Abstract

DEGRUY, Kyle et al. Development of dried tube specimens for Xpert MTB/RIF proficiency testing. Afr. J. Lab. Med. [online]. 2020, vol.9, n.1, pp.1-8. ISSN 2225-2010.  http://dx.doi.org/10.4102/ajlm.v9i1.1166.

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.

Keywords : external quality assessment; EQA; Xpert MTB/RIF; proficiency testing; dried tube specimen; DTS.

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