Pål Rustad - Academia.edu (original) (raw)
Papers by Pål Rustad
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
In the Nordic Reference Interval Project 2000 (NORIP) serum, Li-heparin plasma and EDTA buffy coa... more In the Nordic Reference Interval Project 2000 (NORIP) serum, Li-heparin plasma and EDTA buffy coat were collected at 102 laboratories in 5 Nordic countries from healthy individuals aged 18 years or more and evenly distributed for laboratory, gender and age. Multiple aliquots of these samples from each of about 3000 persons are now stored at the Nordic Reference Interval Project Bio-bank and Database (NOBIDA) at a temperature of below -80 degrees C. The commutable NFKK Reference Serum X with certified values traceable to reference methods and measured in NORIP in the same series as the samples is also available from NOBIDA. Data describing the person and the sample conditions are stored together with analytical results and data describing the measurement systems. The bio-bank along with material and data is administered by the NOBIDA committee on behalf of the NFKK (Scandinavian Society of Clinical Chemistry) to be used by Nordic laboratories for any purpose beneficial to the development of clinical biochemistry in general and particularly for creating reference intervals for other biochemical properties than those established by NORIP. Furthermore, research on the already stored information alone is encouraged. Thus colleagues are now welcome to use this extensive material for research and development in clinical biochemistry.
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
In the Nordic Reference Interval Project (NORIP), data from 102 Nordic clinical chemical laborato... more In the Nordic Reference Interval Project (NORIP), data from 102 Nordic clinical chemical laboratories were obtained. Each laboratory reported analytical data on up to 25 of the most commonly used clinical biochemical properties, including results from each of a minimum of 25 reference individuals. A reference material consisting of a liquid frozen pool of serum with values traceable to reference methods (used as the project "calibrator" for non-enzymes to correct reference values) was measured together with other serum pool controls in each laboratory in the same analytical series as the project samples. The data on the controls were used to evaluate the analytical quality of the routine methods. For reference interval calculations, only such reference values on enzymes were accepted that were obtained by applying the International Federation of Clinical Chemistry (IFCC) compatible methods (37 degrees C), while "calibrator"-corrected reference values were used in the cases of non-enzymes. For each property, gender- and age-specific reference intervals were estimated, based on simple non-parametric calculations and using objective criteria to perform partitioning into subgroups. It is concluded that the same reference intervals are applicable in all five Nordic countries. The following descriptive data for the considered properties are presented in the tables: number of measurement values from each country and measurement system, certified/indicative target values for controls, differences between methods and measurement systems together with coefficients of variation, effects of control correction on the measurement values, differences between subgroups as determined by age, gender, country and material, and comparison of the new reference intervals with those presented in standard textbooks. The 25 components involved in this project were (listed in alphabetical order): Alanine transaminase, albumin, alkaline phosphatase, amylase, amylase pancreatic type, aspartate transaminase, bilirubin, calcium, carbamide, cholesterol, creatine kinase, creatininium, gamma-glutamyltransferase, glucose, HDL-cholesterol, iron, iron-binding capacity, lactate dehydrogenase, magnesium, phosphate, potassium, protein, sodium, triglyceride and urate.
Läkartidningen, Jan 4, 2004
A project engaging the five Nordic countries has presented common reference intervals for the mos... more A project engaging the five Nordic countries has presented common reference intervals for the most frequently used biochemical and haematological analytes. The results are based on samples from up to 3000 healthy adult reference persons and are statistically calculated to include 95% of the reference population's values. Reference samples were analyzed together with commutable control materials traceable to reference methods (IMEP-17). Enzymes were analyzed using methods traceable to IFCC reference methods. The Swedish Society of Clinical Chemistry now recommends its member laboratories to introduce the new reference intervals and new enzyme methods during 2004.
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
Rustad P, Felding P, Franzson L, Kairisto V, Lahti A, Må rtensson A, Hyltoft Petersen P, Simonsso... more Rustad P, Felding P, Franzson L, Kairisto V, Lahti A, Må rtensson A, Hyltoft Petersen P, Simonsson P, Steensland H, Uldall A. The Nordic Reference Interval Project 2000: recommended reference intervals for 25 common biochemical properties. Scand J Clin Lab Invest 2004; 64: 271-284.
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
ABSTRACT
Scandinavian Journal of Clinical & Laboratory Investigation, 1993
Development of quality manuals is a means for the promotion of quality in clinical laboratories b... more Development of quality manuals is a means for the promotion of quality in clinical laboratories by describing the total quality system. It also provides opportunity of checking whether the quality system is implemented in reality and demonstrates to the hospital administration and the clinicians that the laboratory is committed to quality. The intention of these guidelines is to describe the elements of the quality system for a large clinical laboratory, and to present such a system in the form of a quality manual. The proposed guidelines comply, where relevant, with ISO/IEC guide 25 'General requirements for the technical competence of testing laboratories' and EN 45001 'General criteria for the operation of testing laboratories'. The document may be used as an aid for laboratories wishing to be accredited according to EN 45001, or intending to apply for formal certification of their quality systems, according to ISO 9001 'Quality systems--Model for quality assurance in design/development, production, installation, and servicing' utilizing ISO 9004 'Quality management and quality system elements--guidelines; Part 2 Guidelines for service'. However, information about the minimum requirements for official recognition should be obtained from the particular accreditation or certification body concerned.
European Journal of Haematology, 2009
Automation of reticulocyte counting has decreased the analytical imprecision of this parameter. T... more Automation of reticulocyte counting has decreased the analytical imprecision of this parameter. This has made it possible to use the number of reticulocytes and its derived parameters (reticulocyte maturity and reticulocyte cell indices) in new diagnostic and monitoring situations. For rational use of these parameters, it is important to have knowledge of their biological variability. The biological variability of reticulocytes and its derived parameters was studied in 13 healthy people during a period of 7 wk on 2 different instruments. The within-subject coefficient of variation for the reticulocyte count was about 11%, for the mean reticulocyte volume, mean reticulocyte haemoglobin content and mean reticulocyte haemoglobin concentration it was between 1 and 2%, whereas the coefficient of variations for the subpopulations of reticulocytes with different maturity varied depending on the method used for the measurements. The critical difference, that is the change in a result making it significantly different from the previous result, was about 35% for the reticulocyte count and 5-8% for the reticulocyte cell indices, making these indices excellent to follow changes in erythropoiesis. With a possible exception for the mean reticulocyte volume, the within-subject variation was small compared to the between-subject variation.
Clinical Chemistry and Laboratory Medicine, 2000
A suggestion for a standard procedure to establish biological reference intervals for biochemical... more A suggestion for a standard procedure to establish biological reference intervals for biochemical quantities by a multicenter approach is presented. This procedure was developed for and used in the Nordic Reference Interval Project 2000 (NORIP). This project established biological reference intervals for 25 frequently requested biochemical quantities through cooperation of 102 Nordic laboratories. Each laboratory performed collection of reference samples and measurement using their routine methods. The bias of each routine method was eliminated by use of common reference materials measured in each of the participating laboratories.
Clinical Biochemistry, 2009
Reply to: On the importance of the use of proper approaches for comparison of analytical methods ... more Reply to: On the importance of the use of proper approaches for comparison of analytical methods for serum nitrate and evaluation of reference concentrations.
Antimicrobial Agents and Chemotherapy, 1985
Ciprofloxacin was given orally to 10 healthy volunteers for seven consecutive doses of 250 mg eve... more Ciprofloxacin was given orally to 10 healthy volunteers for seven consecutive doses of 250 mg every 12 h. Serum and urine samples were collected at distinct times between 0 and 96 h and analyzed both by high-pressure liquid chromatography and by a microbiological assay. The detection limits were 0.006 and 0.03 ,ug/ml, respectively. For each method, imprecision coefficients of variation were <6.1% at various concentra-
Clinical Chemistry, 2004
Background: The aim of this study was to develop new methods for partitioning biochemical referen... more Background: The aim of this study was to develop new methods for partitioning biochemical reference data, covering in particular nongaussian distributions. Methods: We recently proposed partitioning criteria for gaussian distributions. These criteria relate to proportions of the subgroups outside each of the reference limits of the combined distribution (proportion criteria) and to distances between the subgroup distributions as correlates of these proportions (distance criteria). However, distance criteria do not seem to be ideal for nongaussian distributions because a generally valid relationship between proportions and distances cannot be established for these. Results: Proportion criteria appear preferable to distance criteria for two additional reasons: (a) The prevalences of the subgroup populations may have a considerable effect on stratification, but these are hard to account for by using distance criteria. Two methods to handle prevalences are described, the root method and the multiplication method. (b) Tied reference values, another complication of the partitioning problem, could also be hard to take care of using distance criteria. Some solutions to the problems caused by tied reference values are suggested. Conclusions: Partitioning of biochemical reference data should preferably be based on proportion criteria; this is particularly true for nongaussian distributions. Both of the described complications of the partitioning problem, the prevalences of the subgroups and tied reference values, are hard to deal with using distance criteria, but the proposed methods make it possible to account for them when proportion criteria are applied.
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
In the Nordic Reference Interval Project 2000 (NORIP) serum, Li-heparin plasma and EDTA buffy coa... more In the Nordic Reference Interval Project 2000 (NORIP) serum, Li-heparin plasma and EDTA buffy coat were collected at 102 laboratories in 5 Nordic countries from healthy individuals aged 18 years or more and evenly distributed for laboratory, gender and age. Multiple aliquots of these samples from each of about 3000 persons are now stored at the Nordic Reference Interval Project Bio-bank and Database (NOBIDA) at a temperature of below -80 degrees C. The commutable NFKK Reference Serum X with certified values traceable to reference methods and measured in NORIP in the same series as the samples is also available from NOBIDA. Data describing the person and the sample conditions are stored together with analytical results and data describing the measurement systems. The bio-bank along with material and data is administered by the NOBIDA committee on behalf of the NFKK (Scandinavian Society of Clinical Chemistry) to be used by Nordic laboratories for any purpose beneficial to the development of clinical biochemistry in general and particularly for creating reference intervals for other biochemical properties than those established by NORIP. Furthermore, research on the already stored information alone is encouraged. Thus colleagues are now welcome to use this extensive material for research and development in clinical biochemistry.
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
In the Nordic Reference Interval Project (NORIP), data from 102 Nordic clinical chemical laborato... more In the Nordic Reference Interval Project (NORIP), data from 102 Nordic clinical chemical laboratories were obtained. Each laboratory reported analytical data on up to 25 of the most commonly used clinical biochemical properties, including results from each of a minimum of 25 reference individuals. A reference material consisting of a liquid frozen pool of serum with values traceable to reference methods (used as the project "calibrator" for non-enzymes to correct reference values) was measured together with other serum pool controls in each laboratory in the same analytical series as the project samples. The data on the controls were used to evaluate the analytical quality of the routine methods. For reference interval calculations, only such reference values on enzymes were accepted that were obtained by applying the International Federation of Clinical Chemistry (IFCC) compatible methods (37 degrees C), while "calibrator"-corrected reference values were used in the cases of non-enzymes. For each property, gender- and age-specific reference intervals were estimated, based on simple non-parametric calculations and using objective criteria to perform partitioning into subgroups. It is concluded that the same reference intervals are applicable in all five Nordic countries. The following descriptive data for the considered properties are presented in the tables: number of measurement values from each country and measurement system, certified/indicative target values for controls, differences between methods and measurement systems together with coefficients of variation, effects of control correction on the measurement values, differences between subgroups as determined by age, gender, country and material, and comparison of the new reference intervals with those presented in standard textbooks. The 25 components involved in this project were (listed in alphabetical order): Alanine transaminase, albumin, alkaline phosphatase, amylase, amylase pancreatic type, aspartate transaminase, bilirubin, calcium, carbamide, cholesterol, creatine kinase, creatininium, gamma-glutamyltransferase, glucose, HDL-cholesterol, iron, iron-binding capacity, lactate dehydrogenase, magnesium, phosphate, potassium, protein, sodium, triglyceride and urate.
Läkartidningen, Jan 4, 2004
A project engaging the five Nordic countries has presented common reference intervals for the mos... more A project engaging the five Nordic countries has presented common reference intervals for the most frequently used biochemical and haematological analytes. The results are based on samples from up to 3000 healthy adult reference persons and are statistically calculated to include 95% of the reference population's values. Reference samples were analyzed together with commutable control materials traceable to reference methods (IMEP-17). Enzymes were analyzed using methods traceable to IFCC reference methods. The Swedish Society of Clinical Chemistry now recommends its member laboratories to introduce the new reference intervals and new enzyme methods during 2004.
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
Rustad P, Felding P, Franzson L, Kairisto V, Lahti A, Må rtensson A, Hyltoft Petersen P, Simonsso... more Rustad P, Felding P, Franzson L, Kairisto V, Lahti A, Må rtensson A, Hyltoft Petersen P, Simonsson P, Steensland H, Uldall A. The Nordic Reference Interval Project 2000: recommended reference intervals for 25 common biochemical properties. Scand J Clin Lab Invest 2004; 64: 271-284.
Scandinavian Journal of Clinical & Laboratory Investigation, 2004
ABSTRACT
Scandinavian Journal of Clinical & Laboratory Investigation, 1993
Development of quality manuals is a means for the promotion of quality in clinical laboratories b... more Development of quality manuals is a means for the promotion of quality in clinical laboratories by describing the total quality system. It also provides opportunity of checking whether the quality system is implemented in reality and demonstrates to the hospital administration and the clinicians that the laboratory is committed to quality. The intention of these guidelines is to describe the elements of the quality system for a large clinical laboratory, and to present such a system in the form of a quality manual. The proposed guidelines comply, where relevant, with ISO/IEC guide 25 'General requirements for the technical competence of testing laboratories' and EN 45001 'General criteria for the operation of testing laboratories'. The document may be used as an aid for laboratories wishing to be accredited according to EN 45001, or intending to apply for formal certification of their quality systems, according to ISO 9001 'Quality systems--Model for quality assurance in design/development, production, installation, and servicing' utilizing ISO 9004 'Quality management and quality system elements--guidelines; Part 2 Guidelines for service'. However, information about the minimum requirements for official recognition should be obtained from the particular accreditation or certification body concerned.
European Journal of Haematology, 2009
Automation of reticulocyte counting has decreased the analytical imprecision of this parameter. T... more Automation of reticulocyte counting has decreased the analytical imprecision of this parameter. This has made it possible to use the number of reticulocytes and its derived parameters (reticulocyte maturity and reticulocyte cell indices) in new diagnostic and monitoring situations. For rational use of these parameters, it is important to have knowledge of their biological variability. The biological variability of reticulocytes and its derived parameters was studied in 13 healthy people during a period of 7 wk on 2 different instruments. The within-subject coefficient of variation for the reticulocyte count was about 11%, for the mean reticulocyte volume, mean reticulocyte haemoglobin content and mean reticulocyte haemoglobin concentration it was between 1 and 2%, whereas the coefficient of variations for the subpopulations of reticulocytes with different maturity varied depending on the method used for the measurements. The critical difference, that is the change in a result making it significantly different from the previous result, was about 35% for the reticulocyte count and 5-8% for the reticulocyte cell indices, making these indices excellent to follow changes in erythropoiesis. With a possible exception for the mean reticulocyte volume, the within-subject variation was small compared to the between-subject variation.
Clinical Chemistry and Laboratory Medicine, 2000
A suggestion for a standard procedure to establish biological reference intervals for biochemical... more A suggestion for a standard procedure to establish biological reference intervals for biochemical quantities by a multicenter approach is presented. This procedure was developed for and used in the Nordic Reference Interval Project 2000 (NORIP). This project established biological reference intervals for 25 frequently requested biochemical quantities through cooperation of 102 Nordic laboratories. Each laboratory performed collection of reference samples and measurement using their routine methods. The bias of each routine method was eliminated by use of common reference materials measured in each of the participating laboratories.
Clinical Biochemistry, 2009
Reply to: On the importance of the use of proper approaches for comparison of analytical methods ... more Reply to: On the importance of the use of proper approaches for comparison of analytical methods for serum nitrate and evaluation of reference concentrations.
Antimicrobial Agents and Chemotherapy, 1985
Ciprofloxacin was given orally to 10 healthy volunteers for seven consecutive doses of 250 mg eve... more Ciprofloxacin was given orally to 10 healthy volunteers for seven consecutive doses of 250 mg every 12 h. Serum and urine samples were collected at distinct times between 0 and 96 h and analyzed both by high-pressure liquid chromatography and by a microbiological assay. The detection limits were 0.006 and 0.03 ,ug/ml, respectively. For each method, imprecision coefficients of variation were <6.1% at various concentra-
Clinical Chemistry, 2004
Background: The aim of this study was to develop new methods for partitioning biochemical referen... more Background: The aim of this study was to develop new methods for partitioning biochemical reference data, covering in particular nongaussian distributions. Methods: We recently proposed partitioning criteria for gaussian distributions. These criteria relate to proportions of the subgroups outside each of the reference limits of the combined distribution (proportion criteria) and to distances between the subgroup distributions as correlates of these proportions (distance criteria). However, distance criteria do not seem to be ideal for nongaussian distributions because a generally valid relationship between proportions and distances cannot be established for these. Results: Proportion criteria appear preferable to distance criteria for two additional reasons: (a) The prevalences of the subgroup populations may have a considerable effect on stratification, but these are hard to account for by using distance criteria. Two methods to handle prevalences are described, the root method and the multiplication method. (b) Tied reference values, another complication of the partitioning problem, could also be hard to take care of using distance criteria. Some solutions to the problems caused by tied reference values are suggested. Conclusions: Partitioning of biochemical reference data should preferably be based on proportion criteria; this is particularly true for nongaussian distributions. Both of the described complications of the partitioning problem, the prevalences of the subgroups and tied reference values, are hard to deal with using distance criteria, but the proposed methods make it possible to account for them when proportion criteria are applied.