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Simplexa C. difficile Direct: The Focus Diagnostics Simplexa™ C. difficile Direct assay is intended for use on the Integrated Cycler instrument for the detection of Clostridium difficile toxin B gene (tcdB) present in liquid or unformed stool samples from individuals suspected of C. difficile infection (CDI). This test aids in the diagnosis of illness resulting from CDI. The assay is for professional and prescription use only. Simplexa C. difficile Positive Control Pack: The Simplexa™ C. difficile Positive Control Pack is intended to be used as a control with the Simplexa™ C. difficile Direct kit. This control is not intended for use with other assays or systems.

The Simplexa™ C. difficile Direct assay system is a real-time PCR system that enables the direct amplification and detection of toxigenic C. difficile DNA from unprocessed liquid or unformed stool specimens that have not undergone nucleic acid extraction. The system consists of the Simplexa™ C. difficile Direct assay, the Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ C. difficile Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify C. difficile and DNA internal control targets. The assay targets a sequence which is in a well conserved region of C. difficile toxin B gene (todB). A DNA internal control is used to detect PCR failure and/or inhibition

The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 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 the 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. Focus Diagnostics' Simplexa™ Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa™ Flu A/B & RSV Direct kit. This control is not intended for use with other assays or systems.

The Simplexa™ Flu AB & RSV Direct assay system is a real-time RT-PCR system that enables the direct amplification, detection and differentiation of human influenza A (Flu A) virus RNA, human influenza B (Flu B) virus RNA and RSV RNA from unprocessed nasopharyngeal swabs that have not undergone nucleic acid extraction. The system consists of the Simplexa™ Flu A/B & RSV Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ Flu A/B & RSV Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Flu A, Flu B, RSV and internal control RNA. The assay provides three results; conserved regions of influenza A viruses (matrix gene), influenza B viruses (matrix gene) and RSV (M gene) are targeted to identify these viruses in the specimen. An RNA internal control is used to detect RT-PCR failure and/or inhibition.

The Focus Diagnostics Simplexa™ Group A Strep Direct assay is intended for use on the 3M Integrated Cycler for the in vitro qualitative detection of Group A Streptococcus (GAS) from throat swabs collected from human patients with signs and symptoms of pharyngitis, such as sore throat. This test is intended for use as an aid in the diagnosis of GAS infection. The assay is intended for use in hospital, reference, or state laboratory settings. The device is not intended for point-of-care use.

The Simplexa™ Group A Strep Direct assay system is a real-time PCR system that enables the direct amplification and qualitative detection of Group A Strep bacterial DNA from throat swabs that have not undergone a nucleic acid extraction. The system consists of the Simplexa™ Group A Strep Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc (DAD) and associated accessories. In the Simplexa™ Group A Strep Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Group A Strep bacterial DNA and the Internal Control (DNA IC). The assay targets a conserved region of Group A Strep (pyroqenic exotoxin B gene) to identify this bacteria in the specimen. The DNA IC is used to detect PCR failure and/or inhibition.

The Focus Diagnostics' STRATIFY JCV® DxSelect™ assay is intended for the qualitative detection of antibodies to JC virus in human serum or plasma. The assay is intended for use in conjunction with other clinical data, in multiple sclerosis patients receiving or considering natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only. The assay is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or patients with different disease conditions or undergoing other treatments or in neonates and pediatric patient populations.

The Focus Diagnostics' STRATIFY JCV® DxSelect™ test is an ELISA assay. JC virus-like particles (VLP) are pre-coated onto 96-well microiter plates. Diluted serum or plasma specimens and controls are incubated in the wells to allow JCV-specific antibodies present in the specimens to react with the JC VLP antigen. Nonspecific reactants are removed by washing. Peroxidase-conjugated anti-human antibodies are added to react with JCV-specific antibodies. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD). Specimen OD readings are compared with Cut-Off Calibrator OD readings to determine results. Each specimen result is reported as an index value. A specimen with an index value that is greater than a specified upper cut-off is reported as positive for detectable JCV-specific antibodies, whereas a specimen with an index value less than the specified lower cut-off is reported as negative for detectable JCV-specific antibodies. A specimen with an index value that is equal to or between the upper and lower cut-off values is reported as indeterminate. An indeterminate result requires further evaluation in the confirmation (inhibition) assay. In the confirmation assay, soluble JC VLP antigen will compete with plate bound JC VLP antigen for the JCV-specific antibodies present in the serum or plasma specimens. After washing away the unbound antibodies, peroxidase-conjugated anti-human antibodies are added and bind to any captured JCVspecific antibodies. Excess conjugate is removed by washing. Enzyme substrate and chromagen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of OD. The percent inhibition is calculated to confirm presence of JCV-specific antibodies in the specimens with a percent inhibition value that is greater than the specified cut-off are reported as positive for detectable JCV-specific antibodies, whereas specimens with percent inhibition values less than or equal to the cut-off are reported as negative for detectable JCV-specific antibodies.

The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 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 the 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. Focus Diagnostics' Simplexa™ Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa™ Flu A/B & RSV Direct kit. This control is not intended for use with other assays or systems.

The Simplexa™ Flu A/B & RSV Direct assay system is a real-time RT-PCR system that enables the direct amplification, delection and differentiation of human influenza A (Flu A) virus RNA, human influenza B (Flu B) virus RNA and RSV RNA from unprocessed nasopharyngeal swabs that have not undergone nucleic acid extraction. The system consists of the Simplexa™ Flu A/B & RSV Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ Flu A/B & RSV Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Flu A, Flu B, RSV and internal control RNA. The assay provides three results; conserved regions of influenza A viruses (matrix gene) influenza B viruses (matrix gene) and RSV (M gene) are targeted to identify these viruses in the specimen. An RNA internal control is used to detect RT-PCR failure and/or inhibition. The 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio software.

The Focus Diagnostics Simplexa™ C. difficile Universal Direct is a real-time polymerase chain reaction (PCR) assay and is intended for use on the 3M Integrated Cycler instrument for the detection of toxigenic Clostridium difficile toxin B gene (tcdB) in liquid or unformed stool samples from individuals suspected of C. difficile infection. This test aids in the diagnosis of Clostridium difficile associated disease (CDAD).

The test is a real-time polymerase chain reaction (PCR) amplification system that utilizes bifunctional fluorescent probe-primers for the detection of C. difficile in liquid or unformed stool. The Simplexa™ C. difficile Universal Direct kit contains primes, buffers and controls. The assay is composed of two principal steps: (1) Heat treatment of stool samples, (2) Amplification of the C. difficile DNA and internal control DNA using bi-functional fluorescent probe-primers together with reverse primers. The DNA internal control is used to monitor potential presence of PCR inhibitors. The assay targets a sequence which is in a well conserved region of C. difficile toxin B gene (tcdB).

The STRATIFY JCVTM Antibody ELISA testing service provided by Focus Diagnostics is intended for the qualitative detection of antibodies to John Cunningham virus in human serum or plasma. The assay is intended for use in conjunction with other clinical data, in multiple sclerosis and Crohn's disease patients receiving natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only and is to be performed only at Focus Diagnostics' Reference Laboratory. The assay is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or in neonates and pediatrics patient populations.

The STRATIFY JCV™ Antibody ELISA consists of two devices. The first is an initial detection ELISA and the second device is a confirmatory (inhibition) ELISA. Both tests utilize the same recombinant antigen which is used in two different formats as described in section L. The devices include the following reagents; Recombinant JC virus like particles (VLP), a JCV high and low positive controls, consisting of human sera that is positive for JCV antibodies, and JCV negative control consisting of human sera that is negative for JCV antibodies. The conjugate, substrate, wash buffers and blocking buffers needed for the test are not supplied with the device and are listed together with other reagents and consumables in the device labeling.

The Focus Diagnostics Simplexa™ Flu A/B & RSV assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and discrimination of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2010 influenza season when 2009 H1N1 influenza was the predominant influenza A virus 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 test is a real-time RT-PCR amplification system that utilizes a bi-functional fluorescent probe-primer for the detection and differentiation of human influenza A virus RNA, human influenza B virus RNA and respiratory syncytial virus RNA in nasopharyngeal swabs (NPS). The assay is composed of two principal steps: (1) extraction of RNA from patient specimens, (2) A bi-functional fluorescent probe-primer is used together with a reverse primer to amplify a specific target (for each analyte and the RNA internal control). The assay provides three results; conserved regions of influenza A viruses (matrix gene), influenza B viruses (matrix gene) and RSV (M gene) are targeted to identify these viruses in the specimen. An RNA internal control is used to monitor the extraction process and to detect RT-PCR inhibition. The 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio Software.

The Integrated Cycler and accompanying Studio Software are intended for in vitro diagnostic use in conjunction with legally marketed Simplexa™ reagent kits and assay protocols labeled for in vitro diagnostic use. The Integrated Cycler is a rapid real-time Polymerase Chain Reaction (PCR) thermocycler used for identification of nucleic acid from prepared biological samples. The instrument utilizes disc media to contain and to process samples. The instrument uses real-time flourometric detection to identify targets within the sample wells. The instrument's operation parameters are controlled by the use of an external personal computer and associated software. This instrument is intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment.

The 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio Software.

The Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) assay is intended for use on the 3M Integrated Cycler as part of the Microfluidic Molecular System for the in vitro qualitative detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA in nasopharyngeal swabs (NPS), nasal swabs (NS), and nasopharyngeal aspirates (NPA) from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 H1N1 influenza was the predominant influenza A virus 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.

Simplexa™ Influenza A H1N1 (2009) test kit is a nucleic acid amplification test that uses real-time reverse transcriptase polymerase chain reaction (RT-PCR) amplification to enable simultaneous and distinct detection of influenza A and 2009 H1N1 influenza in a single reaction from nasophayngeal swabs (NPS), nasal swabs (NS), and nasopharyngeal aspirates (NPA). The assay combines real-time PCR amplification with fluorescent signal detection technology. A bi-functional fluorescent probe-primer is used together with a reverse primer to amplify a specific target (for each analyte and internal control). A fluorescent signal is generated after the separation of the fluorophore from the quencher as a result of the binding of a probe element to the extended RNA fragment synthesized during amplification. The 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio Software. Together, the instrument, software and test kit are referred to as the "Microfluidic Molecular System."