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The Accula™ Strep A Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus, Strep A) bacterial nucleic acid. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections from throat swabs of patients with signs and symptoms of pharyngitis. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

The Accula™ Strep A Test is a semi-automated, colorimetric polymerase chain reaction (PCR) nucleic acid amplification test to qualitatively detect Streptococcus pyogenes (Group A Bhemolytic Streptococcus, Strep A) bacterial nucleic acid from unprocessed throat swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, a novel Mesa Biotech PCR nucleic acid amplification technology named OscAR™, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Strep A system consists of a small reusable Dock to drive the automated testing process, and a single-use disposable test cassette that contains all the enzymes and reagents.

The GenePOC"M Strep A assay, performed on the revogene"14 instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC™ Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.

The GenePOC™ Strep A assay is a single-use test for qualitative detection of Streptococcus pyogenes (group A Streptococcus - GAS) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOCTM Strep A assay kit is comprised of the disposable Strep A microfluidic cartridge (PIE), Sample Buffer Tube (SBT), and Disposable Transfer Tool (DTT). These components are used to suspend the sample, extract, amplify, and detect Streptococcus pyogenes (S. pyogenes) nucleic acid. A Process Control (PrC) is also incorporated into each PIE to verify sample processing and amplification steps. The PrC allows for the verification of potential inhibitor substances as well as microfluidic, instrument or reagent failure. The GenePOC™ Strep A assay is designed to be used on the revogene™. The revogene™ is an instrument that automates sample homogenization, sample dilution, cell lysis, DNA amplification and detection of the amplified PCR products. Each GenePOC™ Strep A assay kit provides components for twenty-four (24) tests. User intervention is required for sample preparation, transferring throat swab specimen into the SBT, using the DTT to transfer the sample into the PIE, and loading the PIE into the revogene™ carousel. Each PIE is a completely integrated closed device in which a sample is dispensed and processed through different microfluidic chambers and channels that allow for the sample processing and subsequent real-time PCR steps. During the run and at run completion, the results are computed by the revogene™ from measured fluorescent signals and embedded calculation algorithms. The output results include positive, negative, indeterminate, and unresolved. An Early Positive Result Outcome (E-PRO) feature provides positive result if the signal from the target DNA reaches a predetermined threshold before the full PCR cycles have been completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. Results may be viewed, printed, transferred, and/or stored by the user.

Alere i Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

Alere™ i Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Streptococus pyogenes Group A Strep from throat swab specimens. The Alere™ i Strep A 2 System utilizes isothermal nucleic acid amplification technology and is comprised of: - . Sample Receiver - single use, disposable containing the elution buffer - Test Base – single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet - Transfer Cartridge single use, disposable for transfer of the eluted sample to the Test Base, and ● - . Alere™ i Instrument – repeat use reader The reaction tubes in the Test Base contain the reagents required for Streptococcus pyogenes Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Streptococcus pyggenes, Group A Strep and fluorescently labeled molecular beacons designed to specifically identify the amplified nucleic acid targets. Alere™ i Strep A 2 is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements. To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating bacterial lysis and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported. Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

The Xpert Xpress Strep A test, performed on the GeneXpert Xpress System, is a rapid, qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A B-hemolytic Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The Xpert Xpress Strep A test can be used as an aid in the diagnosis of Group A Streptococcal pharvngitis. The assay is not intended to monitor treatment for Group A Streptococus infections.

The Xpert Xpress Strep A test is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of Streptococcus pyogenes from throat swab specimens from patients with signs and symptoms of pharyngitis. The Xpert Xpress Strep A test is performed on the Cepheid GeneXpert® Xpress System. The GeneXpert Xpress System platform automates sample preparation, amplification and real-time detection. The GeneXpert Xpress System requires the use of single-use, disposable cartridges (the Xpert Xpress Strep A cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. The Xpress Strep A test includes primers and probes for the detection of a targeted sequence of the S. pyogenes genome allowing detection of Strep A directly from throat swab specimens collected from patients with signs and symptoms of pharyngitis. A Sample Processing Control (SPC) and a Probe Check Control (PCC) are internal controls utilized by the GeneXpert Xpress System platform. The SPC is present to control for adequate processing of the target bacteria and to monitor for the presence of inhibitor(s) in the PCR assay to avoid false-negative results. The Probe Check Control verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of genomic DNA S. pyogenes in ~24 minutes or less. The GeneXpert Xpress System, comprised of the GeneXpert Xpress II and GeneXpert Xpress IV, is capable of performing separate sample preparation and realtime PCR and RT-PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and RT-PCR and detection. Throat swab specimens are collected using the ESwab collection device and transported to the GeneXpert area and prepared according to package insert instructions. After mixing the specimen, the liquid sample is transferred to the Xpert Xpress Strep A cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert Xpress instrument platform, which performs hands-off real-time, multiplex PCR for detection of DNA. The results are automatically generated at the end of the process in a report that can be viewed and printed.

The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis. The ARIES® Group A Strep Assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections. The ARIES® Group A Strep Assay is indicated for use with ARIES® Systems.

The ARIES® Group A Strep Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES® System or the ARIES® M1 System with their included ARIES® Software, an assay-specific cassette, and an assay-specific protocol file. The ARIES® Group A Strep Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES® Group A Strep Assay cassette directly detects Streptococcus pyoqenes (Group A ß-hemolytic Streptococcus) in throat swab specimens collected from the surface of human tonsils and posterior pharyngeal wall. Throat swab specimens are collected from patients using a commercially available Liquid Amies based transport system (Nylon Flocked Swab with 1 mL modified Liquid Amies (ESwab™). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using an ARIES® System. An extractable sample processing control (SPC) target is present in the ARIES® Group A Strep Assay cassette and is processed with the specimen. The SPC controls for recovery of extracted nucleic acid, the presence of inhibitory substances and for PCR reagent and instrument integrity. The Ct value of the SPC is designed to verify nucleic acid extraction, to identify PCR inhibition, if any, and verify proper function of the extraction system and real-time instrument. The Tm value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES® Group A Strep Assay lyophilized PCR reagents in the PCR tube that contains primer pairs specific to the S. pyogenes DNaseB (sdaB) gene and the SPC sequence. Each of the primer pairs is labeled with a distinct fluorophore and detected in distinct channels of the ARIES® Systems. PCR amplification is performed and assay fluorescence is monitored. Incorporation of a quencher-labeled nucleotide results in a decrease in fluorescence for the associated primer pair. Following amplification, the reaction is slowly heated to separate the fluorescent-labeled strand from the quencher-labeled strand, a process that results in an increase in the fluorescence signal. The reaction fluorescence is measured during this process and the temperature at which the change in fluorescence is the maximum is the T ,, of the amplicon. The instrument fluorescence output is analyzed and test results are determined using the ARIES® System software and the ARIES® Group A Strep Assay protocol and run files. ARIES® Group A Strep Assay results may be reported from the ARIES® Software or from the optional SYNCT® Software.

The Xpert Xpress Strep A Assay, performed on the GeneXpert Instrument Systems, is a rapid, qualitative in vitro diagnostic test for the detection of Streptoccus pyogenes (Group A beta-hemolytic Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The Xpert Xpress Strep A Assay utilizes an automated real-time polymerase chain reaction (PCR) to detect Streptococcus pyogenes DNA.

The Xpert Xpress Strep A Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of Streptococcus pyogenes from throat swab specimens from patients with signs and symptoms of pharyngitis. The Xpert Xpress Strep A Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System platform automates sample preparation, amplification and real-time detection. The GeneXpert Instrument Systems require the use of single-use, disposable cartridges (the Xpert Xpress Strep A cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. The Xpress Strep A Assay includes primers and probes for the simultaneous detection and differentiation of a targeted sequence of the S. pyogenes genome allowing detection of Strep A directly from throat swab specimens collected from patients with signs and symptoms of pharyngitis. A Sample Processing Control (SPC) and a Probe Check Control (PCC) are internal controls utilized by the GeneXpert Instrument System platform. The SPC is present to control for adequate processing of the target bacteria and to monitor for the presence of inhibitor(s) in the PCR assay to avoid false-negative results. The Probe Check Control verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of genomic DNA S. pyogenes in ~24 minutes or less. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems and the GeneXpert Infinity Systems, have 1 to 80 randomly accessible modules. depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR and RT-PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and RT-PCR and detection. Throat swab specimens are collected using the ESwab collection device and transported to the GeneXpert area and prepared according to package insert instructions. After mixing the specimen, the liquid sample is transferred to the Xpert Xpress Strep A Assay cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert instrument platform, which performs hands-off real-time, multiplex PCR for detection of DNA. The results are automatically generated at the end of the process in a report that can be viewed and printed.

The Solana® Strep Complete Assay is a rapid in vitro diagnostic test, using isothermal amplification technology (helicase-dependent amplification, HDA), for the qualitative detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G ß-hemolytic Streptococus) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana® Strep Complete Assay is intended for use only with the the Solana® instrument.

The Solana Strep Complete Assay amplifies, detects and differentiates Streptococcus pyogenes DNA and Streptococcus dysgalactiae DNA present in throat swab specimens obtained from symptomatic patients. The assay consists of two major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to S. pyogenes (GAS) and S. dysgalactiae (C/G) using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe. Patient specimen on a throat swab is transferred to a Lysis Tube and subjected to heattreatment at 95±°C for 5 minutes. The heat-treated sample is added to a Dilution Tube, and then transferred to two Reaction Tubes, GAS Reaction Tube and Strep C/G Reaction Tube. GAS Reaction Tube contains white lyophilized HDA reagents, dNTPs, primers and probes specific for the amplification and detection of S. pyogenes target sequence, while C/G Reaction Tube contains blue lyophilized HDA reagents, dNTPs, primers and probes specific for the amplification and detection of S. dysgalactiae target sequence. Once rehydrated with the diluted sample, the Reaction Tubes are placed in a Solana Instrument for amplification and detection of the target sequences. In Solana, the target sequences are amplified by specific primers and detected by a specific fluorescence probe included in each Reaction Tube. Two competitive process controls (PRCs) are included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure for each target. PRCs are amplified by the target-specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of the fluorophore from the quencher. Solana measures and interprets the fluorescent signal for each Reaction Tube, using on-board method-specific algorithms. Solana then reports the test results for each Reaction Tube to the user on its display screen, and optionally prints out the results via a printer.

The Solana™ GAS Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A B-hemolytic Streptococus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana™ GAS Assay is intended for use only with the Solana™ instrument.

The Solana™ GAS Assay amplifies and detects GAS DNA present in throat swab specimens obtained from symptomatic patients. The assay consists of two major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to GAS using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe. Patient specimen on a throat swab is transferred to a Lysis Tube and subjected to heattreatment at 95°C for 5 minutes. The heat-treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of GAS-specific target sequence. In Solana, the target sequence is amplified by GAS specific primers and detected by a GAS specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by GAS specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to GAS or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana instrument will then report the test results to the user on its display screen, and it can print out the results via a printer.

Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections. All negative test results should be confirmed by bacterial culture because negative results do not prection with Group A Streptococcus and should not be used as the sole basis for treatment.

Alere™ i Strep A is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens. The Alere™ i Strep A System utilizes isothermal nucleic acid amplification technology and is comprised of: - . Sample Receiver – single use, disposable containing the elution buffer - . Test Base – single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet - Transfer Cartridge – single use, disposable for transfer of the eluted sample to the Test Base, and - Alere™ i Instrument – repeat use reader The reaction tubes in the Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target. Alere™ i Strep A is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements. To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating bacterial lysis and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported. Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

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.