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Comparative Study
. 2025 Aug 1;19(8):e0013248.
doi: 10.1371/journal.pntd.0013248. eCollection 2025 Aug.

Comparative performance of a commercial and in-house Mp1p antigen-detecting enzyme immunoassay for the rapid diagnosis of talaromycosis

Joseph Barwatt  1 , Lottie Brown  2   3 , Nguyen Thi Mai Thu  1 , Paula Gonzalez  1 , Sruthi Venugopalan  4 , Heera Natesan Sambath  1 , Ngo Thi Hoa  5   6   7 , Jian-Piao Cai  8 , Kwok-Yung Yuen  8   9 , Jasper Fuk-Woo Chan  8   9 , Vo Trieu Ly  10 , Thuy Le  1   5
Affiliations
Comparative Study

Comparative performance of a commercial and in-house Mp1p antigen-detecting enzyme immunoassay for the rapid diagnosis of talaromycosis

Joseph Barwatt et al. PLoS Negl Trop Dis. .

Abstract

Background: Several antigen-detection assays have been developed for the rapid diagnosis of talaromycosis, but their utility has been limited by a lack of commercial options. The aim of this study was to perform a head-to-head comparison of the performance of our in-house monoclonal antibody-based Mp1p antigen-detecting enzyme immunoassay (EIA) with its recently-developed commercial platform.

Methods: In this diagnostic accuracy, retrospective, case-cohort study, we compared the sensitivity, specificity, positive likelihood ratio (LR+) and negative likelihood ratio (LR-) of the commercial Wantai Mp1p EIA versus our in-house Mp1p EIA on paired plasma and urine samples from 424 hospitalized adults with advanced HIV disease, including 224 cases of proven talaromycosis, where Talaromyces marneffei was isolated in culture of blood or other clinical specimens, and 200 controls diagnosed with a range of other opportunistic infections. All participants were randomly selected from prospective cohorts recruited between 2011 and 2019 from five centers in Vietnam.

Results: The sensitivity of the Wantai and in-house Mp1p EIAs were comparable in plasma (95.1% vs 92.4%, P = 0.11), in urine (91.5% vs 87.1% P = 0.07), and in combined testing of plasma and urine (96.4% vs 96.0%, P = 1.00), where talaromycosis was diagnosed based on the positivity of either specimen. The specificity of the Wantai and in-house Mp1p EIAs were consistently high in plasma, in urine, and in combined testing (93 - 97%). The Wantai and in-house Mp1p EIAs provided substantially higher sensitivity than blood culture detection (96.4% and 96.0% vs 78.6%, P < 0.001). For both EIAs, LR+ were greater than 10 and LR- were less than 0.1, which increases the confidence to rule in or rule out talaromycosis.

Conclusions: The diagnostic performance of the Wantai Mp1p EIA was comparable to our validated in-house Mp1p EIA, and significantly more sensitive than blood culture, offering a standardized tool for the rapid diagnosis of talaromycosis.

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Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: TL has received investigator-initiated research grant from Gilead Science. No other authors disclose any competing interestings.

Figures

Fig 1
Fig 1. Flow diagram of participant selection.
Cases included 154 participants from the Itraconazole versus Amphotericin for Penicillosis (IVAP) trial plus 70 participants from the prospective talaromycosis screening cohort study. All cases had culture-proven talaromycosis. Controls included 200 participants from the prospective talaromycosis screening study who demonstrated no clinical or culture evidence of talaromycosis over a 6-month follow up period. Paired plasma and urine specimens were available for all included participants. Cases and controls were randomly selected from batches of cases and controls based on availability of sample aliquot and volume without knowledge of clinical and laboratory characteristics of patients. Abbreviations: PcP, Pneumocystis pneumonia; spp, species; TB, tuberculosis.
Fig 2
Fig 2. The diagnostic performance of the Wantai versus in-house Mp1p enzyme immunoassays (EIA) in plasma.
(2A) The optical density (OD) distribution of 224 cases and 200 controls evaluated by the Wantai Mp1p EIA (red) vs the in-house Mp1p EIA (blue) in plasma. The median OD was significantly higher in cases compared with controls in both assays (P < 0.001). (2B) Receiver Operative Curve (ROC) for the Wantai Mp1p EIA (red) vs the in-house Mp1p EIA (blue). Area under curve (AUC) of the Wantai Mp1p EIA is similar to in-house Mp1p EIA, 96.0% vs 96.5% (P = 0.66) (DeLong’s test). Abbreviations: 95% CI, 95% confidence interval; AUC, area under curve; OD450, optical density at a wavelength of 450 nanometers.
Fig 3
Fig 3. The diagnostic performance of the Wantai and in-house Mp1p EIA in urine.
(3A) The optical density (OD) distribution of 224 cases and 200 controls from the Wantai (red) and the in-house Mp1p EIA (blue) on plasma. The median OD was significantly higher in cases compared with controls in both assays (P < 0.001). (3B) Receiver Operative Curve (ROC) for the Wantai Mp1p EIA (red) and the in-house Mp1p EIA (blue). Test accuracy or area under the curve (AUC) of the Wantai Mp1p EIA is similar to the in-house Mp1p EIA, 92.5% vs 95.4% (P = 0.06) (DeLong’s test). Abbreviations: 95% CI, 95% confidence interval; AUC, area under curve; OD450, optical density at a wavelength of 450 nanometers.
Fig 4
Fig 4. Venn diagram demonstrating the diagnostic yield of the Wantai and in-house Mp1p EIA on paired plasma and urine samples.
The Wantai EIA detected 96.4% of cases (216/224) and the in-house Mp1p EIA detected 96.0% of cases of talaromycosis. Abbreviations: + , positive; -, negative.
See this image and copyright information in PMC

References

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