Biofire Filmarray Clinical Trial
Official title:
Diagnosis of Lower Respiratory Tract Infections in Pediatric Patients in Intensive Care Unit Using Biofire Filmarray
Comparison of pathogens causing lower respiratory tract infections in ventilated versus non
ventilated pediatric patients in intensive care unit using biofire filmarray and vitek2
- Antibiotic sensitivity using vitek2
- Comparison of the type of antibiotic resistance using biofire filmarray and vitek2
- To provide information about prevalence of these organisms.
Acute respiratory infections (ARI) are a leading cause of morbidity and mortality worldwide.
Although usually more severe in children, the elderly and immunocompromised patients, all
populations and age groups are susceptible.
Lower respiratory infections are the third leading cause of death worldwide and nearly two
million childhood deaths worldwide are attributable to ARI, with the vast majority occurring
in developing countries.The World Health Organization estimates that in 2013, over 8% of all
deaths in the Eastern Mediterranean Region were attributable to ARIs. However, regional data
on morbidity and etiology of these infections are lacking.
These infections have a significant impact on antimicrobial prescriptions, hospitalizations
and lost time from work and school. The most frequent agents responsible for ARI are
respiratory viruses followed by bacteria .Empiric treatment with antibiotics is frequently
initiated even when viral infection is a strong possibility,leading to unnecessary antibiotic
use . The early diagnosis of the pathogen is beneficial for the precise selection of
medication,which can largely avoid the overuse or even abuse of the antibiotics and improve
the clinical care of patients. More importantly, the early diagnosis of contagious pathogens,
such as Bordetella pertussis (B. pertussis) and influenza viruses, can enable early isolation
of patients, thus reducing the spread of pathogens.
At present, the routine detection methods for respiratory pathogens are mostly based on
immunological methods.
Direct diagnosis of respiratory viruses by antigen detection using immunofluorescence assays
(IFA), is still used but is typically limited to eight viruses (adenovirus [AdV], influenza A
[FluA], influenza B [FluB], parainfluenza [PIV], human metapneumovirus [HMPV] and respiratory
syncytial virus [RSV]) and may lack sensitivity depending on the viral titer, patient´s age
and time of testing in relation to the onset of symptoms .
Molecular methods such as Polymerase chain reaction (PCR) increase viral detection due to a
greater analytic sensitivity compared to conventional methods such as antigen detection
and/or viral culture.
Microbiological analysis and identification of organisms may take 48-72 h,false negative
results may occur as a result of concomitant or previous antibiotic treatment , whereas false
positive may represent colonization or sampling errors.
The VITEK 2 is a fully automated system for microbial identification and antimicrobial
susceptibility testing (AST ), after a primary inoculums has been prepared and standardized .
With its colorimetric reagent cards, the VITEK 2 offers a state of the art technology
platform for phenotypic identification methods.(6) The application of FilmArray respiratory
panel in the diagnosis of lower respiratory tract infections is designed to reduce the time
for identification of the microorganisms FilmArray is a small, desktop, fully automated
multiplex PCR device. The molecular system includes automated nucleic acid extraction, an
initial reverse transcription step and multiplex nested PCR, followed by a melting curve
analysis .
The BIOFIRE® FILMARRAY® Pneumonia Panel plus tests for 18 bacteria (11 Gram negative, 4 Gram
positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses that cause pneumonia
and other lower respiratory tract infections. It offers an overall sensitivity and
specificity for bronchoalveolar (BAL)-like samples of 96,2% and 98.3%, respectively, and for
sputum samples a sensitivity and specificity of 96.3% and 97.2%, respectively.The test is
performed in a closed system that requires 5 min of hands-on time and 65 min of
instrumentation time. Several comparison studies between FilmArray and other tests for
respiratory organisms showed comparable results .
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