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Interlaboratory agreement of coccidioidomycosis enzyme immunoassay from two different manufacturers.
Med Mycol. 2019 Jun 01; 57(4):441-446.MM

Abstract

Coccidioidomycosis, a fungal infection endemic to the Southwestern United States, is challenging to diagnose. The coccidioidomycosis enzyme immunoassay (EIA) test is the least expensive and simplest to perform to detect coccidioidomycosis antibodies in the serum. Concerns regarding falsely positive immunoglobulin (Ig) M EIA test results have led to questions about the agreement of commercially available EIA test kits among laboratories. We sought to evaluate the laboratory agreement of the EIA test at three laboratories using both IMMY and Meridian EIA test kits. Sensitivity and specificity of EIA IgM and IgG were calculated as secondary outcomes. The percent agreement of the EIA IgM and IgG test results among all three laboratories was 90% and 89% for IMMY test kits, respectively, and 67% and 80.5% for Meridian test kits, respectively. Agreement between IgM and IgG combined test results was 85.5% and 70.5%, for IMMY and Meridian, respectively. Combined IgM and IgG assays demonstrated a sensitivity of 68% (62.7%-76%) and a specificity of 99.3% (98%-100%) [IMMY] and a sensitivity of 72.4% (57.3%-87.3%) and a specificity of 91.3% (74%-100%) [Meridian]. In summary, results from the IMMY EIA test kit agreed more often across laboratories than Meridian EIA results, especially for the IgM assay. Isolated positive IgM EIA results using the Meridian test kit should be interpreted with caution and consideration of clinical information and test methodology. Further study of the sensitivity and specificity of coccidioidomycosis EIA test kits is warranted.

Authors+Show Affiliations

University of Arizona School of Medicine, Phoenix, Arizona, USA.Laboratory Sciences of Arizona/Sonora Quest Laboratories, Banner Health, Phoenix, Arizona, USA.Kern County Public Health Laboratory Services, Bakersfield, California, USA.Kern Medical Center, Bakersfield, California, USA.Laboratory Sciences of Arizona/Sonora Quest Laboratories, Banner Health, Phoenix, Arizona, USA.Maricopa County Department of Public Health, Phoenix, Arizona, USA.Maricopa County Department of Public Health, Phoenix, Arizona, USA.Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.Arizona Department of Health Services, Phoenix, Arizona, USA.Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.Kern Medical Center, Bakersfield, California, USA.Maricopa County Department of Public Health, Phoenix, Arizona, USA.Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.Maricopa County Department of Public Health, Phoenix, Arizona, USA. Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

30085141

Citation

Khan, Soofia, et al. "Interlaboratory Agreement of Coccidioidomycosis Enzyme Immunoassay From Two Different Manufacturers." Medical Mycology, vol. 57, no. 4, 2019, pp. 441-446.
Khan S, Saubolle MA, Oubsuntia T, et al. Interlaboratory agreement of coccidioidomycosis enzyme immunoassay from two different manufacturers. Med Mycol. 2019;57(4):441-446.
Khan, S., Saubolle, M. A., Oubsuntia, T., Heidari, A., Barbian, K., Goodin, K., Eguchi, M., McCotter, O. Z., Komatsu, K., Park, B. J., Geiger, M. C., Mohamed, A., Chiller, T., & Sunenshine, R. H. (2019). Interlaboratory agreement of coccidioidomycosis enzyme immunoassay from two different manufacturers. Medical Mycology, 57(4), 441-446. https://doi.org/10.1093/mmy/myy059
Khan S, et al. Interlaboratory Agreement of Coccidioidomycosis Enzyme Immunoassay From Two Different Manufacturers. Med Mycol. 2019 Jun 1;57(4):441-446. PubMed PMID: 30085141.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Interlaboratory agreement of coccidioidomycosis enzyme immunoassay from two different manufacturers. AU - Khan,Soofia, AU - Saubolle,Michael A, AU - Oubsuntia,Terry, AU - Heidari,Arash, AU - Barbian,Kelly, AU - Goodin,Kate, AU - Eguchi,Megan, AU - McCotter,Orion Z, AU - Komatsu,Kenneth, AU - Park,Benjamin J, AU - Geiger,Matthew Casey, AU - Mohamed,Ahmed, AU - Chiller,Tom, AU - Sunenshine,Rebecca H, PY - 2018/03/05/received PY - 2018/05/04/revised PY - 2018/07/13/accepted PY - 2018/8/8/pubmed PY - 2019/4/30/medline PY - 2018/8/8/entrez KW - Coccidioidomycosis KW - enzyme immunoassay KW - laboratory KW - serology SP - 441 EP - 446 JF - Medical mycology JO - Med Mycol VL - 57 IS - 4 N2 - Coccidioidomycosis, a fungal infection endemic to the Southwestern United States, is challenging to diagnose. The coccidioidomycosis enzyme immunoassay (EIA) test is the least expensive and simplest to perform to detect coccidioidomycosis antibodies in the serum. Concerns regarding falsely positive immunoglobulin (Ig) M EIA test results have led to questions about the agreement of commercially available EIA test kits among laboratories. We sought to evaluate the laboratory agreement of the EIA test at three laboratories using both IMMY and Meridian EIA test kits. Sensitivity and specificity of EIA IgM and IgG were calculated as secondary outcomes. The percent agreement of the EIA IgM and IgG test results among all three laboratories was 90% and 89% for IMMY test kits, respectively, and 67% and 80.5% for Meridian test kits, respectively. Agreement between IgM and IgG combined test results was 85.5% and 70.5%, for IMMY and Meridian, respectively. Combined IgM and IgG assays demonstrated a sensitivity of 68% (62.7%-76%) and a specificity of 99.3% (98%-100%) [IMMY] and a sensitivity of 72.4% (57.3%-87.3%) and a specificity of 91.3% (74%-100%) [Meridian]. In summary, results from the IMMY EIA test kit agreed more often across laboratories than Meridian EIA results, especially for the IgM assay. Isolated positive IgM EIA results using the Meridian test kit should be interpreted with caution and consideration of clinical information and test methodology. Further study of the sensitivity and specificity of coccidioidomycosis EIA test kits is warranted. SN - 1460-2709 UR - https://www.unboundmedicine.com/medline/citation/30085141/Interlaboratory_agreement_of_coccidioidomycosis_enzyme_immunoassay_from_two_different_manufacturers_ L2 - https://academic.oup.com/mmy/article-lookup/doi/10.1093/mmy/myy059 DB - PRIME DP - Unbound Medicine ER -