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■ Surveillance of CF patients
I N S T I T U T
■ Detects chronic infection
prevention and controlof infectious diseasesand congenital disorders
■ Guides antibiotic therapy
■ Improves management of infections
IN VITRO DIAGNOSTIC USE
Statens Serum InstitutSSI Diagnostica2 Herredsvejen3400 HillerødDenmark
Tel.: +45 3268 8378Fax: +45 3268 email@example.com
status of the patient for absorption of possible cross-
Pseudomonas-CF-IgG antigen and standard control
reactive antibodies. E-mail: firstname.lastname@example.org for
serum is used for the quantitative measurement of the
antibody level of Pseudomonas aeruginosa
in human serum samples.
Storage and Shelf Life
Store the sealed vial of lyophilized Pseudomonas-CF-
The Pseudomonas-CF-IgG antigen is supplied as a 9
IgG antigen at room temperature. Expiry date of the
mg lyophilized antigen obtained by sonication of the
sealed vial is printed on the package. Dissolved antigen
17 most common P. aeruginosa
serotypes. More than 64
can be frozen at -20oC and refrozen for at least 20 times
different antigens are detectable in the antigen pool.
without any change of activity. Pseudomonas-CF-IgG
Pseudomonas-CF-IgG standard control serum is sup-
standard control serum can be stored at -20oC.
plied in 1 ml and contains high titer antibodies directed against P. aeruginosa
One quantity of Pseudomonas-CF-IgG antigen and
■ Pseudomonas-CF-IgG antigen pool, lyophilized, 9 mg
standard control serum allows for 100 ELISA tests.
■ Pseudomonas-CF-IgG standard control serum, 1 ml
is the most important bacterial patho-
gen in patients with cystic fibrosis. Chronic pulmonary
Information and Ordering
infection with P. aeruginosa
is responsible for most of
the morbidity and mortality in cystic fibrosis.
Diagnostics Sales and Marketing2 Herredsvejen
Chronic P. aeruginosa
infection can be discriminated
from intermittent colonization by measuring serum
IgG antibodies against P. aeruginosa
. During the chro-
nic infection a pronounced and increasing antibody
response develops whereas this is not the case in inter-
mittently colonized patients. The level of the antibody
response in chronically infected patients correlates to the severity of the infection.
Høiby N et al: Eradication of early Pseudomonas aeruginosa
Cystic Fibrosis 4:49-54; 2005.
Since cystic fibrosis patients may experience repeated
Döring G & Høiby N for the consensus study group: Early intervention
intermittent P. aeruginosa
colonization, they will be
and prevention of lung disease in cystic fibrosis: a European consensus. J Cystic Fibrosis 3:67-91; 2004.
subject to repeated courses of antibiotic therapy.
Johansen H K et al: Antibody response to Pseudomonas aeruginosa
Measurements of the antibody response in such cases
cystic fibrosis patients - a marker of therapeutic success? -A 30-year cohort study of survival in Danish CF patients after onset of chronic P.
can be helpful in the management of the infection.
lung infection. Pediat Pulmonol 37:427-432; 2004.
Frederiksen B et al: Changing epidemiology of Pseudomonas aerugi-
infection in Danish cystic fibrosis patients (1974-1995). Pediatr Pulmonol 28:159-66; 1999.
The Pseudomonas-CF-IgG antigen is used as a coating
Frederiksen B et al: Antibiotic treatment at time of initial colonization
agent in a traditional ELISA setup. Pseudomonas-CF-
with Pseudomonas aeruginosa
postpones chronic infection and prevents deterioration in pulmonary function in patients with cystic fibrosis.
IgG standard control serum is used to construct a stan-
dard curve for calibration of a local standard serum.
Frederiksen B et al: Improved survival in the Danish cystic fibrosis cen-tre - results of aggressive treatment. Pediatric Pulmonology 21:153-158,
Lyophilized Pseudomonas-CF-IgG antigen is recon-
stituted with sterile water and coated to ELISA plates.
Valerius N H et al: Prevention of chronic colonization with Pseudomo-nas aeruginosa
in patients with Cystic Fibrosis by early treatment with
Patient serum, standard control serum and afterwards
Ciprofloxacin and inhalation with Colistin. Lancet 338:725-26; 1991.
secondary antibody are added. Absorbance is read after
Pressler T et al: IgG subclass antibodies to Pseudomonas aeruginosa
sera from patients with chronic Ps. aeruginosa
infection investigated by
2O2 addition. The absorbance of the standard control
ELISA. Clin Exp Immunol 81:428-434; 1990.
serum dilutions is used to construct a standard curve.
Høiby N et al: Taxonomic application of crossed immunoelectrophoresis.
The absorbance of the patient sample is extrapolated
Internat J Syst Bacteriol 37:229-240; 1987.
Pedersen S S et al: Diagnosis of chronic Pseudomonas aeruginosa
on the human standard curve and divided by 10.
tion in cystic fibrosis by enzyme-linked immunosorbent assay. J Clin Microbiol 25:1830-1836; 1987.
Høiby N et al: Pseudomonas aeruginosa
infection in cystic fibrosis.
Diagnostic and prognostic significance of Pseudomonas aeruginosa
Sera producing unexplainable results may be sent
cipitins determined by means of crossed immunoelectrophoresis. Scand
to the Reference Laboratory at the Department of Clinical Microbiology & Danish Cystic Fibrosis Centre,
Rigshospitalet, University of Copenhagen, Denmark
together with information about the bacteriological
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