Performance evaluation of Active Melioidosis Detect-Lateral Flow Assay (AMD-LFA) for diagnosis of melioidosis in endemic settings with limited resources

Shaw, Tushar; Tellapragada, Chaitanya; Vandana, KE; AuCoin, David P.; Mukhopadhyay, Chiranjay

doi:10.1371/journal.pone.0194595

Cited by 33 publications

(37 citation statements)

References 13 publications

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“…Recently a lateral flow immunoassay (LFI) was developed to detect B. pseudomallei capsular polysaccharide (CPS) in clinical samples. 4 , 5 Here we evaluate the sensitivity and specificity of the LFI in melioidosis patients and patients with alternative confirmed diagnoses who were enrolled into a prospective sepsis study in Thailand (NCT02217592).…”

Section: Introductionmentioning

confidence: 99%

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

Wongsuvan

Hantrakun

Teparrukkul

et al. 2018

Transactions of the Royal Society of Tropical Medicine and Hygiene

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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.

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Section: Introductionmentioning

confidence: 99%

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

Wongsuvan

Hantrakun

Teparrukkul

et al. 2018

Transactions of the Royal Society of Tropical Medicine and Hygiene

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“…83,84 A lateral flow immunoassay (LFI; detects extracellular CPSs) has been developed and shows good specificity, but seems to have poor sensitivity, especially for blood samples. [85][86][87] A study using a prototype i-STAT cartridge (developed utilizing monoclonal antibody-specific capsule of pathogenic Burkholderia species used on the LFI) reported correct classification of 88% of Australian patients. 88 However, interestingly only 46% of patients in Cambodia with culture-positive melioidosis were correctly classified.…”

Section: Laboratory Diagnosis: Classic Cultures Remain Mainstay Of DImentioning

confidence: 99%

Melioidosis: A Neglected Cause of Community-Acquired Pneumonia

Virk

Mukhopadhyay

Wiersinga

2020

Semin Respir Crit Care Med

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AbstractMelioidosis, caused by the facultative intracellular gram-negative pathogen Burkholderia pseudomallei, is an emerging cause of community-acquired pneumonia across the tropics. The majority of patients present with pneumonia with or without sepsis, but localized and asymptomatic infection is also well recognized. Recent modeling and epidemiological studies have demonstrated the widespread presence of B. pseudomallei in otherwise unrecognized regions with a predicted mortality of 90,000 deaths worldwide. Innovative environmental studies are also uncovering how hydrodynamic, pedology, fauna, and weather events influence geographic distribution and incidence of melioidosis cases. Of concern is the changes associated with global warming, which will be conducive to B. pseudomallei in combination with the global diabetes pandemic. In fact, over 80% of patient developing melioidosis have underlying comorbidities. For this great mimicker, culture remains the mainstay of diagnosis and despite availability of other assays, challenges still remain in reducing time to diagnosis and avoiding misdiagnosis. With institution of timely antimicrobials such as ceftazidime and supportive intensive care, overall mortality can be reduced to 10%, although this can still be as high as 50% in poorly resourced areas. Promise is on the horizon with the first human vaccine trials being planned for 2021. Meanwhile new multiomics techniques are giving us a better understanding of the role of virulence and host–pathogen interactions on patient outcomes.

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“…An alternative to sampling environmental specimens is the analysis of relevant clinical samples-blood and sputum [30,31]. The sensitivity of PCR-based techniques is high for sputum and pus, but, by contrast, the sensitivity for blood samples is quite low [32,33].…”

Section: Melioidosismentioning

confidence: 99%

Medical Devices for Low- and Middle-Income Countries: A Review and Directions for Development

Vasan

Friend

2020

Journal of Medical Devices

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The development of diagnostics and medical devices has historically been concentrated in high-income countries, despite a significant need to expand healthcare services to lowand middle-income countries (LMIC). Poor quality healthcare extends beyond LMIC to underserved communities in developed countries. This paper reviews diseases and conditions that have not received much attention in the past despite imposing a significant burden on healthcare systems in these circumstances. We review the underlying mechanism of action of these conditions and current technology in use for diagnosis or surgical intervention. We aim to identify areas for technological development and review policy considerations that will enable real-world adoption. Specifically, this review focuses on diseases prevalent in sub-Saharan Africa and south Asia: melioidosis, infant and maternal mortality, schistosomiasis, and heavy metal and pesticide poisoning. Our aim with this review is to identify problems facing the world that require the attention of the medical device community and provide recommendations for research directions for groups interested in this field.

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Performance evaluation of Active Melioidosis Detect-Lateral Flow Assay (AMD-LFA) for diagnosis of melioidosis in endemic settings with limited resources

Cited by 33 publications

References 13 publications

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

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

Melioidosis: A Neglected Cause of Community-Acquired Pneumonia

Medical Devices for Low- and Middle-Income Countries: A Review and Directions for Development

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