Download Mycoplasma pneumoniae IgG, IgM

Infectious Disease
Mycoplasma
pneumoniae IgG, IgM
The first fully automated solution for
Mycoplasma pneumoniae antibody detection
FOR OUTSIDE THE US AND CANADA ONLY
Mycoplasma pneumoniae: an elusive pathogen
• Mycoplasmas are the smallest self-replicating organisms that are capable of cell-free existence
• Due to the lack of a cell wall, mycoplasmas do not respond to penicillins and other beta-lactams used
for the treatment of bacterial pneumonia
• Differential diagnosis of M. pneumoniae is crucial for effective patient management
Infection and pathogenesis
• Transmission of M. pneumoniae is primarily through aerosols from person to person, and cyclic
epidemics of the bacterium are observed every 3-7 years, usually in the early autumn
• The infection is most common in children aged 2-12, with 80% of adults being seropositive for IgG
• M. pneumoniae is responsible for 10-30% of cases of Community Acquired Pneumonia (CAP)
• CAP however only represents 10% of M. pneumoniae infections - other complications have been
reported such as tracheobronchitis, upper respiratory tract disease, asthma and a significant rate of
hospitalisation, especially in the elderly
Clinical diagnostics - serology
• IgM is a reliable marker of acute infection in children, but can present several limitations in adults:
- IgM can persist for up to a year, therefore is not always indicative of acute infection
- Approximately 20% of adults, especially the elderly, do not mount an IgM response, particularly in
the case of re-infection
• Due to the late elevation of IgG and the high seroprevalence in adults due to past infection, it is
advisable, where possible, to test simultaneously for both IgG and IgM
• A significant increase in IgG titre from paired specimens collected 2-3 weeks apart indicates current
or recent infection
PRIMARY INFECTION
REINFECTION
INTERPRETATION OF SEROLOGY RESULTS
AB concentration
Result
IgG
IgG
IgM
1 week
3 weeks
Time
Indication
IgG
IgM
Negative
Negative
No indication of
M. pneumoniae infection
Positive
or
Negative
Positive
Indication of current
infection
Positive
Negative
Indication of past
infection
LIAISON® Mycoplasma pneumoniae IgG and IgM assays
The fully automated approach to M. pneumoniae antibody detection
The unique practical and technological advantages of the LIAISON® systems, the quality of the reagents and
antigen selection have been combined to create a new approach to Mycoplasma pneumoniae diagnosis.
LIAISON® Mycoplasma pneumoniae IgG
ABEI
Diagnostic Sensitivity 94.2%*
Magnetic
Particle
Recombinant
P1 antigen
AntiM. pneumoniae
specific IgG
Anti-human
IgG linked
to ABEI tracer
Emitted light
Diagnostic Specificity 98.8%*
LIAISON® Mycoplasma pneumoniae IgM
ABEI
Diagnostic Sensitivity 99.1%*
Anti Magnetic Recombinant
M. pneumoniae
Particle
P1 antigen
specific IgM
+ whole-cell lysate
Anti-human
IgM linked
to ABEI tracer
Emitted light
Diagnostic Specificity 97.8%*
As clinical findings are often insufficient to distinguish between Mycoplasma pneumoniae, and
pneumonia caused by other pathogens, correct etiologic determination depends on differential
laboratory diagnosis.
Serology – the standard in laboratory diagnostics
• Culture is 100% specific but is time-consuming and relatively insensitive
• PCR is very sensitive but a positive result is not always indicative of infection
• Complement fixation does not enable differentiation between antibody classes
• Serology is the method of choice - presence of IgM and/or a significant rise in IgG antibodies always provides evidence of current/recent M. pneumoniae infection
Optimal antigen selection
• LIAISON® Mycoplasma pneumoniae IgG uses recombinant antigens against the 170-kDa P1 adhesion protein of M. pneumoniae
• LIAISON® Mycoplasma pneumoniae IgM, in addition to the P1 antigen, incorporates whole-cell lysate
Versatile testing possibilities
• A three-fold, or greater, increase of IgG concentration in paired samples allows the diagnosis of current or recent infection
• Careful calibration of the IgM cut-off allows for high assay sensitivity without compromise on specificity
* Diagnostic specificity and sensitivity were assessed against EIA by testing 465 specimens (IgG) and 445 specimens (IgM) from a population with signs and
symptoms of atypical pneumonia, collected in different laboratories and consensus with additional serological data was applied to define the expected results.
Infectious Disease
mycoplasma pneumoniae Assays
LIAISON® Mycoplasma pneumoniae IgG
Number of tests
Assay format
Method
Antigen type
Conjugate
Sample type
Integral on board stability
Calibrators availability
Calibration stability
Controls availability
Controls stability once opened
50
Indirect-semi-quantitative
CLIA
Recombinant peptide P1
MoAb to human IgG conjugated to isoluminol derivative
20 μL Serum / Plasma
6 weeks
on board-positive and negative
4 weeks
Positive and Negative (40 test per control kit-code 317021)
6 weeks
LIAISON® Mycoplasma pneumoniae IgM
Number of tests
Assay format
Method
Antigen type
Conjugate
Sample type
Integral on board stability
Calibrators availability
Calibration stability
Controls availability
Controls stability once opened
50
Indirect-qualitative
CLIA
Recombinant peptide P1+Whole cell lysate
MoAb to human IgM conjugated to isoluminol derivative
20 μL Serum / Plasma
6 weeks
on board-positive and negative
4 weeks
Positive and Negative (40 test per control kit-code 317031)
6 weeks
Code
LIAISON Mycoplasma pneumoniae IgG
317020
LIAISON Control Mycoplasma pneumoniae IgG
317021
LIAISON Mycoplasma pneumoniae IgM
317030
LIAISON Control Mycoplasma pneumoniae IgM
317031
®
®
®
®
AVAILABLE ON
SYSTEMS
Product availability subject to required regulatory approval
M0870004252/B 02/15
Ordering Information
DiaSorin Ireland Ltd.
Unit 13/14 Holly Avenue
Stillorgan Industrial Park
Blackrock Co. Dublin Ireland
www.diasorin.com