Evaluation of a <i>Histoplasma</i> antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS

Cáceres, Diego H.; Gómez, Beatriz L.; Tobón, Ángela M.; Chiller, Tom; Lindsley, Mark D.

doi:10.1111/myc.13023

Cited by 45 publications

(49 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…al. [16] recently reported the performance of this test in serum of 75 PLWHIV with suspected histoplasmosis, 24 of them with proven-PDH. They found a sensitivity of 96% and specificity of 90%, by visual reading; while, with the use of an automated reader, the sensitivity and specificity were 92% and 94%, respectively.…”

Section: Plos Neglected Tropical Diseasesmentioning

confidence: 99%

“…[14] Two of the commercially available assays were recently validated, one of them (clarus Histoplasma GM Enzyme Immunoassay) showed a sensitivity and specificity of 98% and 97%, respectively when tested in urine samples from HIV patients, [15] while the other [MiraVista Histoplasma Urine Antigen LFA] showed a sensitivity and specificity of 92% and 94%, respectively when serum samples from patients with HIV and suspected PDH were analyzed. [16] Among the molecular tests for the diagnosis of histoplasmosis, the Hcp100 (H. capsulatum protein 100 kDa) nested PCR has been widely used by different authors and has shown a sensitivity of up to 100% and a specificity of 92�4%. [17] Another recently described PCR directed to the genetic sequence called 1281−1283 220 SCAR in H. capsulatum [18], was evaluated together with Hcp100 nested PCR and real-time quantitative PCR (qPCR) for the ITS1 region of the rDNA.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico

et al. 2021

View full text Add to dashboard Cite

Background The progressive disseminated histoplasmosis (PDH) has been associated with severe disease and high risk of death among people living with HIV (PLWHIV). Therefore, the purpose of this multicenter, prospective, double-blinded study done in ten Mexican hospitals was to determine the diagnostic accuracy of detecting Histoplasma capsulatum antigen in urine using the IMMY ALPHA Histoplasma EIA kit (IAHE), clarus Histoplasma GM Enzyme Immunoassay (cHGEI IMMY) and MiraVista Histoplasma Urine Antigen LFA (MVHUALFA); as well as the Hcp100 and 1281-1283220SCAR nested PCRs in blood, bone-marrow, tissue biopsies and urine. Methodology/Principal findings We included 415 PLWHIV older than 18 years of age with suspicion of PDH. Using as diagnostic standard recovery of H. capsulatum in blood, bone marrow or tissue cultures, or histopathological exam compatible, detected 108 patients (26%, [95%CI, 21.78–30.22]) with proven-PDH. We analyzed 391 urine samples by the IAHE, cHGEI IMMY and MVHUALFA; the sensitivity/specificity values obtained were 67.3% (95% CI, 57.4–76.2) / 96.2% (95% CI, 93.2–98.0) for IAHE, 91.3% (95% CI, 84.2–96.0) / 90.9% (95% CI, 87.0–94.0) for cHGEI IMMY and 90.4% (95% CI, 83.0–95.3) / 92.3% (95% CI, 88.6–95.1) for MVHUALFA. The Hcp100 nested PCR was performed on 393, 343, 75 and 297, blood, bone marrow, tissue and urine samples respectively; the sensitivity/specificity values obtained were 62.9% (95%CI, 53.3–72.5)/ 89.5% (95%CI, 86.0–93.0), 65.9% (95%CI, 56.0–75.8)/ 89.0% (95%CI, 85.2–92.9), 62.1% (95%CI, 44.4–79.7)/ 82.6% (95%CI, 71.7–93.6) and 34.9% (95%CI, 24.8–46.2)/ 67.3% (95%CI, 60.6–73.5) respectively; and 1281-1283220SCAR nested PCR was performed on 392, 344, 75 and 291, respectively; the sensitivity/specificity values obtained were 65.3% (95% CI, 55.9–74.7)/ 58.8% (95%CI, 53.2–64.5), 70.8% (95%CI, 61.3–80.2)/ 52.9% (95%CI, 46.8–59.1), 71.4% (95%CI, 54.7–88.2)/ 40.4% (95%CI, 26.4–54.5) and 18.1% (95%CI, 10.5–28.1)/ 90.4% (95%CI, 85.5–94.0), respectively. Conclusions/Significance The cHGEI IMMY and MVHUALFA tests showed excellent performance for the diagnosis of PDH in PLWHIV. The integration of these tests in clinical laboratories will certainly impact on early diagnosis and treatment.

show abstract

Section: Plos Neglected Tropical Diseasesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico

et al. 2021

View full text Add to dashboard Cite

show abstract

“…Histoplasma antigen serum lateral flow assay developed at MiraVista Diagnostics was evaluated showing a sensitivity of 95.8% (23 of 24) and a specificity of 90.2% (46 of 51). 77 Serum specimens were stored from culture-proven cases enrolled in a prospective study from May 2008 to August 2011 in Medellin, Columbia. The LFA was performed at the Centers for Disease Control in 2019.…”

Section: Antigen Detectionmentioning

confidence: 99%

<p>HIV-Associated Histoplasmosis: Current Perspectives</p>

Myint¹,

Leedy²,

Cari³

et al. 2020

HIV

View full text Add to dashboard Cite

Histoplasmosis is an endemic mycosis caused by Histoplasma capsulatum. Infection develops by inhalation of microconidia from environmental sites inhabited by birds and bats. Disseminated disease is the usual presentation due to impaired cellular immunity. Common clinical manifestations include fever, fatigue, malaise, anorexia, weight loss, and respiratory symptoms. Histoplasma antigen detection is the most sensitive method for diagnosis. The sensitivity of the MVista ® Quantitative Histoplasma antigen enzyme immunoassay is 95-100% in urine, over 90% in serum and bronchoalveolar lavage (BAL) antigen and 78% in cerebral spinal fluid (CSF). A proven diagnosis can be established by culture or pathology with sensitivities between 70% and 80%. The sensitivity of antibody detection by immunodiffusion or complement fixation was between 60% and 70%. Diagnosis using molecular methods has not been adequately validated for implementation and FDA cleared assays are unavailable. Liposomal amphotericin B should be used for 1-2 weeks followed by itraconazole for at least one year until CD4 counts are above 150 cells/mm3, HIV viral load is below 400 copies/mL and Histoplasma urine antigen is negative. Serum itraconazole level should be monitored to avoid drug toxicity. Antigen should be measured periodically to establish that treatment is effective and to assist in identifying relapse. The incidence of immune reconstitution inflammatory syndrome is low but it must be considered in patients who are thought to be failing antifungal treatment as it does not respond to changing antifungal agents but rather to initiation of corticosteroid therapy. In this review, we discuss pathogenesis, clinical manifestations, diagnosis and treatment based on personal experience and relevant publications.

show abstract

“…A Colombian group is working on the development of an IGRA-based assay with promising preliminary results, and a huge potential for the diagnosis of subclinical infections regardless of the immune status of the host (Rubio-Carrasquilla et al, 2019); more results are awaited. A lateral flow device (LFD) for the detection of Histoplasma antigen in serum has been developed recently showing an excellent sensitivity, and extensive validation in non-progressive disseminated cases is expected (Cáceres et al, 2019). Molecular test might be part of the diagnostic armamentarium in settings where clinicians and laboratory personnel are not familiar with this pathogen.…”

Section: Future Directions and Conclusionmentioning

confidence: 99%

Timely Diagnosis of Histoplasmosis in Non-endemic Countries: A Laboratory Challenge

Buitrago

Martín-Gómez

2020

Front. Microbiol.

View full text Add to dashboard Cite

Human histoplasmosis is a fungal infection caused by the inhalation of microconidia of the thermally dimorphic fungi Histoplasma capsulatum. Autochthonous cases of histoplasmosis have been diagnosed in almost every country, but it is considered an endemic infection in specific areas of the world. Many of them are popular travel destinations or the source of migratory movements. Thus, the vast majority of the registered cases in non-endemic countries are imported. They correspond to people having been exposed to the fungus in endemic locations as immigrants, expatriates, transient workers or tourists, with reported cases also associated to organ donation. Misdiagnosis and delays in initiation of treatment are not uncommon in cases of imported histoplasmosis. They are associated to high fatality-rates specially in patients with compromised cellular immunity in which progressive disseminated forms develop. The diagnosis of this infection in non-endemic countries is hampered by the lack of clinical suspicion and a dearth of available diagnostic tools adequate to offer rapid and accurate results. Non-culture-based assays such as nucleic-acid amplification tests present as a suitable alternative in this situation, offering improved sensitivity and specificity, shortened turnaround time, and increased biosafety by avoiding culture manipulation. In non-endemic regions, molecular techniques are being used mainly in laboratories from countries that have registered an increase in the incidence of imported cases. However, the number of published techniques is limited and lack consensus. Efforts are currently under way to standardize nucleic acid amplificationbased techniques for its implementation in areas registering a rising number of imported cases.

show abstract

Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS

Cited by 45 publications

References 14 publications

Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico

Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico

<p>HIV-Associated Histoplasmosis: Current Perspectives</p>

Timely Diagnosis of Histoplasmosis in Non-endemic Countries: A Laboratory Challenge

Contact Info

Product

Resources

About