Objective This study aimed at validating the method for sterility testing of the corneal culture medium, TISSUE-C, and the transport/deswelling medium, CARRY-C, according to the method suitability test, as defined by the European Pharmacopoeia (EP), using RESEP, which is a new medical device for removal of antimicrobial agents and an automated culture system.
Methods and analysis The six EP reference strains were inoculated in TISSUE-C and CARRY-C. Half of the samples were treated with RESEP (RESEP+ group) prior to the sterility testing, whereas the remaining samples were untreated (RESEP− group). Growth controls were obtained by direct inoculation of the micro-organisms in the culture broths. Microbial growth was read by an automated light scattering culture system within 48 hours.
Results The use of RESEP allowed detection of microbial growth in 100% of the tested samples, with a mean time to detection (TTD) comparable with that of the growth control group. Significantly lower sensitivity (38.83%±20.03% for both media, P<0.05) and TTD variability, depending on the tested micro-organism, were observed in the RESEP− group. The method specificity was 100% for both groups.
Conclusion The use of RESEP increased the sensitivity of the sterility testing method to 100% and, for the first time, allowed validation of the method for sterility testing of corneal storage media according to the EP method suitability test. This further increases the safety of the corneas intended for transplantation.
- diagnostic tests/investigation
- eye (tissue) banking
- ocular surface
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Contributors RM and JDT planned and designed the study, analysed the data, drafted the manuscript and critically revised the manuscript. LG, FP, AL and EF acquired, analysed and interpreted the data, as well as drafted and critically revised the manuscript. JDT submitted the manuscript.
Competing interests JDT and LG are employed by the company involved in the research and development of one medical device discussed in the present paper. RM, FP, AL and EF have no financial or proprietary interest in any of the materials or methods mentioned.
Patient consent Patient consent was not required because this study did not involve human subjects.
Provenance and peer review Not commissioned; externally peer reviewed.
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