Abstract
The ideal clinical diagnostic system should deliver rapid, sensitive, specific and reproducible results while minimizing the requirements for specialized laboratory facilities and skilled technicians. We describe an integrated diagnostic platform, the “FilmArray”, which fully automates the detection and identification of multiple organisms from a single sample in about one hour. An unprocessed biologic/clinical sample is subjected to nucleic acid purification, reverse transcription, a high-order nested multiplex polymerase chain reaction and amplicon melt curve analysis. Biochemical reactions are enclosed in a disposable pouch, minimizing the PCR contamination risk. FilmArray has the potential to detect greater than 100 different nucleic acid targets at one time. These features make the system well-suited for molecular detection of infectious agents. Validation of the FilmArray technology was achieved through development of a panel of assays capable of identifying 21 common viral and bacterial respiratory pathogens. Initial testing of the system using both cultured organisms and clinical nasal aspirates obtained from children demonstrated an analytical and clinical sensitivity and specificity comparable to existing diagnostic platforms. We demonstrate that automated identification of pathogens from their corresponding target amplicon(s) can be accomplished by analysis of the DNA melting curve of the amplicon.
Highlights
The ability to rapidly detect and distinguish multiple infectious organisms is critical for the accurate diagnosis of seasonal and sporadic outbreaks, emerging pathogens and agents of bioterrorism [1,2,3,4]
The polymerase chain reaction (PCR) have expanded the range of pathogens that can be identified in clinical laboratories
Nested assays developed on conventional PCR instruments were moved into the FilmArray platform
Summary
The ability to rapidly detect and distinguish multiple infectious organisms is critical for the accurate diagnosis of seasonal and sporadic outbreaks, emerging pathogens and agents of bioterrorism [1,2,3,4]. Accurate pathogen identification allows clinicians to determine the need for additional ancillary diagnostic testing, antibacterial or antiviral therapy and can inform decisions regarding hospitalization and infection control measures [5,6, 7,8,9]. Existing diagnostic assays and technologies are either limited in scope or highly complex [12]. It has many advantages, the introduction of PCR into the standard clinical microbiology and virology laboratory has been associated with practical challenges [13] that have limited routine use to large hospital or reference laboratories. Even simple PCR platforms have instrument requirements that may challenge the capacity of clinical laboratories [14,15,16,17]
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