Performance of the G4 Xpert® MTB/RIF assay for the detection of Mycobacterium tuberculosis and rifampin resistance: a retrospective case-control study of analytical and clinical samples from high- and low-tuberculosis prevalence settings

Dharan, Nila J.; Blakemore, Robert; Sloutsky, Alex; Kaur, Devinder; Alexander, Richard C.; Ghajar, Minoo; Musser, Kimberlee A.; Escuyer, Vincent E.; Rowlinson, Marie-Claire; Crowe, Susanne; Laniado-Laborin, Rafael; Valli, Eloise; Nabeta, Pamela; Johnson, Pamela; Alland, David

doi:10.1186/s12879-016-2039-4

Table 1 AFB smear, culture, TB identification and DST methods for each clinical study

From: Performance of the G4 Xpert^® MTB/RIF assay for the detection of Mycobacterium tuberculosis and rifampin resistance: a retrospective case-control study of analytical and clinical samples from high- and low-tuberculosis prevalence settings

Study number	Geographical location/collection site	Xpert MTB/RIF Assay Testing Site	Specimen Used for Xpert MTB/RIF Assay Testing^a		Specimen Processing for Smear & Culture	AFB Smear Method on Processed Sputum^a	Culture Method^a	TB Identification Method^a	DST Method^a
CS1	Peru	NJMS	Archived (Frozen)	Raw Sputum	NALC-NaOH	ZN	LJ and MGIT	CapilliaTB-Neo	LJ Proportions
CS1	South Africa, Vietnam, Bangladesh^b,c	NJMS	Archived (Frozen)	Raw Sputum	NALC- NaOH	ZN	LJ and MGIT	GenoType^® MTBC	MGIT SIRE
CS2	New York	New York	Archived (4 °C)	Pellet	NaOH	ZN	7H10 and MGIT	In house RT-PCR	MB Proportions
CS3	New York	New York	Fresh	Pellet	NaOH	ZN	7H10 and MGIT	In house RT-PCR	MB Proportions^d
	California	California	Fresh	Pellet	NALC- NaOH	AuRho	7H10 and MGIT	AccuProbe MTBC	MB Proportions^d
	Florida	Florida	Fresh	Pellet or Raw Sputum	NALC-NaOH			AccuProbe	MB Proportions^d
	Florida	Florida	Fresh	Pellet or Raw Sputum	NALC-NaOH	AuO + ZN	LJ and MGIT	AccuProbe MTBC	MB Proportions^d
CS4	Tijuana, Mexico	California	Fresh	Raw Sputum	NALC-NaOH	AuRho	LJ and MGIT	AccuProbe MTBC^e	MB Proportions^e

^aZN Ziehl-Neelsen, AuRho Auramine Rhodamine, AuO Auramine O, Raw Sputum direct, not decontaminated/undigested, Pellet decontaminated/digested sediment, MB Middlebrook, LJ Lowenstein-Jensen, MGIT BD BBL™ MGIT™ Mycobacteria Growth Indicator Tube, OADC Enrichment, PANTA™ Antibiotic Mixture, (Becton, Dickinson and Company, Sparks, MD), AccuProbe MTBC Mycobacterium tuberculosis Complex Culture Identification Test (Hologic, Incorporated, Marlborough MA), MGIT SIRE BD BACTEC™ MGIT™ 960 SIRE Kits For the Antimycobacterial Susceptibility Testing of Mycobacterium tuberculosis, (Becton, Dickinson and Company, Sparks, MD), Capillia TB-Neo Capilia TB Test Kit (Tauns Laboratories, Numazu, Japan), PNB – p-nitrobenzoic acid, Genotype® MTBC GenoType^® MTBC (Hain Lifescience GmbH, Nehren, Germany)
^bSpecimens were originally cultured and identified for MTB using the following methods: Capillia TB-Neo, Hain Genotype, Niacin + PNB5 at these sites: Unit for Clinical and Biomedical TB Research, South African Medical Research Council. Durban, South Africa, Pham Ngoc Thach Hospital Laboratory. Ho Chi Minh City, Vietnam, Bangladesh: International Centre for Diarrhoeal Disease Research, Bangladesh. Dhaka, Bangladesh. Raw frozen sputum specimens were available and sent to the National Reference Center (NRC) for Mycobacteria, Supranational Reference Laboratory (SRL) of WHO, Research Center Borstel - Leibniz Center for Medicine and Biosciences, Borstel Germany for culture confirmation and DST and when appropriate bi-directional sequencing
^cSamples were provided by the Foundation for Innovative Diagnostics (FIND) under their study protocol. FIND staff performed all of the data collection, monitoring and auditing of the study
^dNew York served as the central lab for DST testing and, when appropriate, for bi-directional sequencing
^eUniversity of Massachusetts Medical School served as the central lab for CS4 TB identification and DST testing

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ISSN: 1471-2334

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