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For several decades, the Wampole Isolator system provided a commercial lysis-centrifugation system that was used by many clinical laboratories for blood culture of fungal and mycobacterial organisms. This system was ideal for the low test volumes typically seen with fungal and mycobacterial blood culture orders. It also was flexible and customizable, coming in both pediatric and standard sized collection tubes, and allowed laboratories to select the culture media used for plating the prepared specimen. The Isolator system performed well in published head-to-head studies with other blood culture methods. However, in 2023, the manufacturer discontinued production of the system, forcing many clinical laboratories to seek alternative methods for fungal and mycobacterial blood cultures. 

As with any change in test systems, clinical laboratories face regulatory, logistical, clinical and financial considerations. This guideline seeks to answer frequently asked questions as laboratories that used the Wampole Isolator system switch to a different method. Topics covered include, anticoagulant choice for blood culture of fungi and mycobacteria, alternative systems that address the indications of the Wampole Isolator system, verification/validation requirements and other regulatory concerns. 

This guideline was developed on behalf of the º£½ÇÉçÇøapp Clinical and Public Health Microbiology Committee, Laboratory Practices Subcommittee.