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A survey of total IgE reference intervals reported by Scandinavian and British medical laboratories – a need for harmonisation

Objectives There appears to be marked discrepancies between total IgE reference intervals (RIs) in use by many laboratories and those recommended by published studies. The aim of this study was therefore to review total IgE RIs currently reported by Scandinavian and British laboratories and to compare these to published RIs identified by a literature review. Methods Relevant laboratories were identified by test directories provided by the national accreditation bodies in Norway, Sweden, Denmark and the UK. Total IgE RIs and their sources were acquired by accessing laboratory user handbooks or by an electronic survey. In addition a literature review of published total IgE RI studies was performed. Results From 172 accredited laboratories providing total IgE analysis, data was acquired from 122 laboratories. An adult upper reference limit between 81 to 150 kU/L was reported by 89% of these. Denmark and Sweden reported the most harmonised RIs whilst Norway and the UK exhibited the least degree of harmonisation. Published adult (n = 6) and paediatric (n = 6) RI studies reported markedly higher upper limits than those currently in use by the laboratories included in this study. There were also large variations in the number of age strata in use for paediatric RIs. Conclusion This study demonstrates large variations in currently utilised IgE RIs by Scandinavian and British accredited laboratories and most report markedly lower RIs than those recommended by recent RI publications. Many laboratories likely utilise outdated RIs and should consider critically reviewing and updating their RIs.publishedVersio

Estimating the within-subject (CVI) and between-subject (CVG) biological variation of serum tryptase

Background Tryptase is used as a biomarker to support the diagnosis of anaphylaxis and hematologic diseases. In the event of a mast cell activation during anaphylaxis, a temporary increase in the concentration of tryptase may be seen. On the basis of clinical studies, an increase of 2 µg/L + 20% from basis level has been proposed as significant. To evaluate the increase in tryptase levels, the within-subject (CVI) and between-subject (CVG) biological variations should be known. This study was conducted to estimate the biological variation of tryptase and to identify the reference change value (RCV). Methods Blood samples were collected from healthy volunteers once a week consecutively over a 10-week period. Tryptase was measured by the use of a fluoroenzyme immunoassay (ImmunoCAPTM; Thermo Fisher Scientific), and linear mixed-effects models were used to calculate the biological variation and RCV for both nontransformed and log-transformed tryptase. Results Fourteen presumably healthy young adults (six males and eight females, age 23–35 years) were included. The CVI was 5.6% and the CVG was 31.5% (nontransformed data). Log-transformed data showed similar results. The analytical variation (CVA) was 6.3% and the RCV was 23.5%. Conclusions Young healthy adults without ongoing allergic reactions show low within-subject biological variation. Higher biological variation was observed between subjects.publishedVersio

A novel case of impaired C-reactive protein response following open-heart surgery: A case report and review of the literature

Background C-reactive protein (CRP) is expected to increase in response to a range of inflammatory stimuli such as infections or extensive tissue trauma. Case report We present a novel case of severely impaired CRP response following NSTEMI, influenza A infection and open-heart surgery in which serum CRP concentrations remained < 1 mg/L during an observational period of 28 days. Conclusion To our knowledge, no previous publications exists describing patients with a lack of CRP response following cardiothoracic surgery. We believe this to be a novel finding warranting further investigations regarding the etiology and prevalence of this phenomenon.publishedVersio

Estimating the within-subject (CVI) and between-subject (CVG) biological variation of serum tryptase

Background Tryptase is used as a biomarker to support the diagnosis of anaphylaxis and hematologic diseases. In the event of a mast cell activation during anaphylaxis, a temporary increase in the concentration of tryptase may be seen. On the basis of clinical studies, an increase of 2 µg/L + 20% from basis level has been proposed as significant. To evaluate the increase in tryptase levels, the within-subject (CVI) and between-subject (CVG) biological variations should be known. This study was conducted to estimate the biological variation of tryptase and to identify the reference change value (RCV). Methods Blood samples were collected from healthy volunteers once a week consecutively over a 10-week period. Tryptase was measured by the use of a fluoroenzyme immunoassay (ImmunoCAPTM; Thermo Fisher Scientific), and linear mixed-effects models were used to calculate the biological variation and RCV for both nontransformed and log-transformed tryptase. Results Fourteen presumably healthy young adults (six males and eight females, age 23–35 years) were included. The CVI was 5.6% and the CVG was 31.5% (nontransformed data). Log-transformed data showed similar results. The analytical variation (CVA) was 6.3% and the RCV was 23.5%. Conclusions Young healthy adults without ongoing allergic reactions show low within-subject biological variation. Higher biological variation was observed between subjects

Updated total IgE reference intervals in Norwegian adults

Abstract Background It is important and expected of laboratories to provide updated reference intervals to the clinician. As no recent publications report adult total IgE reference intervals on a Scandinavian population, the aim of our study was therefore to provide an estimate on healthy Norweigian adults. Methods A reference interval study was conducted in accordance to CLSI guidelines. Samples were collected from n = 252 presumably healthy adult participants enrolled through the regional blood donation program. Total IgE measurements were performed on the ImmunoCAPTM platform (Thermo Fisher Diagnostics) traceable to the WHO‐reference standard (75/502) for total IgE measurements. Results An upper 95% total IgE reference limit was estimated to 302 kU/L (90% CI 177–388 kU/L), and the 97.5% percentile was estimated to 391 kU/L (90% CI 344–560 kU/L). No significant differences were found between participants who self‐reported having an allergic disease and participants who did not self‐report having an allergic disease. Conclusion Our results and other recent publications find markedly higher values than adult reference intervals established four decades ago which still remain widely used by clinical laboratories. We therefore recommend total IgE reference intervals should be critically reviewed and updated

Updated total IgE reference intervals in Norwegian adults

Background It is important and expected of laboratories to provide updated reference intervals to the clinician. As no recent publications report adult total IgE reference intervals on a Scandinavian population, the aim of our study was therefore to provide an estimate on healthy Norweigian adults. Methods A reference interval study was conducted in accordance to CLSI guidelines. Samples were collected from n = 252 presumably healthy adult participants enrolled through the regional blood donation program. Total IgE measurements were performed on the ImmunoCAPTM platform (Thermo Fisher Diagnostics) traceable to the WHO-reference standard (75/502) for total IgE measurements. Results An upper 95% total IgE reference limit was estimated to 302 kU/L (90% CI 177–388 kU/L), and the 97.5% percentile was estimated to 391 kU/L (90% CI 344–560 kU/L). No significant differences were found between participants who self-reported having an allergic disease and participants who did not self-report having an allergic disease. Conclusion Our results and other recent publications find markedly higher values than adult reference intervals established four decades ago which still remain widely used by clinical laboratories. We therefore recommend total IgE reference intervals should be critically reviewed and updated.publishedVersio

A novel case of impaired C-reactive protein response following open-heart surgery: A case report and review of the literature

Background C-reactive protein (CRP) is expected to increase in response to a range of inflammatory stimuli such as infections or extensive tissue trauma. Case report We present a novel case of severely impaired CRP response following NSTEMI, influenza A infection and open-heart surgery in which serum CRP concentrations remained < 1 mg/L during an observational period of 28 days. Conclusion To our knowledge, no previous publications exists describing patients with a lack of CRP response following cardiothoracic surgery. We believe this to be a novel finding warranting further investigations regarding the etiology and prevalence of this phenomenon

A survey of total IgE reference intervals reported by Scandinavian and British medical laboratories – a need for harmonisation

There appears to be marked discrepancies between total IgE reference intervals (RIs) in use by many laboratories and those recommended by published studies. The aim of this study was therefore to review total IgE RIs currently reported by Scandinavian and British laboratories and to compare these to published RIs identified by a literature review. Relevant laboratories were identified by test directories provided by the national accreditation bodies in Norway, Sweden, Denmark and the UK. Total IgE RIs and their sources were acquired by accessing laboratory user handbooks or by an electronic survey. In addition a literature review of published total IgE RI studies was performed. From 172 accredited laboratories providing total IgE analysis, data was acquired from 122 laboratories. An adult upper reference limit between 81 to 150 kU/L was reported by 89% of these. Denmark and Sweden reported the most harmonised RIs whilst Norway and the UK exhibited the least degree of harmonisation. Published adult (n = 6) and paediatric (n = 6) RI studies reported markedly higher upper limits than those currently in use by the laboratories included in this study. There were also large variations in the number of age strata in use for paediatric RIs. This study demonstrates large variations in currently utilised IgE RIs by Scandinavian and British accredited laboratories and most report markedly lower RIs than those recommended by recent RI publications. Many laboratories likely utilise outdated RIs and should consider critically reviewing and updating their RIs.</p