Evaluation of a Rapid Diagnostic Test for Detection of Burkholderia pseudomallei in the Lao People's Democratic Republic

Kate L Woods, Latsaniphone Boutthasavong, Caoimhe NicFhogartaigh, Sue J Lee, Viengmon Davong, David P AuCoin, David A B Dance, Kate L Woods, Latsaniphone Boutthasavong, Caoimhe NicFhogartaigh, Sue J Lee, Viengmon Davong, David P AuCoin, David A B Dance

Abstract

Burkholderia pseudomallei causes significant global morbidity and mortality, with the highest disease burden in parts of Asia where culture-based diagnosis is often not available. We prospectively evaluated the Active Melioidosis Detect (AMD; InBios International, USA) lateral flow immunoassay (LFI) for rapid detection of B. pseudomallei in turbid blood cultures, pus, sputum, sterile fluid, urine, and sera. The performance of this test was compared to that of B. pseudomallei detection using monoclonal antibody latex agglutination (LA) and immunofluorescence assays (IFA), with culture as the gold standard. AMD was 99% (99/100; 95% confidence interval, 94.6 to 100%) sensitive and 100% (308/308; 98.8 to 100%) specific on turbid blood culture bottles, with no difference from LA or IFA. AMD specificity was 100% on pus (122/122; 97.0 to 100%), sputum (20/20; 83.2 to 100%), and sterile fluid (44/44; 92 to 100%). Sensitivity on these samples was as follows: pus, 47.1% (8/17; 23.0 to 72.2%); sputum, 33.3% (1/3; 0.84 to 90.6%); and sterile fluid, 0% (0/2; 0 to 84.2%). For urine samples, AMD had a positive predictive value of 94% (32/34; 79.7 to 98.5%) for diagnosing melioidosis in our cohort. AMD sensitivity on stored sera, collected prospectively from melioidosis cases during this study, was 13.9% (5/36; 4.7% to 29.5%) compared to blood culture samples taken on the same day. In conclusion, AMD is an excellent tool for rapid diagnosis of melioidosis from turbid blood cultures and maintains specificity across all sample types. It is a promising tool for urinary antigen detection, which could revolutionize diagnosis of melioidosis in resource-limited settings. Further work is required to improve sensitivity on nonblood culture samples.

Keywords: B. pseudomallei; blood; lateral flow immunoassay; melioidosis; pus; rapid diagnosis; serum; sputum; sterile fluid; urine.

Copyright © 2018 Woods et al.

Figures

FIG 1
FIG 1
Sample flow diagram of turbid blood cultures with Gram-negative bacilli seen on microscopy. In this and all subsequent figures, “not documented” means that there was inadequate documentation to include the result in the analysis; “missed” means that the test was not performed.
FIG 2
FIG 2
Sample flow diagram for pus samples.
FIG 3
FIG 3
Sample flow diagram for sputum samples.
FIG 4
FIG 4
Sample flow diagram for sterile fluid samples.
FIG 5
FIG 5
Sample flow diagram for unselected urine samples (2 July to 2 September 2014).
FIG 6
FIG 6
Sample flow diagram for selected urine samples (3 September to 18 December 2014 and 23 June to 12 November 2015).
FIG 7
FIG 7
Sample flow diagram for serum samples from culture-confirmed melioidosis cases diagnosed between 26 June and 18 December 2014.
FIG A1
FIG A1
Interpretation according to the instructions of the manufacturer (InBios). C, control line; T, test line.
FIG A2
FIG A2
Positive results.

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Source: PubMed

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