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The QIAstat-Dx GI Panel 2 Mini B is a multiplexed nucleic acid test intended for use with the OIAstat-Dx Analyzer 1.0 for the simultaneous in vitro qualitative detection of nucleic acids from multiple bacteria directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B: - Campylobacter - Shigella - Shiga-like toxin Escherichia coli (STEC)* - Salmonella - Yersinia enterocolitica *Only with Para-Pak C&S, not reported for FecalSwab Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QlAstat-Dx GI Panel 2 Mini B is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Postive results do not rule out co-infection with organisms not detected by the QIAstat-Dx GI Panel 2 Mini B. The organisms detected may not be the sole or definitive cause of the disease. Negative QIAstat-Dx GI Panel 2 Mini B results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

The QIAstat-Dx® GI Panel 2 Mini B (Cat. no. 691423) assay is a modified device (reduced version) of the OIAstat-Dx Gastrointestinal Panel 2 (Cat. no. 691421). The OIAstat-Dx GI Panel 2 Mini B is identical to the QIAstat-Dx Gastrointestinal Panel 2 (K220062) but uses an Assay Definition File (ADF) which masks all but five pathogens (targets) from the OIAstat-Dx Gastrointestinal Panel 2. The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the OIAstat-Dx GI Panel 2 Mini B: Campvlobacter. Shigella, Shiga-like toxin E. coli (STEC), Salmonella and Yersinia enterocolitica. The QIAstat-Dx GI Panel 2 Mini B is part of the QIAstat-Dx system and works with the OIAstat-Dx Analyzer 1.0. It will be available in a separately labeled kit. The QIAstat-Dx GI Panel 2 Mini B is intended to be used with stool samples in Para-Pak C&S or FecalSwab transport media. QIAstat-Dx is based on single-test cartridges with pre-packaged reagents including both wet and dry chemistry to handle the sample preparation and detection steps for the presence of a range of selected analytes by PCR technology. After insertion of the sample, the QIAstat-Dx assay cartridge is processed by the QIAstat-Dx Analyzer 1.0. Once the cartridge is inserted into the instrument, the test starts automatically and runs for about 78 minutes. When the test is finished, the cartridge is removed by the user and discarded. The QIAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer if needed. The detected analytes are displayed in red. For other analytes tested, they are displayed in green if not detected or in grav if not applicable or invalid. The analyzer will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL"). All the reagents required for the complete execution of the test are pre-loaded and selfcontained in the QIAstat-Dx GI Panel 2 Mini B cartridge. The user does not need to manipulate any reagents. During the test, reagents are handled by pneumatically operated microfluidics without any direct contact with the user or the analyzer actuators. Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer sample and fluids via the Transfer Chamber (TC) to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially: - Sample Pre-treatment for PCR Inhibitors removal - Resuspension of Internal Control and Proteinase K - Cell lysis using mechanical and/or chemical means - Membrane-based nucleic acid purification - Rehydration of Master Mix - Transfer of defined aliquots of eluate/master mix to different reaction chambers - Performance of multiplex real-time RT-PCR testing within each reaction chamber.

The QIAstat-Dx GI Panel 2 Mini B&V is a multiplexed nucleic acid test intended for use with the OLAstat-Dx Analyzer 1.0 for the simultaneous in vitro qualitative detection of nucleic acids from multiple bacteria and one virus directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following virus and bacteria (including several diarrheagence E. col/Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B&V: - Norovirus - · Campylobacter - · Shigella - · Shiga-like toxin Escherichia coli (STEC)* - · Salmonella *Only with Para-Pak C&S, not reported for FecalSwab Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QlAstat-Dx GI Panel 2 Mini B&V is indicated as an aid in the diagnosis of gastrontestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Postive results do not rule-out co-infection with organisms not detected by the QlAstat-Dx GI Panel 2 Mini B&V. The organisms detected may not be the sole or definitive cause of the disease. Negative QIAstat-Dx GI Panel 2 Mini B&V results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

The QIAstat-Dx® GI Panel 2 Mini B&V (Cat. no. 691424) assay is a modified device (reduced version) of the QIAstat-Dx Gastrointestinal Panel 2 (Cat. no. 691421). The QIAstat-Dx GI Panel 2 Mini B&V is identical to the OIAstat-Dx Gastrointestinal Panel 2 (K220062) with the exception of their respective labeling and Assay Definition File (ADF) which masks all but five pathogens (targets) from the OIAstat-Dx Gastrointestinal Panel 2. The following virus and bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the OIAstat-Dx GI Panel 2 Mini B&V: Norovirus, Campvlobacter, Shigella, Shiga-like toxin Escherichia coli (STEC) and Salmonella. The QIAstat-Dx GI Panel 2 Mini B&V is part of the OIAstat-Dx system and works with the OIAstat-Dx Analyzer 1.0. The QIAstat-Dx GI Panel 2 Mini B&V is intended to be used with stool samples in Para-Pak C&S or FecalSwab transport media. QIAstat-Dx is based on single-test cartridges with pre-packaged reagents including both wet and dry chemistry to handle the sample preparation and detection steps for the presence of a range of selected analytes by PCR technology. After insertion of the sample, the QIAstat-Dx assay cartridge is processed by the QIAstat-Dx Analyzer 1.0. Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 78 minutes. When the test is finished, the cartridge is removed by the user and discarded. The QIAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer if needed. The detected analytes are displayed in red. For other analytes tested, they are displayed in green if not detected or in gray if not applicable or invalid. The analyzer will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL"). All the reagents required for the complete execution of the test are pre-loaded and selfcontained in the QIAstat-Dx GI Panel 2 Mini B&V cartridge. The user does not need to manipulate any reagents. During the test, reagents are handled by pneumatically-operated microfluidics without any direct contact with the user or the analyzer actuators. Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer sample and fluids via the Transfer Chamber (TC) to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially: - Sample Pre-treatment for PCR Inhibitors removal - Resuspension of Internal Control and Proteinase K ● - Cell lysis using mechanical and/or chemical means - Membrane-based nucleic acid purification - Rehydration of Master Mix ● - Transfer of defined aliquots of eluate/master mix to different reaction chambers ● - Performance of multiplex real-time RT-PCR testing within each reaction ● chamber.

The QIAstat-Dx Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid real-time PCR based in vitro diagnostic test intended for use with the QIAstat-Dx Analyzer 1.0. The QIAstat-Dx ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. The following organisms are identified using the OlAstat-Dx ME Panel: Enterovirus, Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis (encapsulated), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, and Cryptococcus neoformans/gattii*. The QIAstat-Dx ME Panel is indicated as an aid in the diagnosis of meningitis and/or encephalitis and results must be used in conjunction with other clinical, endemiological, and laboratory data. Results from the OlAstat-Dx ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME Panel. The agents detected may not be the definite cause of the disease. Negative results do not preclude central nervous system infection. Not all agents of central nervous system infection are detected by this test and sensitivity in clinical use may differ from that described in the instructions for use. The QIAstat-Dx ME Panel is not intended for testing specimens collected from indwelling central nervous system medical devices. The QIAstat-Dx ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing. *Cryptococcus neoformans and Cryptococcus gattii are not differentiated.

The QIAstat-Dx® Meningitis/Encephalitis (ME) Panel is part of the QIAstat-Dx Meningitis/Encephalitis system and works with the OIAstat-Dx Analyzer 1.0. The QIAstat-Dx ME Panel is intended to be used with cerebrospinal fluid (CSF) specimens. Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 80 minutes. When the test is finished, the cartridge is removed by the user and discarded. The OIAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer, if needed. The detected analytes are displayed in red. For other analytes tested, they are displayed in green if not detected or in gray if not applicable or invalid. The analyzer will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL"). QIAstat-Dx consists of single-test cartridges with pre-packaged reagents including both wet and dry chemistry necessary to perform the sample preparation, nucleic acid amplification and detection to be used in conjunction with the QIAstat-Dx Analyzer 1.0. All sample preparation and assay steps are performed within the cartridge, so the user does not need to manipulate any reagent during the test. This eliminates exposure of the user or the Analyzer to chemicals contained in the cartridge during the test and up to the disposal of used cartridges. Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer the sample and fluids via the Transfer Chamber (TC) to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially: - Resuspension of air-dried internal control and Proteinase K (ProtK) enzyme using . provided buffer and mixing with the liquid sample (IC Cavity and ProtK Cavity); - Cell lysis using mechanical (rotation) and chemical (chaotropic and isotonic) ● means (lysis chamber): - Membrane-based nucleic acid purification from Lysate by: ● - Mixing lysate with binding buffer and capturing on the membrane -(purification chamber); - First washing of membrane to remove bound proteins (purification chamber and waste chamber); - Second washing of membrane to leave only bound nucleic acids -(purification chamber and waste chamber); - Rinsing of Transfer Chamber (TC) using the rinsing buffer before introduction of the eluate (Transfer Chamber); - Drying of membrane with bound nucleic acids with an air flow generated by a high flow vacuum pump (purification chamber); and - Elution of nucleic acids with elution buffer (purification chamber and TC); - Mixing of the purified nucleic acid (eluate) with lyophilized "Master Mix" reagents ● (Dry chemistry container (DCC) and TC); - Sequential transfer of defined aliquots of mixed eluate/Master Mix from the ● Transfer Chamber to each of eight Reaction Chambers containing the specified, airdried primers and probes; - Within each Reaction Chamber, real-time, multiplex PCR ("rtPCR") testing is ● performed. Increase in fluorescence (indicative of detection of each target analyte) is detected directly within each Reaction Chamber; and - The detected signal per fluorescent marker per Reaction Chamber is then used by the system software to generate the assay result.

The OlAstat-Dx Respiratory Panel Mini is a multiplexed nucleic acid test intended for use with the OlAstat-Dx system for the simultaneous in vitro qualitative detection of multiple respiratory viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infections, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The following viruses are identified using the OlAstat-Dx Respiratory Panel Mini: Influenza B. Respiratory Syncytial Virus, Human Rhinovirus, and SARS-CoV-2. Nucleic acids from viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological and laboratory findings. The results of this test should not be used as for diagnosis, treatment or other patient management decisions. Negative results in the presence of a respiratory illness may be due to infection with pathogens that are not detected by the test or due to lower respiratory tract infection that is not detected by a NPS specimen. Conversely, positive results are indicative of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the QlAstat-Dx Respiratory Panel Mini. The agent(s) detected by the QlAstat-Dx Respiratory Panel Mini may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

The QIAstat-Dx Respiratory Panel Mini (Cat. no. 691218) assay is a modified device (reduced version) of the QIAstat-Dx Respiratory Panel Plus (Cat. no. 691224). The QIAstat-Dx Respiratory Panel Mini is identical to the QIAstat-Dx Respiratory Panel Plus (K233100) with the exception of the labeling and Assay Definition File (ADF), which masks all but five pathogens (targets) from the QIAstat-Dx Respiratory Panel Plus. The following viruses are identified using the OlAstat-Dx Respiratory Panel Mini: Influenza A, Influenza B, Respiratory Syncytial Virus, Human Rhinovirus, and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The OIAstat-Dx Respiratory Panel Mini is part of the QIAstat-Dx system and works with the QIAstat-Dx Analyzer 1.0. The QIAstat-Dx Respiratory Panel Mini is intended to be used with I nasopharyngeal swab (NPS) eluted in Universal Transport Media (UTM), which is not provided with the QIAstat-Dx Respiratory Panel Mini. Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 1 hour. When the test is finished, the cartridge is removed by the user and discarded. The QlAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer if needed. The detected analytes are displayed in red. All other tested but not detected analytes are listed in green. The analyzer will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL"). All the reagents required for the complete execution of the test are pre-loaded and selfcontained in the QIAstat-Dx Respiratory Panel Mini cartridge. The user does not need to manipulate any reagents. During the test, reagents are handled by pneumatically-operated microfluidics without any direct contact with the user or the analyzer actuators. Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer sample and fluids via the Transfer Chamber (TC) to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially: - Resuspension of Internal Control ● - Cell lysis using mechanical and/or chemical means ● - Membrane-based nucleic acid purification ● - . Mixing of the purified nucleic acid with lyophilized master mix reagents - Transfer of defined aliquots of eluate/master mix to different reaction chambers - Performance of multiplex real-time RT-PCR testing within each reaction chamber. ●

The QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 1.0. for the simultaneous in vitro qualitative detection of nucleic acids from multiple viruses, bacteria. and parasites directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including several diarrheagenic E. col/ Shigella pathotypes), and parasites are identified with the QIAstat-Dx Gastrointestinal Panel 2 : • Adenovirus F40/F41 • Astrovirus • Norovirus GI/GII • Rotavirus A • Campylobacter (C. jejuni, C. coli and C. upsaliensis) • Shigella/Enteroinvasive Escherichia coli (EIEC) • Enteropathogenic Escherichia coli (EPEC) • Enterotoxigenic Escherichia coli (ETEC) lt/st • Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of E. coli O157 serogroup within STEC) • Salmonella • Plesiomonas shigelloides • Yersinia enterocolitica • Cryptosporidium • Cyclospora cayetanensis • Entamoeba histolytica • Giardia lamblia* *(Also known as Giardia intestinalis and Giardia duodenalis) Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QIAstat-Dx Gastrointestinal Panel 2 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out coinfection with organisms not detected by the QIAstat-Dx Gastrointestinal Panel 2. The organisms detected may not be the sole or definitive cause of the disease. Negative QIAstat-Dx Gastrointestinal Panel 2 results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

QIAstat-Dx is based on single-test cartridges with pre-packaged reagents including both wet and dry chemistry to handle the sample preparation and detection steps for the presence of a range of selected analytes by PCR technology. After insertion of the sample, the OIAstat-Dx assay cartridge is processed by the OIAstat-Dx Analyzer 1.0.

The QIAstat-Dx Respiratory Panel Plus is a multiplexed nucleic acid test intended for use with the QIAstat-Dx system for the simultaneous in vitro qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infection, including SARS-CoV-2. The following organism types and subtypes are identified using the QIAstat-Dx Respiratory Panel Plus: Adenovirus, Human Coronavirus 229E, Human Coronavirus HKU1, Human Coronavirus NL63, Human Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A H1, Influenza A H1N1 pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Respiratory Syncytial Virus, Human Rhinovirus/Enterovirus (not differentiated), Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2), Bordetella pertussis, Chlamydophila pneumoniae and Mycoplasma pneumoniae. Nucleic acids from viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral and bacterial nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results in the presence of a respiratory illness may be due to infection with pathogens that are not detected by the test or due to lower respiratory tract infection that is not detected by a NPS specimen. Conversely, positive results are indicative of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the QIAstat-Dx Respiratory Panel Plus. The agent(s) detected by the QIAstat-Dx Respiratory Panel Plus may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

The QIAstat-Dx Respiratory Panel Plus is part of the QIAstat-Dx system and works with the QIAstat-Dx Analyzer 1.0. The QIAstat-Dx Respiratory Panel Plus is intended to be used with I nasopharyngeal swab (NPS) eluted in Universal Transport Media (UTM), which is not provided with the QIAstat-Dx Respiratory Panel Plus. Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 1 hour. When the test is finished, the cartridge is removed by the user and discarded. The OIAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer if needed. The detected analytes are displayed in red. All other tested but not detected analytes are listed in green. The analyzer will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL"). All the reagents required for the complete execution of the test are pre-loaded and selfcontained in the QIAstat-Dx Respiratory Panel Plus cartridge. The user does not need to manipulate any reagents. During the test, reagents are handled by pneumatically-operated microfluidics without any direct contact with the user or the analyzer actuators. Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer sample and fluids via the Transfer Chamber (TC) to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially: - Resuspension of air-dried internal control and Proteinase K (ProtK) enzyme using ● provided buffer and mixing with the liquid sample (IC Cavity and ProtK Cavity); - Cell lysis using mechanical (rotation) and chemical (chaotropic and isotonic) means ● (lysis chamber); - Membrane based nucleic acid purification from Lysate by: - -Mixing lysate with binding buffer and capturing on the membrane (purification chamber); - First washing of membrane to remove bound proteins (purification chamber and waste chamber); - Second washing of membrane to leave only bound nucleic acids -(purification chamber and waste chamber); - -Rinsing of Transfer Chamber (TC) using the rinsing buffer before introduction of the eluate (Transfer Chamber); - Drying of membrane with bound nucleic acids with an air flow generated by a high flow vacuum pump (purification chamber); - -Elution of nucleic acids with elution buffer (purification chamber and TC); - Mixing of the purified nucleic acid (eluate) with lyophilized "Master Mix" reagents (Dry chemistry container (DCC) and TC); - Sequential transfer of defined aliquots of mixed eluate/Master Mix from the . Transfer Chamber to each of eight Reaction Chambers containing the specified, airdried primers and probes; - Within each Reaction Chamber, real-time, multiplex PCR ("rtPCR") testing is . performed. Increase in fluorescence (indicative of detection of each target analyte) is detected directly within each Reaction Chamber; - The detected signal per fluorescent marker per Reaction Chamber is then used by . the system software to generate the assay result. The QIAstat-Dx Respiratory Panel Plus includes the addition of the SARS-CoV-2 analyte to the analytes that were cleared in the OIAstat-Dx Respiratory Panel (K183597).

The QIAstat-Dx Respiratory Panel is a multiplexed nucleic acid test intended for use with QIAstat-Dx system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) eluted in Universal Transport Media (UTM) obtained from individuals suspected of respiratory tract infections. The following organism types are identified using the QIAstat-Dx Respiratory Panel: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by the test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the QIAstat-Dx Respiratory Panel may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence and radiography) may be necessary when evaluating a patient with possible respiratory tract infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis and Parainfluenza Virus 1 were established primarily with retrospective clinical specimens. Performance characteristics for Chlamydophila pneumoniae, Parainfluenza Virus 2, Parainfluenza Virus 4, Influenza A subtype H1 and Coronavirus 229E were established primarily using contrived clinical specimens. Due to the genetic similarity between Human Rhinovirus and Enterovirus, the QIAstat-Dx Respiratory Panel cannot reliably differentiate them. A positive QI Respiratory Panel Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g., cell culture or sequence analysis). Performance characteristics for Influenza A were established when Influenza A H1N1-2009 and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges. 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 departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

QIAstat-Dx® is based on single-test cartridges with pre-packaged reagents including both wet and dry chemistry to handle the sample preparation and detection steps for the presence of a range of selected analytes by PCR technology. After insertion of the sample, the QIAstat-Dx assay cartridge is processed by the QIAstat-Dx® Analyzer 1.0.