Validation of an Immunodiagnostic Assay for Detection of 13 Streptococcus pneumoniae Serotype-Specific Polysaccharides in Human Urine

Pride, Michael W.; Huijts, Susanne M.; Wu, Kangjian; Souza, Victor Costa de; Passador, Sherry; Tinder, Chunyan; Song, Esther; Elfassy, Arik; McNeil, Lisa K.; Menton, R. G.; French, R. C.; Callahan, Janice D.; Webber, Chris; Gruber, William C.; Bonten, Marc J. M.; Jansen, Kathrin U.

doi:10.1128/cvi.00064-12

Cited by 104 publications

(147 citation statements)

References 40 publications

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“…In addition to the usual methods for diagnosing PP, a specially developed urine antigen test was used. This assay selectively detects antigens of the pneumococcal serotypes contained in PCV13 [71]. That allowed cases caused by vaccine serotypes (VT-PP) to be distinguished from those caused by non-vaccine serotypes, even in non-invasive pneumococcal pneumonia.…”

Section: Pcv13mentioning

confidence: 99%

Background paper to the updated pneumococcal vaccination recommendation for older adults in Germany

Falkenhorst

Remschmidt

Harder

et al. 2016

Bundesgesundheitsbl

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are members of the German Standing Committee on Vaccination (STIKO). Bundesgesundheitsblatt -Gesundheitsforschung -Gesundheitsschutz 12 · 2016 1624Tätigkeitsberichte Summary Background and objective The incidence of pneumococcal diseases among adults increases with age. Therefore, Germany's Standing Committee on Vaccination (Ständige Impfkommission, STIKO) has since 1998 recommended vaccination with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all people aged ≥60 years. PPSV23 has been the only pneumococcal vaccine licensed for adults until few years ago. Universal pneumococcal vaccination of infants, using a conjugate vaccine, has been recommended by STIKO since 2006. Since then, pneumococcal serotypes contained in conjugate vaccines have declined among cases of pneumococcal disease not only in children, but -through herd protection -also in older adults. The 13-valent pneumococcal conjugate vaccine (PCV13), currently used for most infants in Germany, has now been approved for use in adults as well. Data on the efficacy of PCV13 against clinical endpoints in older adults was published in 2015. For that reason, STIKO investigated whether one of the two vaccines (or the combination of both) should be preferred in order to reduce the burden of pneumococcal diseases in older adults, and at what age the vaccine should be given. Efficacy against invasive pneumococcal diseasesPooled data from 4 randomised controlled trials (RCTs) of PPSV23 in older adults show an efficacy of 73 % against invasive pneumococcal disease (IPD) caused by any serotype (95 % confidence interval [CI], 10-92 %). The IPD cases in these studies were mostly caused by one of the 23 serotypes contained in the vaccine. The efficacy of PCV13 in older adults was investigated in one RCT. Efficacy against IPD by any serotype was 49 % (95 % CI, 21-67 %, modified-intention-to-treat analysis). Efficacy against IPD by the 13 serotypes contained in the vaccine (VT-IPD) was 76 % (95 % CI, 47-90 %). Efficacy against pneumococcal pneumoniaAfter exclusion of 2 RCTs with a high risk of bias, pooled efficacy of PPSV23 against pneumococcal pneumonia (PP) caused by any serotype in the remaining 2 RCTs was 64 % (95 % CI, 35-80 %). In the included observational studies, pooled efficacy ranged from 37 % to 53 %, with broadly overlapping CIs, depending on study type. The efficacy of PCV13 against PP caused by any serotype was 22 % (95 % CI, 2-39 %), and against VT-PP it was 38 % (95 % CI, 14-55 %). Anticipated epidemiological and health economic effectsThe above-mentioned studies do not provide clear evidence of a difference between the two vaccines regarding efficacy against clinical endpoints (IPD, PP) caused by the serotypes contained in the respective vaccine. In the 2015-'16 season, 70 % of IPD cases in people aged ≥60 years were caused by PPSV23 serotypes, but only 30 % by PCV13 serotypes. Because PPSV23 contains all the serotypes in PCV13 (except for serotype 6A), vaccination with PPSV23 confers broader serotype coverage and can thereby prevent ...

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Section: Pcv13mentioning

confidence: 99%

Background paper to the updated pneumococcal vaccination recommendation for older adults in Germany

Falkenhorst

Remschmidt

Harder

et al. 2016

Bundesgesundheitsbl

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“…A third analyst interpreted the results when the first two analysts did not agree. The UAD test is a Luminex technology-based multiplex UAD assay, which can detect simultaneously 13 different serotypes of S. pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) by capturing serotype-specific polysaccharides secreted in human urine [14]. The in vitro validation of the test (based on a subset of the current study population) and specificity determination in noninfected individuals has been reported elsewhere [14].…”

Section: Diagnostic Approachmentioning

confidence: 99%

“…In preparation for a large randomised placebo-controlled double-blind trial [13], we evaluated the diagnostic properties and clinical utility of a novel serotype-specific urinary antigen detection (UAD) multiplex assay [14] for the identification of 13 serotype-specific polysaccharides of S. pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) in human urine samples in patients hospitalised with CAP. The 13 polysaccharide antigens correspond to the serotypes used in the 13-valent pneumococcal conjugate vaccine.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic accuracy of a serotype-specific antigen test in community-acquired pneumonia

et al. 2013

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Our aim was to evaluate the diagnostic accuracy and clinical utility of a serotype-specific urinary antigen detection multiplex assay for identification of 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) in urine of patients with community-acquired pneumonia.Adult patients with clinical suspicion of community-acquired pneumonia were included. In addition to standard diagnostic procedures, a urine sample was collected to perform the urinary antigen detection test. Demographic, clinical, radiological and microbiological data were collected.Among 1095 community-acquired pneumonia patients Streptococcus pneumoniae was identified as causative pathogen in 257 (23%), when using conventional diagnostic methods and in 357 (33%) when urinary antigen detection was added. Of the 49 bacteraemic episodes caused by one of the 13 serotypes covered by the urinary antigen detection, 48 were detected by the urinary antigen detection, indicating a sensitivity of 98%. Of the 77 community-acquired pneumonia episodes with a ''non-urinary antigen detection'' causative pathogen, none had a positive urinary antigen detection result, indicating a specificity of 100%.Addition of the urinary antigen detection test to conventional diagnostic methods increased the prevalence of S. pneumoniae community-acquired pneumonia by 39%. Using bacteraemic episodes as reference sensitivity and specificity of the urinary antigen detection was 98% and 100%, respectively. @ERSpublications Addition of urinary antigen detection test to conventional diagnostic methods increases prevalence of S. pneumoniae CAP http://ow.ly/nSA1l

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“…The assessment of efficacy became possible with the development of a serotype-specific urinary antigen detection assay. 22,23 Using this assay, we were able to evaluate a 13-valent pneumococcal conjugate vaccine (PCV13) for the prevention of vaccine-type invasive and noninvasive community-acquired pneumonia in adults 65 years of age or older.…”

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confidence: 99%

Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults

et al. 2015

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BACKGROUNDPneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants, but their efficacy against pneumococcal community-acquired pneumonia in adults 65 years of age or older is unknown. METHODSIn a randomized, double-blind, placebo-controlled trial involving 84,496 adults 65 years of age or older, we evaluated the efficacy of 13-valent polysaccharide conjugate vaccine (PCV13) in preventing first episodes of vaccine-type strains of pneumococcal community-acquired pneumonia, nonbacteremic and noninvasive pneumococcal community-acquired pneumonia, and invasive pneumococcal disease. Standard laboratory methods and a serotype-specific urinary antigen detection assay were used to identify community-acquired pneumonia and invasive pneumococcal disease. RESULTSIn the per-protocol analysis of first episodes of infections due to vaccine-type strains, community-acquired pneumonia occurred in 49 persons in the PCV13 group and 90 persons in the placebo group (vaccine efficacy, 45.6%; 95.2% confidence interval [CI], 21.8 to 62.5), nonbacteremic and noninvasive community-acquired pneumonia occurred in 33 persons in the PCV13 group and 60 persons in the placebo group (vaccine efficacy, 45.0%; 95.2% CI, 14.2 to 65.3), and invasive pneumococcal disease occurred in 7 persons in the PCV13 group and 28 persons in the placebo group (vaccine efficacy, 75.0%; 95% CI, 41.4 to 90.8). Efficacy persisted throughout the trial (mean follow-up, 3.97 years). In the modified intention-totreat analysis, similar efficacy was observed (vaccine efficacy, 37.7%, 41.1%, and 75.8%, respectively), and community-acquired pneumonia occurred in 747 persons in the PCV13 group and 787 persons in placebo group (vaccine efficacy, 5.1%; 95% CI, −5.1 to 14.2). Numbers of serious adverse events and deaths were similar in the two groups, but there were more local reactions in the PCV13 group. CONCLUSIONSAmong older adults, PCV13 was effective in preventing vaccine-type pneumococcal, bacteremic, and nonbacteremic community-acquired pneumonia and vaccinetype invasive pneumococcal disease but not in preventing community-acquired pneumonia from any cause. (Funded by Pfizer; CAPITA ClinicalTrials.gov number NCT00744263.)

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Validation of an Immunodiagnostic Assay for Detection of 13 Streptococcus pneumoniae Serotype-Specific Polysaccharides in Human Urine

Cited by 104 publications

References 40 publications

Background paper to the updated pneumococcal vaccination recommendation for older adults in Germany

Background paper to the updated pneumococcal vaccination recommendation for older adults in Germany

Diagnostic accuracy of a serotype-specific antigen test in community-acquired pneumonia

Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults

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