การประเมินการตรวจ Galactomannan Antigen ด้วยวิธี ELISA  และ CLIA

Thipaporn Jaroonsirimaneekul; Prinya Prasongdee; Naphitta  Bausri; Sumalai  Dechyotin; Papawadee  Hongart; Yotsombat  Changtrakul; Chanpen Sriphan; Kutcharin  Phunikhom

doi:10.64960/srimedj.v41i2.266790

Authors

Thipaporn Jaroonsirimaneekul Department of Immunology and Clinical Chemistry, Srinagarind hospital, Faculty of Medicine, Khon Kaen university.
Prinya Prasongdee Srinagarind Laboratory Excellent Center, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University.
Naphitta Bausri Department of Immunology and Clinical Chemistry, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University.
Sumalai Dechyotin Srinagarind Laboratory Excellent Center, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University.
Papawadee Hongart Department of Immunology and Clinical Chemistry, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University.
Yotsombat Changtrakul Department of Diagnostic Microscopy, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University.
Chanpen Sriphan Medical Laboratory, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University.
Kutcharin Phunikhom Department of Pharmacology, Faculty of Medicine, Khon Kaen University.

DOI:

https://doi.org/10.64960/srimedj.v41i2.266790

Keywords:

invasive aspergillosis, Aspergillus galactomannan antigen, ELISA, CLIA

Abstract

Background and Objective: Invasive Aspergillus spp. has a high mortality rate. Early-stage diagnosis is crucial for effective treatment. This study aimed to compare the detection results of Aspergillus galactomannan antigen between two methods: enzyme-linked immunoassay (ELISA) by Analyzer I-2P and chemiluminescence immunoassay (CLIA) by VirClia® monotest.

Methods: A total of 22 samples were tested for Aspergillus galactomannan antigen according to the specific interpretation criteria of each platform. Statistical differences were analyzed using Fisher’s exact test and Chi-square test. Specificity and the degree of agreement (concordance) were also evaluated.

Results: ELISA yielded 3 positive and 19 negative results. In comparison, CLIA produced 3 positive, 17 negative, and 2 equivocal (borderline) results. Statistical analysis via Fisher’s exact and Chi-square tests showed no significant differences between the two methods, with p-values of 0.561 and 0.508, respectively (p > 0.05). The specificity was 89.4%, and the overall agreement was 81.8%, which is considered a good level of concordance.

Conclusions: The comparison between ELISA and CLIA for Aspergillus galactomannan antigen detection showed no statistically significant differences. Both methods demonstrated good specificity and agreement. Clinical application of these test results should be interpreted in conjunction with the patient’s clinical symptoms.

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