Development of dried tube specimens for Xpert MTB/RIF proficiency testing

ABSTRACT

Background: Proficiency testing (PT) is part of a comprehensive quality assurance programme, which is critical to ensuring patients receive accurate and reliable diagnostic testing. Implementation of the Cepheid Xpert® MTB/RIF assay to aid in the diagnosis of tuberculosis has expanded rapidly in recent years; however, PT material for Xpert MTB/RIF is not readily available in many resource-limited settings.Objective: To develop an accurate and precise PT material based on the dried tube specimen (DTS) method, using supplies and reagents available in most tuberculosis culture laboratories.Methods: Dried tube specimens were produced at the United States Centers for Disease Control and Prevention from 2013 to 2015 by inactivating liquid cultures of well-characterised mycobacterial strains. Ten percent of DTS produced were tested with Xpert MTB/RIF and evaluated for accuracy and precision.Results: Validation testing across eight rounds of PT demonstrated that DTS are highly accurate, achieving an average of 96.8% concordance with the Xpert MTB/RIF results from the original mycobacterial strains. Dried tube specimen testing was also precise, with cycle threshold standard deviations below two cycles when inherent test cartridge variability was low.Conclusion: Dried tube specimens can be produced using equipment already present in tuberculosis culture laboratories, making Xpert MTB/RIF PT scale-up more feasible in resource-limited settings. Use of DTS may fill the gap in tuberculosis laboratory access to external quality assessment, which is an essential component of a comprehensive continuous quality improvement programme