Comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay: importance of storage conditions
Introduction: Galactomannan antigen is a valuable biomarker for diagnosing invasive aspergillosis. Traditional methods, such as enzyme immunoassays (EIA), require batch sampling, whereas lateral flow assays (LFA) provide a simpler and faster diagnostic process. This study aimed to compare the diagn...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
The Journal of Infection in Developing Countries
2025-04-01
|
| Series: | Journal of Infection in Developing Countries |
| Subjects: | |
| Online Access: | https://jidc.org/index.php/journal/article/view/20587 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850187602615861248 |
|---|---|
| author | Enes Erbağcı Ayşe Ö Mete Handan H Şahin Yasemin Zer İlkay Karaoğlan |
| author_facet | Enes Erbağcı Ayşe Ö Mete Handan H Şahin Yasemin Zer İlkay Karaoğlan |
| author_sort | Enes Erbağcı |
| collection | DOAJ |
| description |
Introduction: Galactomannan antigen is a valuable biomarker for diagnosing invasive aspergillosis. Traditional methods, such as enzyme immunoassays (EIA), require batch sampling, whereas lateral flow assays (LFA) provide a simpler and faster diagnostic process. This study aimed to compare the diagnostic efficacy of both testing methods.
Methodology: This prospective case-control study involved 192 serum samples categorized according to the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG criteria). LFA were conducted following the manufacturer’s instructions, utilizing a cube reader. Receiver operating characteristic (ROC) analysis was performed to determine the optimal LFA threshold, and concordance analysis was conducted for both assays.
Results: The indicated sensitivity and specificity of LFA at the recommended galactomannan index threshold (GMI ≥ 0.5) were 15.3% (9/59) and 99% (132/133), respectively. Post-ROC analysis at a threshold of 0.4 revealed an area under the curve (AUC) of 0.685, with sensitivity, specificity, positive predictive value, and negative predictive value at 18%, 99%, 91%, and 73%, respectively. Qualitative agreement between the tests, assessed using the Kappa statistic, indicated a very low degree of agreement (κ = 0.18). In contrast, quantitative agreement, evaluated through Kendall’s W-test, demonstrated a very high degree of agreement (W = 0.84).
Conclusions: Despite previous literature suggesting the efficacy of LFA, our study found it unsuitable for screening due to its low sensitivity. We recommend exercising caution regarding the manufacturer's storage recommendations until further studies on sample storage conditions are conducted.
|
| format | Article |
| id | doaj-art-38419e2aed084ca78172588848a8d6a5 |
| institution | OA Journals |
| issn | 1972-2680 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | The Journal of Infection in Developing Countries |
| record_format | Article |
| series | Journal of Infection in Developing Countries |
| spelling | doaj-art-38419e2aed084ca78172588848a8d6a52025-08-20T02:16:03ZengThe Journal of Infection in Developing CountriesJournal of Infection in Developing Countries1972-26802025-04-01190410.3855/jidc.20587Comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay: importance of storage conditionsEnes Erbağcı0Ayşe Ö Mete1Handan H Şahin2Yasemin Zer3İlkay Karaoğlan4Ağrı Training and Research Hospital, İnfectious Diseases, Ağrı, TurkeyGaziantep University Faculty of Medicine, İnfectious Diseases, Gaziantep, TurkeyLiv Hospital Gaziantep, Hematology, Gaziantep, TurkeyGaziantep University Faculty of Medicine, Medical Microbiology, Gaziantep, TurkeyGaziantep University Faculty of Medicine, İnfectious Diseases, Gaziantep, Turkey Introduction: Galactomannan antigen is a valuable biomarker for diagnosing invasive aspergillosis. Traditional methods, such as enzyme immunoassays (EIA), require batch sampling, whereas lateral flow assays (LFA) provide a simpler and faster diagnostic process. This study aimed to compare the diagnostic efficacy of both testing methods. Methodology: This prospective case-control study involved 192 serum samples categorized according to the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG criteria). LFA were conducted following the manufacturer’s instructions, utilizing a cube reader. Receiver operating characteristic (ROC) analysis was performed to determine the optimal LFA threshold, and concordance analysis was conducted for both assays. Results: The indicated sensitivity and specificity of LFA at the recommended galactomannan index threshold (GMI ≥ 0.5) were 15.3% (9/59) and 99% (132/133), respectively. Post-ROC analysis at a threshold of 0.4 revealed an area under the curve (AUC) of 0.685, with sensitivity, specificity, positive predictive value, and negative predictive value at 18%, 99%, 91%, and 73%, respectively. Qualitative agreement between the tests, assessed using the Kappa statistic, indicated a very low degree of agreement (κ = 0.18). In contrast, quantitative agreement, evaluated through Kendall’s W-test, demonstrated a very high degree of agreement (W = 0.84). Conclusions: Despite previous literature suggesting the efficacy of LFA, our study found it unsuitable for screening due to its low sensitivity. We recommend exercising caution regarding the manufacturer's storage recommendations until further studies on sample storage conditions are conducted. https://jidc.org/index.php/journal/article/view/20587aspergillosisAspergillusdiagnosisgalactomannanserum |
| spellingShingle | Enes Erbağcı Ayşe Ö Mete Handan H Şahin Yasemin Zer İlkay Karaoğlan Comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay: importance of storage conditions Journal of Infection in Developing Countries aspergillosis Aspergillus diagnosis galactomannan serum |
| title | Comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay: importance of storage conditions |
| title_full | Comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay: importance of storage conditions |
| title_fullStr | Comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay: importance of storage conditions |
| title_full_unstemmed | Comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay: importance of storage conditions |
| title_short | Comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay: importance of storage conditions |
| title_sort | comparison of diagnostic efficacy of galactomannan lateral flow assay vs enzyme immunoassay importance of storage conditions |
| topic | aspergillosis Aspergillus diagnosis galactomannan serum |
| url | https://jidc.org/index.php/journal/article/view/20587 |
| work_keys_str_mv | AT eneserbagcı comparisonofdiagnosticefficacyofgalactomannanlateralflowassayvsenzymeimmunoassayimportanceofstorageconditions AT ayseomete comparisonofdiagnosticefficacyofgalactomannanlateralflowassayvsenzymeimmunoassayimportanceofstorageconditions AT handanhsahin comparisonofdiagnosticefficacyofgalactomannanlateralflowassayvsenzymeimmunoassayimportanceofstorageconditions AT yaseminzer comparisonofdiagnosticefficacyofgalactomannanlateralflowassayvsenzymeimmunoassayimportanceofstorageconditions AT ilkaykaraoglan comparisonofdiagnosticefficacyofgalactomannanlateralflowassayvsenzymeimmunoassayimportanceofstorageconditions |