Analytical robustness of nine common assays: frequency of outliers and extreme differences identified by a large number of duplicate measurements.

Abstract:

INTRODUCTION:Duplicate measurements can be used to describe the performance and analytical robustness of assays and to identify outliers. We performed about 235,000 duplicate measurements of nine routinely measured quantities and evaluated the observed differences between the replicates to develop new markers for analytical performance and robustness. MATERIALS AND METHODS:Catalytic activity concentrations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and concentrations of calcium, cholesterol, creatinine, C-reactive protein (CRP), lactate, triglycerides and thyroid-stimulating hormone (TSH) in 237,261 patient plasma samples were measured in replicates using routine methods. The performance of duplicate measurements was evaluated in scatterplots with a variable and symmetrical zone of acceptance (A-zone) around the equal line. Two quality markers were established: 1) AZ95: the width of an A-zone at which 95% of all duplicate measurements were within this zone; and 2) OPM (outliers per mille): the relative number of outliers if an A-zone width of 5% was applied. RESULTS:The AZ95 ranges from 3.2% for calcium to 11.5% for CRP and the OPM from 5 (calcium) to 250 (creatinine). Calcium, TSH and cholesterol have an AZ95 of less than 5% and an OPM of less than 50. CONCLUSIONS:Duplicate measurements of a large number of patient samples identify even low frequencies of extreme differences and thereof defined outliers. We suggest two additional quality markers, AZ95 and OPM, to complement description of assay performance and robustness. This approach can aid the selection process of measurement procedures in view of clinical needs.

journal_name

Biochem Med (Zagreb)

journal_title

Biochemia medica

authors

Neubig S,Grotevendt A,Kallner A,Nauck M,Petersmann A

doi

10.11613/BM.2017.021

subject

Has Abstract

pub_date

2017-02-15 00:00:00

pages

192-198

issue

1

eissn

1330-0962

issn

1846-7482

pii

bm-27-192

journal_volume

27

pub_type

杂志文章
  • Molecular pathways in cancer-related inflammation.

    abstract::Accumulating evidence shows that chronic inflammation is associated to increased risk of cancer. An inflammatory component is present also in the microenvironment of tumours epidemiologically unrelated to inflammation. Extensive investigations over the past decade have uncovered many of the important mechanistic pathw...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/bm.2011.036

    authors: Del Prete A,Allavena P,Santoro G,Fumarulo R,Corsi MM,Mantovani A

    更新日期:2011-01-01 00:00:00

  • Sigma metrics in laboratory medicine revisited: We are on the right road with the wrong map.

    abstract::Reliable procedures are needed to quantify the performance of instruments and methods in order to increase the quality in clinical laboratories. The Sigma metrics serves that purpose, and in the present study, the current methods for the calculation of the Sigma metrics are critically evaluated. Although the conventio...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/BM.2018.020503

    authors: Oosterhuis WP,Coskun A

    更新日期:2018-06-15 00:00:00

  • IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity.

    abstract:INTRODUCTION:The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 pro...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/BM.2016.035

    authors: Krleža-Jerić K,Gabelica M,Banzi R,Martinić MK,Pulido B,Mahmić-Kaknjo M,Reveiz L,Šimić J,Utrobičić A,Hrgović I

    更新日期:2016-10-15 00:00:00

  • Interrater reliability: the kappa statistic.

    abstract::The kappa statistic is frequently used to test interrater reliability. The importance of rater reliability lies in the fact that it represents the extent to which the data collected in the study are correct representations of the variables measured. Measurement of the extent to which data collectors (raters) assign th...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:

    authors: McHugh ML

    更新日期:2012-01-01 00:00:00

  • Understanding logistic regression analysis.

    abstract::Logistic regression is used to obtain odds ratio in the presence of more than one explanatory variable. The procedure is quite similar to multiple linear regression, with the exception that the response variable is binomial. The result is the impact of each variable on the odds ratio of the observed event of interest....

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2014.003

    authors: Sperandei S

    更新日期:2014-02-15 00:00:00

  • Eosinophil cationic protein--current concepts and controversies.

    abstract::Eosinophil cationic protein (ECP) is a heterogeneous molecule originating from activated eosinophil granulocytes. Biological activity and the cellular content of ECP are determined by genetic and posttranslational factors. Several single nucleotide polymorphisms (SNPs) in human ECP gene (RNASE3) have been described so...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/bm.2011.019

    authors: Topic RZ,Dodig S

    更新日期:2011-01-01 00:00:00

  • The chi-square test of independence.

    abstract::The Chi-square statistic is a non-parametric (distribution free) tool designed to analyze group differences when the dependent variable is measured at a nominal level. Like all non-parametric statistics, the Chi-square is robust with respect to the distribution of the data. Specifically, it does not require equality o...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/bm.2013.018

    authors: McHugh ML

    更新日期:2013-01-01 00:00:00

  • Scientific author names: errors, corrections, and identity profiles.

    abstract::Authorship problems are deep-rooted in the field of science communication. Some of these relate to lack of specific journal instructions. For decades, experts in journal editing and publishing have been exploring the authorship criteria and contributions deserving either co-authorship or acknowledgment. The issue of i...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2016.017

    authors: Gasparyan AY,Yessirkepov M,Gerasimov AN,Kostyukova EI,Kitas GD

    更新日期:2016-01-01 00:00:00

  • Utility of routine laboratory preoperative tests based on previous results: Time to give up.

    abstract:INTRODUCTION:The usefulness and cost-effectiveness of routine laboratory preoperative tests (POTs) have been challenged recently. In fact, the American Society of Anesthesiologists (ASA) Task Force has stated that test results obtained from the medical record within 6 months of surgery generally are mostly acceptable. ...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2017.030902

    authors: Rodríguez-Borja E,Corchon-Peyrallo A,Aguilar-Aguilar G,Carratala-Calvo A

    更新日期:2017-10-15 00:00:00

  • Urinary free cortisol assessment by liquid chromatography tandem mass spectrometry: a case study of ion suppression due to unacquainted administration of piperacillin.

    abstract:Introduction:Liquid chromatography coupled to atmospheric pressure ionization tandem mass spectrometry (LC-ESI-MS/MS) is currently considered the reference method for quantitative determination of urinary free cortisol (UFC). One of the major drawbacks of this measurement is a particular form of matrix effect, conventi...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/BM.2017.031001

    authors: Danese E,Salvagno GL,Guzzo A,Scurati S,Fava C,Lippi G

    更新日期:2017-10-15 00:00:00

  • External Quality Assessment in Croatia: problems, challenges, and specific circumstances.

    abstract::In Croatian medical laboratories (ML), external quality assessment (EQA) has a long tradition of almost half of a century. At national level, EQA is provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) which is a part of Croatian Society of Medical Biochemistry and Laboratory Medicine.
T...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/BM.2017.011

    authors: Krleza JL,Celap I,Tanaskovic JV

    更新日期:2017-02-15 00:00:00

  • Redefinition of gestational diabetes mellitus: implications for laboratory practice in Croatia.

    abstract::An increasing prevalence of gestational diabetes has become a very challenging task in prenatal care worldwide. International Association of Diabetes and Pregnancy Study Groups (IADPSG) has recently issued recommendations on the diagnosis and classification of hyperglycaemia in pregnancy. These recommendations, the fi...

    journal_title:Biochemia medica

    pub_type: 社论

    doi:10.11613/bm.2013.002

    authors: Lovrencić MV,Honović L,Kralik S,Matica J,Prasek M,Pape-Medvidović E,Ivanisević M,Delmis J

    更新日期:2013-01-01 00:00:00

  • The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria.

    abstract:INTRODUCTION:ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO ...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/bm.2012.027

    authors: Ho B,Ho E

    更新日期:2012-01-01 00:00:00

  • A paradigmatic case of haemolysis and pseudohyperkalemia in blood gas analysis.

    abstract::A 51-year old male patient was admitted to the hospital with acute dyspnea and history of chronic asthma. Venous blood was drawn into a 3.0 mL heparinized syringe and delivered to the laboratory for blood gas analysis (GEM Premier 4000, Instrumentation Laboratory), which revealed high potassium value (5.2 mmol/L; refe...

    journal_title:Biochemia medica

    pub_type:

    doi:10.11613/BM.2019.011003

    authors: Salvagno GL,Demonte D,Lippi G

    更新日期:2019-02-15 00:00:00

  • Evaluating analytical quality in clinical biochemistry laboratory using Six Sigma.

    abstract:Introduction:In recent years, Six Sigma metrics has became the hotspot in all trades and professions, which contributes a general procedure to explain the performance on sigma scale. Nowadays, many large companies, such as General Healthcare, Siemens, etc., have applied Six Sigma to clinical medicine and achieved satis...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2018.020904

    authors: Mao X,Shao J,Zhang B,Wang Y

    更新日期:2018-06-15 00:00:00

  • Optimizing laboratory defined macroprolactin algorithm.

    abstract:Introduction:Macroprolactinaemia is a well-known analytical problem in diagnostics of hyperprolactinaemia usually detected with polyethylene glycol (PEG) precipitation method. Since there is no harmonization in macroprolactin detection and reporting results, this study proposes and evaluates the usefulness of in-house ...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2019.020706

    authors: Šostarić M,Bokulić A,Marijančević D,Zec I

    更新日期:2019-06-15 00:00:00

  • Diagnostic accuracy of urinary prostate protein glycosylation profiling in prostatitis diagnosis.

    abstract:INTRODUCTION:Although prostatitis is a common male urinary tract infection, clinical diagnosis of prostatitis is difficult. The developmental mechanism of prostatitis is not yet unraveled which led to the elaboration of various biomarkers. As changes in asparagine-linked-(N-)-glycosylation were observed between healthy...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2015.045

    authors: Vermassen T,Van Praet C,Poelaert F,Lumen N,Decaestecker K,Hoebeke P,Van Belle S,Rottey S,Delanghe J

    更新日期:2015-10-15 00:00:00

  • Detection of acute kidney injury in premature asphyxiated neonates by serum neutrophil gelatinase-associated lipocalin (sNGAL)--sensitivity and specificity of a potential new biomarker.

    abstract:INTRODUCTION:Acute kidney injury (AKI) is common in neonatal intensive care units (NICU). In recent years, every effort is made for early detection of AKI. Our hypothesis was that serum neutrophil gelatinase-associated lipocalin (sNGAL) may be a reliable screening test for early diagnosis of AKI in premature neonates a...

    journal_title:Biochemia medica

    pub_type: 临床试验,杂志文章

    doi:10.11613/BM.2015.046

    authors: Pejović B,Erić-Marinković J,Pejović M,Kotur-Stevuljević J,Peco-Antić A

    更新日期:2015-10-15 00:00:00

  • Clinical and diagnostic utility of saliva as a non-invasive diagnostic fluid: 
a systematic review.

    abstract::This systematic review presents the latest trends in salivary research and its applications in health and disease. Among the large number of analytes present in saliva, many are affected by diverse physiological and pathological conditions. Further, the non-invasive, easy and cost-effective collection methods prompt a...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/BM.2015.018

    authors: Nunes LA,Mussavira S,Bindhu OS

    更新日期:2015-06-05 00:00:00

  • Oxidative status parameters in children with urinary tract infection.

    abstract:INTRODUCTION:Urinary tract infection (UTI) is one of the most common bacterial infectious diseases in children. The aim of this study was to determine the total prooxidant and antioxidant capacity of children with UTI, as well as changes of oxidative status parameters according to acute inflammation persistence and acu...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2014.029

    authors: Petrovic S,Bogavac-Stanojevic N,Kotur-Stevuljevic J,Peco-Antic A,Ivanisevic I,Ivanisevic J,Paripovic D,Jelic-Ivanovic Z

    更新日期:2014-01-01 00:00:00

  • The likelihood ratio and its graphical representation.

    abstract::Diagnostic tests are important clinical tools. Bayes' theorem and Bayesian approach are important methods for interpreting test results. The Bayesian factor, the so-called likelihood ratio, has not always been well-understood. In this article, we try to discuss the likelihood ratio and its value for a specific test re...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/BM.2019.020101

    authors: Habibzadeh F,Habibzadeh P

    更新日期:2019-06-15 00:00:00

  • Classical pathway activity C3c, C4 and C1-inhibitor protein reference intervals determination in EDTA plasma.

    abstract:Introduction:Reference intervals (RIs) for complement assays in EDTA plasma samples have not previously been published. The objectives of the present study were to validate and/or determine RIs for classical pathway (CP50) activity and C3c, C4 and C1 inhibitor protein (C1INH) assays and to assess the need for age-speci...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2019.030707

    authors: Lopez B,Bertier N,Ledoult E,Joudinaud R,Maanaoui M,Majerus V,Moitrot E,Deleplancque AS,Rogeau S,Launay D,Lefèvre G,Labalette M,Dubucquoi S

    更新日期:2019-10-15 00:00:00

  • Reference intervals for six salivary cortisol measures based on the Croatian Late Adolescence Stress Study (CLASS).

    abstract:Introduction:The aim of this nested study is to provide the reference intervals for already published measurements of salivary cortisol from the Croatian Adolescence Stress Study (CLASS). Material and methods:A total of 969 individuals (372 males and 597 females) were included in the reference sample (age range: 18-21...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2018.010902

    authors: Šupe-Domić D,Milas G,Stanišić L,Drmić Hofman I,Martinović Klarić I

    更新日期:2018-02-15 00:00:00

  • Effect of winter swimming on haematological parameters.

    abstract:INTRODUCTION:Winter swimming represents an intensive short-term exposure to cold, and thus it is considered a strong physical stress. Cold-based treatments, i.e. immersions in cold water, are spreading in sport medicine for improving recovery following muscle traumas, although a universal acceptance of that method is n...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/bm.2011.014

    authors: Lombardi G,Ricci C,Banfi G

    更新日期:2011-01-01 00:00:00

  • How to conduct External Quality Assessment Schemes for the pre-analytical phase?

    abstract::In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades ...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/BM.2014.013

    authors: Kristensen GB,Aakre KM,Kristoffersen AH,Sandberg S

    更新日期:2014-02-15 00:00:00

  • Determining biological variation of serum parathyroid hormone in healthy adults.

    abstract:Introduction:Measurement of parathyroid hormone (PTH) is essential in the investigation and management of calcium metabolism disorders. To assess the significance of any assay result when clinical decision making biological variation (BV) of the measurand must be taken into consideration. The aim of the present study i...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2019.030702

    authors: Ercan M,Akbulut ED,Avcı E,Yücel Ç,Oğuz EF,Turhan T,Serdar M

    更新日期:2019-10-15 00:00:00

  • Inflammatory and angiogenic biomarkers in diabetic retinopathy.

    abstract::Diabetic retinopathy (DR) is one of the most common microvascular complications of diabetes mellitus (DM) and a leading cause of blindness in working-age adults in developed countries. Numerous investigations have recognised inflammation and angiogenesis as important factors in the development of this complication of ...

    journal_title:Biochemia medica

    pub_type: 杂志文章,评审

    doi:10.11613/BM.2020.030502

    authors: Kaštelan S,Orešković I,Bišćan F,Kaštelan H,Gverović Antunica A

    更新日期:2020-10-15 00:00:00

  • Topiramate induced metabolic acidosis and kidney stones - a case study.

    abstract:INTRODUCTION:The aim of this study is to present a case of 44 years old woman with topiramate induced metabolic acidosis and kidney stones. MATERIALS AND METHODS:The laboratory features of topiramate caused renal tubular acidosis in blood and urine during topiramate treatment, with correction of metabolic acidosis by ...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2017.042

    authors: Salek T,Andel I,Kurfurstova I

    更新日期:2017-06-15 00:00:00

  • General position of Croatian medical biochemistry laboratories on autovalidation: survey of the Working Group for Post-analytics of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

    abstract:Introduction:Autovalidation (AV) is an algorithm based on predefined rules designed, among others, to automate and standardize the postanalytical phase of laboratory work. The aim of this study was to examine the overall opinion of Croatian medical biochemistry laboratories regarding various aspects of AV. Material an...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2020.020702

    authors: Rimac V,Jokic A,Podolar S,Vlasic Tanaskovic J,Honovic L,Lenicek Krleza J

    更新日期:2020-06-15 00:00:00

  • Using clinical guidelines to assess the potential value of laboratory medicine in clinical decision-making.

    abstract:Introduction:It is often quoted that 70% of clinical decisions are based on laboratory results, but the evidence to substantiate this claim is lacking. Since clinical guidelines aim to document best-practice decision making for specific disease conditions, inclusion of any laboratory test means that the best available ...

    journal_title:Biochemia medica

    pub_type: 杂志文章

    doi:10.11613/BM.2021.010703

    authors: Hicks AJ,Carwardine ZL,Hallworth MJ,Kilpatrick ES

    更新日期:2021-02-15 00:00:00