Performance of the ImmuView and BinaxNOW assays for the detection of urine and cerebrospinal fluid Streptococcus pneumoniae and Legionella pneumophila serogroup 1 antigen in patients with Legionnaires’ disease or pneumococcal pneumonia and meningitis
The performances of the ImmuView Streptococcus pneumoniae (Sp) and Legionella pneumophila (Lp) urinary antigen test were compared to that of the BinaxNOW Sp and Lp assays, using frozen urine from 166 patients with Legionnaires' disease (LD) and 59 patients with pneumococcal pneumonia. Thirty Sp...
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| description | The performances of the ImmuView Streptococcus pneumoniae (Sp) and Legionella pneumophila (Lp) urinary antigen test were compared to that of the BinaxNOW Sp and Lp assays, using frozen urine from 166 patients with Legionnaires' disease (LD) and 59 patients with pneumococcal pneumonia. Thirty Sp-positive or contrived cerebrospinal fluids (CSF) were also tested. Test specimens were collected and tested at different sites, with each site testing unique specimens by technologists blinded to expected results. No significant differences in test concordances were detected for the ImmuView and BinaxNOW assays for the Sp or Lp targets for urine from patients with pneumococcal pneumonia or LD when performance from both sites were combined. At one of two test sites the ImmuView Lp assay was more sensitive than the BinaxNOW assay, with no correlation between test performance and Lp serogroup 1 monoclonal type. Urines from six of seven patients with LD caused by Legionella spp. bacteria other than Lp serogroup 1 were negative in both assays. Both tests had equivalent performance for Sp-positive CSF. The clinical sensitivities for pneumococcal pneumonia were 88.1 and 94.4% for the ImmuView and Binax assays, and 87.6 and 84.2% for the Lp assays, respectively. Test specificities for pneumococcal pneumonia were 96.2 and 97.0% for the ImmuView and Binax assays, and 99.6 and 99.1% for the Lp assays. Both assays were highly specific for Sp in pediatric urines from children with nasopharyngeal colonization by the bacterium. ImmuView and BinaxNOW assay performance was equivalent in these studies. |
| doi_str_mv | 10.1371/journal.pone.0238479 |
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Thirty Sp-positive or contrived cerebrospinal fluids (CSF) were also tested. Test specimens were collected and tested at different sites, with each site testing unique specimens by technologists blinded to expected results. No significant differences in test concordances were detected for the ImmuView and BinaxNOW assays for the Sp or Lp targets for urine from patients with pneumococcal pneumonia or LD when performance from both sites were combined. At one of two test sites the ImmuView Lp assay was more sensitive than the BinaxNOW assay, with no correlation between test performance and Lp serogroup 1 monoclonal type. Urines from six of seven patients with LD caused by Legionella spp. bacteria other than Lp serogroup 1 were negative in both assays. Both tests had equivalent performance for Sp-positive CSF. The clinical sensitivities for pneumococcal pneumonia were 88.1 and 94.4% for the ImmuView and Binax assays, and 87.6 and 84.2% for the Lp assays, respectively. Test specificities for pneumococcal pneumonia were 96.2 and 97.0% for the ImmuView and Binax assays, and 99.6 and 99.1% for the Lp assays. Both assays were highly specific for Sp in pediatric urines from children with nasopharyngeal colonization by the bacterium. ImmuView and BinaxNOW assay performance was equivalent in these studies.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0238479</identifier><identifier>PMID: 32866217</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Antigens ; Assaying ; Bacteria ; Bacterial meningitis ; Bias ; Biology and Life Sciences ; Cerebrospinal fluid ; Colonization ; Diagnosis ; Equivalence ; Evaluation ; Health aspects ; Immunoassay ; Laboratories ; Legionella pneumophila ; Legionnaire's disease ; Legionnaires disease ; Legionnaires' disease bacterium ; Medicine ; Medicine and Health Sciences ; Meningitis ; Methods ; Patients ; Pediatrics ; Physical Sciences ; Pneumonia ; Reading ; Streptococcal infections ; Streptococcus infections ; Streptococcus pneumoniae ; Supervision ; Technologists ; Testing ; Urinalysis ; Urine</subject><ispartof>PloS one, 2020-08, Vol.15 (8), p.e0238479-e0238479</ispartof><rights>COPYRIGHT 2020 Public Library of Science</rights><rights>2020 Edelstein et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 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Thirty Sp-positive or contrived cerebrospinal fluids (CSF) were also tested. Test specimens were collected and tested at different sites, with each site testing unique specimens by technologists blinded to expected results. No significant differences in test concordances were detected for the ImmuView and BinaxNOW assays for the Sp or Lp targets for urine from patients with pneumococcal pneumonia or LD when performance from both sites were combined. At one of two test sites the ImmuView Lp assay was more sensitive than the BinaxNOW assay, with no correlation between test performance and Lp serogroup 1 monoclonal type. Urines from six of seven patients with LD caused by Legionella spp. bacteria other than Lp serogroup 1 were negative in both assays. Both tests had equivalent performance for Sp-positive CSF. The clinical sensitivities for pneumococcal pneumonia were 88.1 and 94.4% for the ImmuView and Binax assays, and 87.6 and 84.2% for the Lp assays, respectively. 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ImmuView and BinaxNOW assay performance was equivalent in these studies.</description><subject>Antigens</subject><subject>Assaying</subject><subject>Bacteria</subject><subject>Bacterial meningitis</subject><subject>Bias</subject><subject>Biology and Life Sciences</subject><subject>Cerebrospinal fluid</subject><subject>Colonization</subject><subject>Diagnosis</subject><subject>Equivalence</subject><subject>Evaluation</subject><subject>Health aspects</subject><subject>Immunoassay</subject><subject>Laboratories</subject><subject>Legionella pneumophila</subject><subject>Legionnaire's disease</subject><subject>Legionnaires disease</subject><subject>Legionnaires' disease bacterium</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Meningitis</subject><subject>Methods</subject><subject>Patients</subject><subject>Pediatrics</subject><subject>Physical Sciences</subject><subject>Pneumonia</subject><subject>Reading</subject><subject>Streptococcal 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of the ImmuView and BinaxNOW assays for the detection of urine and cerebrospinal fluid Streptococcus pneumoniae and Legionella pneumophila serogroup 1 antigen in patients with Legionnaires’ disease or pneumococcal pneumonia and meningitis</title><author>Edelstein, Paul H ; Jorgensen, Charlotte Svaerke ; Wolf, Leslie A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c669t-19445d017b2514d080d403cf83cfa40780fc1bb41b839691a1e8682a80c056ac3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antigens</topic><topic>Assaying</topic><topic>Bacteria</topic><topic>Bacterial meningitis</topic><topic>Bias</topic><topic>Biology and Life Sciences</topic><topic>Cerebrospinal fluid</topic><topic>Colonization</topic><topic>Diagnosis</topic><topic>Equivalence</topic><topic>Evaluation</topic><topic>Health aspects</topic><topic>Immunoassay</topic><topic>Laboratories</topic><topic>Legionella 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one</jtitle><date>2020-08-31</date><risdate>2020</risdate><volume>15</volume><issue>8</issue><spage>e0238479</spage><epage>e0238479</epage><pages>e0238479-e0238479</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>The performances of the ImmuView Streptococcus pneumoniae (Sp) and Legionella pneumophila (Lp) urinary antigen test were compared to that of the BinaxNOW Sp and Lp assays, using frozen urine from 166 patients with Legionnaires' disease (LD) and 59 patients with pneumococcal pneumonia. Thirty Sp-positive or contrived cerebrospinal fluids (CSF) were also tested. Test specimens were collected and tested at different sites, with each site testing unique specimens by technologists blinded to expected results. No significant differences in test concordances were detected for the ImmuView and BinaxNOW assays for the Sp or Lp targets for urine from patients with pneumococcal pneumonia or LD when performance from both sites were combined. At one of two test sites the ImmuView Lp assay was more sensitive than the BinaxNOW assay, with no correlation between test performance and Lp serogroup 1 monoclonal type. Urines from six of seven patients with LD caused by Legionella spp. bacteria other than Lp serogroup 1 were negative in both assays. Both tests had equivalent performance for Sp-positive CSF. The clinical sensitivities for pneumococcal pneumonia were 88.1 and 94.4% for the ImmuView and Binax assays, and 87.6 and 84.2% for the Lp assays, respectively. Test specificities for pneumococcal pneumonia were 96.2 and 97.0% for the ImmuView and Binax assays, and 99.6 and 99.1% for the Lp assays. Both assays were highly specific for Sp in pediatric urines from children with nasopharyngeal colonization by the bacterium. ImmuView and BinaxNOW assay performance was equivalent in these studies.</abstract><cop>San Francisco</cop><pub>Public Library of Science</pub><pmid>32866217</pmid><doi>10.1371/journal.pone.0238479</doi><tpages>e0238479</tpages><orcidid>https://orcid.org/0000-0002-4069-5279</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Antigens Assaying Bacteria Bacterial meningitis Bias Biology and Life Sciences Cerebrospinal fluid Colonization Diagnosis Equivalence Evaluation Health aspects Immunoassay Laboratories Legionella pneumophila Legionnaire's disease Legionnaires disease Legionnaires' disease bacterium Medicine Medicine and Health Sciences Meningitis Methods Patients Pediatrics Physical Sciences Pneumonia Reading Streptococcal infections Streptococcus infections Streptococcus pneumoniae Supervision Technologists Testing Urinalysis Urine |
| title | Performance of the ImmuView and BinaxNOW assays for the detection of urine and cerebrospinal fluid Streptococcus pneumoniae and Legionella pneumophila serogroup 1 antigen in patients with Legionnaires’ disease or pneumococcal pneumonia and meningitis |
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