干旱区生态环境知识资源中心(Arid): Clinical Laboratory Utility of a Humanized Antibody in Commercially Available Enzyme Immunoassays for Coccidioidomycosis

Arid

DOI	10.1128/spectrum.02573-22
	Clinical Laboratory Utility of a Humanized Antibody in Commercially Available Enzyme Immunoassays for Coccidioidomycosis
	Grill, Francisca J.; Jugler, Collin; Kaleta, Erin; Chen, Qiang; Magee, D. Mitchell; Grys, Thomas E.; Lake, Douglas F.; Carvalho, Agostinho; Fierer, Joshua
通讯作者	Lake, DF
来源期刊	MICROBIOLOGY SPECTRUM
ISSN	2165-0497
出版年	2022
卷号	10 期号:5
英文摘要	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. 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.
英文关键词	coccidioidomycosis diagnostic enzyme immunoassay CLIA monoclonal antibodies
类型	Article
语种	英语
开放获取类型	Green Published, gold
收录类别	SCI-E
WOS记录号	WOS:000859649200001
WOS关键词	COMPLEMENT-FIXATION ANTIGEN ; CHITINASE ; DIAGNOSIS ; CLONING ; UPDATE
WOS类目	Microbiology
WOS研究方向	Microbiology
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/393787
推荐引用方式 GB/T 7714	Grill, Francisca J.,Jugler, Collin,Kaleta, Erin,et al. Clinical Laboratory Utility of a Humanized Antibody in Commercially Available Enzyme Immunoassays for Coccidioidomycosis[J],2022,10(5).
APA	Grill, Francisca J..,Jugler, Collin.,Kaleta, Erin.,Chen, Qiang.,Magee, D. Mitchell.,...&Fierer, Joshua.(2022).Clinical Laboratory Utility of a Humanized Antibody in Commercially Available Enzyme Immunoassays for Coccidioidomycosis.MICROBIOLOGY SPECTRUM,10(5).
MLA	Grill, Francisca J.,et al."Clinical Laboratory Utility of a Humanized Antibody in Commercially Available Enzyme Immunoassays for Coccidioidomycosis".MICROBIOLOGY SPECTRUM 10.5(2022).