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The UniGold(TM) Streptococcus pneumoniae urinary antigen test: an interassay comparison with the BinaxNOW (R) Streptococcus pneumoniae test on consecutive urine samples and evaluation on patients with bacteremia
Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Infectious Diseases.
Department of Clinical Microbiology, Karolinska University Hospital Huddinge, Stockholm, Sweden.
Department of Clinical Microbiology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.
Department of Clinical Microbiology, Karolinska University Hospital Huddinge, Stockholm, Sweden.
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2015 (English)In: European Journal of Clinical Microbiology and Infectious Diseases, ISSN 0934-9723, E-ISSN 1435-4373, Vol. 34, no 8, 1583-1588 p.Article in journal (Refereed) Published
Abstract [en]

The performance of the recently commercialized UniGoldTM Streptococc-us pneurnonfac test for the detection of pneumococcal antigen in urine was studied in a multicenter study. First, we studied the interassay agreement between UniGoldTm and the BinaxNOVs," S. pneumoniae urinary antigen test on 337 consecutive urine samples sent to the laboratory for the detection of pneumococcal antigen. The two tests performed similarly (K-0.82): both tests positive in 27 cases, both tests negative in 299 cases, and with divergent test results in 11 cases. Secondly, the tests were run on urine samples from 203 patients with bacteremia, including 51 patients with pneumococcal bacteremia. The sensitivities and specificities were 67 and 86 A for Uni-GoldTm, and 57 % and 94 % for BinaxNOW, respectively. The false-positivity rate was significantly higher for Uni-GoldTm compared with BinaxNOW in patients with Escherichia colt bacteremia (15 vs. 2.1 %. p=0.04), and tended to be higher in patients with bacteremia with alpha-hemolytic streptococci (32 vs. 11 %, p=0.13). When cases with E. coli and alphahemolytic streptococci were excluded from the analysis, the overall false-positivity rate was 9/85 (11 A) for Uni-GoldTm and 6/85 (7.1 %) for BinaxNOW. In conclusion, the study showed that UniGold(TM) was not inferior to BinaxNOW (R) for the detection of pneumococcal urinary antigen in patients with pneumococcal bacteremia. The specificity of UniGold(TM) was suboptimal due to false-positive results in cases with E. colt and alpha-hemolytic streptococci bacteremia. However, in patient populations usually subjected to testing for pneumococcal urinary antigen, such as pneumonia and meningitis patients, bacteremia with these pathogens is uncommon. The diagnostic usefulness of the UniGoldTM test should be further evaluated.

Place, publisher, year, edition, pages
Springer, 2015. Vol. 34, no 8, 1583-1588 p.
National Category
Infectious Medicine
Research subject
Infectious Diseases
Identifiers
URN: urn:nbn:se:oru:diva-45627DOI: 10.1007/s10096-015-2390-1ISI: 000358545900013PubMedID: 25926305Scopus ID: 2-s2.0-84937967844OAI: oai:DiVA.org:oru-45627DiVA: diva2:848173
Note

Funding Agency:

Region Örebro County Council Research Committee OLL-137011

Available from: 2015-08-24 Created: 2015-08-24 Last updated: 2017-10-18Bibliographically approved

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