Immunologic Research

, Volume 65, Issue 1, pp 363–368 | Cite as

A novel bedside test for ACPA: the CCPoint test is moving the laboratory to the rheumatologist’s office

  • Gisele Zandman Goddard
  • Alessandra Soriano
  • Boris Gilburd
  • Merav Lidar
  • Shaye Kivity
  • Ron Kopilov
  • Pnina Langevitz
  • Yehuda Shoenfeld
  • Nancy Agmon-Levin
Mechanism in Autoimmunity

Abstract

Rheumatoid Arthritis (RA) is an autoimmune destructive joint disease affecting 1 % of the general population. In recent years, the benefits of identifying RA at an early stage and initiating therapy before joint damage occurs have been acknowledged. An elevated anti-citrullinated peptide antibody (ACPA) level serves as a marker for the early diagnosis of RA. Often the diagnosis is delayed because conventional methods of antibody detection require referral to a specific laboratory. In the current study, we determined the diagnostic accuracy of a new lateral flow point-of-care kit available for ACPA detection in the rheumatologist office. The presence of ACPA was determined by the visually read, qualitative rapid CCPoint® test (Euro-Diagnostica, Malmö, Sweden) compared to routinely used ELISA assays (Immunoscan CCPlus®-Euro-Diagnostica, Sweden, and QuantLite® CCP3-INOVA Diagnostics Inc., USA), in the sera of 184 patients: early RA(n = 38), established RA (n = 84), inflammatory arthritis(n = 34) and systemic lupus erythematosus (SLE) (n = 28). ACPA was detected in 18/38(47 %), 53/84(63 %), 2/34(6 %) and 2/28(7 %) of patients with early RA, established RA, inflammatory arthritis and SLE, respectively. The sensitivity and specificity, negative and positive predictive values of the CCPoint® test were equivalent to the Immunoscan CCPlus® and Quanta Lite® CCP3 ELISA assays. Correlation between ACPA positive results detected in the different assays was 97 %, while negative agreement reached 98 %. Excellent correlation (100 %) was observed between CCPoint® results obtained using capillary blood versus serum. CCPoint® is a novel technology that allows for a rapid accurate analysis of ACPA and diagnosis during the patient’s visit in the rheumatologist office.

Keywords

ACPA POC CCPoint test Rheumatoid arthritis Diagnostics 

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Gisele Zandman Goddard
    • 1
    • 2
    • 5
  • Alessandra Soriano
    • 1
    • 4
  • Boris Gilburd
    • 1
  • Merav Lidar
    • 2
    • 3
  • Shaye Kivity
    • 2
    • 3
  • Ron Kopilov
    • 1
  • Pnina Langevitz
    • 2
    • 3
  • Yehuda Shoenfeld
    • 1
    • 6
  • Nancy Agmon-Levin
    • 1
    • 2
  1. 1.Zabludowicz Center for Autoimmune DiseasesChaim Sheba Medical CenterTel-HashomerIsrael
  2. 2.Sackler School of MedicineTel Aviv UniversityTel AvivIsrael
  3. 3.The Zabludowicz Center for Autoimmune Diseases, Rheumatology UnitSheba Medical CenterTel-HashomerIsrael
  4. 4.Department of Clinical Medicine and RheumatologyCampus Bio-Medico UniversityRomeItaly
  5. 5.Department of Medicine C Wolfson Medical CenterHolonIsrael
  6. 6.Incumbent of the Laura Schwarz-Kipp Chair for Research of Autoimmune Diseases, Sackler Faculty of MedicineTel-Aviv UniversityTel-AvivIsrael

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