Rapid Presumptive Identification of Burkholderia mallei and Burkholderia pseudomallei Clinical Isolates Using a Highly Specific Lateral Flow Assay
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 or , used in conjunction with the Omni Array Reader for the rapid identification of culture isol...
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| Veröffentlicht in: | Health security 2022-04, Vol.20 (2), p.164-171 |
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| creator | 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 |
| description | 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
or
, used in conjunction with the Omni Array Reader for the rapid identification of culture isolates of
or
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
and 95.6% for
; 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
and
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
and
in a clinical setting. |
| doi_str_mv | 10.1089/hs.2021.0172 |
| format | Article |
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or
, used in conjunction with the Omni Array Reader for the rapid identification of culture isolates of
or
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
and 95.6% for
; 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
and
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
and
in a clinical setting.</description><identifier>ISSN: 2326-5094</identifier><identifier>EISSN: 2326-5108</identifier><identifier>DOI: 10.1089/hs.2021.0172</identifier><identifier>PMID: 35467946</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Arrays ; Burkholderia mallei ; Burkholderia pseudomallei ; Capsular polysaccharides ; Clinical isolates ; Cross-reactivity ; Diagnosis ; Humans ; Immunoassay ; Melioidosis ; Melioidosis - diagnosis ; Polysaccharides ; Reproducibility of Results ; Saccharides ; Sensitivity analysis ; Strains (organisms)</subject><ispartof>Health security, 2022-04, Vol.20 (2), p.164-171</ispartof><rights>Copyright Mary Ann Liebert, Inc. Apr 2022</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c234t-972405420d53da74843f42ff22741a56e9c4db3f71145b66edcc32090bd38b733</citedby><cites>FETCH-LOGICAL-c234t-972405420d53da74843f42ff22741a56e9c4db3f71145b66edcc32090bd38b733</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35467946$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Venkateswaran, Kodumudi S</creatorcontrib><creatorcontrib>Parameswaran, Nishanth</creatorcontrib><creatorcontrib>Sarwar, Jawad</creatorcontrib><creatorcontrib>Plummer, Andrea</creatorcontrib><creatorcontrib>Santos, Alan</creatorcontrib><creatorcontrib>Pillai, Christine A</creatorcontrib><creatorcontrib>Bowen, Samantha</creatorcontrib><creatorcontrib>Granville, Maria</creatorcontrib><creatorcontrib>Selvan, Senthamil</creatorcontrib><creatorcontrib>Babu, Prasanti</creatorcontrib><creatorcontrib>Thirunavukkarasu, Nagarajan</creatorcontrib><creatorcontrib>Venkateswaran, Neeraja</creatorcontrib><creatorcontrib>Sharma, Shashi</creatorcontrib><creatorcontrib>Morse, Stephen A</creatorcontrib><creatorcontrib>Anderson, Kevin</creatorcontrib><creatorcontrib>Hodge, David R</creatorcontrib><creatorcontrib>Pillai, Segaran P</creatorcontrib><title>Rapid Presumptive Identification of Burkholderia mallei and Burkholderia pseudomallei Clinical Isolates Using a Highly Specific Lateral Flow Assay</title><title>Health security</title><addtitle>Health Secur</addtitle><description>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
or
, used in conjunction with the Omni Array Reader for the rapid identification of culture isolates of
or
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
and 95.6% for
; 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
and
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
and
in a clinical setting.</description><subject>Arrays</subject><subject>Burkholderia mallei</subject><subject>Burkholderia pseudomallei</subject><subject>Capsular polysaccharides</subject><subject>Clinical isolates</subject><subject>Cross-reactivity</subject><subject>Diagnosis</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Melioidosis</subject><subject>Melioidosis - diagnosis</subject><subject>Polysaccharides</subject><subject>Reproducibility of Results</subject><subject>Saccharides</subject><subject>Sensitivity analysis</subject><subject>Strains (organisms)</subject><issn>2326-5094</issn><issn>2326-5108</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkc1LwzAYxoMoTuZuniXgxYOb-e561OHcYKCoO5e0Sbdo2tSkVfZv-BebsSnoKS95fjzvxwPAGUYjjMbp9TqMCCJ4hHBCDsAJoUQMeVQOf2qUsh4YhPCKUGQYQTw5Bj3KmUhSJk7A15NsjIKPXoeualrzoeFc6bo1pSlka1wNXQlvO_-2dlZpbySspLXaQFmrv_9N0J1ye3ViTR0NLJwHZ2WrA1wGU6-ghDOzWtsNfG50se0BF1H1EZxa9wlvQpCbU3BUShv0YP_2wXJ69zKZDRcP9_PJzWJYEMraYZoQhnjcSHGqZMLGjJaMlCUhCcOSC50WTOW0TDBmPBdCq6KgBKUoV3ScJ5T2weXOt_HuvdOhzSoTCm2trLXrQkYE51zgeNmIXvxDX13n6zjdlmJ0jLlII3W1owrvQvC6zBpvKuk3GUbZNq5sHfkYV4Z2pud70y6vtPqFf8Kh33TLkI4</recordid><startdate>20220401</startdate><enddate>20220401</enddate><creator>Venkateswaran, Kodumudi S</creator><creator>Parameswaran, Nishanth</creator><creator>Sarwar, Jawad</creator><creator>Plummer, Andrea</creator><creator>Santos, Alan</creator><creator>Pillai, Christine A</creator><creator>Bowen, Samantha</creator><creator>Granville, Maria</creator><creator>Selvan, Senthamil</creator><creator>Babu, Prasanti</creator><creator>Thirunavukkarasu, Nagarajan</creator><creator>Venkateswaran, Neeraja</creator><creator>Sharma, Shashi</creator><creator>Morse, Stephen A</creator><creator>Anderson, Kevin</creator><creator>Hodge, David R</creator><creator>Pillai, Segaran P</creator><general>Mary Ann Liebert, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T7</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20220401</creationdate><title>Rapid Presumptive Identification of Burkholderia mallei and Burkholderia pseudomallei Clinical Isolates Using a Highly Specific Lateral Flow Assay</title><author>Venkateswaran, Kodumudi S ; 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or
, used in conjunction with the Omni Array Reader for the rapid identification of culture isolates of
or
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
and 95.6% for
; 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
and
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
and
in a clinical setting.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>35467946</pmid><doi>10.1089/hs.2021.0172</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2326-5094 |
| ispartof | Health security, 2022-04, Vol.20 (2), p.164-171 |
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| language | eng |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Arrays Burkholderia mallei Burkholderia pseudomallei Capsular polysaccharides Clinical isolates Cross-reactivity Diagnosis Humans Immunoassay Melioidosis Melioidosis - diagnosis Polysaccharides Reproducibility of Results Saccharides Sensitivity analysis Strains (organisms) |
| title | Rapid Presumptive Identification of Burkholderia mallei and Burkholderia pseudomallei Clinical Isolates Using a Highly Specific Lateral Flow Assay |
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