SeroCP™ Quant IgG

Enzyme -Linked Immunosorbent Assay (ELISA) for the semiquantitative
determination of specific IgG antibodies to
Chlamydia pneumoniae in human serum.
Enzym-Immunoassay (ELISA) für die semiquantitive
Bestimmung von spezifischen IgG-Antikörpern gegen
Chlamydia pneumoniae in menschlichem Serum.
Test (ELISA), immunoenzymatique utilisant un antigène
absorbé, pour la détermination semi - quantitative d’anticorps
IgG spécifiques pour Chlamydia pneumoniae, dans un sérum
humain.
Ensayo Inmunoenzimático (ELISA) para la determinación
semicuantitativa de anticuerpos IgG específicos contra
Chlamydia pneumoniae En suero humano
Enzyme-Linked Immunosorbent Assay (ELISA) per la
determinazione semi-quantitativa di anticorpi IgG specifici
per Chlamydia pneumoniae nel siero umano.

Intended Use
SeroCP™ Quant IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the
semi-quantitative determination of species-specific IgG antibodies to Chlamydia
pneumoniae in human serum.
For In Vitro Diagnostic Use Only.
Introduction
Chlamydia pneumoniae (TWAR-183) is an emerging infectious agent with a spectrum of
clinical manifestations, including upper and lower respiratory tract infections (1). The
majority of C.pneumoniae infections are mild and asymptomatic yet, may cause serious
diseases, such as pharyngtitis, sinusitis, acute bronchitis and community acquired
pneumonia. Undetected and untreated infection may lead to prolonged and persistent
disease. Recent data indicates a possible association between C.pneumoniae infection
and chronic diseases (2).
Seroprevalence of C.pneumoniae among children is low but increases sharply until
middle age, where after it remains high (>50%).
Difficulties in sample collection and inaccessibility of the infected site seriously affect the
usefulness of direct detection methods. Therefore, serological testing is routinely used
and serves as a non-invasive tool in identification of both distal and chronic chlamydial
infections (3), where direct detection methods are rarely efficient (4). In addition, the
presence of certain antibody types may also indicate the state of the disease.
Primary chlamydial infection is characterized by a predominant IgM response within 2 to
4 weeks and a delayed IgG and IgA response within 6 to 8 weeks. After acute
C.pneumoniae infection, IgM antibodies are usually lost within 2 to 6 months (5), IgG
antibody titers usually decrease slowly; whereas IgA antibodies tend to disappear rapidly
(6). When primary chlamydial infection is suspected, the detection of IgM is highly
diagnostic (7). However, in recurrent or chronic infections the prevalence of IgM is low
and therefore absence of IgM does not necessarily exclude on-going infection.
In reinfection, IgG and IgA levels rise quickly, often in one to two weeks (8).
IgA antibodies have shown to be a reliable immunological marker of primary, chronic and
recurrent infections. These antibodies usually decline rapidly to baseline levels following
treatment and eradication of the chlamydia infections (3). The persistence of elevated
IgA antibody titers is generally considered as a sign of chronic infection (6).
IgG antibodies persist for long periods and decline very slowly. Therefore, the presence
of IgG antibodies is mainly indicative of a chlamydia infection at an undetermined time.
However, a four-fold rise in IgG or high levels of IgG antibodies may indicate an on-going
chronic infection.
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SeroCP™ Quant is an ELISA based assay in which purified elementary bodies of
C.pneumonaie (TWAR-183) are used as antigens to detect the antibody response in
humans. For complete diagnosis of current, chronic or past infections, it is recommended
to determine IgG, IgM and IgA antibodies to C.pneumoniae.