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Performance characteristics of a new automated method for measurement of anti-cyclic citrullinated peptide

  • Madelon Noordegraaf EMAIL logo , Albert Wolthuis , Frans Peters , Monique de Groot and Rein Hoedemakers
Published/Copyright: January 12, 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 53 Issue 7

Abstract

Background: Rheumatoid arthritis (RA) is a chronic inflammatory auto-immune disease affecting approximately 1%–2% of the population worldwide. RA is a potentially crippling disease since it results in malformation of the joints. RA is mostly diagnosed based on clinical manifestations but serological tests against autoantibodies, such as rheumatoid factor and anti-cyclic citrullinated peptides (aCCP), are available. The presence of aCCP antibodies is strongly associated with a more severe, destructive disease course. Recently, a new test for the measurement of aCCP antibodies on the IMMULITE 2000(XPi) platform was developed by Siemens Healthcare. In this study we investigated the performance characteristics of this new aCCP test in four different hospital laboratories and compared the new test with three different commercially available platforms.

Methods: Samples were collected from patients presented to the hospital for aCCP measurement. Serum aCCP levels were determined by aCCP (Ig)G assay for IMMULITE 2000(XPi) systems (Siemens Healthcare), ImmunoScan RA enzyme-linked immunosorbent assay (ELISA) test (Eurodiagnostica), Immunocap 250 (Thermofisher) or aCCP IgG assay on the Modular system (Roche Diagnostics). The evaluation protocol consisted of within-run imprecision (20 sequential runs), between-run imprecision (16 workdays), comparison of serum and plasma measurement and method comparison.

Results: The within-run imprecision (n=20) for aCCP IgG assay on three different IMMULITE 2000(XPi) systems ranged from 3.0% to 6.9% at levels 3.2–171.2 U/mL. Between-run imprecision (n=16 days) ranged from 5.2% to 11% at levels of 3.2–106.9 U/mL. Method comparison showed good correlation when samples were measured on two different Immulite analyzers in two different hospital laboratories [0.21+0.96x (n=40)]. Method comparison of the IMMULITE 2000(XPi) aCCP test with aCCP on Immunoscan RA ELISA (n=112), Immunocap 250 (n=105) and the Modular system (n=289) resulted in a concordance of 90.2%, 93.3% and 94.8%, respectively. Correlation of serum versus heparin samples showed a correlation of 0.12+1.08x for the Immulite 2000(XPi) test.

Conclusions: The aCCP assay on the IMMULITE 2000(XPi) has good performance characteristics and shows high level of concordance with the aCCP test on Immunoscan RA ELISA test, Immunocap 250 and the Modular systems.

Keywords: aCCP; autoimmunity; diagnosis; rheumatoid arthritis
Corresponding author: Madelon Noordegraaf, Jeroen Bosch Hospital, Laboratory of Clinical Chemistry and Hematology, PO Box 90153, ‘s-Hertogenbosch 5200 ME, The Netherlands, E-mail:

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Received: 2014-9-29
Accepted: 2014-11-17
Published Online: 2015-1-12
Published in Print: 2015-6-1

©2015 by De Gruyter

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Personalized medicine: moving from simple theory to daily practice
  4. Evaluating and using innovative technologies: a lesson from Theranos?
  5. Review
  6. Emerging biomarkers in the detection and prognosis of prostate cancer
  7. Mini Review
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  9. Opinion Papers
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  23. Performance characteristics of a new automated method for measurement of anti-cyclic citrullinated peptide
  24. The clinical performance of a chemiluminescent immunoassay in detecting anti-cardiolipin and anti-β2 glycoprotein I antibodies. A comparison with a homemade ELISA method
  25. Reference Values and Biological Variations
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  27. Development of the first urinary reproductive hormone ranges referenced to independently determined ovulation day
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  30. Cardiovascular Diseases
  31. Elevated circulating levels of lipoprotein-associated phospholipase A2 in obese children
  32. Letters to the Editors
  33. Reporting of hemolysis index (HI) with laboratory results should be obligatory in newborns and infants
  34. Unmeasurably high chloride: a surrogate marker of thiocyanate poisoning identification
  35. Association between red cell distribution width and myocardial infarction in rheumatoid arthritis
  36. Plasmatic and urinary glycosaminoglycan profile in a patient affected by multiple sulfatase deficiency
  37. Rapid diagnosis of cryptococcal meningitis by Türk staining
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https://doi.org/10.1515/cclm-2014-0961
Keywords for this article
aCCP; autoimmunity; diagnosis; rheumatoid arthritis

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Personalized medicine: moving from simple theory to daily practice
  4. Evaluating and using innovative technologies: a lesson from Theranos?
  5. Review
  6. Emerging biomarkers in the detection and prognosis of prostate cancer
  7. Mini Review
  8. Could molecular assessment of calcium metabolism be a useful tool to early screen patients at risk for pre-eclampsia complicated pregnancy? Proposal and rationale
  9. Opinion Papers
  10. Is laboratory medicine ready for the era of personalized medicine? A survey addressed to laboratory directors of hospitals/academic schools of medicine in Europe
  11. Theranos phenomenon: promises and fallacies
  12. Clinical laboratories: production industry or medical services?
  13. Genetics and Molecular Diagnostics
  14. Role of JAK2 V617F mutation and aberrant expression of microRNA-143 in myeloproliferative neoplasms
  15. Direct identification of Gram-positive bacteria and resistance determinants from blood cultures using a microarray-based nucleic acid assay: in-depth analysis of microarray data for undetermined results
  16. General Clinical Chemistry and Laboratory Medicine
  17. Comparison between bottom-up and top-down approaches in the estimation of measurement uncertainty
  18. Role of vitamin D and sFlt-1/PlGF ratio in the development of early- and late-onset preeclampsia
  19. Adenosine deaminase, dipeptidyl peptidase-IV activities and lipid peroxidation are increased in the saliva of obese young adult
  20. PON-1 and ferroxidase activities in older patients with mild cognitive impairment, late onset Alzheimer’s disease or vascular dementia
  21. Comparison of five automated hematology analyzers in a university hospital setting: Abbott Cell-Dyn Sapphire, Beckman Coulter DxH 800, Siemens Advia 2120i, Sysmex XE-5000, and Sysmex XN-2000
  22. Dacryocytes are a common morphologic feature of autoimmune and microangiopathic haemolytic anaemia
  23. Performance characteristics of a new automated method for measurement of anti-cyclic citrullinated peptide
  24. The clinical performance of a chemiluminescent immunoassay in detecting anti-cardiolipin and anti-β2 glycoprotein I antibodies. A comparison with a homemade ELISA method
  25. Reference Values and Biological Variations
  26. Reference interval for immature platelet fraction on Sysmex XN hematology analyzer: a comparison study with Sysmex XE-2100
  27. Development of the first urinary reproductive hormone ranges referenced to independently determined ovulation day
  28. Cancer Diagnostics
  29. Urinary miR-183 and miR-205 do not surpass PCA3 in urine as predictive markers for prostate biopsy outcome despite their highly dysregulated expression in prostate cancer tissue
  30. Cardiovascular Diseases
  31. Elevated circulating levels of lipoprotein-associated phospholipase A2 in obese children
  32. Letters to the Editors
  33. Reporting of hemolysis index (HI) with laboratory results should be obligatory in newborns and infants
  34. Unmeasurably high chloride: a surrogate marker of thiocyanate poisoning identification
  35. Association between red cell distribution width and myocardial infarction in rheumatoid arthritis
  36. Plasmatic and urinary glycosaminoglycan profile in a patient affected by multiple sulfatase deficiency
  37. Rapid diagnosis of cryptococcal meningitis by Türk staining
  38. A high selectivity and sensitivity analytical method for the analysis of 8-hydroxy-2′-deoxyguanosine in the urine of Alzheimer’s disease patients
  39. S100B protein concentration measurement according to two different immunoassays
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