For in vitro diagnostic use. Others cobas liat Bordetella panel IVD cobas® liat Bordetella panel PID00001180 nucleic acid test 09 857 664 190 9 857 664 190 09857664190 9857664190 09857664190 KIT COBAS LIAT BORDETELLA PANEL IVD KIT COBAS LIAT BORDETELLA PANEL IVD 00875197007350 Reagents, kits 1 pack 20 tests false 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, B. parapertussis, and B. holmesii DNA in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection. Negative results do not preclude B. pertussis, B. parapertussis, or B. holmesii 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. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. The cobas® liat Bordetella panel is intended for professional use in a clinical laboratory setting, near-patient testing, or point-of-care (POC) location in conjunction with clinical and epidemiological risk factors. en 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. en The test is performed on the cobas® liat analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time PCR assays. The assay targets the IS110- like element IS1663 family transposase of Bordetella pertussis, the ISL3-like element IS1001 family transposase of Bordetella parapertussis, and the ISL3 family transposase of Bordetella holmesii. An Internal Control (IC) is also included. The IC is present to control for adequate processing of the target bacteria through steps of sample purification, nucleic acid amplification, and to monitor the presence of inhibitors in the PCR processes. The sample to result time is approximately 15 minutes. en

	PPA (95 % KI)	NPA (95 % KI)	*Nachweisgrenze (KBE/ml)**
B. pertussis	97,8 % (93,7–99,2)	99,9 % (99,4–100,0)	36–43
B. parapertussis	98,6 % (94,9–99,6)	99,8 % (99,2–99,9)	32–36
B. holmesii	100,0 % (97,3–100,0)	99,7 % (99,0–99,9)	21–34

Instrument	cobas® liat Analysegerät
Ziele	B. pertussis B. parapertussis B. holmesii
Zulassung	CE-IVD
Probentyp	Nasopharyngeal (NPS)
Sammelmedien	UTM, VTM und flüssige Amine
Probenextraktion	Vollautomatisch und integriert
Technologie	Echtzeit-PCR
Kontrolle	Interne Probenverarbeitungskontrolle, positive und negative Kontrollen
Kontrolle
Zeit bis zum Ergebnis	~ 15 Minuten
Reagenzien	Gebrauchsfertiges, vorverpacktes Röhrchen
Lagerung des Kits	2–8 °C

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cobas^® liat Bordetella Panel

Schnelle, genaue diagnostische Lösungen. Bordetella-Nachweis leicht gemacht.

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cobas^® liat Bordetella-Panel – Klinische Leistung²