Superiority of a novel Mp1p antigen detection enzyme immunoassay compared to standard BACTEC blood culture in the diagnosis of talaromycosis.

Thu, Nguyen TM

Chan, Jasper FW

Ly, Vo Trieu

Ngo, Hoa T

Hien, Ha TA

Lan, Nguyen PH

Chau, Nguyen VV

Cai, Jian-Piao

Woo, Patrick CY

Day, Jeremy N

van Doorn, Rogier

Thwaites, Guy

Perfect, John

Yuen, Kwok

Le, Thuy

2020-08-03T22:50:22Z

2020-08-03T22:50:22Z

2020-06-21

2020-08-03T22:50:21Z

BACKGROUND:Talaromycosis is an invasive mycosis endemic in Southeast Asia and causes substantial morbidity and mortality in individuals with advanced HIV disease. Current diagnosis relies on isolating Talaromyces marneffei in cultures, which takes up to 14 days and is detectable only during late-stage infection, leading to high mortality. METHODS:In this retrospective case-control study, we assessed the accuracy of a novel Mp1p antigen-detecting enzyme immunoassay (EIA) in stored plasma samples of 372 patients who had culture-proven talaromycosis from blood or sterile body fluids(reference standard) and of 517 individuals without talaromycosis (338 healthy volunteers; 179 with other infections). All participants were recruited between 2011-2017 in Vietnam. RESULTS:66.1% and 75.4% of cases and controls were male; the median age was 33 and 37, respectively. All cases were HIV-infected; median CD4 count was 10 cells/mm3. At an optical density cut-off of 0.5, the specificity was 98.1% (95% CI: 96.3%-99.0%); the sensitivity was superior to blood culture, 86.3% (95% CI: 82.3%-89.5%) versus 72.8% (95% CI: 68.0%-77.2%), P<0.001, McNemar test. The time-to-diagnosis was 6 hours versus 6.6 ± 3.0 days for blood culture. Paired plasma and urine testing in the same patients (N=269) significantly increased sensitivity compared to testing plasma alone P<0.001, or testing urine alone P=0.02, McNemar tests. CONCLUSIONS:The Mp1p EIA is highly specific and is superior in sensitivity and time-to-diagnosis compared to blood culture for the diagnosis of talaromycosis. Paired plasma and urine testing further increases sensitivity, introducing a new tool for rapid diagnosis, enabling early treatment and potentially reducing mortality.

5860475

1058-4838

1537-6591

https://hdl.handle.net/10161/21279

eng

Oxford University Press (OUP)

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

10.1093/cid/ciaa826

Mp1p enzyme immunoassay

Penicillium marneffei

Talaromyces marneffei

Talaromycosis

penicilliosis

Superiority of a novel Mp1p antigen detection enzyme immunoassay compared to standard BACTEC blood culture in the diagnosis of talaromycosis.

Journal article

Perfect, John|0000-0002-6606-9460|0000-0003-3465-5518

Le, Thuy|0000-0002-3393-6580

School of Medicine

Molecular Genetics and Microbiology

Medicine, Infectious Diseases

Duke

Basic Science Departments

Medicine

Clinical Science Departments

Duke Global Health Institute

University Institutes and Centers

Institutes and Provost's Academic Units

Published