1. General Supporting Evidence
MEEHAN – 1997
CAP is the only acute respiratory tract infection in which delayed antibiotic therapy has been associated with increased risk of death1
HOUCK – 2004
15% reduction in mortality in the patients who received antibiotic therapy within 4 hours of admission2
ZISS – 2003
Patients treated for CAP within 4 hours of arrival at hospital had a significantly shorter inpatient length of stay, compared to patients who received antibiotics more than 4 hours after arrival3
Quality of Care, Process and Outcomes in Elderly Patients with Pneumonia - Meehan et al, JAMA (23)
Antibiotic administration in community-acquired pneumonia – Houck et al, Chest (1) 320-1
CAP: compliance with centers for Medicare and Medicaid services, national guidelines, and factors associated with outcomes – Ziss et al, SouthMedJ. 2003: 96 (10) 1

2. Targeted Treatment for CAP
Penicillin is drug of choice for pneumococcal pneumonia
‘Penicillin resistant strains’
CLSI modification of MIC breakpoints
Cheaper, more effective and better for patient
Macrolide for Legionella pneumonia 2

3. BinaxNOW S. pneumoniae: Supporting Evidence
KANAVAKI
Diagnostic investigation of 66 severe cases of CAP of unknown etiology
Sample
No tested
Acceptable
Microscopy
Culture
BinaxNOW
Sputum
64/66
45 (70%)
7 (10.9%)
3 (6.7%)
Blood
36/66
1 (2.7%)
Urine
66/66
14 (21.2%)
BinaxNOW is a considerable alternative for microbiological diagnosis of pneumococcal pneumonia
BinaxNOW should be incorporated into the test algorithms
Alternative microbiological methods for the diagnosis of pneumococcal
Alternative microbiological methods for the diagnosis of pneumococcal pneumonia - Kanavaki et al, PNEUMON (15) 3

4. BinaxNOW S. pneumoniae: Supporting Evidence
KOBASHI – 2007
156 cases of CAP
Blood culture 3 positive results
Sputum culture 20 positive results
Conventional total 23 positive results
BinaxNOW 44 positive results
BinaxNOW increased the yield of pneumococcal pneumonia patients
leading to shorter hospital stay
reduction in medical costs
By positively determining appropriate antibiotics for CAP patients
Evaluating the Use of a Streptococcus pneumoniae Urinary Antigen Detection Kit for the Management of community acquired pneumonia in Japan - Kobashi et al Respir 2007; 74 (4) 4

5. BinaxNOW S. pneumoniae: Supporting Evidence
Matta, 2009
541 patients, 233 patients with pneumonia
BinaxNOW 58/233 positive results
25% yield of pneumococcal pneumonia
Sputum/Blood culture 17 positives
8% yield of pneumococcal pneumonia
Increase in amoxicillin treatment following Binax positive result
Binax detected an additional 17 % of pneumococcal pneumonia
Sensitivity and specificity of Binax allows change of antibiotic therapy.
Recommend use of Binax for diagnosis and implementing treatment guidelines
Do Clinicians Consider the Results of Binax NOW Streptococcus pneumoniae Urinary Antigen to Adapt Antibiotic Regimen in Pneumonia Patients?
Clinical Microbiology and Infection. Accepted Article 2009 Oct 5

6. BinaxNOW S. pneumoniae: Supporting Evidence
Sorde´ 2010
474 cases of CAP (S. pneumoniae 171, (36%)
Blood culture 53/171 (30.9%)
Sputum culture/Gram 38/171 (22.2%),
Pleural fluid 5/171 (2.9%)
BinaxNOW 130/153 (85%)
BinaxNOW diagnosed 75 additional cases of pneumococcal pneumonia
BinaxNOW results allowed a change in antibiotic treatment
BinaxNOW High specificity, High Sensitivity and High PPV
UAT is a useful tool in the treatment of adults with CAP and should be incorporated into Clinical Guidelines
Current and Potential Usefulness of Pneumococcal Urinary Antigen Detection in Hospitalized Patients With Community-Acquired Pneumonia to Guide Antimicrobial Therapy 6

7. BinaxNOW S. pneumoniae: Supporting Evidence
Weatherall 2008
Evaluated BinaxNOW testing with nurses in the ED
98% Concordance
Results available within 4 hours
Rapid results would allow initial targeted treatment
Reduce antibiotic resistance and reduce costs.
Point-of-care urinary pneumococcal antigen test in the emergency department for community acquired pneumonia 7

8. Conclusion BinaxNOW S. pneumoniae UAT Simple to Use (ED testing)
Easy to collect sample
Results enable early appropriate treatment
Increases the yield of pneumococcal pneumonia
Results not affected by previous antibiotic treatment
Advocated by many Worldwide CAP Guidelines 8

9. CAP Guidelines Advocating use of UAT
Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults  
British Thoracic Society guidelines for the management of community acquired pneumonia in adults: update  
Brazilian guidelines for community-acquired pneumonia in immunocompetent adults – 2009
(French Guidelines) Prise en charge des infections des voies respiratoires basses de l’adulte immunocompétent  
(European) Guidelines for the management of adult lower respiratory tract infections
Swedish guidelines for the management of community-acquired pneumonia in immunocompetent adults
Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia. Spanish Society of Pulmonology and Thoracic Surgery (SEPAR)  
Canadian Guidelines for the Initial Management of Community-Acquired Pneumonia: An Evidence- Based Update by the Canadian Infectious Diseases Society and the Canadian Thoracic Society
Infectious Disease Society of America/American Thoracic Society CAP Guidelines 2007

10. IDSA/ATS CAP Guidelines 2007
Great enthusiasm for developing guidelines
Avoidance of inappropriate antibiotic therapy has been associated with lower mortality rate
All adult patients with severe CAP, should have blood culture, sputum culture, Legionella UAT and S. pneumoniae UAT
Initial treatment for most patients will be empirical however urinary antigen tests will allow for specific antibiotic treatment
Infectious Disease Society of America/American Thoracic Society CAP Infectious Disease Society of America/American Thoracic Society CAP Guidelines 2007

11. IDSA/ATS CAP Guidelines 2007
Diagnostic testing to determine etiology of CAP is justified as follows:
Antibiotic treatment can be narrowed, broadened or completely changed
Increased mortality is common with inappropriate antibiotic therapy
Management of initial antibiotic therapy is greatly facilitated by etiological diagnosis at admission
General recommendation of the committee is to strongly encourage diagnostic testing whenever the result is likely to change individual antibiotic management. The variety of methods is shown in table 5 but only the urine antigen tests can deliver results in a window to allow clinical decisions
Infectious Disease Society of America/American Thoracic Society CAP Guidelines 2007

12. IDSA/ATS CAP Guidelines 2007
Infectious Disease Society of America/American Thoracic Society CAP Guidelines 2007

13. IDSA/ATS CAP Guidelines 2007
Rapid Urinary antigen Tests
Pneumococcal urinary antigen test
Vey useful when sputum cannot be collected or when antibiotic therapy has commenced
Only 50% of Binax positive results can be detected by conventional methods.
Legionella Urinary antigen test
Plouffe study suggested that therapy with a macrolide alone is adequate for hospitalised patients with CAP who test positive with Legionella urinary antigen tests.
Infectious Disease Society of America/American Thoracic Society CAP Guidelines 2007

14. Legionella Disease Burden
Legionnaire’s disease is a serious pneumonia infection caused by inhaling Legionella bacteria (through aerosols)
Water is the major natural reservoir e.g. cooling towers, hotel water systems, spas, air conditioning units, showers
20% of cases of Legionnaires disease detected in Europe are travel related.
First recognised in 1976 in people (American Legion Convention) attending a hotel conference in the USA 14

15. Legionella Disease Burden
Predominantly caused by Legionella pneumophila with serogroup 1 accounting for 70-90%
Legionella pneumophila can account for 2-15% of CAP and Nosocomial pneumonia
Legionnaires disease can account for >30% CAP cases requiring admission to ICU
High Mortality rate (25-40%)
Known risk factors 15

16. Legionella Disease Burden
Water Masterclass – Warsaw 2009
*extrapolated data 16

17. BinaxNOW Legionella: Supporting Evidence
LEPINE – 1998
Introduction of a rapid urinary antigen test improved case ascertainment1
If the urinary antigen test had been available in previous years, more cases of Legionnaire’s Disease may have been reported1
KOOL – 1999
Introduction of the urinary antigen test led to recognition of nosocomial cases2
Evidenced by the temporal relation between the introduction of this test in San Antonio hospitals and the rise in detected Legionellosis cases2
A recurrent Outbreak of Nosocomial Legionnaires’s Disease Detected by Urinary Antigen Testing: Evidence for Long term Colonization of a Hospital Plumbing System Lepine L et al. Infection Control and Hospital Epidemiology December 1998 (12)
Hospital Characteristics Associated with Colonization of Water Systems by Legionella and Risk of Nosocomial Legionnaires’ Disease; A cohort study of 15 Hospitals, Kool J et al Infection Control and Hospital Epidemiology December 1999 (20) 17

18. BinaxNOW Legionella Supporting Evidence
KANAVAKI – 2003
88 patients suffering from severe CAP
Outcome of Legionnaire’s disease depends on the timely diagnosis
Conventional microbiology methods have limitations
UAT is an important tool for the diagnosis of Legionnaires' disease
highly sensitive results
Reliability not affected by prior antibiotics
Test is performed on easily obtained specimens
Laboratory Diagnosis of Legionnaires' Disease in Patients with Community Acquired Pneumonia (CAP) 18

19. BinaxNOW Legionella Supporting Evidence
ALVAREZ – 2010
No of outbreaks detected increased with the use of the Legionella UAT
Early detection and treatment reduced case fatality rate (CFR) by 68%
Detection of an outbreak depends on the diagnosis of the first case.
Not always a history of risk factors
The UAT should be available in all hospitals and all cases of the disease should be reported.
Impact of the Legionella urinary antigen test on epidemiological trends in community outbreaks of
legionellosis in Catalonia, Spain, 1990—2004 19

20. Legionella Supporting Evidence
CAPNETZ 2010
All cases were sporadic
Legionella pneumonia was found to occur at identical frequencies in outpatients and inpatients
Challenges the current view that Legionella tends to be associated with more severe pneumonia
Appropriate coverage remains mandatory for any patient with LD
High rates of initial discordant antimicrobial treatment may be overcome by regular UAT testing for L. pneumophila in all hospitalized patients.
Community-Acquired Legionella Pneumonia: New Insights from the German Competence Network for Community Acquired Pneumonia

21. Legionella Supporting Evidence
Yu and Stout 2010
L. pneumophila shown to be one of the commonest causes of CAP
Incidence among ambulatory patients (3.7%) was essentially identical to that among hospitalized patients (3.8%)
Clinical manifestations are unreliable in diagnosing LD
Confining Legionella laboratory testing to “high-risk” patients will overlook a notable number of cases
Legionella and S. pneumoniae UAT should be applied to all patients with pneumonia.
Community-Acquired Legionnaires Disease: Implications for Underdiagnosis and Laboratory Testing

22. Legionella UAT Supporting Evidence
Yu and Stout 2009
Legionella UAT is one of the most successful diagnostic aids for infectious diseases
Most importantly, results affect management at POC
The UAT is the most common method to diagnose LD
A positive UAT allows targeted anti-Legionella therapy
UAT results should be available in 3hr instead of 3 days
The ease of use of ICT card-type UAT makes it ideal for use in EDs, long-term care facilities, and physician offices.
Rapid Diagnostic Testing for Community-Acquired Pneumonia Can Innovative Technology for Clinical Microbiology be exploited

23. Conclusion BinaxNOW Legionella UAT Simple to Use (ED testing)
Easy to collect sample
Most sensitive test on the market
Results enable early appropriate detection and treatment
Results not affected by previous antibiotic treatment
Advocated by many Worldwide CAP Guidelines 23

24. BinaxNOW UAT: Supporting Evidence
Victor Yu 2011
‘We should halt the widespread practice of empirical antibiotics’
POC tests allow use of narrow spectrum antibiotics
Positive S. pneumoniae UAT will allow treatment with Penicillin
Legionella UAT has revolutionised diagnosis of Legionnaires’ disease
Physician education is necessary to encourage use of narrow spectrum antibiotics
UAT’s should be obtained as soon as possible
Testing should be performed in the clinic, ED and hospital
A clinical Solution to Antimicrobial Resistance in Community-Acquired-Pneumonia Narrowing the Spectrum of Antimicrobial Therapy 24