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 death 1 HOUCK – 2004  15% reduction in mortality in the patients who received antibiotic therapy within 4 hours of admission 2 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 arrival 3

1.

2.

3.

Quality of Care, Process and Outcomes in Elderly Patients with Pneumonia - Meehan et al, JAMA 1997 278 (23) 2080-2084 Antibiotic administration in community-acquired pneumonia – Houck et al, Chest 2004 126 (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) 949-59

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

BinaxNOW S. pneumoniae: Supporting Evidence

KANAVAKI - 2002  Diagnostic investigation of 66 severe cases of CAP of unknown etiology

Sample

Sputum Blood Urine

No tested Acceptable Microscopy

64/66 45 (70%) 7 (10.9%) 36/66 66/66

Culture

3 (6.7%) 1 (2.7%)

BinaxNOW

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 2002 2 (15)

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) 387-393

BinaxNOW S. pneumoniae: Supporting Evidence

  Matta, 2009 541 patients, 233 patients with pneumonia   BinaxNOW 58/233 positive results  Sputum/Blood culture 17 positives  25% yield of pneumococcal pneumonia 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

BinaxNOW S. pneumoniae: Supporting Evidence

  Sorde ´ 2010 474 cases of CAP (    

S. pneumoniae

Blood culture 53/171 (30.9%) Sputum culture/Gram 38/171 (22.2%), Pleural fluid 5/171 (2.9%) BinaxNOW 130/153 (85%) 171, (36%)     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

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

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

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 2009 

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

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

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

IDSA/ATS CAP Guidelines 2007

Infectious Disease Society of America/American Thoracic Society CAP Guidelines 2007

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

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

Legionella Disease Burden

 Predominantly caused by

Legionella pneumophila

serogroup 1 accounting for 70-90% with 

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

Legionella Disease Burden

Water Masterclass – Warsaw 2009 *extrapolated data

BinaxNOW Legionella: Supporting Evidence

LEPINE – 1998  Introduction of a rapid urinary antigen test improved case ascertainment 1  If the urinary antigen test had been available in previous years, more cases of Legionnaire’s Disease may have been reported 1 KOOL – 1999  Introduction of the urinary antigen test led to recognition of nosocomial cases 2  Evidenced by the temporal relation between the introduction of this test in San Antonio hospitals and the rise in detected Legionellosis cases 2

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) 905-910 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) 798-805

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)

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

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

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. pne

umoniae UAT should be applied to all patients with pneumonia.

Community-Acquired Legionnaires Disease: Implications for Underdiagnosis and Laboratory Testing

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

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

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