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The IMDx Flu A/B and RSV for Abbott m2000 assay performed on the Abbott m2000 System is a qualitative in vitro diagnostic test designed for the detection of influenza B, and RSV RNA directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The assay detects RNA from influenza A. influenza B, and RSV (A and B) using real-time, reverse transcription polymerase chain reaction (rRT-PCR) and fluorogenic target specific hybridization for unique sequences in the viral target genomes. The IMDx Flu A/B and RSV for Abbott m2000 assay is intended for use as an aid in diagnosing influenza A and/or RSV infection. Negative results for influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent(s) detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered when diagnosing respiratory viral infection. Performance characteristics for influenza A were established during the 2011-2013 influenza seasons when Influenza A/2009 H1N1 and Influenza A/H3 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary, If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The IMDx Flu A/B and RSV for Abbott m2000 assay uses nucleic acid extraction and purification technology, performed on the Abbott m2000sp. combined with rRT-PCR. performed with the Abbott m2000rt, to generate and detect amplified products from influenza A, influenza B, and RSV RNA that is isolated from clinical specimens. The assay targets the influenza A matrix (M) gene, influenza B non-structural protein (NS1) gene, and RSV A and RSV B fusion (F) gene. The presence of a viral RNA target sequence is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes on the Abbott m2000rt instrument. The probes do not generate a signal unless they are specifically bound to the amplification cycle at which fluorescent signal is detected by the Abbott m2000rt is inversely proportional to the viral RNA target concentration present in the original sample. An RNA bacteriophage species unrelated to influenza B, or RSV is introduced into each specimen during sample preparation to serve as a process control bacteriophage is lysed simultaneously with influenza A, influenza B and RSV B in the sample, and amplified in the same reaction as the viral RNA targets using rRT-PCR. The process control serves to demonstrate that the entire assay process has proceeded correctly for each sample.

The IMDx VanR for Abbott m2000 assay is an in vitro diagnostic assay that uses polymerase chain reaction (PCR) amplification for the qualitative detection of nucleic acids encoding the vancomycin resistance genes vanA and/or vanB. The assay is performed directly on human perirectal swabs, rectal swabs, or stool specimens from patients at risk for Vancomycin Resistant Enterococcus (VRE) colonization. The IMDx VanR for Abbott m2000 assay detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci. The IMDx VanR for Abbott m2000 assay can be used as an aid to identify. prevent and control vancomycin-resistant colonization in healthcare settings. The IMDx VanR for Abbott m2000 assay is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Culture methods are necessary to recover organisms for epidemiology typing and confirmation testing.

The IMDx VanR for Abbott m2000 assay is a PCR-based assay that targets regions unique to the vanA and vanB vancomycin resistance genes that may be associated with vancomycin resistant Enterococcus (VRE). Detection of the vanA and vanB genes is measured by the presence of fluorescently-labeled oligonucleotide probes that generate a fluorescent signal when specifically bound to amplified vanA and/or vanB PCR products. Differentiation of vanA from vanB is attained by labeling the oligonucleotide probes with different colored fluorescent dyes. The amplification cycle at which fluorescent signal is detected by the Abbott m2000rt is inversely proportional to the vanA and vanB DNA target level present in the sample. The IMDx VanR for Abbott m2000 assay includes reagents for the detection of the assay process control, which contains inactivated bacteria, unrelated to enterococci, and is introduced into each specimen during sample preparation. The process control (also acting as an internal control (IC)) is co-extracted with the specimen and co-amplified in the same PCR reaction as the vanA and vanB targets. The IC demonstrates that the entire assay process has proceeded within specification.