scholarly journals Validation and Concordance Analysis of a New Lateral Flow Assay for Detection of Histoplasma Antigen in Urine

2021 ◽  
Vol 7 (10) ◽  
pp. 799
Author(s):  
Diego H. Cáceres ◽  
Beatriz L. Gómez ◽  
Ángela M. Tobón ◽  
Melissa Minderman ◽  
Nicole Bridges ◽  
...  

Histoplasmosis is a major cause of mortality in people living with HIV (PLHIV). Rapid methods to diagnose Histoplasma capsulatum disease could dramatically decrease the time to initiate treatment, resulting in reduced mortality. The aim of this study was to validate a MiraVista® Diagnostics (MVD) Histoplasma urine antigen lateral flow assay (MVD LFA) for the detection of H. capsulatum antigen (Ag) in urine and compare this LFA against the MVista® Histoplasma Ag quantitative enzyme immunoassays (MVD EIA). We assessed the MVD LFA using a standardized reference panel of urine specimens from Colombia. We tested 100 urine specimens, 26 from PLHIV diagnosed with histoplasmosis, 42 from PLHIV with other infectious diseases, and 32 from non-HIV infected persons without histoplasmosis. Sensitivity and specificity of the MVD LFA was 96%, compared with 96% sensitivity and 77% specificity of the MVD EIA. Concordance analysis between MVD LFA and the MVD EIA displayed an 84% agreement, and a Kappa of 0.656. The MVD LFA evaluated in this study has several advantages, including a turnaround time for results of approximately 40 min, no need for complex laboratory infrastructure or highly trained laboratory personnel, use of urine specimens, and ease of performing.

2020 ◽  
Vol 58 (11) ◽  
Author(s):  
Matthew A. Hevey ◽  
Ige A. George ◽  
Adriana M. Rauseo ◽  
Lindsey Larson ◽  
William Powderly ◽  
...  

ABSTRACT Cryptococcal epidemiology is shifting toward HIV-negative populations who have diverse presentations. Cryptococcal antigen (CrAg) testing is also changing, with development of the lateral flow assay (LFA) having reported increased sensitivity and specificity, but with minimal knowledge in the HIV-negative population. In this study, we evaluate the real-life performance of CrAg testing in patients with cryptococcal disease. We conducted a retrospective review of patients with cryptococcosis from 2002 to 2019 at Barnes-Jewish Hospital. Latex agglutination (LA) was used exclusively until April 2016, at which point LFA was used exclusively. Demographics, presentations, and testing outcomes were evaluated. Serum CrAg testing was completed in 227 patients with cryptococcosis. Of 141 HIV-negative patients, 107 had LA testing and 34 had LFA testing. In patients with disseminated disease, serum CrAg sensitivity by LA was 78.1% compared to 82.6% for LFA. In patients with localized pulmonary disease, serum CrAg sensitivity was 23.5% compared to 90.9% for LFA. Of 86 people living with HIV (PLWH), 76 had LA testing, and 10 had LFA testing. Serum CrAg sensitivity for LA was 94.7% compared to 100% for LFA in patients with disseminated disease. We noted a significant improvement in sensitivity from LA testing to LFA testing, predominantly in those with localized pulmonary disease. However, both LFA and LA appear to be less sensitive in HIV-negative patients than previously described in PLWH.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S141-S141
Author(s):  
Wesley J Candelaria

Abstract Background Coccidioidomycosis (Valley fever) is an airborne, invasive fungal infection endemic to Arizona, California, Mexico, and Central and South America. The dominant method of diagnosis is serology, which includes complement fixation (CF), immunodiffusion (ID), and enzyme immunoassay (EIA). These serological assays require highly trained personnel and are time consuming, with turnaround times (TAT) that range anywhere from 5 days to 2+ weeks. Due to costs of send outs and long TAT, Valley fever presents a diagnostic challenge to physicians and laboratorians. IMMY developed the sōna Coccidioides Antibody Lateral Flow Assay (LFA), a rapid and simple diagnostic assay that detects anti-Coccidioides antibodies in patient serum in 30 minutes. Methods We tested the sōna Coccidioides antibody LFA using 315 patient specimens and compared cost-analysis and TAT to a send out reference lab’s ID and CF assays. Results In this study, we found that after implementing the sōna Coccidioides Antibody LFA as a screening test, the cost of send-outs reduced by 84%, and the cost of all testing reduced by 68%. The TAT for sending out testing averaged 5–10 days, whereas the sōna Coccidioides Antibody LFA averaged a total TAT of <24 hours. Conclusion The sōna Coccidioides Antibody LFA offers a rapid, simple, and inexpensive method for accurately detecting antibodies against Coccidioides spp. in patient serum. Disclosures All authors: No reported disclosures.


2018 ◽  
Vol 56 (6) ◽  
Author(s):  
Diego H. Cáceres ◽  
Blanca E. Samayoa ◽  
Narda G. Medina ◽  
Angela M. Tobón ◽  
Brenda J. Guzmán ◽  
...  

ABSTRACTHistoplasmosis is an important cause of mortality in patients with AIDS, especially in countries with limited access to antiretroviral therapies and diagnostic tests. However, many disseminated infections in Latin America go undiagnosed. A simple, rapid method to detectHistoplasma capsulatuminfection in regions where histoplasmosis is endemic would dramatically decrease the time to diagnosis and treatment, reducing morbidity and mortality. The aim of this study was to validate a commercial monoclonalHistoplasmagalactomannan (HGM) enzyme-linked immunosorbent assay (Immuno-Mycologics [IMMY], Norman, OK, USA) in two cohorts of people living with HIV/AIDS (PLHIV). We analyzed urine samples from 589 people (466 from Guatemala and 123 from Colombia), including 546 from PLHIV and 43 from non-PLHIV controls. Sixty-three of these people (35 from Guatemala and 28 from Colombia) had confirmed histoplasmosis by isolation ofH. capsulatum. Using the standard curve provided by the quantitative commercial test, the sensitivity was 98% (95% confidence interval [CI], 95 to 100%) and the specificity was 97% (95% CI, 96 to 99%) (cutoff = 0.5 ng/ml). Semiquantitative results, using a calibrator of 12.5 ng/ml ofHistoplasmagalactomannan to calculate an enzyme immunoassay index value (EIV) for the samples, showed a sensitivity of 95% (95% CI, 89 to 100%) and a specificity of 98% (95% CI, 96 to 99%) (cutoff ≥ 2.6 EIV). This relatively simple-to-perform commercial antigenuria test showed a high performance with reproducible results in both countries, suggesting that it can be used to detect progressive disseminated histoplasmosis in PLHIV in a wide range of clinical laboratories in countries where histoplasmosis is endemic.


2021 ◽  
Vol 2021 (8) ◽  
Author(s):  
Ruvandhi R Nathavitharana ◽  
Philip Lederer ◽  
Marty Chaplin ◽  
Stephanie Bjerrum ◽  
Karen R Steingart ◽  
...  

2021 ◽  
Vol 7 (6) ◽  
pp. 481
Author(s):  
Spinello Antinori ◽  
Andrea Giacomelli ◽  
Mario Corbellino ◽  
Alessandro Torre ◽  
Marco Schiuma ◽  
...  

Human histoplasmosis is a mycosis caused by two distinct varieties of a dimorphic fungus: Histoplasma capsulatum var. capsulatum and H. capsulatum var. duboisii. In Europe, it is usually imported by migrants and travellers, although there have been some autochthonous cases, especially in Italy; however, most European physicians are unfamiliar with its clinical and pathological picture, particularly among immunocompromised patients without HIV infection. This systematic review of all the cases of histoplasmosis reported in Europe and Israel between 2005 and 2020 identified 728 cases diagnosed in 17 European countries and Israel described in 133 articles. The vast majority were imported (mainly from Central and South America), but there were also seven autochthonous cases (six in Europe and one in Israel). The patients were prevalently males (60.4%), and their ages ranged from 2 to 86 years. The time between leaving an endemic region and the diagnosis of histoplasmosis varied from a few weeks to more than 40 years. Progressive disseminated histoplasmosis was the most frequent clinical picture among people living with HIV infection (89.5%) or a different immunocompromising condition (57.1%), but it was also recorded in 6.2% of immunocompetent patients. Twenty-eight cases were caused by Histoplasma duboisii. Immunocompromised patients without HIV infection had the worst outcomes, with a mortality rate of 32%.


2015 ◽  
Vol 49 (0) ◽  
Author(s):  
Delsa Nagata ◽  
Eliana Battaggia Gutierrez

ABSTRACT OBJECTIVE: To analyze whether sociodemographic characteristics, consultations and care in special services are associated with scheduled infectious diseases appointments missed by people living with HIV. METHODS: This cross-sectional and analytical study included 3,075 people living with HIV who had at least one scheduled appointment with an infectologist at a specialized health unit in 2007. A secondary data base from the Hospital Management & Information System was used. The outcome variable was missing a scheduled medical appointment. The independent variables were sex, age, appointments in specialized and available disciplines, hospitalizations at the Central Institute of the Clinical Hospital at the Faculdade de Medicina of the Universidade de São Paulo, antiretroviral treatment and change of infectologist. Crude and multiple association analysis were performed among the variables, with a statistical significance of p ≤ 0.05. RESULTS: More than a third (38.9%) of the patients missed at least one of their scheduled infectious diseases appointments; 70.0% of the patients were male. The rate of missed appointments was 13.9%, albeit with no observed association between sex and absences. Age was inversely associated to missed appointment. Not undertaking anti-retroviral treatment, having unscheduled infectious diseases consultations or social services care and being hospitalized at the Central Institute were directly associated to missed appointments. CONCLUSIONS: The Hospital Management & Information System proved to be a useful tool for developing indicators related to the quality of health care of people living with HIV. Other informational systems, which are often developed for administrative purposes, can also be useful for local and regional management and for evaluating the quality of care provided for patients living with HIV.


Author(s):  
Stephanie Bjerrum ◽  
Ian Schiller ◽  
Nandini Dendukuri ◽  
Mikashmi Kohli ◽  
Ruvandhi R Nathavitharana ◽  
...  

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