SIMPLEXA COVID-19 DIRECT ASSAY

Description of Event or Problem

DIASORIN MOLECULAR RECEIVED A COMPLAINT ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 21070N FOR A SUSPECTED FALSE NEGATIVE ON ONE (1) SAMPLE THAT WAS PREVIOUSLY DETERMINED POSITIVE ON A COMPETITOR ASSAY, BD MAX. THE SAMPLE WAS DETECTED FOR COVID ON THE SIMPLEXA ASSAY ONLY AFTER A 1:10 DILUTION. THE CUSTOMER CONFIRMED THE SUSPECTED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN OR CLINICIAN DUE TO THE DISCREPANCY WITH THE PREVIOUS POSITIVE RESULTS ON THE COMPETITOR ASSAY. NO ALLEGED HARM OCCURRED.

Additional Manufacturer Narrative

DIASORIN MOLECULAR RECEIVED A COMPLAINT ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 21070N FOR A SUSPECTED FALSE NEGATIVE ON ONE (1) SAMPLE THAT REPEATED AS POSITIVE ON COMPETITOR ASSAY, BD MAX. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: RUN FILE: CCOVID+INFLU_2025-04-02_9H08_JCH.RUN (MDX# 1D0594) - SAMPLE ID: (B)(6) - NOT DETECTED RUN FILE: COVID+INFLU_2025-04-02_9H21_JCH (MDX# 1D0101) - SAMPLE ID: (B)(6) - S GENE (32.9), ORF1AB NOT DETECTED - SAMPLE ID: (B)(6) (COVID PC) - S GENE (26.6), ORF1AB (26.7) RUN FILE: COVID+INFLU _2025-04-02_9H28_JCH (MDX# 1D0063) - SAMPLE ID: (B)(6)- NOT DETECTED RUN FILE: COVID_2025_04_02_15H25_MF.RUN (MDX# 1D0594) - SAMPLE ID: (B)(6) DILUTION - S GENE (27.3), ORF1AB (21.9) RUN FILE: COVID_2025_04_02_15H30_MF.RUN (MDX# 1D0063) - SAMPLE ID: (B)(6) DILUTION - S GENE (27.1), ORF1AB (20.9) BD MAX RESULT = COVID 19 POS (CT = 12) A POSITIVE CONTROL WAS RUN CONCURRENTLY DURING THE REPEAT TEST PERFORMED ON THE SAME DAY AT 09H21 AND WAS DETECTED WITHOUT ISSUES FOR BOTH TARGETS. NO OTHER SAMPLES CHANGED INTERPRETATION ON ANY RUNS OTHER THAN SAMPLE ID (B)(6). IT IS NOTED THE CUSTOMER PERFORMED AN OFF-LABEL DILUTION OF THE SAMPLE (1:10) FOR THE 2 RUNS AT 15H25 AND 15H30 WITH DETECTION OF BOTH TARGETS. IT IS KNOWN THAT THE BD MAX ASSAY DETECTS THE N1 AND N2 GENES (DIFFERENT TARGETS THAN THE SIMPLEXA ASSAY) AND UTILIZES AN EXTRACTION OF THE SAMPLE (SIMPLEXA IS A DIRECT MODERATE COMPLEXITY ASSAY) WHICH COULD EXPLAIN THE BD MAX DETECTION AT CT = 12, BUT NO DETECTION FOR THE SIMPLEXA ASSAY. THE CUSTOMER'S DEVICE WAS NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 21071N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. POS CTRLS WERE DETECTED WITH AN AVG CT = 26.4 (S GENE) AND 27.6 (ORF1AB). NO MALFUNCTIONS OCCURRED DURING QC RELEASE. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON (B)(6) 2025 WITH 14 REPLICATES (2 DISCS OF 7 PC EACH) OF MOL4160 POSITIVE CONTROL. BOTH TIMES THE TARGETS WERE DETECTED ON ALL REPLICATES (S GENE AVG CT = 26.5 / ORF1AB AVG CT = 27.1). NO FALSE NEGATIVES OCCURRED. NO MALFUNCTIONS OCCURRED. POTENTIAL CAUSES FOR THE FALSE NEGATIVE RESULTS MAY BE AN INSTRUMENT FAILURE OR ERROR, AN OPERATOR ERROR, INCORRECT HANDLING OF REAGENTS DURING TESTING OR STORAGE, OR DEVIATION FROM THE ASSAY PROCEDURE OUTLINED IN THE PACKAGE INSERT. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE NEGATIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. IT IS NOT CONFIRMED TO BE AN ASSAY REAGENT ISSUE AT THIS TIME. AS STATED IN THE INSTRUCTIONS FOR USE, IFUK.EN.MOL4150, "NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION" AND PER THE LIMITATIONS SECTION, "FALSE-NEGATIVE RESULTS MAY OCCUR IF THE VIRUSES ARE PRESENT AT A LEVEL THAT IS BELOW THE ANALYTICAL SENSITIVITY OF THE ASSAY OR IF THE VIRUS HAS GENOMIC MUTATIONS, INSERTIONS, DELETIONS, OR REARRANGEMENTS OR IF PERFORMED VERY EARLY IN THE COURSE OF ILLNESS."