Multicenter feasibility study to assess external quality assessment panels for Xpert MTB/RIF assay in South Africa.
External quality assessment (EQA) for the Xpert MTB/RIF assay is part of the quality system required for clinical and laboratory practice. Five newly developed EQA panels that use different matrices, including a lyophilized sample (Vircell, Granada, Spain), a dried tube specimen (CDC), liquid (Maine Molecular Quality Control, Inc. [MMQCI], Scarborough, ME), artificial sputum (Global Laboratory Initiative [GLI]), and a dried culture spot (National Health Laboratory Services [NHLS]), were evaluated at 11 GeneXpert testing sites in South Africa. The panels comprised Mycobacterium tuberculosis complex (MTBC)-negative, MTBC-positive (including rifampin [RIF] susceptible and RIF resistant), and nontuberculosis mycobacterial material that was inactivated and safe for transportation. Twelve qualitative and quantitative variables were scored as acceptable (1) or unacceptable (0); the overall panel performance score for the Vircell, CDC, GLI, and NHLS panels was 9 of 12, while the MMQCI panel scored 6 of 12 (owing to the need for cold chain maintenance). All panels showed good compatibility with Xpert MTB/RIF testing, and none showed PCR inhibition. The use of a liquid or dry matrix did not appear to be a distinguishing criterion, as both matrices had reduced scores on insufficient volumes, a need for extra consumables, and the ability to transfer to the Xpert MTB/RIF cartridge. EQA is an important component of the quality system required for diagnostic testing programs, but it must be complemented by routine monitoring of performance indicators and instrument verification. This study aims to introduce EQA concepts for Xpert MTB/RIF testing and evaluates five potential EQA panels.
Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa lesley.scott@nhls.ac.za.
Lesley
L
Scott
Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Heidi
H
Albert
Global TB Programme, World Health Organization, Geneva, Switzerland.
Chris
C
Gilpin
Division of Global HIV/AIDS, U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Heather
H
Alexander
Division of Global HIV/AIDS, U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Kyle
K
DeGruy
Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa National Health Laboratory Service, Johannesburg, South Africa.
Wendy
W
Stevens
D000995:Antitubercular Agents / Q000494:pharmacology; D005240:Feasibility Studies; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000379:methods*; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D011786:Quality Control; D012293:Rifampin / Q000494:pharmacology; D013019:South Africa; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy*
D000995:Antitubercular Agents; D012293:Rifampin