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Introduction
Bordetella pertussis is a small gram-negative, immobile, encapsulated,
aerobic pathogen that produces a variety of toxins and virulence factors,
including pertussis toxin (PT), filamentous haemagglutinin (FHA), tracheal
cytotoxin, pertactin, heat-labile toxin, and adenylate cyclase haemolysin.
Bordetella multiplies on the ciliated epithelium of the respiratory mucosa,
causing local destruction of the mucosa. Some of the toxins also impair the
immune system and cause tissue damage. [1, 2]
B. pertussis is the primary pathogen causing whooping cough. Infections
with B. parapertussis or B. holmesii can also lead to a clinical picture similar
to whooping cough, but the course is typically milder and shorter than that
of a disease caused by B. pertussis.
Whooping cough is highly contagious and is transmitted through respiratory
droplets generated by coughing, sneezing, and even talking.
Pertussis can last several weeks to months. The typical initial infection in
unvaccinated individuals progresses in three stages:
• Catharral phase (duration 1-2 weeks; interval 5-21 days): This stage is
characterized by cold-like symptoms, such as a cold and mild cough, but
usually no or only moderate fever.
• Paroxysmal phase (duration 4-6 weeks): In this stage, there are the classic
symptoms of bouts of coughing (staccato cough), followed by inspiratory
dragging. The coughing attacks are often accompanied by regurgitation of
viscous mucus followed by vomiting.
• Convalescent phase (duration 6-10 weeks): The coughing fits gradually
subside.
Since pertussis often does not present with the classic symptoms, especial-
ly in adults, but also in older children and adolescents, laboratory diagnostic
methods are crucial for diagnostics. In patients with cough (regardless of its
duration), laboratory diagnostics for pertussis should be performed if there
has been contact with a confirmed pertussis case or if classic symptoms
such as cough attacks, inspiratory stridor or vomiting after the cough attacks
are present; or in the case of a longer persistent cough (>14 days duration),
even if these are absent. Patients who have received a pertussis vaccine
are not excluded. Even if classical symptoms occur laboratory diagnostics
should be performed for confirmation. The laboratory diagnostic method
recommended depends on the stage of the disease. During the first 2 to 3
weeks after the onset of coughing, it is strongly advised to use a culture or
nucleic acid amplification technique (NAT), usually PCR, to detect these
pathogens from deep nasopharyngeal swabs, nasopharyngeal secretions, or
material obtained by suction. [1, 2]
Package Contents
15 Vivalytic Bordetella test cartridges for the qualitative detection of B.
pertussis, B. parapertussis and B. holmesii specific gene sequences in eNAT®
transport medium (eNAT® 608C, COPAN Italia s.p.a.).
The Vivalytic Bordetella test is configured for use with a Vivalytic one analyser.
Intended Use
The Vivalytic Bordetella test is an automated, qualitative in vitro diagnostic
test based on real-time polymerase chain reaction (PCR) for the detection
of nucleic acids from Bordetella pertussis, Bordetella parapertussis and
Bordetella holmesii from human nasopharyngeal swabs to aid in the diagno-
sis of pertussis, parapertussis or pertussis like infections of symptomatic
individuals.
Results should not be used as the sole basis for diagnosis, treatment,
or other patient management decisions. Positive results do not exclude
co-infection with other pathogens. The agent(s) detected may not be the
definite cause of disease. Negative results do not exclude a Bordetella
infection or another respiratory tract infection. Results must be clinically
correlated with patient history, clinical observations, and epidemiological
information. Other diagnostic information is necessary to determine patient
infection status. Intended for use with a Vivalytic one analyser by healthcare
professionals only in laboratory settings such as hospital laboratories and
reference laboratories.
Vivalytic Bordetella
2
– Instructions for Use
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