Reference Values

Solberg, Helge Erik; Gräsbeck, Ralph

doi:10.1016/s0065-2423(08)60181-x

Cited by 106 publications

(74 citation statements)

References 82 publications

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“…The normal ranges for the three populations of antibodies were defined as the upper limits of the 90% CI of the 95th percentile (15). In 150 plasma samples from healthy volunteers, the upper normal range was found to be 0.5% bound/ total (B/T) for HI-specific antibodies, 4.6% B/T for IAsp-specific antibodies, and 1.0% B/T for cross-reacting antibodies.…”

Section: Antibody Assaymentioning

confidence: 99%

Immune Responses to Insulin Aspart and Biphasic Insulin Aspart in People With Type 1 and Type 2 Diabetes

et al. 2002

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OBJECTIVE -The antibody responses to a novel rapid-acting insulin analog, insulin aspart (IAsp), and their potential clinical correlates were studied with a specifically developed method in 2,420 people with diabetes treated for up to 1 year with preprandial subcutaneous injections of IAsp. RESEARCH DESIGN AND METHODS -Circulating insulin antibodies were analyzed by radioimmunoassay with 125I insulin or IAsp tracers and polyethylene glycol precipitation. Four multinational, open, parallel group studies were conducted in Europe and North America, with a total of 1,534 people with diabetes exposed to IAsp and 886 people exposed to human insulin (HI) as meal-related insulin for 6 -12 months.RESULTS -Insulin antibodies specific to HI or IAsp were absent in a majority of patients throughout the 6-to 12-month study periods. A majority of the patients (64 -68%) had antibodies cross-reacting between HI and IAsp when entering the studies, with baseline levels (means Ϯ SD of percent bound/total) of 16.6 Ϯ 16.3% in study 1 and 10.3 Ϯ 14.0% in study 4. In all four studies, cross-reactive antibodies increased in patients exposed to IAsp, with a maximum at 3 months, and thereafter there was a decline toward baseline levels at 9 -12 months (levels at 3 and 12 months: 22.3 Ϯ 19.7 and 16.8 Ϯ 16.5% in study 1 and 21.5 Ϯ 21.9 and 16.9 Ϯ 17.4% in study 4). Antibody levels showed similar changes in people with type 1 and type 2 diabetes, and there was no consistent relationship between antibody formation and glycemic control or between antibody formation and safety in terms of adverse events.CONCLUSIONS -Treatment with IAsp is associated with an increase in cross-reactive insulin antibodies, with a subsequent fall toward baseline values, without any indication of clinical relevance because no effect on efficacy or safety could be identified. Diabetes Care 25:876 -882, 2002A nti-insulin antibodies are common in people with diabetes treated with subcutaneous human insulin (HI) (1). It has been shown that up to 80% of people treated with subcutaneous insulin may develop anti-insulin antibodies (1). Hypothetically, anti-insulin antibodies could affect the pharmacokinetics of the exogenously administered insulin by several mechanisms, which would either enhance or reduce the pharmacodynamic response. Antibodies could enhance and prolong the pharmacodynamic action by serving as a carrier, or they could reduce insulin action by neutralization. As the insulin-binding sites of the antibodies produced vary from individual to individual, the pharmacodynamic effect could be expected to vary from subject to subject in an unpredictable manner.Insulin aspart (IAsp) is, together with insulin lispro (2), one of the two available rapid-acting insulin analogs with the advantage of being able to mimic the peripheral insulin response to a meal more closely than soluble HI, even when administered immediately before the meal (3-5). This has been made possible by substitution of aspartic acid for proline in position B28, thereby reducing the tendency to fo...

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Section: Antibody Assaymentioning

confidence: 99%

Immune Responses to Insulin Aspart and Biphasic Insulin Aspart in People With Type 1 and Type 2 Diabetes

et al. 2002

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“…Once quality has been assured, the next steps involve a series of comparisons [6] that include comparisons of test results with reference values based on healthy subjects [5], comparisons with known disease or abnormal physiological patterns (i.e. obstruction and restriction), and comparisons with self, a rather formal term for evaluating change in an individual patient.…”

mentioning

confidence: 99%

Interpretative strategies for lung function tests

Pellegrino¹

2005

European Respiratory Journal

4,918

4,636

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“…Blood samples were collected randomly, after giving 15 minutes of physical rest, 3 in sitting posture. In a plain red-topped vacutainer tubes containing clot activator, 2 mL of blood sample was collected from antecubital vein.…”

Section: Methodsmentioning

confidence: 99%

Establishment of Reference Intervals of Serum Hepatic Enzymes in Tertiary Care Hospital: A Pilot Study

P¹,

Shetty²,

Patil³

et al. 2017

Indian Journal of Medical Biochemistry

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Introduction Reference intervals are the most common decision-making tools for the interpretation of various biochemical reports. Age, sex, ethnicity, diet, physical, and socioeconomic conditions affect the physiology of population. Hence, it is necessary to set up the reference values that are applicable to a specific population rather than using the reference values established for other population-based studies or from the literature provided by the reagent kit manufacturers. Aims and objectives To establish the reference intervals of serum hepatic enzymes in tertiary care hospital. Materials and methods Hospital-based cross-sectional study was done involving 200 subjects. The subjects were randomly selected from the population, which included medical students, health professionals, and those attending different outpatient departments and health camps organized by the hospital for general checkups under health plan scheme. Serum alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) were estimated by the International Federation of Clinical Chemistry-recommended kinetic method and GGT by enzymatic colorimetric method. To obtain reference interval, 97.5th percentile and 2.5th percentile were used. Results The results for serum AST and GGT were found to be statistically significant. Hence separate reference intervals for both male and female were set up. Generalized reference intervals were established for serum ALT and ALP levels. Conclusion The present study revealed a significant difference in the reference intervals between males and females. How to cite this article Rai PS, Shetty S, Patil P, Bhandary R. Establishment of Reference Intervals of Serum Hepatic Enzymes in Tertiary Care Hospital: A Pilot Study. Indian J Med Biochem 2017;21(1):22-24.

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Reference Values

Cited by 106 publications

References 82 publications

Immune Responses to Insulin Aspart and Biphasic Insulin Aspart in People With Type 1 and Type 2 Diabetes

Immune Responses to Insulin Aspart and Biphasic Insulin Aspart in People With Type 1 and Type 2 Diabetes

Interpretative strategies for lung function tests

Establishment of Reference Intervals of Serum Hepatic Enzymes in Tertiary Care Hospital: A Pilot Study

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