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 language | English (US) |
|---|---|
| Pages (from-to) | 741-753 |
| Number of pages | 13 |
| Journal | International Journal of Tuberculosis and Lung Disease |
| Volume | 22 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 1 2018 |
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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
}
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 journal › Review 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 -