Diagnostic accuracy of the InBiOS AMD rapid diagnostic test for the detection of <italic>Burkholderia pseudomallei</italic> antigen in grown blood culture broth.

To assess the diagnostic and operational performance of the InBiOS AMD rapid diagnostic test (RDT) (Seattle, USA) for the detection of <italic>B. pseudomallei</italic> in grown blood culture broth. The InBiOS RDT is a lateral flow immunoassay in a strip format detecting <italic>B. pseudomallei</italic> capsular polysaccharide in culture fluids, marketed for research only. Broth of blood culture bottles (BacT/Alert, bioMérieux, Marcy L’Etoile, France) sampled in adult patients at the Sihanouk Hospital Center of HOPE, Phnom Penh, Cambodia, during 2010-2017 and stored at − 80 °C was tested. They included samples grown with <italic>B. pseudomallei</italic> (<italic>n</italic> = 114), samples with no growth (<italic>n</italic> = 12), and samples with growth of other pathogens (<italic>n</italic> = 139, among which <italic>Burkholderia cepacia</italic> (<italic>n</italic> = 5)). Diagnostic sensitivity and specificity were 96.5% [95% confidence interval (CI): 91.3-98.6%] and 100% [CI: 97.5-100%] respectively. Background clearance and line intensities were good and very good. The RDT’s test strip, not housed in a cassette, caused difficulties in manipulation and biosafety. The centrifugation step prescribed by the procedure challenged biosafety, but processing of 19 <italic>B. pseudomallei</italic> samples without centrifugation showed similar results for line intensity and background clearance, compared to centrifugation. The InBiOS RDT showed excellent accuracy for detection of <italic>B. pseudomallei</italic> in grown blood culture broth. Provided operational adaptations such as cassette housing, it has the potential to reduce time to diagnosis of melioidosis. [ABSTRACT FROM AUTHOR]