FOR OUTSIDE THE US AND CANADA ONLY

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: info@diasorin.it