Evaluation of Mycobacterium tuberculosis viability in OMNIgene-SPUTUM reagent upon multi-day transport at ambient temperature

Abstract Background Maintaining the quality of clinical specimens for tuberculosis (TB) testing is a major challenge in many high TB burden-limited resources countries. Sample referral systems in low and middle income countries are often weak and the maintenance of the cold-chain challenging and ver...

Full description

Bibliographic Details
Main Authors: Elisa Tagliani, Riccardo Alagna, Silva Tafaj, Hasan Hafizi, Daniela Maria Cirillo
Format: Article
Language:English
Published: BMC 2017-10-01
Series:BMC Infectious Diseases
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12879-017-2756-3
_version_ 1828403228576841728
author Elisa Tagliani
Riccardo Alagna
Silva Tafaj
Hasan Hafizi
Daniela Maria Cirillo
author_facet Elisa Tagliani
Riccardo Alagna
Silva Tafaj
Hasan Hafizi
Daniela Maria Cirillo
author_sort Elisa Tagliani
collection DOAJ
description Abstract Background Maintaining the quality of clinical specimens for tuberculosis (TB) testing is a major challenge in many high TB burden-limited resources countries. Sample referral systems in low and middle income countries are often weak and the maintenance of the cold-chain challenging and very costly for TB programs. The development of transport media allowing the preservation of samples without refrigeration is critical for increasing access to TB diagnostic services and for reducing the costs related to testing. Methods We evaluated the performance of OMNIgene-SPUTUM (OM-S) reagent for the maintenance of Mycobacterium tuberculosis (MTB) viability in sputum samples in the absence of refrigeration and its capacity to stabilize nucleic acid for molecular testing. A total of 329 sputum specimens from presumptive TB cases collected at the National Reference Laboratory in Tirana, Albania, were either decontaminated by a conventional method or processed with OM-S reagent and stored at room temperature. Samples in OM-S were shipped to the Supranational Reference Laboratory in Milan, Italy, at various times and processed for liquid culture. Results Our data show that OM-S maintains MTB viability for at least three weeks in the absence of refrigeration and improves the quality of culture resulting in a contamination rate lower than 0.5%. However, a significant delay in the time to culture positivity was observed for samples stored for more than two weeks in OM-S. Conclusions Overall, OM-S offers multiple benefits both at laboratory and TB national program level by increasing the availability to quality diagnostics, promoting access to health care services and strengthening TB patient care especially in hard to reach populations.
first_indexed 2024-12-10T10:14:31Z
format Article
id doaj.art-04bed565927c43db8b4cfac7a490c6ce
institution Directory Open Access Journal
issn 1471-2334
language English
last_indexed 2024-12-10T10:14:31Z
publishDate 2017-10-01
publisher BMC
record_format Article
series BMC Infectious Diseases
spelling doaj.art-04bed565927c43db8b4cfac7a490c6ce2022-12-22T01:53:01ZengBMCBMC Infectious Diseases1471-23342017-10-011711510.1186/s12879-017-2756-3Evaluation of Mycobacterium tuberculosis viability in OMNIgene-SPUTUM reagent upon multi-day transport at ambient temperatureElisa Tagliani0Riccardo Alagna1Silva Tafaj2Hasan Hafizi3Daniela Maria Cirillo4Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific InstituteEmerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific InstituteUniversity Hospital Shefqet NdroqiUniversity Hospital Shefqet NdroqiEmerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific InstituteAbstract Background Maintaining the quality of clinical specimens for tuberculosis (TB) testing is a major challenge in many high TB burden-limited resources countries. Sample referral systems in low and middle income countries are often weak and the maintenance of the cold-chain challenging and very costly for TB programs. The development of transport media allowing the preservation of samples without refrigeration is critical for increasing access to TB diagnostic services and for reducing the costs related to testing. Methods We evaluated the performance of OMNIgene-SPUTUM (OM-S) reagent for the maintenance of Mycobacterium tuberculosis (MTB) viability in sputum samples in the absence of refrigeration and its capacity to stabilize nucleic acid for molecular testing. A total of 329 sputum specimens from presumptive TB cases collected at the National Reference Laboratory in Tirana, Albania, were either decontaminated by a conventional method or processed with OM-S reagent and stored at room temperature. Samples in OM-S were shipped to the Supranational Reference Laboratory in Milan, Italy, at various times and processed for liquid culture. Results Our data show that OM-S maintains MTB viability for at least three weeks in the absence of refrigeration and improves the quality of culture resulting in a contamination rate lower than 0.5%. However, a significant delay in the time to culture positivity was observed for samples stored for more than two weeks in OM-S. Conclusions Overall, OM-S offers multiple benefits both at laboratory and TB national program level by increasing the availability to quality diagnostics, promoting access to health care services and strengthening TB patient care especially in hard to reach populations.http://link.springer.com/article/10.1186/s12879-017-2756-3Mycobacterium tuberculosisSample transportLiquid cultureOMNIgene-SPUTUM
spellingShingle Elisa Tagliani
Riccardo Alagna
Silva Tafaj
Hasan Hafizi
Daniela Maria Cirillo
Evaluation of Mycobacterium tuberculosis viability in OMNIgene-SPUTUM reagent upon multi-day transport at ambient temperature
BMC Infectious Diseases
Mycobacterium tuberculosis
Sample transport
Liquid culture
OMNIgene-SPUTUM
title Evaluation of Mycobacterium tuberculosis viability in OMNIgene-SPUTUM reagent upon multi-day transport at ambient temperature
title_full Evaluation of Mycobacterium tuberculosis viability in OMNIgene-SPUTUM reagent upon multi-day transport at ambient temperature
title_fullStr Evaluation of Mycobacterium tuberculosis viability in OMNIgene-SPUTUM reagent upon multi-day transport at ambient temperature
title_full_unstemmed Evaluation of Mycobacterium tuberculosis viability in OMNIgene-SPUTUM reagent upon multi-day transport at ambient temperature
title_short Evaluation of Mycobacterium tuberculosis viability in OMNIgene-SPUTUM reagent upon multi-day transport at ambient temperature
title_sort evaluation of mycobacterium tuberculosis viability in omnigene sputum reagent upon multi day transport at ambient temperature
topic Mycobacterium tuberculosis
Sample transport
Liquid culture
OMNIgene-SPUTUM
url http://link.springer.com/article/10.1186/s12879-017-2756-3
work_keys_str_mv AT elisatagliani evaluationofmycobacteriumtuberculosisviabilityinomnigenesputumreagentuponmultidaytransportatambienttemperature
AT riccardoalagna evaluationofmycobacteriumtuberculosisviabilityinomnigenesputumreagentuponmultidaytransportatambienttemperature
AT silvatafaj evaluationofmycobacteriumtuberculosisviabilityinomnigenesputumreagentuponmultidaytransportatambienttemperature
AT hasanhafizi evaluationofmycobacteriumtuberculosisviabilityinomnigenesputumreagentuponmultidaytransportatambienttemperature
AT danielamariacirillo evaluationofmycobacteriumtuberculosisviabilityinomnigenesputumreagentuponmultidaytransportatambienttemperature