Sensitivity and specificity of a lateral flow immunoassay (LFI) in serum samples for diagnosis of melioidosis

Gumphol Wongsuvan,Viriya Hantrakun,Nicholas P J Day,T Eoin West,Vanaporn Wuthiekanun,Prapit Teparrukkul,Direk Limmathurotsakul,David Aucoin,Mallika Imwong

doi:10.1093/trstmh/try099

Abstract

BackgroundCulture is the gold standard for the diagnosis of melioidosis, an infection caused by Burkholderia pseudomallei. Here we evaluate a lateral flow immunoassay (LFI) to detect B. pseudomallei capsular polysaccharide (CPS) in serum samples.MethodsPatients with culture from any clinical specimen positive for B. pseudomallei were selected as cases. Patients who were blood culture positive for Staphylococcus aureus, Escherichia coli or Klebsiella pneumoniae as well as those who were malaria or dengue polymerase chain reaction assay positive were selected as controls.ResultsThe sensitivity of the LFI was 31.3% (60/192 case patients [95% confidence interval {CI} 24.8 to 38.3]) and the specificity was 98.8% (559/566 control patients [95% CI 97.4 to 99.5]) in serum samples.ConclusionsAlthough LFI may have limited sensitivity in serum, it can rapidly diagnose melioidosis in resource-limited settings.

Highlights

Melioidosis, an infectious disease caused by Burkholderia pseudomallei, is estimated to account for 89 000 deaths worldwide every year.[1,2] Patients commonly present with sepsis and the disease is difficult to diagnose and treat.[1]
B. pseudomallei is intrinsically resistant to a wide range of antibiotics; effective antibiotics recommended for the treatment of acute melioidosis include ceftazidime and carbapenems.[1]
Blood was drawn from all patients at the time of enrolment for culture and polymerase chain reaction (PCR) assays and serum samples were frozen at −80°C

Summary

Introduction

Melioidosis, an infectious disease caused by Burkholderia pseudomallei, is estimated to account for 89 000 deaths worldwide every year.[1,2] Patients commonly present with sepsis and the disease is difficult to diagnose and treat.[1] Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection and the cause of sepsis can be due to any organism, including bacterial, fungal and viral agents.[3] Culture is the gold standard for the diagnosis of melioidosis, but microbiology laboratories are not widely available in developing tropical countries, where the disease is endemic. Culture is the gold standard for the diagnosis of melioidosis, an infection caused by Burkholderia pseudomallei. We evaluate a lateral flow immunoassay (LFI) to detect B. pseudomallei capsular polysaccharide (CPS) in serum samples

Methods

Results

Conclusion