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Validation of a Lateral Flow Test for the Presumptive Identification of the Presence of Burkholderia mallei or Burkholderia pseudomallei in Environmental Samples.
Venkateswaran, Kodumudi S; Parameswaran, Nishanth; Sarwar, Jawad; Plummer, Andrea; Santos, Alan; Pillai, Christine A; Bowen, Samantha; Granville, Maria; Selvan, Senthamil; Babu, Prasanti; Thirunavukkarasu, Nagarajan; Venkateswaran, Neeraja; Sharma, Shashi; Morse, Stephen A; Anderson, Kevin; Hodge, David R; Pillai, Segaran P.
Affiliation
  • Venkateswaran KS; Kodumudi S. Venkateswaran, PhD, is Chief Executive Officer, Omni Array Biotechnology, Rockville, MD.
  • Parameswaran N; Nishanth Parameswaran, MPH, is Scientists, Omni Array Biotechnology, Rockville, MD.
  • Sarwar J; Jawad Sarwar, MS, is Scientists, Omni Array Biotechnology, Rockville, MD.
  • Plummer A; Andrea Plummer is Microbiologists, Tetracore, Inc., Rockville, MD.
  • Santos A; Alan Santos is Microbiologists, Tetracore, Inc., Rockville, MD.
  • Pillai CA; Christine A. Pillai is a Oak Ridge Institute for Science and Education Fellow Research Scientist, Molecular Methods Development Branch, Division of Microbiology, Office of Regulatory Science, Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD.
  • Bowen S; Samantha Bowen, MS is Project Managers, Science and Technology Directorate, US Department of Homeland Security, Washington, DC.
  • Granville M; Maria Granville is Project Managers, Science and Technology Directorate, US Department of Homeland Security, Washington, DC.
  • Selvan S; Senthamil Selvan, PhD, is Vice President, Omni Array Biotechnology, Rockville, MD.
  • Babu P; Prasanti Babu, MS, is a Research Associate, Omni Array Biotechnology, Rockville, MD.
  • Thirunavukkarasu N; Nagarajan Thirunavukkarasu, PhD, is a Microbiologist, Molecular Methods Development Branch, Division of Microbiology, Office of Regulatory Science, Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD.
  • Venkateswaran N; Neeraja Venkateswaran, PhD, is a Senior Scientist, Tetracore, Inc., Rockville, MD.
  • Sharma S; Shashi Sharma, PhD, is Principal Investigator, Molecular Methods Development Branch, Division of Microbiology, Office of Regulatory Science, Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD.
  • Morse SA; Stephen A. Morse, MSPH, PhD, is Senior Scientist, IHRC, Inc., Atlanta, GA.
  • Anderson K; Kevin Anderson, PhD, is Program Manager, Science and Technology Directorate, US Department of Homeland Security, Washington, DC.
  • Hodge DR; David R. Hodge, PhD, is Program Manager, Science and Technology Directorate, US Department of Homeland Security, Washington, DC.
  • Pillai SP; Segaran P. Pillai, PhD, FAAM, SM(NRCM), SM(ASCP), is Director, Office of Laboratory Safety, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.
Health Secur ; 20(2): 154-163, 2022.
Article in En | MEDLINE | ID: mdl-35467945
ABSTRACT
We conducted a comprehensive, multiphase laboratory evaluation of InBios Active Melioidosis Detect (AMD) rapid test, a lateral flow immunoassay designed to detect capsular polysaccharides produced by Burkholderia mallei or Burkholderia pseudomallei, used in conjunction with the Omni Array Reader (OAR) for the rapid detection of B mallei or B pseudomallei in environmental (nonclinical) samples at 2 sites. The limit of detection, using reference strains B mallei strain ATCC 23344 and B pseudomallei strain ATCC 11668, was determined to be 103 to 104 CFU/mL. In different phases of the evaluation, inclusivity strains that included geographically diverse strains of B mallei (N = 13) and B pseudomallei (N = 22), geographically diverse phylogenetic near neighbor strains (N = 66), environmental background strains (N = 64), white powder samples (N = 26), and environmental filter extracts (N = 1 pooled sample from 10 filter extracts) were also tested. A total of 1,753 tests were performed, which included positive and negative controls. Visual and OAR results showed that the AMD test detected 92.3% of B mallei and 95.5% of B pseudomallei strains. Of the 66 near-neighbor strains tested, cross-reactivity was observed with only B stabilis 2008724195 and B thailandensis 2003015869. Overall, the specificity and sensitivity were 98.8% and 98.7%, respectively. The results of this evaluation support the use of the AMD test as a rapid, qualitative assay for the presumptive detection of B mallei and B pseudomallei in suspicious environmental samples such as white powders and aerosol samples by first responders and laboratory personnel.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Burkholderia pseudomallei / Burkholderia mallei / Melioidosis Type of study: Diagnostic_studies / Prognostic_studies / Qualitative_research Limits: Humans Language: En Journal: Health Secur Year: 2022 Type: Article Affiliation country: Moldova
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Burkholderia pseudomallei / Burkholderia mallei / Melioidosis Type of study: Diagnostic_studies / Prognostic_studies / Qualitative_research Limits: Humans Language: En Journal: Health Secur Year: 2022 Type: Article Affiliation country: Moldova