The Alere BinaxNOW Pneumococcal Urinary Antigen Test: Diagnostic Sensitivity for Adult Pneumococcal Pneumonia and Relationship to Specific Serotypes

Abstract

Little is known about the sensitivity of the BinaxNOW pneumococcal urinary antigen (PUA) test for adult pneumococcal pneumonia caused by different serotypes. In this study, we aimed to analyze the trends in the sensitivity of the PUA test over a 15-year period (2001 to 2015) and to analyze its sensitivity for pneumococcal pneumonia caused by different serotypes. In total, we analyzed 1,096 pneumococcal isolates from adults with pneumococcal pneumonia who had a PUA test performed at the onset of the episode. Three periods were analyzed: 2001 to 2005 (early use of the seven-valent pneumococcal conjugate vaccine [early PCV7]), 2006 to 2010 (late PCV7), and 2011 to 2015 (early PCV13). The sensitivity of the PUA test varied from 76.4% (95% confidence interval [CI], 70.5% to 82.4%) in the period from 2001 to 2005 to 77.9% in 2006 to 2010 (95% CI, 74.4% to 81.4%) and decreased to 60.5% (95% CI, 55.4% to 65.6%) in 2011 to 2015. This decrease was observed in 560 proven (83.2% in 2001 to 2005, 86.5% in 2006 to 2010, and 78.1%) and 536 probable (70.0% in 2001 to 2005, 68.7% in 2006 to 2010, and 41.5% in 2011 to 2015) episodes of pneumococcal pneumonia. Differences were observed in the sensitivity of the PUA test for diagnosing pneumonia caused by certain serotypes, being highest for the 9V (90.6%), 14 (86.8%), 18C (100%), and 20 (100%) serotypes and lowest for the 8 (55.2%), 9L/N (39.1%), 11A (48.8%), 23B (33.3%), and nontypeable (47.8%) serotypes. Comparing 2001 to 2005, 2006 to 2010, and 2011 to 2015, the prevalence of serotypes 9V (3.1%, 3.7%, and 1.7%, respectively) and 14 (7.2%, 5.1%, and 3.1%, respectively) decreased, while the prevalence of serotypes 23B (0%, 0.7%, and 1.4%, respectively), 9L/N (1.0%, 1.6%, and 3.4%, respectively), 11A (2.6%, 4.2%, and 3.7%, respectively), and 8 (1.5%, 1.5%, and 5.1%, respectively) increased. The PUA test sensitivity varied by pneumococcal pneumonia serotype, and these differences and the changes in serotype distribution were associated with an overall decrease in the sensitivity of the PUA test.

Urinary antigen testing for pneumococcal pneumonia: is there evidence to make its use uncommon in clinical practice?

“…There is evidence suggesting that UAT is less sensitive following the introduction of the 13-valent polysaccharide conjugate vaccine (PCV-13), with the sensitivity of UAT varying from 33.1% to 100% depending on the serotype [20]. The sensitivity of BinaxNOW ® to S. pneumoniae serotypes not included in PCV-13 was below 70% in this study [20].…”

“…Several studies published after the meta-analysis have found the sensitivity of the BinaxNOW ® UAT to be between 60% and 65% [18,19], significantly lower than that found by SINCLAIR et al [17]. There is evidence suggesting that UAT is less sensitive following the introduction of the 13-valent polysaccharide conjugate vaccine (PCV-13), with the sensitivity of UAT varying from 33.1% to 100% depending on the serotype [20]. The sensitivity of BinaxNOW ® to S. pneumoniae serotypes not included in PCV-13 was below 70% in this study [20].…”

Re-validation and update of an extended-specificity multiplex assay for detection of Streptococcus pneumoniae capsular serotype/serogroup-specific antigen and cell-wall polysaccharide in urine specimens

“…However, on repeat testing the 11A/C/E or serogroup 16 antigen was detected below the positivity cut-off whilst the serotype 5 antigen was detected just above the cut-off, and therefore the sample was reported as positive for the serotype 5 antigen only. The BinaxNOW pneumococcal test can detect pneumococcal cell-wall C polysaccharide in urine and cerebrospinal fluid (CSF) samples with reported sensitivities of 74–90 % and specificities of 71–97 % [ 20–23 ], although sensitivities may vary in relation to the serotype [ 23 ]. In total, 412 urine samples tested positive for the pneumococcal antigen with the BinaxNOW test and 374 (90.8 %) of these were positive for a pneumococcal serotype and/or CWP antigen with the BioPlex assay.…”

Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol

“…11 The same CAP guidelines encourage attempts to broaden, narrow or modify the spectrum of antibiotic therapy based on diagnostic test results, but traditional microbiological investigations have significant limitations and little influence on patient management. [12][13][14] Indeed, a randomised trial of 177 patients found that the routine implementation of urine antigen detection tests did not bring any substantial disease or economic-related benefits to patients hospitalised with CAP. 15 Significantly, CAP is one of the leading causes of antibiotic prescribing, and often, the causative agent is not early identified and patients are overtreated.…”