Evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of China
ObjectiveThis study aimed to assess the efficacy of innovative Chemiluminescence Immunoassay (CLIA) in testing Cryptococcal Antigen (CrAg) across two medical centers, employing the FDA-approved CrAg Lateral Flow Assay (LFA) by IMMY as a reference standard.MethodsThe study encompassed patients diagno...
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Frontiers Media S.A.
2024-11-01
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| Series: | Frontiers in Cellular and Infection Microbiology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcimb.2024.1451539/full |
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| author | Zhuo-Yun Tang Ping Xu Zhong-Hao Wang Ting-Ting Wang Dan Zhou Ke-Ping Ao Hua-Feng Song Xiao-Yun Yin Dong-Dong Li |
| author_facet | Zhuo-Yun Tang Ping Xu Zhong-Hao Wang Ting-Ting Wang Dan Zhou Ke-Ping Ao Hua-Feng Song Xiao-Yun Yin Dong-Dong Li |
| author_sort | Zhuo-Yun Tang |
| collection | DOAJ |
| description | ObjectiveThis study aimed to assess the efficacy of innovative Chemiluminescence Immunoassay (CLIA) in testing Cryptococcal Antigen (CrAg) across two medical centers, employing the FDA-approved CrAg Lateral Flow Assay (LFA) by IMMY as a reference standard.MethodsThe study encompassed patients diagnosed with cryptococcosis at West China Hospital of Sichuan University (HX) between July 2022 and May 2023, and Suzhou Fifth People’s Hospital (SZ) from September 2020 to September 2023. All specimens underwent simultaneous detection using the LFA (IMMY, Norman, USA) and CLIA (Chuanglan, Suzhou, China).ResultsA total of 628 patients were enrolled, revealing a remarkable 99.20% concordance between LFA and CLIA (623/628, 99.20%). The LFA exhibited a sensitivity of 96.83% (244/252) and specificity of 98.35% (179/182). Among the 42 patients with unaltered CrAg titers, the changes of Signal-to-Cut-Off ratio (ΔS/CO) results exhibited a noteworthy discrepancy, with 71.43% (30/42) demonstrating a decreasing trend in ΔS/CO of at least 10%.ConclusionsThe CLIA method demonstrated commendable specificity and sensitivity, exhibiting a high level of agreement with the FDA-approved LFA method. Additionally, CLIA demonstrated superior utility for treatment monitoring compared to LFA, offering continuous insight into the fluctuation of CrAg concentrations. |
| format | Article |
| id | doaj-art-80fe2109b2ea42569289ee85ea259eb9 |
| institution | OA Journals |
| issn | 2235-2988 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cellular and Infection Microbiology |
| spelling | doaj-art-80fe2109b2ea42569289ee85ea259eb92025-08-20T01:54:15ZengFrontiers Media S.A.Frontiers in Cellular and Infection Microbiology2235-29882024-11-011410.3389/fcimb.2024.14515391451539Evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of ChinaZhuo-Yun Tang0Ping Xu1Zhong-Hao Wang2Ting-Ting Wang3Dan Zhou4Ke-Ping Ao5Hua-Feng Song6Xiao-Yun Yin7Dong-Dong Li8Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Clinical Laboratory, The Fifth People’s Hospital of Suzhou, Infectious Disease Hospital Affiliated to Soochow University, Suzhou, Jiangsu, ChinaDepartment of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Clinical Laboratory, The Fifth People’s Hospital of Suzhou, Infectious Disease Hospital Affiliated to Soochow University, Suzhou, Jiangsu, ChinaDepartment of Clinical Laboratory, The Fifth People’s Hospital of Suzhou, Infectious Disease Hospital Affiliated to Soochow University, Suzhou, Jiangsu, ChinaDepartment of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaObjectiveThis study aimed to assess the efficacy of innovative Chemiluminescence Immunoassay (CLIA) in testing Cryptococcal Antigen (CrAg) across two medical centers, employing the FDA-approved CrAg Lateral Flow Assay (LFA) by IMMY as a reference standard.MethodsThe study encompassed patients diagnosed with cryptococcosis at West China Hospital of Sichuan University (HX) between July 2022 and May 2023, and Suzhou Fifth People’s Hospital (SZ) from September 2020 to September 2023. All specimens underwent simultaneous detection using the LFA (IMMY, Norman, USA) and CLIA (Chuanglan, Suzhou, China).ResultsA total of 628 patients were enrolled, revealing a remarkable 99.20% concordance between LFA and CLIA (623/628, 99.20%). The LFA exhibited a sensitivity of 96.83% (244/252) and specificity of 98.35% (179/182). Among the 42 patients with unaltered CrAg titers, the changes of Signal-to-Cut-Off ratio (ΔS/CO) results exhibited a noteworthy discrepancy, with 71.43% (30/42) demonstrating a decreasing trend in ΔS/CO of at least 10%.ConclusionsThe CLIA method demonstrated commendable specificity and sensitivity, exhibiting a high level of agreement with the FDA-approved LFA method. Additionally, CLIA demonstrated superior utility for treatment monitoring compared to LFA, offering continuous insight into the fluctuation of CrAg concentrations.https://www.frontiersin.org/articles/10.3389/fcimb.2024.1451539/fullcryptococcal antigencryptococcosischemiluminescence assay (CLIA)lateral flow assay (LFA)diagnostic performancetreatment monitoring |
| spellingShingle | Zhuo-Yun Tang Ping Xu Zhong-Hao Wang Ting-Ting Wang Dan Zhou Ke-Ping Ao Hua-Feng Song Xiao-Yun Yin Dong-Dong Li Evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of China Frontiers in Cellular and Infection Microbiology cryptococcal antigen cryptococcosis chemiluminescence assay (CLIA) lateral flow assay (LFA) diagnostic performance treatment monitoring |
| title | Evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of China |
| title_full | Evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of China |
| title_fullStr | Evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of China |
| title_full_unstemmed | Evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of China |
| title_short | Evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of China |
| title_sort | evaluation of cryptococcal antigen testing using a novel chemiluminescence assay in two medical centers of china |
| topic | cryptococcal antigen cryptococcosis chemiluminescence assay (CLIA) lateral flow assay (LFA) diagnostic performance treatment monitoring |
| url | https://www.frontiersin.org/articles/10.3389/fcimb.2024.1451539/full |
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