TY - JOUR
T1 - Commercial products to preserve specimens for tuberculosis diagnosis
T2 - A systematic review
AU - Reeve, B. W.P.
AU - McFall, S. M.
AU - Song, R.
AU - Warren, R.
AU - Steingart, K. R.
AU - Theron, G.
N1 - Funding Information:
Declarations of interest: BR, SMM, KRS, and GT received funding support from FIND for performing this review. GT has received Xpert MTB/RIF kits for a separate project. GT collaborated on a project with RW, who has received funding and donated tests from Hain Lifescience, Nehren, Germany. GT and RW have collaborated on a project in which the Principal Investigator received a donation from PS-MTM (Longhorn Vaccines and Diagnostics, San Antonio, TX, USA). GT was partly supported by a South African Medical Research Council Intramural Flagship Project (Improving TB diagnosis and treatment through basic, applied and health systems research), the South African National Research Foundation (Pretoria, South Africa) and the Wellcome Trust (London, UK). RS was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health, Bethesda, MD, USA (K23HD072802). RS was working for FIND, who provided funding for this systematic review. Otherwise, the review authors have no financial involvement with any organisation or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the review apart from those disclosed.
Publisher Copyright:
© 2018 The Union.
PY - 2018/7/1
Y1 - 2018/7/1
N2 - SETTING: Eliminating tuberculosis in high-burden settings requires improved diagnostic capacity. Important tests such as Xpert® MTB/RIF and culture are often performed at centralised laboratories that are geographically distant from the point of specimen collection. Preserving specimen integrity during transportation, which could affect test performance, is challenging. OBJECTIVE: To conduct a systematic review of commercial products for specimen preservation for a World Health Organization technical consultation. DESIGN: Databases were searched up to January 2018. Methodological quality was assessed using Quality Assessment of Technical Studies, a new technical study quality-appraisal tool, and Quality Assessment of Diagnostic Accuracy Studies-2. Studies were analysed descriptively in terms of the different products, study designs and diagnostic strategies used. RESULTS: Four products were identified from16 studies: PrimeStore-Molecular-Transport-Medium (PS-MTM), FTA card, GENO·CARD (all for nucleic acid amplification tests [NAATs]) and OMNIgene·SPUTUM (OMS; culture, NAATs). PS-MTM, but not FTA card or GENO·CARD, rendered Mycobacterium tuberculosis non-culturable. OMS reduced Löwenstein-Jensen but not MGIT™ 960™ contamination, led to delayed MGIT timeto- positivity, resulted in Xpert performance similar to cold chain-transported untreated specimens, and obviated the need for N-acetyl-L-cysteine-sodium hydroxide decontamination. Data from paucibacillary specimens were limited. Evidence that a cold chain improves culture wasmixed and absent for Xpert. The effect of the product alone could be discerned in only four studies. CONCLUSION: Limited evidence suggests that transport products result in test performance comparable to that seen in cold chain-transported specimens.
AB - SETTING: Eliminating tuberculosis in high-burden settings requires improved diagnostic capacity. Important tests such as Xpert® MTB/RIF and culture are often performed at centralised laboratories that are geographically distant from the point of specimen collection. Preserving specimen integrity during transportation, which could affect test performance, is challenging. OBJECTIVE: To conduct a systematic review of commercial products for specimen preservation for a World Health Organization technical consultation. DESIGN: Databases were searched up to January 2018. Methodological quality was assessed using Quality Assessment of Technical Studies, a new technical study quality-appraisal tool, and Quality Assessment of Diagnostic Accuracy Studies-2. Studies were analysed descriptively in terms of the different products, study designs and diagnostic strategies used. RESULTS: Four products were identified from16 studies: PrimeStore-Molecular-Transport-Medium (PS-MTM), FTA card, GENO·CARD (all for nucleic acid amplification tests [NAATs]) and OMNIgene·SPUTUM (OMS; culture, NAATs). PS-MTM, but not FTA card or GENO·CARD, rendered Mycobacterium tuberculosis non-culturable. OMS reduced Löwenstein-Jensen but not MGIT™ 960™ contamination, led to delayed MGIT timeto- positivity, resulted in Xpert performance similar to cold chain-transported untreated specimens, and obviated the need for N-acetyl-L-cysteine-sodium hydroxide decontamination. Data from paucibacillary specimens were limited. Evidence that a cold chain improves culture wasmixed and absent for Xpert. The effect of the product alone could be discerned in only four studies. CONCLUSION: Limited evidence suggests that transport products result in test performance comparable to that seen in cold chain-transported specimens.
KW - FTA card
KW - GENO·CARD
KW - Mycobacterium tuberculosis
KW - OMNIgene·SPUTUM
KW - PrimeStore molecular transport medium
KW - Specimen transport
UR - http://www.scopus.com/inward/record.url?scp=85049170280&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85049170280&partnerID=8YFLogxK
U2 - 10.5588/ijtld.17.0816
DO - 10.5588/ijtld.17.0816
M3 - Review article
C2 - 29914599
AN - SCOPUS:85049170280
VL - 22
SP - 741
EP - 753
JO - International Journal of Tuberculosis and Lung Disease
JF - International Journal of Tuberculosis and Lung Disease
SN - 1027-3719
IS - 7
ER -
