CHROMID® CANDIDA

Additional Manufacturer Narrative

CONTEXT. A PUBLICATION IN FRANCE DOCUMENTS UNEXPECTED COLOR WITH CANDIDA CATENULATE STRAIN IN ASSOCIATION WITH CHROMID CANDIDA 20 PLATES (REF. (B)(4), LOT UNKNOWN). THIS ARTICLE DESCRIBED A STUDY ON CHROMID CANDIDA ONTO FOURTEEN STRAINS COMING FROM HUMAN, VETERINARY AND ENVIRONNEMENTAL ECOSYSTEMS WERE INOCULATED. THE RESULTS SHOWED THAT 93% (13/14) OF THESE STRAINS EXPRESSED LIGHT BLUE COLOR ON THE AGAR WHILE 7% (1/14) EXPRESSED MIXED PHENOTYPE WITH WHITE AND LIGHT BLUE COLORS. VITEK MS MASS SPECTROMETRY AND ITS RDNA SEQUENCING RESULTS WERE CONSISTENT TO IDENTIFY ALL THE STRAINS AS BELONGING TO DIUTINA CATENULATA SPECIES. THESE CHROMOGENIC PROFILES WERE VISUALLY SIMILAR TO THAT OF CANDIDA ALBICANS WHICH ALSO PRODUCES BLUE COLONIES, POTENTIALLY LEADING MISIDENTIFICATION BY NON-SPECIALISTS. BATCH HISTORY RECORD AND COMPLAINT TREND ANALYSIS. THERE IS NO CAPA RELATED TO THE CUSTOMER¿S COMPLAINT RECORDED. NO COMPLAINTS TREND IS DETECTED REGARDING CHROMID CANDIDA PRODUCT. INVESTIGATION RESULTS INTERNAL DATA ANALYSIS WAS CONDUCTED TO INTEGRATE THIS FALSE POSITIVE NOTIFICATION IN CHANGE REQUEST DEDICATED THE PERFORMANCE UPDATE OF CHROMID CANDIDA. THE NOTE "DIUTINA CATENULATA FORMERLY CANDIDA CATENULATA COULD GROW AND PRODUCE BLUE COLONIES WHICH CANNOT BE DISTINGUISHED FROM CANDIDA ALBICANS" WILL BE INTEGRATED WITHIN THE NEW VERSION OF THE PACKAGE INSERT.

Description of Event or Problem

INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION OF YEASTS AND THE DIRECT IDENTIFICATION OF CANDIDA ALBICANS. THIS MEDIUM IS A MEDIUM FOR: THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF THE SPECIES C. ALBICANS, THE PRESUMPTIVE DIFFERENTIATION OF A GROUP OF SPECIES COMPRISING C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. ISSUE DESCRIPTION: A PUBLICATION IN FRANCE DOCUMENTS UNEXPECTED COLOR WITH CANDIDA CATENULATE STRAIN IN ASSOCIATION WITH CHROMID CANDIDA 20 PLATES (REF. 43631, LOT: UNKNOWN). BIOMERIEUX R&D AND MEDICAL AFFAIRS HAVE REVIEWED THE PUBLICATION PMS 383124886: ¿A ONE HEALTH PERSPECTIVE ON DIUTINA CATENULATA: PHENOTYPIC TRAITS, STRESS SENSITIVITY, AND VIRULENCE ACROSS DIVERSE ISOLATES ALBURQUERQUE ET AL., METHOD AND PROTOCOLS, 2025¿. 1) NATURE OF THE EVENT AND IMPACT. THIS STUDY AIMED TO PHENOTYPICALLY CHARACTERIZE DIUTINA CATENULATA, FORMERLY CANDIDA CATENULATE, ISOLATES FROM DIFFERENT ORIGINS (HUMAN, VETERINARY, AND ENVIRONMENTAL). ALL STRAINS WERE PREVIOUSLY IDENTIFIED USING THE VITEK® MS (DATABASE V3.2.0) AND FURTHER CONFIRMED BY ITS RDNA SEQUENCING. ISOLATES WERE CULTURED ONTO CHROMID® CANDIDA AGAR. C. ALBICANS SC5314, C. PARAPSILOSIS ATCC 22019, C. AURIS CAAU941, C. TROPICALIS ATCC 750, AND N. GLABRATUS ATCC 2001 WERE USED AS COMPARATORS. ALL BUT ONE (DCAT29) OF THE ISOLATES TESTED IN THIS STUDY APPEARED AS LIGHT BLUE COLONIES ON CHROMID® CANDIDA AGAR, SIMILAR TO C. ALBICANS. ALTHOUGH SIMILAR, THE PREDOMINANT LIGHT BLUE COLORATION SEEN IN D. CATENULATA ISOLATES DIFFERS FROM THE DARKER BLUE TYPICALLY OBSERVED WITH C. ALBICANS. DCAT29 EXHIBITED A MIXED PROFILE, DISPLAYING TWO DISTINCT COLORS: WHITE AND LIGHT BLUE, THE LATTER EXHIBITING THE SAME BLUE AS THE OTHER D. CATENULATA ISOLATES. 2) RESPECT FOR INSTRUCTIONS FOR USE OF THE PRODUCT. ALL D. CATENULATA ISOLATES WERE GROWN ON SABOURAUD DEXTROSE AGAR (SDA) AT 30 C ±2 C FOR 24 H, BEFORE BEING STREAKED ON CHROMID® CANDIDA AGAR PLATES. PLATES WERE INCUBATED AT 30 C ±2 C FOR 48 H BEFORE MACROSCOPIC EXAMINATION OF THE COLONIES. THERE IS NO EVIDENCE THAT THE MANUFACTURER INSTRUCTIONS WERE NOT FOLLOWED. 3) RELEVANCE OF THE METHODOLOGY: VITEK® MS (DATABASE V3.2.0) AND ITS RDNA SEQUENCING WERE USED AS CONFIRMATORY IDENTIFICATION METHODS. THE LATTER IS THE GOLD STANDARD METHOD FOR CANDIDA SPP. IDENTIFICATION. 3) OBSERVED STUDY RESULTS COMPARED TO CLAIMED PRODUCT PERFORMANCE. CHROMID CANDIDA INTENDED USE IS FOR THE SELECTIVE ISOLATION OF YEASTS, THE IDENTIFICATION OF C. ALBICANS AND THE PRESUMPTIVE DIFFERENTIATION OF C. TROPICALIS, C. LUSITANIAE AND C. KEFYR. THE BLUE COLORATION OF D. CATENULATA ON THE CHROMID® CANDIDA MEDIUM CAN LEAD TO MISINTERPRETATIONS DUE TO ITS SIMILARITY TO THAT OF C. ALBICANS ON THIS MEDIUM. THEREFORE, FURTHER INVESTIGATION IS NEEDED. THE AUTHORS NOTED THAT SUCH SUBTLE COLOR DIFFERENCES COULD LEAD TO MISIDENTIFICATION BY NON-SPECIALISTS. DESPITE THIS LIMITATION, 100% OF ISOLATES EXHIBITED GOOD GROWTH PERFORMANCE ON CHROMID® CANDIDA, CONFIRMING THAT THE MEDIUM ADEQUATELY SUPPORTS D. CATENULATA PROLIFERATION. NEVERTHELESS, ITS SPECIFICITY FOR VISUAL DIFFERENTIATION REMAINS LOW, AS IT DID NOT CLEARLY DISCRIMINATE D. CATENULATA FROM C. ALBICANS. OVERALL, CHROMID CANDIDA DEMONSTRATED EXCELLENT GROWTH PERFORMANCE (14/14 ISOLATES) BUT LIMITED DIFFERENTIAL ACCURACY (SPECIFIC DISTINCTION FROM C. ALBICANS ACHIEVED IN 0/14 CASES). TO BE NOTED, THE CHROMID CANDIDA MEDIUM DOES NOT CLAIM D. CATENULATA. R&D AND GMA (GLOBAL MEDICAL AFFAIRS) HAVE TAKEN THEIR DECISION TO FURTHER INVESTIGATE. AT THE TIME OF ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.