Elecsys® Toxo IgM

Immunoassay for the qualitative determination of IgM-antibodies against Toxoplasma gondii

Elecsys® Toxo IgM

Immunoassay for the qualitative determination of IgM-antibodies against Toxoplasma gondii

Toxoplasmosis is a common infection caused by the protozoan Toxoplasma gondii (T. gondii).1 The infection is mainly acquired by ingestion of food or water contaminated by cat feces or by undercooked meat from infected animals.1 During primary infection healthy individuals generally have mild symptoms or show no signs of the disease. However, if primary infection occurs during pregnancy it can result in severe damage to the fetus.1

The risk of fetal damage is highest when the infection is acquired early in pregnancy, while the risk of transmitting the infection increases if the infection is acquired later in the pregnancy.1 Early treatment in acute infection during pregnancy can prevent or ameliorate congenital damage1.

The diagnosis of T. gondii infection starts with the detection of anti-Toxoplasma IgG and IgM antibodies. The presence of Toxo IgM antibodies is presumptive of an acute, recent or reactivated Toxoplasma infection. The diagnosis of acute acquired infection during pregnancy is established by a seroconversion or a significant rise in antibody titres (IgG and/or IgM) in serial samples. Toxoplasma IgG avidity test is performed to date the infection.2 The antibodies produced during the primary response have a lower avidity than those produced during the non-primary response, hence a high avidity performed early in gestation suggests that infection has taken place more than 4 months ago and rules out a recent primary acute infection2. However, no clinical interpretation can be deduced from a low or grey-zone avidity result.2.

Elecsys® Toxo IgM

Elecsys® Toxo IgM

  • Systems

    cobas e 411 analyser, cobas e 601 / cobas e 602 modules, cobas e 801 module

  • Testing Time

    18 minutes

  • Test principle

    μ-capture assay

  • Calibration

    2-point

  • Interpretation

    <0.8 COI = non-reactive
    0.8≤ COI <1.0 = gray zone
    ≥1.0 COI = reactive    

  • Traceability

    This method has been standardised against a Roche standard (arbitrary units)

  • Sample material

    cobas e 411 analyser, cobas e 601 / cobas e 602 modules: Serum collected using standard sampling tubes or tubes containing separating gel. Li‑heparin, K3‑EDTA and Na‑citrate plasma.  

     

    cobas e 801 module: Serum collected using standard sampling tubes or tubes containing separating gel. Li‑heparin, K2‑EDTA, K3‑EDTA and Na‑citrate plasma. Plasma tubes containing separating gel can be used.   

  • Sample volume

    10 μL cobas e 411 analyser, cobas e 601 / cobas e 602 modules
    6 μL cobas e 801 module

  • Onboard stability

    14 days for cobas e 411 analyser, cobas e 601 / cobas e 602 modules
    16 weeks for cobas e 801 module

  • Intermediate precision in positive samples

    cobas e 411 analyser: CV 2.5 – 4.6 % 
    cobas e 601 / 602 modules: CV 1.6 – 2.4 %  
    cobas e 801 module: CV 1.3 – 2.3 %

  • Relative sensitivity

    95.3 % (n = 170) lower 95 % C.I.: 91.7 %
    98.8 % (n = 84) lower 95 % C.I.: 94.4 %    

  • Relative specificity

    98.9 % (n = 602) lower 95 % C.I.: 97.8 %
    99.7 % (n = 295) lower 95 % C.I.: 98.4 %    

References

 

  1. Montoya, J.G. et. al. (2004). Lancet 363, 1965-1976.
  2. Remington, J.S. et al. (2006). Infectious Diseases of the Fetus and Newborn Infant (Sixth Edition). Philadelphia: W.B. Saunders, 947-1091.