Commercial products to preserve specimens for tuberculosis diagnosis: A systematic review

B. W.P. Reeve, Sally M McFall, R. Song, R. Warren, K. R. Steingart, G. Theron*

*Corresponding author for this work

Research output: Contribution to journalReview article

3 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)741-753
Number of pages13
JournalInternational Journal of Tuberculosis and Lung Disease
Volume22
Issue number7
DOIs
StatePublished - Jul 1 2018

Fingerprint

Refrigeration
Nucleic Acid Amplification Techniques
Tuberculosis
Specimen Handling
Sodium Hydroxide
Decontamination
Acetylcysteine
Mycobacterium tuberculosis
Referral and Consultation
Databases

Keywords

  • FTA card
  • GENO·CARD
  • Mycobacterium tuberculosis
  • OMNIgene·SPUTUM
  • PrimeStore molecular transport medium
  • Specimen transport

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Infectious Diseases

Cite this

Reeve, B. W.P. ; McFall, Sally M ; Song, R. ; Warren, R. ; Steingart, K. R. ; Theron, G. / Commercial products to preserve specimens for tuberculosis diagnosis : A systematic review. In: International Journal of Tuberculosis and Lung Disease. 2018 ; Vol. 22, No. 7. pp. 741-753.
@article{d1a5d00e443f40ed8c14165060cc975f,
title = "Commercial products to preserve specimens for tuberculosis diagnosis: A systematic review",
abstract = "SETTING: Eliminating tuberculosis in high-burden settings requires improved diagnostic capacity. Important tests such as Xpert{\circledR} 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 L{\"o}wenstein-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.",
keywords = "FTA card, GENO·CARD, Mycobacterium tuberculosis, OMNIgene·SPUTUM, PrimeStore molecular transport medium, Specimen transport",
author = "Reeve, {B. W.P.} and McFall, {Sally M} and R. Song and R. Warren and Steingart, {K. R.} and G. Theron",
year = "2018",
month = "7",
day = "1",
doi = "10.5588/ijtld.17.0816",
language = "English (US)",
volume = "22",
pages = "741--753",
journal = "International Journal of Tuberculosis and Lung Disease",
issn = "1027-3719",
publisher = "International Union against Tubercul. and Lung Dis.",
number = "7",

}

Commercial products to preserve specimens for tuberculosis diagnosis : A systematic review. / Reeve, B. W.P.; McFall, Sally M; Song, R.; Warren, R.; Steingart, K. R.; Theron, G.

In: International Journal of Tuberculosis and Lung Disease, Vol. 22, No. 7, 01.07.2018, p. 741-753.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Commercial products to preserve specimens for tuberculosis diagnosis

T2 - A systematic review

AU - Reeve, B. W.P.

AU - McFall, Sally M

AU - Song, R.

AU - Warren, R.

AU - Steingart, K. R.

AU - Theron, G.

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 -