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The cobas® liat Bordetella panel nucleic acid test (cobas® liat Bordetella panel) is an automated real-time polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of Bordetella pertussis (Bp), Bordetella parapertussis (Bpp), and Bordetella holmesii (Bh) nucleic acid in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.

The test is meant to be used in conjunction with other clinical and epidemiological information and laboratory findings. When clinical factors suggest that B. pertussis, B. parapertussis or B. holmesii may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results do not preclude Bp, Bpp, or Bh infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out co-infection with other bacteria or viruses. The agent detected may not be the definite cause of disease.

The cobas® liat Bordetella panel nucleic acid test (cobas® liat Bordetella panel) is an automated multiplex real-time polymerase chain reaction (PCR) assay for the rapid in vitro qualitative detection and differentiation of B. pertussis (Bp), B. parapertussis (Bpp), and B. holmesii (Bh) DNA in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.

The different fluorescent dye designs enable the specific detection and differentiation of the three microorganisms (Bp, Bpp, and Bh) independently in a multiplex system. The system automates all nucleic acid amplification test sample processing steps, including inhibitor removal, nucleic acid extraction, purification, amplification, real-time detection, and result interpretation in a rapid manner. The test is designed for use in near-patient settings to deliver results in approximately 15 minutes.

The cobas® liat system is comprised of the cobas® liat analyzer (analyzer) hardware with integrated cobas® liat system software (analyzer software + liat assay specific package (script)) for running tests and analyzing the results, and a single-use disposable cobas® liat assay tube (assay tube).

• cobas® liat analyzer is a system component that consists of one software subsystem and three hardware units:

  • Infrastructure unit, which consists of the hardware and embedded software (firmware).
  • Thermal, loading and motion unit: the processing module that interacts physically with the assay tube during the assay execution.
  • Detection unit consisting of the photodetectors that is used for the fluorescence detection during the PCR reaction

• The assay script provides a set of instructions to the analyzer hardware and software for assay tube processing, PCR, result calculation and interpretation and result reporting. The assay script can be installed on the analyzer independently of the analyzer software.

The cobas® liat Bordetella panel nucleic acid test is supported with a Liat Assay Specific Package (Assay Script): cobas® liat Bordetella panel LASP (BPTA).

• The assay tube holds all reagents needed for sample preparation and PCR processes. The assay specific reagents are packaged into a single assay tube in separate segments that are separated by frangible seals. An internal control (IC) is also included. The IC is present to control for adequate processing of the target bacteria through all steps of the assay process and to monitor the presence of inhibitors in the PCR reaction.

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