult Treatment Panel II (NCEP-ATP 11) and American Diabetes Association (ADA) 2000 guidelines, we conducted a retrospective study by integrating data from medical, laboratory, and pharmacy claims databases. Subjects were selected from a 232,000-member staff-model managed care organization consisting of 19 clinics in the Minneapolis-St. Paul, Minnesota, metropolitan area. A total of 124,971 members aged 18 years and older, who had been continuously enrolled from July 1, 1996-June 6, 1998, were included. Outcome measures were the extent of achievement of goal LDL as defined by NCEP-ATP II and the use of antihyperlipidemic drugs for patients with and without diabetes at various levels of risk for coronary heart disease (CHD). Of 124,971 subjects, 6538 had a history of CHD, 1523 of whom met their LDL goal. Of the population with CHD who did not achieve goal, 1141 (43%) missed by over 30 mg/dl; 621 (54%) of these patients were not receiving drug therapy A total of 17,267 had no history of CHD but had two or more risk factors; 3,298 of these achieved their LDL goal. Of those who did not achieve goal, 1,136 (35%) missed by over 30 mg/dl; 897 (79%) of these were not receiving drug therapy A total of 6,586 had a history of diabetes; 1,004 and 2,340 reached an LDL of 100 mg/dl or lower and less than 130 mg/dl, respectively Of those with diabetes who had an LDL greater than 100 mg/dl, 1,276 (49%) missed their goal by over 30 mg/dl; 898 (70%) of these were not receiving drug therapy. Inadequate use of pharmacologic agents plays a significant role in failure to achieve goal LDL for patients with CHD, without CHD, and with diabetes. Analysis of the data based on the new ADA guidelines for LDL demonstrates the need for continued vigilance. Finally, the successful merging of medical, laboratory, and pharmacy claims databases provides a benchmark for other institutions.

Adult↗
PubMed1998

Prostate-specific antigen utilization in Ontario: extent of testing in patients with and without cancer.

OBJECTIVES: To ascertain the extent of prostate-specific antigen (PSA) testing in patients with prostate cancer (PC), with other cancers (OC), and with no cancer (NC) in two clinical laboratory databases. DESIGN AND METHODS: PSA test records were obtained from a tertiary care hospital, Sunnybrook Health Science Centre (SHSC) and from a private laboratory, Gamma-Dynacare Medical Laboratories (GDL), during the period 1988 to 1995. These records were linked with the Ontario Cancer Registry (OCR) to establish a diagnosis of PC, OC, or NC. Trends in PSA testing according to diagnostic category, testing laboratory, patient age (by decade), and PSA value (in microgram/L) were determined. RESULTS: Major cancer sites identified in the patients tested for PSA were prostate (60%), bladder and colon (7% each), lung (5%), kidney (3%), and rectum (3%). There were 11,867 patients (8.5%) with PC, 8,002 (5.9%) with OC, and 118,954 (86%) with NC. The total number of PSA tests performed on these patients was 230,756, of which 21% were on PC, 5% on OC, and 74% on NC; of these tests, 64% were performed through GDL and 36% through SHSC. The mean (median) number of tests per patient was: PC, 4.0 (2); OC, 1.4 (1); and NC, 1.5 (1). For PC 89% and for OC 72% of all tests occurred after diagnosis. Between 1990 and 1995 the number of PSA tests increased two-fold in PC and OC, and 20-fold in NC. We estimate that about one-half of the PSA tests in the NC group were for screening purposes. The proportion of PSA tests occurring in PC, OC, and NC for patients 50 to 70 years of age was 41%, 50%, and 63%, respectively; for patients over 70 years of age, this proportion was 58%, 46%, and 22% respectively; and for patients under 50 it was 1%, 4%, and 15%, respectively. Between 1990 and 1995, the largest increase in testing frequency was in the NC group, particularly in patients 50 to 70 years of age, which was accompanied by a decrease in patients over 70. Less than 10% of testing occurred in patients under 50 in all diagnostic groups. We estimate that about 26% of PSA screening tests in NC occurred outside the guidelines for patient age. Between 1988 and 1995, the proportion of PSA results below our detection limit (< 0.2 micrograms/L) showed a steady rise in the PC group, as did the proportion between 0.2 and 3.9 micrograms/L; these were accompanied by a fall in the proportion > 20.0 micrograms/L. However, the proportion of PSA results within these ranges did not change much during the same time period for the OC and NC groups. At cutoffs of PSA = 4.0 micrograms/L (or PSA = 10.0 micrograms/L), estimates of clinical specificity were 84.0% (or 96.3%), and of clinical sensitivity were 83.4% (or 47.1%). CONCLUSIONS: Most (86%) PSA testing occurred in men with NC, consistent with diagnosis or screening. There were more PSA tests per patient in PC than in OC, and most testing occurred after diagnosis. PSA testing in the NC group continues to increase rapidly. The proportion of PSA tests in patients over age 70 decreased in the order of PC > NC > OC. Between 1990 and 1995, there was an increase in the proportion of patients tested who were between 50 and 70 in the NC group, which may suggest more screening in this group. Over this same time period, there was an increase in the proportion of undetectable PSA values, possibly suggesting increased use of radical therapy; there was also a decrease in the proportion of PSA > 20 micrograms/L, possibly suggesting a decrease in the prevalence of advanced stage PC.

Age Factors↗