LIAISON SARS-COV-2-AG

Additional Manufacturer Narrative

CUSTOMER NOTICED THAT IN THE CONTEST OF EQAS, TEST A SAMPLE EXPECTED TO BE POSITIVE WAS REPORTED AS NEGATIVE. CURRENTLY INVESTIGATION IS ON GOING.

Description of Event or Problem

IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS AND PER THE CONDITIONS OF THE EMERGENCY USE AUTHORIZATION, SUSPECTED FALSE NEGATIVES, FALSE POSITIVES AND SIGNIFICANT CHANGES IN EXPECTED PERFORMANCE CHARACTERISTICS WILL BE REPORTED UNDER 21 CFR 803. THE ALLEGED FALSE TEST RESULTS IN THIS EVENT HAVE NOT CAUSED PATIENT INJURY OR DEATH; HOWEVER, THIS EVENT IS BEING REPORTED CONSERVATIVELY BECAUSE IF THE ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR SERIOUS INJURY OR DEATH. DIASORIN ITALIA S.P.A. RECEIVED A COMPLAINT ABOUT POTENTIAL FALSE NEGATIVE RESULTS OF COV-2 ANTIGENS (REF: 311490 LOT: 371033).

Additional Manufacturer Narrative

THE LABORATORY (OSPEDALE DI BOLZANO) PARTICIPATED IN THE UK NEQAS MICROBIOIOGY SARS-COV-2 POINT OF CARE SURVEY. THE SPECIMEN 8000 OF THE DISTRIBUTION N.5434 WAS EXPECTED TO BE POSITIVE. SAMPLE IS A SIMULATED NASOPHARYNGEAL SWAB CONTAINING APPROXIMATEIY 6X104 COPIES/MI X-RAY IRRADIATED VIRUS ALPHA B.1.1.7 VARIANT AND HEP-2 CELIS. WE RETRIEVED DATA FROM THE LIAISON XL S/N (B)(6) AND ANAIYZED FILES COVERING THE PERIOD FROM (B)(6) 2023. DATA SHOWED THAT THE RELEVANT SAMPLE WAS TESTED IN THE LABORATORY ON 5TH JULY 2023 AND ON 6TH JUIY 2023 WITH THE LIAISON SARS-COV-2 AG LOT 371033. THE SAMPLE WAS GRADED NEGATIVE IN BOTH TESTS PERFORMED. THE DIASORIN CONTROLS LOT 372017 WERE TESTED ON THE RELEVANT ROUTINE DAYS AND FELL WITHIN COA RANGES. HOWEVER, IN GENERAL IT WAS NOTICED THAT BOTH CTRL LEVEL 1 AND 2 WERE OBSERVED FLUCTUATING LOW AND HIGH DURING THE PERIOD ANALYSED. LOGFILE ANALYSIS SHOWED THAT MAINTENANCE ON THE INSTRUMENT (WEEKLY AND MONTHLY TASKS) WERE OFTEN RUN WITH DELAYS DURING THE PERIOD ANALYSED: - MAINTENANCE WAS RUN IN DELAY IN JUNE, JULY, OCTOBER 2023; - RUNS PERFORMED ON 5TH AND 6TH JULY WERE COVERED BY A DELAYED WEEKLY MAINTENANCE; - WEEKLY MAINTENANCE WAS SUPPOSED TO BE RUN ON 6TH JULY 2023 BUT IT WAS NOT PERFORMED ON THAT DAY (IT WAS PERFORMED ON 11TH JUIY 2023, IN DELAY). MAINTENANCE ON THE INSTRUMENT SHOULD BE RUN ACCORDING TO PROCEDURE TO GUARANTEE OPTIMAL PERFORMANCE OF THE EQUIPMENT. BASED ON THE GATHERED INFORMATION, WE CANNOT EXCLUDE THE ISSUE BEING RELATED TO SUBOPTIMAL INSTRUMENT CONDITIONS. PLEASE ALSO NOTE THAT BASED ON THE EQAS REPORT RECEIVED, OTHER PARTICIPANTS USING DIFFERENT METHODS FAILED TO CORRECTLY SCORE THE SAMPLE: 20% PARTICIPANTS BELONGING TO THE SURVEY GROUP "SARS-COV-2 TEST METHOD 2" FAILED TO GIVE THE CORRECT INTERPRETATION FOR SAMPLE 8000. SINCE THE LAUNCH OF THE LIAISON® SARS-COV-2 AG (P/N 311490) DIASORIN REGULARLY PARTICIPATES IN INTERNATIONAL EXTERNAL QUALITY ASSESSMENT PROGRAMS TO MONITOR KIT PERFORMANCE (E.G CAP, INSTAND) AND THAT REPORTS RECEIVED REGULARLY SHOW ADEQUATE PERFORMANCE OF THE ASSAY.

Description of Event or Problem

IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS AND PER THE CONDITIONS OF THE EMERGENCY USE AUTHORIZATION, SUSPECTED FALSE NEGATIVES, FALSE POSITIVES AND SIGNIFICANT CHANGES IN EXPECTED PERFORMANCE CHARACTERISTICS WILL BE REPORTED UNDER 21 CFR 803. THE ALLEGED FALSE TEST RESULTS IN THIS EVENT HAVE NOT CAUSED PATIENT INJURY OR DEATH; HOWEVER, THIS EVENT IS BEING REPORTED CONSERVATIVELY BECAUSE IF THE ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR SERIOUS INJURY OR DEATH. DIASORIN ITALIA S.P.A. RECEIVED A COMPLAINT ABOUT POTENTIAL FALSE NEGATIVE RESULT OF COV-2 ANTIGEN (REF: 311490 LOT 371033).