DIASORIN MOLECULAR LLC MOL2750 Simplexa™ Bordetella Direct

The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.

The illumigene Pertussis External Control Kit contains Positive Control Reagent for use with the illumigene Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.

IVD reagent kit containing 30 tests.

Simplexa™ Bordetella Positive Control Pack

Bordetella Direct Test Cartridge

The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.

AmpliVue Bordetella Assay

Solana Bordetella Complete

The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome.Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.

The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.

The illumigene Pertussis External Control Kit contains Positive Control Reagent for use with the illumigene Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.

IVD reagent kit containing 30 tests.