Clinical Laboratory Utility of a Humanized Antibody in Commercially Available Enzyme Immunoassays for Coccidioidomycosis.
Clinical Laboratory Utility of a Humanized Antibody in Commercially Available Enzyme Immunoassays for Coccidioidomycosis.
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DOI：
10.1128/spectrum.02573-22
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发表时间：
2022-10-26
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
球孢子菌病，也称为山谷热（VF），是一种在美国西部沙漠地区以及中美洲和南美洲某些干旱地区流行的真菌感染。VF的诊断通常依赖于三种血清学诊断的综合结果：补体结合、免疫扩散和酶免疫测定（EIA）。EIA通常在临床实验室进行，因为可以在几个小时内获得结果。两种市售EIA，IMMY clarus Coccidioides antibody和Meridian Premier Coccidioides，在1：441稀释的患者血清中寻找抗球虫IgG和IgM的存在。根据法规要求，该稀释步骤必须使用稀释步骤对照进行验证，尽管未作为FDA批准的EIA试剂盒中的试剂提供。因此，临床实验室收集并在随后的测试中重复使用在先前测试中具有阳性结果的患者血清。这是一个非标准的过程，加强了对一致和可靠的稀释控制的需求。在此，我们评估了人源化IgG和IgM抗体作为两种EIA试剂盒中稀释对照的性能。人源化IgG和IgM两者在每个EIA中都很好地起作用，并且满足适当的阳性阈值。在美国西南部和西部地区，每年至少有50万例球孢子菌病（山谷热）的诊断试验。酶免疫测定（EIA）是血液测试，需要在测试前精确稀释患者血清。为确保患者血清得到适当稀释，法规要求确保稀释步骤准确。两种FDA批准的用于辅助诊断球孢子菌病的EIA不包含该稀释步骤的对照，使得临床实验室只能选择使用先前阳性的患者血清，其可能不会以可靠或可预测的方式反应。在这里，我们评估了一个人源化的单克隆抗体抗球虫抗原和其效用作为稀释控制在两个可用的商业EIA。人源化单克隆抗体的使用提供了标准化和充分表征的稀释对照，用于辅助诊断球孢子菌病的血清学测定。
Coccidioidomycosis, also called valley fever (VF), is a fungal infection with endemicity in desert regions of the western United States as well as certain arid regions of Central and South America. Laboratory-based diagnosis of VF often relies on the composite results from three serologic-based diagnostics, complement fixation, immunodiffusion, and enzyme immunoassay (EIA). EIA is commonly performed in clinical laboratories because results can be obtained in a few hours. Two commercially available EIAs, IMMY clarus Coccidioides antibody and Meridian Premier Coccidioides, look for the presence of anticoccidioidal IgG and IgM in patient sera that are diluted 1:441. Per regulatory requirements, this dilution step must be verified with a dilution step control despite not being provided as a reagent in either FDA-approved EIA kit. Therefore, clinical laboratories collect and reuse patient sera in subsequent tests that had a positive result in a previous test. This is a nonstandard process, reinforcing the need for a consistent and reliable dilution control. Here, we evaluate the performance of a humanized IgG and IgM antibody as a dilution control in both EIA kits. Both humanized IgG and IgM work well in each EIA and meet the appropriate threshold for positivity. IMPORTANCE In southwestern and western regions of the United States, at least half a million diagnostic tests for coccidioidomycosis (valley fever) are run annually. Enzyme immunoassays (EIAs) are blood tests which require precise dilution of patient serum prior to testing. To ensure patient serum is properly diluted, there is a regulatory requirement to ensure the dilution step is accurate. Two FDA-approved EIAs used to aid in the diagnosis of coccidioidomycosis do not contain controls for this dilution step, leaving clinical laboratories with the only option of using previously positive patient sera, which may not react in a reliable or predictable manner. Here, we evaluate a humanized monoclonal antibody against a coccidioidal antigen and its utility as a dilution control in both available commercial EIAs. The use of a humanized monoclonal antibody provides a standardized and well-characterized dilution control for use in serological assays that aid in diagnosis of coccidioidomycosis.
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影响因子：
3.1
作者：
JOHNSON, SM;PAPPAGIANIS, D
通讯作者：
PAPPAGIANIS, D
影响因子：
15.8
作者：
Hector RF;Laniado-Laborin R
通讯作者：
Laniado-Laborin R
DOI：
10.1016/j.diagmicrobio.2020.115198
发表时间：
2021-01-01
影响因子：
2.9
作者：
Peng, Tao;Zong, Yue;Galgiani, John N.
通讯作者：
Galgiani, John N.
影响因子：
5.5
作者：
Blair, Janis E.;Coakley, Brandon;Wengenack, Nancy L.
通讯作者：
Wengenack, Nancy L.
影响因子：
12.7
作者：
SMITH, CE;BEARD, RR;ROSENBERGER, HG
通讯作者：
ROSENBERGER, HG