TY - JOUR
T1 - Evaluation of the Bio-Rad BioPlex 2200 Toxoplasma gondii IgM Multiplex Flow Immunoassay
AU - Theel, Elitza S.
AU - Yarbrough, Melanie L.
AU - Hilgart, Heather
AU - Gronowski, Ann M.
N1 - Publisher Copyright:
© 2018 American Association for Clinical Chemistry.
PY - 2019/5/1
Y1 - 2019/5/1
N2 - Background: Toxoplasmosis is routinely diagnosed through detection of Toxoplasma gondii-specific antibodies. However, the imperfect specificity of T. gondii serologic assays is a well-recognized limitation. The new BioPlex 2200 (Bio-Rad Laboratories) T. gondii, rubella, and cytomegalovirus (ToRC) IgM multiplex flow immunoassay (MFI) received FDA clearance in May 2017. We evaluated the clinical performance of the new T. gondii IgM and existing IgG portion of this MFI. Methods: Three hundred prospectively collected consecutive, residual sera, submitted for T. gondii serologic testing as part of routine clinical care, and an archived set of 52 residual sera previously positive for anti-T. gondii IgM and IgG with the predicate ADVIA Centaur Toxoplasma IgM and IgG assays (Siemens) were evaluated. Performance of the BioPlex 2200 T. gondii IgM and IgG MFIs was assessed by calculating positive (PPA) and negative percent agreement (NPA) compared to the Centaur tests. Results: Among prospective specimens, the BioPlex 2200 T. gondii IgM and IgG MFIs demonstrated a PPA of 0% (0/7) and 82.3% (28/34) and NPA of 99.3% (288/290) and 95.8% (251/262), respectively, with the Centaur assays. Chart review of the 7 Centaur T. gondii IgM-positive samples revealed that these were likely falsely positive. Among archived samples, the BioPlex 2200 T. gondii IgM and IgG MFIs showed PPAs of 90.4% (47/52) and 100% (52/52), respectively. Conclusions: The BioPlex 2200 T. gondii IgM and IgG MFIs demonstrated excellent concordance with the Centaur assays. The T. gondii IgM MFI may provide higher specificity in low-prevalence populations.
AB - Background: Toxoplasmosis is routinely diagnosed through detection of Toxoplasma gondii-specific antibodies. However, the imperfect specificity of T. gondii serologic assays is a well-recognized limitation. The new BioPlex 2200 (Bio-Rad Laboratories) T. gondii, rubella, and cytomegalovirus (ToRC) IgM multiplex flow immunoassay (MFI) received FDA clearance in May 2017. We evaluated the clinical performance of the new T. gondii IgM and existing IgG portion of this MFI. Methods: Three hundred prospectively collected consecutive, residual sera, submitted for T. gondii serologic testing as part of routine clinical care, and an archived set of 52 residual sera previously positive for anti-T. gondii IgM and IgG with the predicate ADVIA Centaur Toxoplasma IgM and IgG assays (Siemens) were evaluated. Performance of the BioPlex 2200 T. gondii IgM and IgG MFIs was assessed by calculating positive (PPA) and negative percent agreement (NPA) compared to the Centaur tests. Results: Among prospective specimens, the BioPlex 2200 T. gondii IgM and IgG MFIs demonstrated a PPA of 0% (0/7) and 82.3% (28/34) and NPA of 99.3% (288/290) and 95.8% (251/262), respectively, with the Centaur assays. Chart review of the 7 Centaur T. gondii IgM-positive samples revealed that these were likely falsely positive. Among archived samples, the BioPlex 2200 T. gondii IgM and IgG MFIs showed PPAs of 90.4% (47/52) and 100% (52/52), respectively. Conclusions: The BioPlex 2200 T. gondii IgM and IgG MFIs demonstrated excellent concordance with the Centaur assays. The T. gondii IgM MFI may provide higher specificity in low-prevalence populations.
UR - http://www.scopus.com/inward/record.url?scp=85072623693&partnerID=8YFLogxK
U2 - 10.1373/jalm.2018.026906
DO - 10.1373/jalm.2018.026906
M3 - Article
C2 - 31639693
AN - SCOPUS:85072623693
SN - 2576-9456
VL - 3
SP - 1022
EP - 1027
JO - The journal of applied laboratory medicine
JF - The journal of applied laboratory medicine
IS - 6
ER -