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Performance Comparison of Three Rapid Tests for the Diagnosis of Drug-Resistant Tuberculosis.

Catanzaro A, Rodwell TC, Catanzaro DG, Garfein RS, Jackson RL, Seifert M, Georghiou SB, Trollip A, Groessl E, Hillery N, Crudu V, Victor TC, Rodrigues C, Lin GS, Valafar F, Desmond E, Eisenach K - PLoS ONE (2015)

Bottom Line: In terms of agreement, statistically significant differences were only found for detection of RIF (MODS outperformed PSQ) and KAN (MODS outperformed LPA and PSQ) resistance.Mean time-to-result was 1.1 days for LPA and PSQ, 14.3 days for MODS, and 24.7 days for MGIT.In particular, the very high specificity seen for detection of drug resistance means that clinicians can use the results of these rapid tests to avoid the use of toxic drugs to which the infecting organism is resistant and develop treatment regiments that have a higher likelihood of yielding a successful outcome.

View Article: PubMed Central - PubMed

Affiliation: University of California San Diego, La Jolla, California, United States of America.

ABSTRACT

Background: The aim of this study was to compare the performance of several recently developed assays for the detection of multi- and extensively drug-resistant tuberculosis (M/XDR-TB) in a large, multinational field trial.

Methods: Samples from 1,128 M/XDR-TB suspects were examined by Line Probe Assay (LPA), Pyrosequencing (PSQ), and Microscopic Observation of Drug Susceptibility (MODS) and compared to the BACTEC MGIT960 reference standard to detect M/XDR-TB directly from patient sputum samples collected at TB clinics in India, Moldova, and South Africa.

Results: Specificity for all three assays was excellent: 97-100% for isoniazid (INH), rifampin (RIF), moxifloxacin (MOX) and ofloxacin (OFX) and 99-100% for amikacin (AMK), capreomycin (CAP) and kanamycin (KAN) resistance. Sensitivities were lower, but still very good: 94-100% for INH, RIF, MOX and OFX, and 84-90% for AMK and CAP, but only 48-62% for KAN. In terms of agreement, statistically significant differences were only found for detection of RIF (MODS outperformed PSQ) and KAN (MODS outperformed LPA and PSQ) resistance. Mean time-to-result was 1.1 days for LPA and PSQ, 14.3 days for MODS, and 24.7 days for MGIT.

Conclusions: All three rapid assays evaluated provide clinicians with timely detection of resistance to the drugs tested; with molecular results available one day following laboratory receipt of samples. In particular, the very high specificity seen for detection of drug resistance means that clinicians can use the results of these rapid tests to avoid the use of toxic drugs to which the infecting organism is resistant and develop treatment regiments that have a higher likelihood of yielding a successful outcome.

No MeSH data available.


Related in: MedlinePlus

Sensitivity, specificity and percent agreement between three rapid drug susceptibility tests and MGIT for seven drugs: isoniazid (INH), rifampin (RIF), moxifloxacin (MOX), ofloxacin (OFX), amikacin (AMK), kanamycin (KAN), and capreomycin (CAP).Mean values and 95% confidence intervals for each comparison are represented in the figure; full data is included as a supplementary table.
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pone.0136861.g002: Sensitivity, specificity and percent agreement between three rapid drug susceptibility tests and MGIT for seven drugs: isoniazid (INH), rifampin (RIF), moxifloxacin (MOX), ofloxacin (OFX), amikacin (AMK), kanamycin (KAN), and capreomycin (CAP).Mean values and 95% confidence intervals for each comparison are represented in the figure; full data is included as a supplementary table.

Mentions: All three assays performed well for direct detection of INH and RIF resistance, with specificities ranging from 96% to 100% and sensitivities ranging from 94% to 100% (Fig 2, S1 Table). For direct detection of MOX and OFX resistance, specificities and sensitivities were high, 94% to 99% and 94% to 98%, respectively. For the detection of resistance to AMK or CAP specificity was also very high (almost 100%) while sensitivity was considerably lower (84%-90% for AMK and CAP and 48%-68% for KAN). The positive likelihood ratios of all three assays for all seven drugs were >20 and negative likelihood ratios were all ~0.1 or lower, with the exception of the assays detecting KAN resistance, which had somewhat higher negative likelihood ratios (0.38–0.52).


Performance Comparison of Three Rapid Tests for the Diagnosis of Drug-Resistant Tuberculosis.

Catanzaro A, Rodwell TC, Catanzaro DG, Garfein RS, Jackson RL, Seifert M, Georghiou SB, Trollip A, Groessl E, Hillery N, Crudu V, Victor TC, Rodrigues C, Lin GS, Valafar F, Desmond E, Eisenach K - PLoS ONE (2015)

Sensitivity, specificity and percent agreement between three rapid drug susceptibility tests and MGIT for seven drugs: isoniazid (INH), rifampin (RIF), moxifloxacin (MOX), ofloxacin (OFX), amikacin (AMK), kanamycin (KAN), and capreomycin (CAP).Mean values and 95% confidence intervals for each comparison are represented in the figure; full data is included as a supplementary table.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4556461&req=5

pone.0136861.g002: Sensitivity, specificity and percent agreement between three rapid drug susceptibility tests and MGIT for seven drugs: isoniazid (INH), rifampin (RIF), moxifloxacin (MOX), ofloxacin (OFX), amikacin (AMK), kanamycin (KAN), and capreomycin (CAP).Mean values and 95% confidence intervals for each comparison are represented in the figure; full data is included as a supplementary table.
Mentions: All three assays performed well for direct detection of INH and RIF resistance, with specificities ranging from 96% to 100% and sensitivities ranging from 94% to 100% (Fig 2, S1 Table). For direct detection of MOX and OFX resistance, specificities and sensitivities were high, 94% to 99% and 94% to 98%, respectively. For the detection of resistance to AMK or CAP specificity was also very high (almost 100%) while sensitivity was considerably lower (84%-90% for AMK and CAP and 48%-68% for KAN). The positive likelihood ratios of all three assays for all seven drugs were >20 and negative likelihood ratios were all ~0.1 or lower, with the exception of the assays detecting KAN resistance, which had somewhat higher negative likelihood ratios (0.38–0.52).

Bottom Line: In terms of agreement, statistically significant differences were only found for detection of RIF (MODS outperformed PSQ) and KAN (MODS outperformed LPA and PSQ) resistance.Mean time-to-result was 1.1 days for LPA and PSQ, 14.3 days for MODS, and 24.7 days for MGIT.In particular, the very high specificity seen for detection of drug resistance means that clinicians can use the results of these rapid tests to avoid the use of toxic drugs to which the infecting organism is resistant and develop treatment regiments that have a higher likelihood of yielding a successful outcome.

View Article: PubMed Central - PubMed

Affiliation: University of California San Diego, La Jolla, California, United States of America.

ABSTRACT

Background: The aim of this study was to compare the performance of several recently developed assays for the detection of multi- and extensively drug-resistant tuberculosis (M/XDR-TB) in a large, multinational field trial.

Methods: Samples from 1,128 M/XDR-TB suspects were examined by Line Probe Assay (LPA), Pyrosequencing (PSQ), and Microscopic Observation of Drug Susceptibility (MODS) and compared to the BACTEC MGIT960 reference standard to detect M/XDR-TB directly from patient sputum samples collected at TB clinics in India, Moldova, and South Africa.

Results: Specificity for all three assays was excellent: 97-100% for isoniazid (INH), rifampin (RIF), moxifloxacin (MOX) and ofloxacin (OFX) and 99-100% for amikacin (AMK), capreomycin (CAP) and kanamycin (KAN) resistance. Sensitivities were lower, but still very good: 94-100% for INH, RIF, MOX and OFX, and 84-90% for AMK and CAP, but only 48-62% for KAN. In terms of agreement, statistically significant differences were only found for detection of RIF (MODS outperformed PSQ) and KAN (MODS outperformed LPA and PSQ) resistance. Mean time-to-result was 1.1 days for LPA and PSQ, 14.3 days for MODS, and 24.7 days for MGIT.

Conclusions: All three rapid assays evaluated provide clinicians with timely detection of resistance to the drugs tested; with molecular results available one day following laboratory receipt of samples. In particular, the very high specificity seen for detection of drug resistance means that clinicians can use the results of these rapid tests to avoid the use of toxic drugs to which the infecting organism is resistant and develop treatment regiments that have a higher likelihood of yielding a successful outcome.

No MeSH data available.


Related in: MedlinePlus