SIMPLEXA COVID-19 DIRECT ASSAY

Additional Manufacturer Narrative

DIASORIN MOLECULAR RECEIVED A COMPLAINT ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 18852N FOR A SUSPECTED FALSE NEGATIVE ON ONE (1) SAMPLE THAT REPEATED AS POSITIVE ON COMPETITOR ASSAYS. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: RUN (B)(6) 2024 AT 1624: SAMPLE ID (B)(6) - NOT DETECTED, IC CT = 36.9 THE CUSTOMER STATED THE SAMPLE WAS REPEATED AND RESULTED POSTIIVE ON THEIR ROCHE 6800 AND EPLEX SYSTEMS. IT IS KNOWN THE ROCHE COBAS ASSAY DETECTS DIFFERENT TARGETS (ORF1AB, E-GENE) AND UTILIZES AUTOMATED EXTRACTION OF THE SAMPLE. THE SIMPLEXA ASSAY TARGETS DIFFERENT REGIONS (ORF1AB, S-GENE) AND DOES NOT UTILIZE EXTRACTION. INTERNAL CONTROL CTS ARE TYPICALLY BETWEEN 22-32CTS WITH THE SIMPLEXA ASSAY, AND WITH THIS SAMPLE'S CT = 36.9 THERE MY BE SOME INHIBITION OF THE SIMPLEXA CHEMISTRY OCCURING. IN ADDITION, THE CUSTOMER WAS HAVING ISSUES WITH INTERNAL CONTROLS NOT AMPLIFYING WITH ONLY ONE SPECIFIC LIAISON MDX SERIAL# (B)(6). BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 18856N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151 LOT# 18856N WAS TESTED USING POSITIVE CONTROLS AND NO-TEMPLATE CONTROLS (NTC). POSITIVE CONTROLS WERE TESTED IN QUADRUPLICATE AND RESULTED IN ZERO (0) OCCURRENCES OF FALSE NEGATIVES IN ANY OF THE COVID-19 TARGETS. ALL POSITIVE CONTROLS WERE DETECTED AT AN AVERAGE CT = 26.8 (S GENE), 27.1 (ORF1AB), AND THE INTERNAL CONTROL AVG CT = 30.2. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON (B)(6) 2024 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 = 28.3 / ORF1AB AVG CT = 28.6). 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."

Description of Event or Problem

DIASORIN MOLECULAR RECEIVED A COMPLAINT ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 18852N FOR A SUSPECTED FALSE NEGATIVE ON ONE (1) SAMPLE THAT REPEATED AS POSITIVE ON COMPETITOR ASSAYS. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN. NO ALLEGED HARM OCCURRED.