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Diagnostic Laboratory Immunology

Large-Scale Evaluation of the Immuno-Mycologics Lateral Flow and Enzyme-Linked Immunoassays for Detection of Cryptococcal Antigen in Serum and Cerebrospinal Fluid

Jessica Hansen, E. Susan Slechta, Marcellene A. Gates-Hollingsworth, Brandon Neary, Adam P. Barker, Sean Bauman, Thomas R. Kozel, Kimberly E. Hanson
Jessica Hansen
aARUP Laboratories, Salt Lake City, Utah, USA
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E. Susan Slechta
aARUP Laboratories, Salt Lake City, Utah, USA
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Marcellene A. Gates-Hollingsworth
bDepartment of Microbiology and Immunology, University of Nevada School of Medicine, Reno, Nevada, USA
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Brandon Neary
cImmuno-Mycologics Inc., Norman, Oklahoma, USA
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Adam P. Barker
dDepartment of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA
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Sean Bauman
cImmuno-Mycologics Inc., Norman, Oklahoma, USA
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Thomas R. Kozel
bDepartment of Microbiology and Immunology, University of Nevada School of Medicine, Reno, Nevada, USA
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Kimberly E. Hanson
dDepartment of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA
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DOI: 10.1128/CVI.00536-12
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    Fig 1

    MAb binding patterns for purified GXM (A) and discordant patient specimens (B). Refer to Materials and Methods for a detailed description of the anti-GXM EIA. MAb, monoclonal antibody; GXM, glucuronoxylomannan.

Tables

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  • Table 1

    Qualitative test results

    IMMY test resultNo. of samples with Meridian EIA result
    CSFSerum
    PositiveNegativePositiveNegative
    IMMY LFA results
        Positive1514121
        Negative03950527
    IMMY EIA results
        Positive1524119
        Negative03940529
  • Table 2

    Qualitative assay agreement

    Comparison and agreement% AgreementKappa value (95% CI)
    Meridian EIA vs IMMY LFA97.80.82 (0.75–0.9)
        Positive agreement71.8
        Negative agreement97.7
    Meridian EIA vs IMMY EIA98.00.84 (0.77–0.91)
        Positive agreement73.7
        Negative agreement97.9
    IMMY LFA vs IMMY EIA99.70.98 (0.96–1.00)
        Positive agreement97.4
        Negative agreement99.9
  • Table 3

    Discrepant specimen resultsa

    Specimen ID no.SourceIMMY LFA resultLFA titerIMMY EIA resultEIA titerMeridian EIA resultIMMY latex test resultLatex test titerGXM serotype
    058SerumPOS<1:5POS1:5NEGQNSNANA
    804SerumPOS1:44POS1:40NEGQNSNANA
    122SerumPOS1:35POS1:40NEGQNSNANA
    104SerumPOS1:14POS1:5NEGQNSNANA
    953SerumPOS1:17POS1:5NEGQNSNANA
    207SerumPOS1:59POS1:80NEGQNSNANA
    749SerumPOS<1:5POS1:5NEGQNSNANA
    894SerumPOS<1:5POS1:5NEGQNSNANA
    046SerumPOS<1:5POS1:5NEGQNSNANA
    520SerumPOS1:14POS1:5NEGQNSNANA
    806SerumPOSQNSPOS1:20NEGQNSNANA
    309SerumNEGNAPOS1:5NEGQNSNANA
    777CSFPOSQNSNEGNANEGNEGNANA
    287SerumPOS1:12POS1:5NEGPOSQNSC-like
    028SerumPOS<1:5POS1:5NEGPOS1:2INDETERM
    603SerumPOS1:86POS1:40INDETERMPOS1:32C-like
    963CSFPOS1:10POS1:5NEGNEGNAINDETERM
    050SerumPOS1:27POS1:10INDETERMPOS1:8INCONb
    497SerumPOS1:105POS1:320NEGPOS1:32C-like
    378SerumPOS<1:5POS1:5NEGPOS<1.2INDETERM
    161SerumNEGNAPOS1:5NEGNEGNAINDETERM
    780SerumPOS<1:5POS1:10NEGPOS<1:2INDETERM
    785SerumPOS1:62POS1:320NEGPOS1:128C-like
    • ↵a Abbreviations: POS, positive; NEG, negative; NA, not applicable; QNS, quantity of the specimen was not sufficient for repeat testing; INDETERM, indeterminate; INCON, inconclusive; GXM, glucuronoxylomannan.

    • ↵b MAb reactivity was not typical of patterns observed with GXM from the four major serotypes.

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Large-Scale Evaluation of the Immuno-Mycologics Lateral Flow and Enzyme-Linked Immunoassays for Detection of Cryptococcal Antigen in Serum and Cerebrospinal Fluid
Jessica Hansen, E. Susan Slechta, Marcellene A. Gates-Hollingsworth, Brandon Neary, Adam P. Barker, Sean Bauman, Thomas R. Kozel, Kimberly E. Hanson
Clinical and Vaccine Immunology Jan 2013, 20 (1) 52-55; DOI: 10.1128/CVI.00536-12

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Large-Scale Evaluation of the Immuno-Mycologics Lateral Flow and Enzyme-Linked Immunoassays for Detection of Cryptococcal Antigen in Serum and Cerebrospinal Fluid
Jessica Hansen, E. Susan Slechta, Marcellene A. Gates-Hollingsworth, Brandon Neary, Adam P. Barker, Sean Bauman, Thomas R. Kozel, Kimberly E. Hanson
Clinical and Vaccine Immunology Jan 2013, 20 (1) 52-55; DOI: 10.1128/CVI.00536-12
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