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 Result Indication IgG IgM IgG IgG No indication of Negative Negative M. pneumoniae infection Positive IgM or Positive Indication of current Negative infection AB concentration Indication of past Negative 1 week 3 weeks Time Positive 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 Recombinant Anti- Anti-human Emitted light Particle P1 antigen M. pneumoniae IgG linked Diagnostic Specificity 98.8%* specific IgG to ABEI tracer LIAISON® Mycoplasma pneumoniae IgM ABEI Diagnostic Sensitivity 99.1%* Magnetic Recombinant Anti - Anti-human Emitted light Particle P1 antigen M. pneumoniae IgM linked Diagnostic Specificity 97.8%* + whole-cell lysate specific IgM to ABEI tracer 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 50 Assay format Indirect-semi-quantitative Method CLIA Antigen type Recombinant peptide P1 Conjugate MoAb to human IgG conjugated to isoluminol derivative Sample type 20 μl Serum / Plasma Integral 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 IgM Number of tests 50 Assay format Indirect-qualitative Method CLIA Antigen type Recombinant peptide P1+Whole cell lysate Conjugate MoAb to human IgM conjugated to isoluminol derivative Sample type 20 μl Serum / Plasma Integral 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 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 M0870004252/D 02/19 DiaSorin S.p.A. Via Crescentino 13040 Saluggia (VC) - Italy Tel. +39.0161.487526 Fax: +39.0161.487670 www.diasorin.com E-mail: [email protected].