mycoplasma pneumoniae igg, igm - diasorin.com · symptoms of atypical pneumonia, collected in...
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Infectious Disease
The first fully automated solution for Mycoplasma pneumoniae antibody detection
Mycoplasmapneumoniae IgG, IgM
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
AB
co
nce
ntr
atio
n
1 week 3 weeks Time
IgG IgG
IgM
INTERPRETATION OF SEROLOGY RESULTS
Result
IgG
Negative
Positive or
Negative
Positive
IgM
Negative
Positive
Negative
Indication
No indication of M. pneumoniae infection
Indication of current infection
Indication of past infection
* 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.
LIAISON® Mycoplasma pneumoniae IgG and IgM assaysThe 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
LIAISON® Mycoplasma pneumoniae IgM
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
MagneticParticle
RecombinantP1 antigen
Anti -M. pneumoniae
specific IgG
Anti-humanIgG linked
to ABEI tracer
Emitted light
ABEI
MagneticParticle
RecombinantP1 antigen
+ whole-cell lysate
Anti -M. pneumoniae
specific IgM
Anti-humanIgM linked
to ABEI tracer
Emitted light
ABEI
Diagnostic Sensitivity 94.2%*
Diagnostic Specificity 98.8%*
Diagnostic Sensitivity 99.1%*
Diagnostic Specificity 97.8%*
LIAISON® Mycoplasma pneumoniae IgGNumber of tests 50Assay format Indirect-semi-quantitativeMethod CLIAAntigen type Recombinant peptide P1Conjugate MoAb to human IgG conjugated to isoluminol derivativeSample type 20 μl Serum / PlasmaIntegral on board stability 6 weeks Calibrators availability on board-positive and negative Calibration stability 4 weeks Controls availability Positive and Negative (40 test per control kit-code 317021)Controls stability once opened 6 weeks
LIAISON® Mycoplasma pneumoniae IgMNumber of tests 50Assay format Indirect-qualitativeMethod CLIAAntigen type Recombinant peptide P1+Whole cell lysateConjugate MoAb to human IgM conjugated to isoluminol derivativeSample type 20 μl Serum / PlasmaIntegral on board stability 8 weeks Calibrators availability on board-positive and negative Calibration stability 8 weeks Controls availability Positive and Negative (40 test per control kit-code 317031)Controls stability once opened 6 weeks
Infectious Disease
M08
7000
4252
/D 0
2/19
Ordering Information 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
Mycoplasma pneumoniae Assays
DiaSorin S.p.A.Via Crescentino
13040 Saluggia (VC) - ItalyTel. +39.0161.487526Fax: +39.0161.487670
www.diasorin.comE-mail: [email protected]