Journal of Epidemiology and Global Health

Volume 7, Issue 2, June 2017, Pages 103 - 109

Investigation of OMNIgene·SPUTUM performance in delayed tuberculosis testing by smear, culture, and Xpert MTB/RIF assays in Uganda

Authors
C.D. Kelly-Cirinoa, *, 1, casseycirino@gmail.com, E. Musisib, 1, emusisi@idrc-uganda.org, P. Byanyimab, pbyanyima@idrc-uganda.org, S. Kaswabulib, skaswabuli@idrc-uganda.org, A. Andamab, andama.alf@gmail.com, A. Sessolob, asessolo@idrc-uganda.org, I. Sanyub, singvar@idrc-uganda.org, J. Zaweddeb, jzawedde@idrc-uganda.org, P.S. Currya, pat.curry@dnagenotek.com, L. Huangc, Laurence.Huang@ucsf.edu
aDNA Genotek, 500 Palladium Dr., Suite 3000, Ottawa, Ontario K2V 1C2, Canada
bInfectious Diseases Research Collaboration Kampala, 2C Nakasero Hill Road, PO Box 7475, Kampala, Uganda
cUniversity of California San Francisco, HIV, Infectious Diseases, and Global Medicine Division and Division of Pulmonary and Critical Care Medicine - Ward 84, San Francisco General Hospital, 995 Potrero Avenue, San Francisco, CA 94110, USA
1

C.D. Kelly-Cirino and E. Musisi are equally contributing co-first authors.

*Corresponding author.
Corresponding Author
C.D. Kelly-Cirinocasseycirino@gmail.com
Available Online 13 April 2017.
DOI
10.1016/j.jegh.2017.04.001How to use a DOI?
Keywords
MGIT; Molecular detection; Mycobacterium tuberculosis; Preservation; Solid culture; Specimen transport medium
Abstract

OMNIgene·SPUTUM (OM-S) is a sample transport reagent designed to work with all tuberculosis diagnostics while eliminating the need for cold chain. OM-S-treated sputum samples were assayed in several tests after multiday holds. Raw sputa from 100 patients underwent direct smear microscopy, were manually split and assigned to the OM-S group [OM-S added at collection (no other processing required) and tested after 0- to 5-day holds at room temperature] or standard-of-care (SOC) group (NaOH/N-acetyl l-cysteine decontamination, all tested on day of collection). Concentrated smear microscopy, Lowenstein Jensen (LJ) culture, and mycobacteria growth indicator tube (MGIT) culture were performed. For patients with negative direct smear, a second sample was split, with SOC (raw sputum) and OM-S portions (sediment) tested in the Xpert MTB/RIF (Xpert) assay. OM-S group and SOC group results were strongly concordant on all four tests [range, 89% (MGIT)–97% (Xpert)]. OM-S MGIT, LJ, and Xpert tests were in statistical agreement with SOC MGIT as reference. OM-S specimens had lower culture contamination rates (3% vs. 10% LJ; 2% vs. 5% MGIT) but required, on average, 5.6 additional days to become MGIT-positive. The findings suggest that samples held/transported in OM-S are compatible with smear microscopy, LJ or MGIT culture, and Xpert, and perform comparably to fresh sputum samples. Larger feasibility studies are warranted.

Copyright
© 2017 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd.
Open Access
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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Journal
Journal of Epidemiology and Global Health
Volume-Issue
7 - 2
Pages
103 - 109
Publication Date
2017/04/13
ISSN (Online)
2210-6014
ISSN (Print)
2210-6006
DOI
10.1016/j.jegh.2017.04.001How to use a DOI?
Copyright
© 2017 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd.
Open Access
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Cite this article

TY  - JOUR
AU  - C.D. Kelly-Cirino
AU  - E. Musisi
AU  - P. Byanyima
AU  - S. Kaswabuli
AU  - A. Andama
AU  - A. Sessolo
AU  - I. Sanyu
AU  - J. Zawedde
AU  - P.S. Curry
AU  - L. Huang
PY  - 2017
DA  - 2017/04/13
TI  - Investigation of OMNIgene·SPUTUM performance in delayed tuberculosis testing by smear, culture, and Xpert MTB/RIF assays in Uganda
JO  - Journal of Epidemiology and Global Health
SP  - 103
EP  - 109
VL  - 7
IS  - 2
SN  - 2210-6014
UR  - https://doi.org/10.1016/j.jegh.2017.04.001
DO  - 10.1016/j.jegh.2017.04.001
ID  - Kelly-Cirino2017
ER  -