Index and reference test information

Francis Drobniewski; Mary Cooke; Jake Jordan; Nicola Casali; Tendai Mugwagwa; Agnieszka Broda; Catherine Townsend; Anand Sivaramakrishnan; Nathan Green; Mark Jit; Marc Lipman; Joanne Lord; Peter J White; Ibrahim Abubakar

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Drobniewski F, Cooke M, Jordan J, et al. Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis. Southampton (UK): NIHR Journals Library; 2015 May. (Health Technology Assessment, No. 19.34.)

Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis.

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Appendix 5Index and reference test information

Study	Microscopy				Index test details		Reference test details
Study	Microscopy?	Type of microscopy	Number of samples per participant tested	Type of smear	Test category	Rapid test type (other)	Reference test category	Reference test type (solid)	Reference test type (liquid)	Indeterminate results reported?	Reference test (other)	Number of contaminated cultures (Reference)	Number of cultures performed	Pretreatment of sample?
Ajbani (2012)⁷⁶	No microscopy	Yes, Ziehl–Neelsen	One specimen per patient	Concentrated (processed)	MTBDRsl	MTBDRsl	Liquid culture		BACTEC MGIT 960^a	No		1	170	NALC-NaOH
Albert (2010)⁷³	No microscopy	Yes, Ziehl–Neelsen	Multiple specimens per patient	Not stated	MTBDRplus		Liquid culture		BACTEC MGIT 960^a	Yes		92	118	NALC-NaOH
Anek-Vorapong (2010)⁷²	No microscopy	Not stated	Not stated	Not stated	MTBDRplus		Liquid culture		BACTEC MGIT 960^a	Yes			164	NALC-NaOH
Antonova (2008)⁸¹	Not stated	Not stated	Not stated	Not stated	TB biochip/microchip	Biological microchip assay	Solid culture	LJ		Not stated		78	78
Asencios (2012)⁷¹	Not stated	Not stated	Not stated	Concentrated (processed)	MTBDRplus	GenoType MTBDRplus	Solid and liquid culture	LJ		No			100	NALC-NaOH
Barnard (2008)⁷⁰	No microscopy	Yes-FM 99	Not stated	Concentrated (processed)	MTBDRplus		Solid and liquid culture	7H11		Yes			536	NALC-NaOH
Barnard (2012)⁷¹	No microscopy	Not stated	Not stated	Direct	MTBDRsl	GenoType MDRsl LPA	Liquid culture		Other (specify)	No	MGIT	1	657	NALC-NaOH
Boehme (2010)²⁹	No microscopy	Yes, Ziehl–Neelsen	Multiple specimens per patient	Concentrated (processed)	GeneXpert		Solid and liquid culture	LJ	BACTEC MGIT 960^a	Yes			1462	NALC-NaOH
Boehme (2011)³⁸	No microscopy	Not stated	Multiple specimens per patient	Concentrated (processed)	GeneXpert		Solid and liquid culture	LJ	BACTEC MGIT 960^a	No		1	1266	NALC-NaOH
Calderón-Espinoza (2006)⁸²	No microscopy	Not stated	Not stated	Concentrated (processed)	PCR/in-house assays	PCR-UHG-RIF	Solid culture	Not stated		Not stated	DST, proportion method	1	200	NALC-NaOH
Cauwelaert (2011)⁶⁷	Ziehl–Neelsen	Not stated	Not stated	Concentrated (processed)	MTBDRplus		Solid culture	LJ		No				NALC-NaOH
Cho (2009)⁸³	Not stated	Not stated	Not stated	Not stated	PCR/in-house assays	Sequencing	Solid culture	LJ		Not stated		1	46	NaOH (Petroff)
Choi (2010)⁸⁴	No microscopy	Yes, Ziehl–Neelsen	Multiple specimens per patient	Not stated	PCR/in-house assays	Direct DNA sequencing analysis of katG, rpoB, embB and pncA	Solid culture	LJ		Not stated			113	Not stated
Costeira (2007)⁵¹	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	INNO-LiPA		Liquid culture		BACTEC MGIT 960^a	No		1	113	Not stated
Crudu (2012)⁶⁹	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	MTBDRplus	MTBDRplus	Solid culture	7H11					156	NALC-NaOH
Dorman (2012)⁶⁸	No	Not stated	One specimen per patient	Not stated	MTBDRplus		Liquid culture		BACTEC MGIT 960^a	Yes		1	529	NALC-NaOH
Drobniewski (2000)⁵²	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	INNO-LiPA	DNA hybridisation (Accuprobe, Gen-Probe, San Diego, CA, USA)	Liquid culture		BACTEC 460 TB^a					NALC-NaOH
Eliseev (2013)⁶⁶	No microscopy	Not stated	Multiple specimens per patient	Not stated	MTBDRplus	MTBDRplus	Liquid culture		BACTEC MGIT 960^a	Yes			211	Not stated
Farooqi (2012)⁶⁵	No microscopy	Not stated	Not stated	Concentrated (processed)	MTBDRplus		Solid culture	LJ		No		1	108	NALC-NaOH
García-Sierra (2011)⁸⁵	No microscopy	Yes, Ziehl–Neelsen	Multiple specimens per patient	Not stated	PCR/in-house assays	Pyrosequencing	Liquid culture		BACTEC 460 TB^a	Not stated			48	Not stated
Gryadunov (2005)⁸⁶	No microscopy	Yes, Ziehl–Neelsen	Not stated	Concentrated (processed)	TB biochip/microchip	Biochip assay	Solid culture	LJ		No			113	NALC-NaOH
Guo (2009)⁸⁷	Not stated	Not stated	Not stated	Not stated	TB biochip/microchip	In-house biochip system	Solid culture	LJ						NaOH (Petroff)
Higuchi (2004)⁵³	Not stated	Not stated	Not stated	Concentrated (processed)	INNO-LiPA	Finnos LiPA/Rif TB (Nipro, Osaka, Japan) Also, AMPLICOR MTB (Roche Diagnostics, Tokyo, Japan)	Liquid culture		BACTEC MGIT 960^a	No		1	42	NALC-NaOH
Hillemann (2006)⁶⁴	Not stated	Not stated	Not stated	Concentrated (processed)	MTBDRplus		Solid culture	LJ					42	NALC-NaOH
Hillemann (2009)⁷⁸	No microscopy	Yes, Ziehl–Neelsen	Not stated	Concentrated (processed)	MTBDRsl	MTBDRsl assay	Solid and liquid culture	LJ	BACTEC MGIT 960^a	Yes		1	64	NALC-NaOH
Johansen (2003)⁵⁴	Not stated	Not stated	Not stated	Not stated	INNO-LiPA		Liquid culture		BACTEC 460 TB^a	Yes		1	60	Not stated
Kim (2001)⁸⁹	Not stated		Not stated	Not stated	PCR/in-house assays	Nested PCR-linked single-strand conformation	Solid culture	Not stated		Yes		1	56	Not stated
Kim (2012)⁵⁸	No microscopy	Not stated	Not stated	Concentrated (processed)	GeneXpert		Solid culture	LJ		No		1	62	NALC-NaOH
Kontsevaya (2013)³⁷	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	MTBDRsl	GenoType MTBDRplus	Solid and liquid culture	LJ	BACTEC MGIT 960^a	Yes		1	90	Not stated
Kurbatov (2013)⁵⁹	No microscopy	Yes, Ziehl–Neelsen	Multiple specimens per patient	Concentrated (processed)	GeneXpert	Also TB biochip (Biochip-IMB Ltd, Russia)	Solid and liquid culture	LJ	BACTEC MGIT 960^a	Yes		1	62	NALC-NaOH
Lacoma (2008)⁷⁵	No microscopy	Yes, Ziehl–Neelsen	Multiple specimens per patient	Concentrated (processed)	MTBDRplus	MTBDRplus	Liquid culture		BACTEC 460 TB^a	No			51	NALC-NaOH
Lacoma (2012)⁷⁷	Ziehl–Neelsen	Yes, Ziehl–Neelsen	Multiple specimens per patient	Concentrated (processed)	MTBDRsl	MTBDRsl	Liquid culture		BACTEC 460 TB^a	Yes		1	54	NALC-NaOH
Lu (2012)⁹⁰	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	TB biochip/Microchip	Biochip MDR assay	Solid culture	LJ		No			690	NALC-NaOH
Lyu (2013)⁶³	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	MTBDRplus	MTBDRplus	Liquid culture		BACTEC MGIT 960^a	No			428	Not stated
Macedo (2009)⁹⁸	No microscopy	Yes, Ziehl–Neelsen	Not stated	Concentrated (processed)	MTBDRplus	MTBDRplus	Liquid culture		BACTEC 460 TB^a	Not stated			68
Maschmann (2013)¹⁰⁰	Not stated	Not stated	Not stated	Not stated	MTBDRplus		Solid culture	LJ		No		1	68	NaOH (Petroff)
Mikhailovich (2001)⁹¹	Not stated	Not stated	Not stated	Concentrated (processed)	TB biochip/microchip	Hybridisation – TB-MAGIChip	Solid culture	LJ		No		1	31	NALC-NaOH
Miotto (2012)⁷⁹	No microscopy	Yes, Ziehl–Neelsen	Not stated	Concentrated (processed)	MTBDRsl	MTBDRsl	Liquid culture		BACTEC MGIT 960^a	Yes		1	59	NALC-NaOH
Mironova (2012)³⁴	Not stated	Not stated	Not stated	Not stated	MTBDRplus	MTBDRplus	Solid and liquid culture	LJ	BACTEC MGIT 960^a	Yes			689	NALC-NaOH
Mokrousov (2003)⁹²	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	PCR/in-house assays	NAS-PCR assay	Not stated			Yes		1	114	Not stated
Naidoo (2010)⁶⁰	Not stated	Not stated	Not stated	Not stated	GeneXpert		Liquid culture		BACTEC MGIT 960^a	Not stated		801	801	Not stated
Nikolayevskyy (2009)⁹⁹	No microscopy	Yes, Ziehl–Neelsen	One specimen per patient	Concentrated (processed)	MTBDRplus		Solid and liquid culture	LJ	BACTEC MGIT 960^a	Not stated		149	165	NALC-NaOH
Nosova (2013)⁹³	No microscopy	Yes, Ziehl–Neelsen	Not stated	Concentrated (processed)	TB biochip/Microchip	TB biochip	Liquid culture		BACTEC MGIT 960^a	No		38	38	None
O’Grady (2012)⁶¹	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	GeneXpert		Liquid culture		BACTEC MGIT 960	No		99	111	NALC-NaOH
Ogwang (2009)⁵⁵	No microscopy	Not stated	Unknown number of specimens per patient	Concentrated (processed)	INNO-LiPA		Liquid culture		BACTEC 460 TB^a	Not stated			203	NaOH (Petroff)
Pang (2013)⁸⁸	No microscopy	Yes, Ziehl–Neelsen	Not stated	Concentrated (processed)	TB biochip/Microchip	Genechip	Solid culture	LJ		No			1814	NALC-NaOH
Sam (2006)⁵⁶	No microscopy	Yes, Ziehl–Neelsen	Multiple specimens per patient	Not stated	INNO-LiPA		Solid culture	LJ		Yes			657	NALC-NaOH
Seoudi (2012)³⁵	No microscopy	Yes-FM 99	One specimen per patient	Concentrated (processed)	INNO-LiPA		Solid and liquid culture	LJ	BACTEC MGIT 960^a	Yes				NALC-NaOH
Sheen (2009)⁹⁴	No microscopy	Yes-FM 99	Unknown number of specimens per patient	Concentrated (processed)	PCR/in-house assays	PCR-SSCP test	Liquid culture		BACTEC 460 TB^a	Not stated		1	52	Other, specify
Siu (2011)⁹⁵	No microscopy	Yes, Ziehl–Neelsen	Not stated	Not stated	PCR/in-house assays	MAS-PCR	Solid culture	7H10		Yes			198	Other, specify
Skenders (2005)⁵⁷	No microscopy	Yes, Ziehl–Neelsen	Unknown number of specimens per patient	Not stated	INNO-LiPA		Liquid culture		BACTEC 460 TB^a	Yes		1	89	Other, specify
Somoskovi (2006)⁷⁴	No microscopy	Yes, Ziehl–Neelsen	One specimen per patient	Concentrated (processed)	MTBDRplus		Liquid culture		BACTEC 460 TB^a	Yes		1	143	NaOH (Petroff)
Tukvadze (2012)⁶²	No microscopy	Yes, Ziehl–Neelsen	Not stated	Concentrated (processed)	MTBDRplus	MTBDR plus	Solid and liquid culture	LJ	BACTEC MGIT 960^a	Yes		1	500	NALC-NaOH
Vadwai (2012)⁹⁶	No microscopy	Yes, Ziehl–Neelsen	One specimen per patient	Not stated	PCR/in-house assays	MAS PCR	Solid and liquid culture	LJ	BACTEC MGIT 960^a	Yes	MGIT SIRE		289	NALC-NaOH
Viveiros (2005)³³	No microscopy	Yes, Ziehl–Neelsen	Unknown number of specimens per patient	Not stated	INNO-LiPA		Liquid culture		BACTEC MGIT 960^a	No			342	NALC-NaOH
Zhang (2012)⁹⁷			One specimen per patient		PCR/in-house assays	CapitalBio DNA microarray (CapitalBio Corp, Beijing, China)	Liquid culture	LJ	BACTEC MGIT 960^a	Yes		1	93	NALC-NaOH

: MAS-PCR, multiplex allele-specific PCR; NAS-PCR, nested allele-specific; NALC-NaOH, N-acetyl-L-cysteine-sodium hydroxide PCR; SSCP, single-strand conformation polymorphism test; UHG, universal heteroduplex generator.
a: Becton Dickinson Diagnostic Instrument Systems, Towson, MD, USA.

Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Drobniewski et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK293775

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Drobniewski F, Cooke M, Jordan J, et al. Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis. Southampton (UK): NIHR Journals Library; 2015 May. (Health Technology Assessment, No. 19.34.) Appendix 5, Index and reference test information.
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Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis.

Appendix 5Index and reference test information

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