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Rapid Presumptive Identification of Burkholderia mallei and Burkholderia pseudomallei Clinical Isolates Using a Highly Specific Lateral Flow Assay.
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 Scientist, Omni Array Biotechnology, Rockville, MD.
  • Sarwar J; Jawad Sarwar, MS, is Scientist, Omni Array Biotechnology, Rockville, MD.
  • Plummer A; Andrea Plummer Microbiologist, Tetracore, Inc., Rockville, MD.
  • Santos A; Alan Santos is Microbiologist, 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 Manager, Science and Technology Directorate, US Department of Homeland Security, Washington, DC.
  • Granville M; Maria Granville, MS, is Project Manager, 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): 164-171, 2022.
Article in En | MEDLINE | ID: mdl-35467946
ABSTRACT
We conducted a comprehensive, multiphase laboratory evaluation of the 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 for the rapid identification of culture isolates of B mallei or B pseudomallei to support clinical diagnosis for response and triage during a mass casualty event, such as a biological attack. The study was conducted at 2 sites to assess the performance of the AMD test. The sensitivity, specificity, and reproducibility of the assay was determined using 5 replicates of 35 inclusivity strains and 64 clinical background strains. A total of 520 tests were performed, which included both positive and negative controls. Results obtained visually and with the Omni Array Reader showed a sensitivity of 92.3% for B mallei and 95.6% for B pseudomallei; no cross-reactivity was observed with any of the 64 clinical background organisms. The results from this study indicate that the AMD test for the presumptive identification of B mallei and B pseudomallei isolates to support clinical diagnosis is highly robust, specific, and sensitive. This evaluation supports the use of this test as a rapid, qualitative assay for the presumptive identification of B mallei and B pseudomallei in a clinical setting.
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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