MYCO-TB: the first IVD kit suitable for the digestion and decontamination of extra-pulmonary specimens to detect Mycobacteria

MYCO-TB: the first IVD kit suitable for the digestion and decontamination of extra-pulmonary specimens to detect Mycobacteria

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Abstract Extra-pulmonary mycobacterial infections are characterized by a paucibacillary nature and extra-pulmonary samples consist of different matrices; the processing of these samples requires a high level of manual skills and non-standardized procedures.The aim of this study was to compare the performance of MYCO-TB with MycoPrep on extra-pulmonary samples in terms of Mycobacteria detection, culture contamination and suitability for molecular assay.This prospective study was conducted on 201 extra-pulmonary samples from suspected cases of mycobacterial infection.

Specimens were divided into two equal aliquots; one was decontaminated with MYCO-TB the other with MycoPrep.The contamination rate of liquid cultures was significantly different: 2.5% Water Bottle (5/201) for MYCO-TB and 7.

5% (15/201) for MycoPrep (p = 0.036).At least 1 Mycobacterium tuberculosis complex (MTBc) positive culture was detected in 6 specimens treated with MYCO-TB and 8with MycoPrep, without significant differences in times to positivity (TTP) in liquid culture.

No Xpert MTB/RIF Ultra invalid results were obtained with samples decontaminated with MYCO-TB.The MYCO-TB kit had greater activity than MycoPrep in the digestion and decontamination of extra-pulmonary specimens for the detection of Mycobacteria, supporting the use of MYCO-TB in this type of sample.Ready-to use reagents, rapid protocol and single-sample formulation of MYCO-TB reduced Small Animal Habitat Accessories the level of manual skills required as well as the risk of sample contamination.