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Analytical evaluation of 17 laboratory tests on the Bayer Centaur system.
POSTER ABSTRACTS
Objectives: To use monoclonal anti-CD4 antibodies (CD4MAb) to deplete CD4 positive T-cells prior to implantation to prevent the development of neutralizing antibodies. Methods: We have used a non-autologous method of gene therapy in which “universal” cell lines engineered to secrete hFIX were immuno-isolated in alginate microcapsules to treat FIX deficient mice. One group of mice also received CD4-MAb treatment. Results: Hemophilic mice treated with microcapsules enclosing hFIX-secreting C2C12 myoblasts showed activated partial thromboplastin times (aPTT’s) of 89 to 99 seconds on days 3 to 21 post-implantation, a 20 to 29% reduction from hemophilic levels (124.5 seconds), but still above the normal level (71.5 seconds). Plasma hFIX levels were a maximum on day 2 at 16 ng/mL, then falling to baseline by day 7. The declining hFIX levels corresponded to an increase in anti-hFIX antibody level above the baseline on day 10, rising to high levels by day 28. In hemophilic mice treated with CD4-MAb prior to implantation, the antibody level was suppressed (below the level in control mice implanted similarly but without CD4-MAb treatment) until day 42 (p⬍0.05). This treatment also led to a 6-12% reduction in aPTT’s from days 7 to 29 (versus hemophilic levels of 72 seconds, p⬍0.05 for all time points), but still above the normal level (45 seconds). Conclusions: Non-autologous gene therapy for hemophilia with microencapsulated cells and CD4-MAb is a clinically effective treatment in the murine model. 36 ANALYTICAL EVALUATION OF 13 LABORATORY TESTS ON THE ABBOTT ARCHITECT SYSTEM Qureshi, M.,1 Peters, S.,2 and Lehotay, D.C.1,2 Department of Pathology1, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 0W8, Provincial Laboratory Department of Health2, 3211 Albert Street, Regina, Saskatchewan, Canada S4S 5W6 Objectives: Our objectives were to assess the Abbott Architect i2000 analyzer for the measurement of 13 laboratory tests (TSH, T4, FT4, T3, FT3, Testosterone, LH, FSH, Prolactin, Progesterone, B-12, Ferritin and Estradiol). We were unable to evaluate the estradiol assay as the kit was not available temporarily at the time of evaluation. Design and Methods: The precision was evaluated by using three level Biorad Immuno Plus Controls. Serial measurements in the same run were used to estimate within-run precision, while 20 measurements over multiple days were used to estimate between-run precision. Correlations with the ACS-180 (T4, FSH, TSH, T3, LH, FT3), Immulite (Testosterone), Immulite 2000 (FT4, Prolactin, Progesterone) and Beckman Access (B-12, Ferritin) were assessed by measuring approximately 100 –200 patient specimens with values across the assay range. Correlation was assessed by linear regression of the Abbott Architect measurements versus the respective existing instrument results. Results: A good correlation between Abbott Architect and existing instruments was observed. The inter and intra CLINICAL BIOCHEMISTRY, VOLUME 33, APRIL 2000
assay precisions ranged from 3.6 –18.4% and 1.7–11.6% respectively. Bias between our present methods and the Architect was less than 20% except with TSH and T3. Conclusion: Our studies showed that the Abbott Architect i2000 Immunoassay Analyzer can produce equivalent results to existing systems in our laboratory and will allow consolidation of the above tests from 4 different analyzers to a single high throughput instrument. 37 ANALYTICAL EVALUATION OF 17 LABORATORY TESTS ON THE BAYER CENTAUR SYSTEM. Qureshi M.,1 Thompson, G.,2 Lehotay, D.C.1,2 Department of Pathology1, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 0W8, Provincial Laboratory2, Department of Health, 3211 Albert Street, Regina, Saskatchewan, Canada S4S 5W6 Objectives: Our objectives were to assess the Bayer Centaur analyzer for the measurement of 17 laboratory tests (T4, FT4, T3, FT3, TSH, TSH3,Testosterone, Prolactin, Progesterone, FSH, LH, Cortisol, Estradiol, IgE, Ferritin, B-12, & Folate). Design and Methods: The precision was evaluated by using three level Biorad Immuno Plus controls. Serial measurements in the same-run were used to estimate within-run precision, while 20 measurements over multiple days were used to estimate between-run precision. Correlation with ACS-180 (T4, FSH, TSH, TSH3, T3, LH, FT3), Immulite (Testosterone), Immulite 2000 (FT4, Prolactin, Progesterone, Cortisol, Estradiol) and Beckman Access (B-12, Ferritin, IgE, Folate) were assessed by measuring approximately 100 –200 patient specimens with values across the assay range. Correlation was assessed by linear regression of the Centaur measurements versus the respective existing instrument results. Results: A good correlation between the Bayer Centaur and existing instruments was observed. The inter and intra assay precisions ranged 4.0 –27.2% and 3.2–15.6% respectively. Bias between our present methods and the Centaur were less than 20% with the exception of Progesterone. Conclusion: Our studies showed that the Bayer Centaur Immunoassay Analyzer can produce equivalent results to existing systems in our laboratory and will allow consolidation of the above tests from 4 different analyzers to a single high throughput instrument. 38 EVALUATION OF A SCREENING ALGORITHM FOR IDENTIFICATION OF ACUTE CORONARY SYNDROMES IN THE EMERGENCY ROOM Randell, E.W.1,2 and Besso-Waterman, J.1 Dept. of Lab. Medicine1, Health Care Corp. of St. John’s, Faculty of Medicine2, Memorial University of Newfoundland, Health Sciences Centre, 300 Prince Philip Dr., St. John’s, Newfoundland, Canada, A1B 3V6 Objectives: This study evaluates the impact of an algorithm derived from the National Academy of Clinical 237
Objectives: To use monoclonal anti-CD4 antibodies (CD4MAb) to deplete CD4 positive T-cells prior to implantation to prevent the development of neutralizing antibodies. Methods: We have used a non-autologous method of gene therapy in which “universal” cell lines engineered to secrete hFIX were immuno-isolated in alginate microcapsules to treat FIX deficient mice. One group of mice also received CD4-MAb treatment. Results: Hemophilic mice treated with microcapsules enclosing hFIX-secreting C2C12 myoblasts showed activated partial thromboplastin times (aPTT’s) of 89 to 99 seconds on days 3 to 21 post-implantation, a 20 to 29% reduction from hemophilic levels (124.5 seconds), but still above the normal level (71.5 seconds). Plasma hFIX levels were a maximum on day 2 at 16 ng/mL, then falling to baseline by day 7. The declining hFIX levels corresponded to an increase in anti-hFIX antibody level above the baseline on day 10, rising to high levels by day 28. In hemophilic mice treated with CD4-MAb prior to implantation, the antibody level was suppressed (below the level in control mice implanted similarly but without CD4-MAb treatment) until day 42 (p⬍0.05). This treatment also led to a 6-12% reduction in aPTT’s from days 7 to 29 (versus hemophilic levels of 72 seconds, p⬍0.05 for all time points), but still above the normal level (45 seconds). Conclusions: Non-autologous gene therapy for hemophilia with microencapsulated cells and CD4-MAb is a clinically effective treatment in the murine model. 36 ANALYTICAL EVALUATION OF 13 LABORATORY TESTS ON THE ABBOTT ARCHITECT SYSTEM Qureshi, M.,1 Peters, S.,2 and Lehotay, D.C.1,2 Department of Pathology1, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 0W8, Provincial Laboratory Department of Health2, 3211 Albert Street, Regina, Saskatchewan, Canada S4S 5W6 Objectives: Our objectives were to assess the Abbott Architect i2000 analyzer for the measurement of 13 laboratory tests (TSH, T4, FT4, T3, FT3, Testosterone, LH, FSH, Prolactin, Progesterone, B-12, Ferritin and Estradiol). We were unable to evaluate the estradiol assay as the kit was not available temporarily at the time of evaluation. Design and Methods: The precision was evaluated by using three level Biorad Immuno Plus Controls. Serial measurements in the same run were used to estimate within-run precision, while 20 measurements over multiple days were used to estimate between-run precision. Correlations with the ACS-180 (T4, FSH, TSH, T3, LH, FT3), Immulite (Testosterone), Immulite 2000 (FT4, Prolactin, Progesterone) and Beckman Access (B-12, Ferritin) were assessed by measuring approximately 100 –200 patient specimens with values across the assay range. Correlation was assessed by linear regression of the Abbott Architect measurements versus the respective existing instrument results. Results: A good correlation between Abbott Architect and existing instruments was observed. The inter and intra CLINICAL BIOCHEMISTRY, VOLUME 33, APRIL 2000
assay precisions ranged from 3.6 –18.4% and 1.7–11.6% respectively. Bias between our present methods and the Architect was less than 20% except with TSH and T3. Conclusion: Our studies showed that the Abbott Architect i2000 Immunoassay Analyzer can produce equivalent results to existing systems in our laboratory and will allow consolidation of the above tests from 4 different analyzers to a single high throughput instrument. 37 ANALYTICAL EVALUATION OF 17 LABORATORY TESTS ON THE BAYER CENTAUR SYSTEM. Qureshi M.,1 Thompson, G.,2 Lehotay, D.C.1,2 Department of Pathology1, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 0W8, Provincial Laboratory2, Department of Health, 3211 Albert Street, Regina, Saskatchewan, Canada S4S 5W6 Objectives: Our objectives were to assess the Bayer Centaur analyzer for the measurement of 17 laboratory tests (T4, FT4, T3, FT3, TSH, TSH3,Testosterone, Prolactin, Progesterone, FSH, LH, Cortisol, Estradiol, IgE, Ferritin, B-12, & Folate). Design and Methods: The precision was evaluated by using three level Biorad Immuno Plus controls. Serial measurements in the same-run were used to estimate within-run precision, while 20 measurements over multiple days were used to estimate between-run precision. Correlation with ACS-180 (T4, FSH, TSH, TSH3, T3, LH, FT3), Immulite (Testosterone), Immulite 2000 (FT4, Prolactin, Progesterone, Cortisol, Estradiol) and Beckman Access (B-12, Ferritin, IgE, Folate) were assessed by measuring approximately 100 –200 patient specimens with values across the assay range. Correlation was assessed by linear regression of the Centaur measurements versus the respective existing instrument results. Results: A good correlation between the Bayer Centaur and existing instruments was observed. The inter and intra assay precisions ranged 4.0 –27.2% and 3.2–15.6% respectively. Bias between our present methods and the Centaur were less than 20% with the exception of Progesterone. Conclusion: Our studies showed that the Bayer Centaur Immunoassay Analyzer can produce equivalent results to existing systems in our laboratory and will allow consolidation of the above tests from 4 different analyzers to a single high throughput instrument. 38 EVALUATION OF A SCREENING ALGORITHM FOR IDENTIFICATION OF ACUTE CORONARY SYNDROMES IN THE EMERGENCY ROOM Randell, E.W.1,2 and Besso-Waterman, J.1 Dept. of Lab. Medicine1, Health Care Corp. of St. John’s, Faculty of Medicine2, Memorial University of Newfoundland, Health Sciences Centre, 300 Prince Philip Dr., St. John’s, Newfoundland, Canada, A1B 3V6 Objectives: This study evaluates the impact of an algorithm derived from the National Academy of Clinical 237