ELECSYS ANTI-CCP

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-CCP RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024, THE PATIENT HAD AN ANTI-CCP RESULT OF 145 U/ML. THE CUSTOMER LATER HAD ANOTHER SAMPLE COLLECTED AND TESTED AT ANOTHER LABORATORY WHERE THE ANTI-CCP RESULT WAS NORMAL, WHICH MADE THE PATIENT QUESTION THE INITIAL RESULT. ON (B)(6) 2024, THE SAMPLE FROM 29-MAY WAS RETESTED AND THE RESULT WAS 111 U/ML. THE SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY FOR ELISA IMMUNOBLOT TESTING AND THE ANTI-CCP RESULT WAS 13.16 IU/ML. CLARIFICATION ON THE CORRECT UNITS OF MEASUREMENT WAS REQUESTED.

Additional Manufacturer Narrative

MULTIPLE SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION. FOR SOME OF THE SAMPLES, AN INTERFERENCE WITH THE STREPTAVIDIN COMPONENT OF THE ASSAY WAS FOUND. FOR OTHERS, THE RESULT INDICATED A BORDERLINE INTERFERENCE. PER PRODUCT LABELING FOR THE ASSAY: IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.