title: A novel bedside test for ACPA: the CCPoint test is moving the laboratory to the rheumatologist's office.
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.
authors.affiliation: Zabludowicz Center for Autoimmune Diseases, Chaim Sheba Medical Center, Tel-Hashomer, 52621, Israel.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.|Department of Medicine C, Wolfson Medical Center, Holon, Israel.
authors.forename: Gisele
authors.initials: G
authors.lastname: Zandman-Goddard
authors.affiliation: Zabludowicz Center for Autoimmune Diseases, Chaim Sheba Medical Center, Tel-Hashomer, 52621, Israel.|Department of Clinical Medicine and Rheumatology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Soriano
authors.affiliation: Zabludowicz Center for Autoimmune Diseases, Chaim Sheba Medical Center, Tel-Hashomer, 52621, Israel.
authors.forename: Boris
authors.initials: B
authors.lastname: Gilburd
authors.affiliation: Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.|The Zabludowicz Center for Autoimmune Diseases, Rheumatology Unit, Sheba Medical Center, Tel-Hashomer, 52621, Israel.
authors.forename: Merav
authors.initials: M
authors.lastname: Lidar
authors.affiliation: Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.|The Zabludowicz Center for Autoimmune Diseases, Rheumatology Unit, Sheba Medical Center, Tel-Hashomer, 52621, Israel.
authors.forename: Shaye
authors.initials: S
authors.lastname: Kivity
authors.affiliation: Zabludowicz Center for Autoimmune Diseases, Chaim Sheba Medical Center, Tel-Hashomer, 52621, Israel.
authors.forename: Ron
authors.initials: R
authors.lastname: Kopilov
authors.affiliation: Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.|The Zabludowicz Center for Autoimmune Diseases, Rheumatology Unit, Sheba Medical Center, Tel-Hashomer, 52621, Israel.
authors.forename: Pnina
authors.initials: P
authors.lastname: Langevitz
authors.affiliation: Zabludowicz Center for Autoimmune Diseases, Chaim Sheba Medical Center, Tel-Hashomer, 52621, Israel.|Incumbent of the Laura Schwarz-Kipp Chair for Research of Autoimmune Diseases, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Yehuda
authors.initials: Y
authors.lastname: Shoenfeld
authors.affiliation: Zabludowicz Center for Autoimmune Diseases, Chaim Sheba Medical Center, Tel-Hashomer, 52621, Israel. nancy.agmon-levin@sheba.health.gov.il.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. nancy.agmon-levin@sheba.health.gov.il.
authors.forename: Nancy
authors.initials: N
authors.lastname: Agmon-Levin
mesh_terms: D000328:Adult; D000368:Aged; D000075422:Anti-Citrullinated Protein Antibodies / Q000097:blood*; D001172:Arthritis, Rheumatoid / Q000097:blood* / Q000175:diagnosis; D015415:Biomarkers / Q000097:blood; D042241:Early Diagnosis; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000097:blood; D008297:Male; D008875:Middle Aged; D000067716:Point-of-Care Testing; D000072140:Rheumatologists; D012680:Sensitivity and Specificity; D044967:Serum / Q000737:chemistry
chemical_list: D000075422:Anti-Citrullinated Protein Antibodies; D015415:Biomarkers
keywords: ACPA; CCPoint test; Diagnostics; POC; Rheumatoid arthritis