Agreement of SLD testing in different laboratories in phase I and phase II of the “Baltic-Nordic TB-Laboratory Network” study.

<p>PAS, p-amino salicylic acid.</p

Methods applied in the different laboratories in both phases of SLD proficiency testing (“Baltic-Nordic TB-Laboratory Network” study).

*<p>some laboratories used more than one method.</p><p>PAS, p-amino salicylic acid.</p><p>LJ, Löwenstein Jensen; MIC, minimal inhibitory concentration.</p

Agreement of SLD results between laboratories in the “Workpackage 3 of the FP7 TB PAN-NET”.

*<p>All strains were tested in three rounds of testing: round 1 (n = 13), in the intermediate round (n = 11), and in round 2 of the “Workpackage 3 of the FP7 TB PAN-NET”.</p>**<p>All laboratories applied line probe assays, some additionally DNA sequencing methods.</p>***<p>The majority of laboratories applied MGIT 960 DST, some the proportion method on solid media, but the data are incomplete; intermediate level strains were excluded from this analysis.</p

Compilation of strains in round 1 of the WP3 of the TB PAN-NET” project.

<p>Compilation of strains in round 1 of the WP3 of the TB PAN-NET” project.</p

Certificates issued for a succesful EQA round.

<p>Certificates issued for a succesful EQA round.</p

Agreement of SLD results between laboratories in the four rounds of quality control.

*<p>The majority of laboratories applied MGIT 960 DST, only one laboratory performed the proportion method on solid media, but the data are incomplete.</p>**<p>susc. = susceptible, res. = resistant; intermediate level strains were excluded from this analysis.</p>***<p>n.d. = not done.</p

Comparative accuracy of the REBA MTB MDR and Hain MTBDR<i>plus</i> line probe assays for the detection of multidrug-resistant tuberculosis: A multicenter, non-inferiority study

<div><p>Introduction</p><p>Despite recent diagnostic advances, the majority of multidrug-resistant tuberculosis (MDR-TB) cases remain undiagnosed. Line probes assays (LiPAs) hold great promise to curb the spread of MDR-TB as they can rapidly detect MDR-TB even when laboratory infrastructure is limited, yet few of these assays are currently widely available or supported by World Health Organization (WHO) policy.</p><p>Methods</p><p>The aim of this prospective, blinded, non-inferiority study was to compare the performance of YD Diagnostics REBA MTB MDR LiPA (YD) to the WHO-endorsed Hain MTBDR<i>plus</i> V1 LiPA (Hain V1) for the detection of rifampicin and isoniazid resistance. In phase 1, YD and Hain V1 diagnostic performance was assessed with selected culture isolates and results were compared to phenotypic drug susceptibility testing (DST) results and targeted sequencing data. In phase 2, both assays were tested on processed sputum samples and results were compared to phenotypic DST results.</p><p>Results</p><p>In phase 1, YD did not achieve non-inferiority to Hain V1. For isoniazid resistance detection, Hain V1 had a sensitivity of 89% (95%CI 83.8–93%) and specificity of 99.4% (95%CI 96.9–100%). While YD had a similar sensitivity of 92% (95%CI 87.3–95.4%), the specificity was inferior at 92.6% (95%CI 87.6–96%). For rifampicin resistance detection, Hain V1 had a sensitivity of 90.2% (95%CI 84.8–94.2%) and specificity of 98.5% (95%CI 95.7–99.7%) while YD had an inferior sensitivity of 72.4% (95%CI 65.1–78.9%) and a comparable specificity of 98% (95%CI 95–99.5%). Similar results were observed in phase 2. For MDR-TB detection, the sensitivity and specificity of Hain V1 was 93.4% (95%CI 88.2–96.2%) and 96.2% (95%CI 88.2–96.8%), respectively, compared to 75.7% (95%CI 68–82.2%) and 92% (95%CI 88.2–94.9%) for YD.</p><p>Conclusions</p><p>YD did not achieve non-inferiority with Hain V1. Further improvements and repeat evaluation of YD is necessary prior to recommending its use for clinical settings.</p></div

Phase 1 sample characteristics and total number of samples included in the line probe assay comparative performance assessment by site.

<p>Phase 1 sample characteristics and total number of samples included in the line probe assay comparative performance assessment by site.</p

External Quality Control modules and specimen panel composition for six rounds, 2010–2014.

<p>External Quality Control modules and specimen panel composition for six rounds, 2010–2014.</p

Phase 1 comparative accuracy of the YD line probe assay versus Hain V1 line probe assay on characterized strains.

<p>Phase 1 comparative accuracy of the YD line probe assay versus Hain V1 line probe assay on characterized strains.</p