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The iCubate, Inc. iC-GN Assay™ for use on the iC-System™ is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay™ is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli. Cultures demonstrating mixed Gram stain results should not be tested on the assay. The iC-GN Assay™ is validated for use with select BACTEC™, BacT/ALERT® and VersaTREK® blood culture bottles. The iC-GN Assay™ is indicated for use in conjunction with other clinical and laboratory findings, such as culture, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections. The iC-GN Assay™ detects target DNA and identifies the following: Bacterial Genera and Species: Acinetobacter baumannii complex, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus species, Serratia marcescens Resistance Markers: KPC (blaKPC)- associated with resistance to carbapenems, NDM (blaNDM)- associated with resistance to carbapenems, CTX-M group 1(blaCTX-M group 1)- associated with resistance to extended spectrum beta-lactams In mixed growth, the iC-GN Assay™ does not specifically attribute detection of KPC, NDM, or CTX-M group 1 to a specific genera or species. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identification of organisms not detected by the iC-GN Assay™, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

The iC-GN Assay™ utilizes polymerase chain reaction (PCR) for the multiplex amplification of specific targets and detects the amplified targets with microarray hybridization. Targets are detected directly from patient positive blood cultures confirmed by Gram stain to contain gram negative bacilli. The iC-GN Assay utilizes proprietary ARM-PCR (Amplicon Rescued Multiplex PCR) technology allowing for multiple targets to be amplified in one reaction. Testing is done in a self-contained, automated, disposable cassette using the iCubate™ processor (iC-Processor™). After the reaction is complete, the cassette is read on the iCubate® reader (iC-Reader™). Results from the iC-Reader™ are interpreted by iC-Report™ software and a final report is displayed on the iMac® computer. To operate, the user opens the iC-Cassette™ cap and pipettes an aliquot of the diluted positive blood culture sample into the sample/PCR well in the bottom well plate of the cassette. Once inoculated, the cassette cap is closed, and all extraction, amplification and detection processes are completed in the cassette, a closed system. Extraction, amplification and detection sequences are defined by an assay script controlled by the iC-Processor™. The processing script is defined within a barcode label positioned on the top of each iC-Cassette™ which communicates with the iC-Processor™. To access and pierce the foilsealed reagent wells located in the bottom well plate of the cassette, the processor manipulates the cassette to move the cassette pipette horizontally and vertically. The script directs the transfer of reagents between the wells in the bottom well plate and finally to the array within the cassette. The iC-Processor™ is capable of processing four (4) iC-Cassettes™ with random access. Once processing is complete, the cassette is manually transferred from the iC-Processor™ to the iC-Reader™ where the microarray within the cassette is read. The iC-Reader™ is capable of reading up to four (4) iC-Cassettes™ at one time. The results are interpreted via the iC-Report™ software and displayed for the user on the iMac®. Raw data and result interpretations are stored within the iMac®; raw data is accessible to iCubate® service personnel only and not to the end user. When finished with a loaded iC-GN Cassette™, it should be disposed as biohazardous waste.

The iCubate iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci. Cultures demonstrating mixed Gram stain results should not be tested with the assay. The iC-GPC Assay is validated for use with select BACTEC, BacTIALERT and VersaTREK blood culture bottles. The iC-GPC Assay is indicated for use in conjunction with other clinical and laboratory findings, such as blood culture isolate identification and antimicrobial susceptibility testing, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections. The iC-GPC Assay detects organism DNA and identifies the following bacterial species and resistance markers: Bacterial Species Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Enterococcus faecalis Enterococcus faecium Resistance Markers mecA- associated with methicillin resistance vanA- associated with vancomycin resistance vanB- associated with vancomycin resistance The iC-GPC Assay detects the mecA resistance marker, inferring mecA-mediated methicillin resistance, and the vanA and vanB resistance markers, inferring vanAlvanB-mediated vancomycin resistance. In mixed growth, the iC-GPC Assay does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing. identification of organisms not detected by the iC-GPC Assay, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

The iC-GPC Assay utilizes polymerase chain reaction (PCR) for the amplification of specific targets and detects the amplified target DNA with fluorescence-based microarray hybridization. The iC-GPC Assay uses proprietary ARM-PCR (Amplicon Rescued Multiplex PCR) technology allowing for multiple targets to be amplified in one reaction. Targets are detected directly from patient positive blood cultures, confirmed by Gram stain to contain gram positive cocci. Testing is performed within a closed, disposable cassette that contains all the reagents required to complete the iC-GPC Assay, including a universal microarray. To operate, the user opens the iC-GPC Cassette cap and pipettes an aliquot of the positive blood culture sample into the sample well of the cassette is then inserted into the iC-Processor, which performs the processes of DNA extraction, multiplex amplification, and microarray After processing is complete, the cassette is inserted into the iC-Reader for hybridization. fluorescence-based detection and data analysis. Final results are generated by iC-Report, computer software for data acquisition, analysis, and display. Extraction, amplification, and hybridization are defined by an assay script controlled by the iC-Processor. The processing script is defined within a barcode label positioned on the top of each iC-GPC Cassette which communicates with the iC-Processor. To access and pierce the foil-sealed reagent wells located in the bottom well plate of the cassette, the processor manipulates the cassette to move the internal pipette horizontally and vertically. The script directs the transfer of reagents between the wells in the bottom well plate and finally to the array within the cassette. The iC-Processor is capable of processing 4 iC-Cassettes with random access. Once processing is complete, the cassette is manually transferred from the iC-Processor to the iC-Reader where the microarray within the cassette is read. The iC-Reader is capable of reading up to 4 iC-Cassettes at one time. The results are interpreted via the iC-Report software and displayed for the user on an iMac computer. Raw data and result interpretations are stored within the iMac; raw data is accessible to authorized personnel only and is not available to the end user.