Novel multi-day sputum transport reagent works with routine tuberculosis tests and eliminates need for cold chain: Preliminary study of compatibility with the Xpert® MTB/RIF assay

Kelly-Cirino, Cassandra; Curry, Patricia S.; Marola, Jamie L.

doi:10.1016/j.diagmicrobio.2016.08.013

Cited by 12 publications

(7 citation statements)

References 1 publication

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“…OMNIgene·SPUTUM (OM-S; DNA Genotek Inc., Ottawa, ON, Canada) is a transport reagent that liquefies and decontaminates sputum, and that maintains live MTb for 8 days at temperatures up to 40 °C [ 3 ]. When OM-S is added, cold chain is not required for shipping and samples are directly compatible with molecular assays and gold standard TB tests, such as smear microscopy, solid and liquid culture, and the Cepheid Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA, USA) [ 3 – 6 ]. The aim of this study was to evaluate the performance of OM-S-treated clinical samples in multiple TB tests, including culture, after various hold times.…”

Section: Introductionmentioning

confidence: 99%

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

Kelly-Cirino¹,

Musisi²,

Byanyima³

et al. 2017

JEGH

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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.

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Section: Introductionmentioning

confidence: 99%

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

Kelly-Cirino¹,

Musisi²,

Byanyima³

et al. 2017

JEGH

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“…According to the company, this reagent liquefies and decontaminates sputum samples while at the same time preserving MTB viability for at least 8 days at ambient temperature and up to 40° [ 2 ]. Recent studies have shown OM-S compatibility with Xpert®MTB/RIF assay [ 3 ] and other routine TB tests [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2017

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BackgroundMaintaining 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.MethodsWe 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.ResultsOur 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.ConclusionsOverall, 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.

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“…Finally, we observed a substantial delay in days to positivity between untreated and OM-S-treated samples at both time points. Previous studies have also noted delayed culture growth in samples treated with OM-S (13,15,21,22). This raises further concerns about the utility of OM-S in its current procedure and the compatibility with MGIT cultures.…”

Section: Discussionmentioning

confidence: 88%

Evaluation of OMNIgene Sputum and Ethanol Reagent for Preservation of Sputum Prior to Xpert and Culture Testing in Uganda

et al. 2019

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Xpert MTB/RIF (Xpert) and culture are the most reliable methods for tuberculosis diagnosis but are still poorly accessible in many low-resource countries. We aimed to assess the effects of OMNIgene Sputum (OM-S) and ethanol in preserving sputum for Xpert and OM-S for mycobacterial growth indicator tube (MGIT) testing over periods of 15 and 8 days, respectively. Sputum samples were collected from newly diagnosed smear-positive patients. For Xpert, pooled samples were split into 5 aliquots: 3 for Xpert on days 0, 7, and 15 without additive and 2 with either OM-S or ethanol at day 15. For MGIT, 2 aliquots were tested without preservative and 2 with OM-S at 0 and 8 days. Totals of 48 and 47 samples were included in the analysis for Xpert and culture. With Xpert, using day 0 as a reference, untreated samples stored for 7 and 15 days showed concordances of 45/46 (97.8%) and 46/48 (95.8%). For samples preserved with OM-S or ethanol for 15 days compared with untreated samples processed at day 0 or after 15 days, OM-S concordances were 46/48 (95.8%) and 47/48 (97.9%), while those of ethanol were 44/48 (91.7%) and 45/48 (93.8%). With MGIT, concordances between untreated and OM-S-treated samples were 21/41 (51.2%) at day 0 and 21/44 (47.7%) at day 8. In conclusion, Xpert equally detected tuberculosis in OM-S-treated and untreated samples up to 15 days but showed slightly lower detection in ethanol-treated samples. Among OM-S-treated samples, MGIT positivity was significantly lower than in untreated samples at both time points.

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Novel multi-day sputum transport reagent works with routine tuberculosis tests and eliminates need for cold chain: Preliminary study of compatibility with the Xpert® MTB/RIF assay

Cited by 12 publications

References 1 publication

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

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

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

Evaluation of OMNIgene Sputum and Ethanol Reagent for Preservation of Sputum Prior to Xpert and Culture Testing in Uganda

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