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

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...

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Veröffentlicht in:PLoS neglected tropical diseases 2021-03, Vol.15 (3), p.e0009215-e0009215
Hauptverfasser: Martínez-Gamboa, Areli, Niembro-Ortega, María Dolores, Torres-González, Pedro, Santiago-Cruz, Janeth, Velázquez-Zavala, Nancy Guadalupe, Rangel-Cordero, Andrea, Crabtree-Ramírez, Brenda, Gamboa-Domínguez, Armando, Reyes-Gutiérrez, Edgardo, Reyes-Terán, Gustavo, Lozano-Fernandez, Víctor Hugo, Ahumada-Topete, Víctor Hugo, Martínez-Ayala, Pedro, Manríquez-Reyes, Marisol, Ramírez-Hinojosa, Juan Pablo, Rodríguez-Zulueta, Patricia, Hernández-León, Christian, Ruíz-Quiñones, Jesús, Rivera-Martínez, Norma Eréndira, Chaparro-Sánchez, Alberto, Andrade-Villanueva, Jaime, González-Hernández, Luz Alicia, Cruz-Martínez, Sofia, Flores-Barrientos, Oscar, Gaytán-Martínez, Jesús Enrique, Magaña-Aquino, Martín, Cervantes-Sánchez, Axel, Olivas-Martínez, Antonio, Araujo-Meléndez, Javier, Del Rocío Reyes-Montes, María, Duarte-Escalante, Esperanza, Frías-De León, María Guadalupe, Ramírez, José Antonio, Taylor, María Lucia, de León-Garduño, Alfredo Ponce, Sifuentes-Osornio, José
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container_issue 3
container_start_page e0009215
container_title PLoS neglected tropical diseases
container_volume 15
creator Martínez-Gamboa, Areli
Niembro-Ortega, María Dolores
Torres-González, Pedro
Santiago-Cruz, Janeth
Velázquez-Zavala, Nancy Guadalupe
Rangel-Cordero, Andrea
Crabtree-Ramírez, Brenda
Gamboa-Domínguez, Armando
Reyes-Gutiérrez, Edgardo
Reyes-Terán, Gustavo
Lozano-Fernandez, Víctor Hugo
Ahumada-Topete, Víctor Hugo
Martínez-Ayala, Pedro
Manríquez-Reyes, Marisol
Ramírez-Hinojosa, Juan Pablo
Rodríguez-Zulueta, Patricia
Hernández-León, Christian
Ruíz-Quiñones, Jesús
Rivera-Martínez, Norma Eréndira
Chaparro-Sánchez, Alberto
Andrade-Villanueva, Jaime
González-Hernández, Luz Alicia
Cruz-Martínez, Sofia
Flores-Barrientos, Oscar
Gaytán-Martínez, Jesús Enrique
Magaña-Aquino, Martín
Cervantes-Sánchez, Axel
Olivas-Martínez, Antonio
Araujo-Meléndez, Javier
Del Rocío Reyes-Montes, María
Duarte-Escalante, Esperanza
Frías-De León, María Guadalupe
Ramírez, José Antonio
Taylor, María Lucia
de León-Garduño, Alfredo Ponce
Sifuentes-Osornio, José
description 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. 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. 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.
doi_str_mv 10.1371/journal.pntd.0009215
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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. 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. 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.</description><identifier>ISSN: 1935-2735</identifier><identifier>ISSN: 1935-2727</identifier><identifier>EISSN: 1935-2735</identifier><identifier>DOI: 10.1371/journal.pntd.0009215</identifier><identifier>PMID: 33684128</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Accuracy ; Acquired immune deficiency syndrome ; AIDS ; Analysis ; Antigens ; Aspartate aminotransferase ; Biology and Life Sciences ; Biopsy ; Bleeding ; Body weight ; Body weight loss ; Bone marrow ; Care and treatment ; Cholecystitis ; Consortia ; Deoxyribonucleic acid ; Diagnosis ; Diagnostic systems ; Diarrhea ; Disease ; DNA ; Enzyme immunoassay ; Enzymes ; Epididymitis ; Ethical standards ; Ethics ; Ferritin ; Fever ; Fungal infections ; Fungi ; Heart ; Hemoglobin ; Histopathology ; Histoplasmosis ; HIV ; HIV patients ; Human immunodeficiency virus ; Immunoassay ; Immunoassays ; Laboratories ; Lesions ; Leukocytes (neutrophilic) ; Lymphadenopathy ; Markers ; Medical testing products ; Medicine and Health Sciences ; Mycosis ; Observers ; Pancreatitis ; Pancytopenia ; Patients ; Physiological aspects ; Platelets ; Polymerase chain reaction ; Prostate ; Protocols ; Research and Analysis Methods ; Skin diseases ; Spleen ; Splenomegaly ; Testing ; Tropical diseases ; Tuberculosis ; Ulcers ; Urine ; Weight loss ; Yeasts</subject><ispartof>PLoS neglected tropical diseases, 2021-03, Vol.15 (3), p.e0009215-e0009215</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Martínez-Gamboa et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Martínez-Gamboa et al 2021 Martínez-Gamboa et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c624t-d3c053c0936cc324a277a8979a6742f1f79e6230982544d68d590f2cc07f1ae03</citedby><cites>FETCH-LOGICAL-c624t-d3c053c0936cc324a277a8979a6742f1f79e6230982544d68d590f2cc07f1ae03</cites><orcidid>0000-0002-0905-0835 ; 0000-0002-0505-6340 ; 0000-0002-2279-1558 ; 0000-0003-2640-2916 ; 0000-0002-3160-8698 ; 0000-0001-5395-6418 ; 0000-0003-2613-4878 ; 0000-0003-1948-655X ; 0000-0001-5094-7890 ; 0000-0002-4609-4415 ; 0000-0002-1983-0384 ; 0000-0001-9822-3496 ; 0000-0002-7163-0566 ; 0000-0002-6315-7860 ; 0000-0003-2779-0068 ; 0000-0001-9584-1360 ; 0000-0002-6716-1234 ; 0000-0002-3866-9995 ; 0000-0001-5011-5939 ; 0000-0002-2587-1123 ; 0000-0002-3773-613X ; 0000-0002-9545-2522 ; 0000-0002-3723-333X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7971897/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7971897/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2100,2926,23865,27923,27924,53790,53792,79371,79372</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33684128$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Gonzalez, Angel</contributor><creatorcontrib>Martínez-Gamboa, Areli</creatorcontrib><creatorcontrib>Niembro-Ortega, María Dolores</creatorcontrib><creatorcontrib>Torres-González, Pedro</creatorcontrib><creatorcontrib>Santiago-Cruz, Janeth</creatorcontrib><creatorcontrib>Velázquez-Zavala, Nancy Guadalupe</creatorcontrib><creatorcontrib>Rangel-Cordero, Andrea</creatorcontrib><creatorcontrib>Crabtree-Ramírez, Brenda</creatorcontrib><creatorcontrib>Gamboa-Domínguez, Armando</creatorcontrib><creatorcontrib>Reyes-Gutiérrez, Edgardo</creatorcontrib><creatorcontrib>Reyes-Terán, Gustavo</creatorcontrib><creatorcontrib>Lozano-Fernandez, Víctor Hugo</creatorcontrib><creatorcontrib>Ahumada-Topete, Víctor Hugo</creatorcontrib><creatorcontrib>Martínez-Ayala, Pedro</creatorcontrib><creatorcontrib>Manríquez-Reyes, Marisol</creatorcontrib><creatorcontrib>Ramírez-Hinojosa, Juan Pablo</creatorcontrib><creatorcontrib>Rodríguez-Zulueta, Patricia</creatorcontrib><creatorcontrib>Hernández-León, Christian</creatorcontrib><creatorcontrib>Ruíz-Quiñones, Jesús</creatorcontrib><creatorcontrib>Rivera-Martínez, Norma Eréndira</creatorcontrib><creatorcontrib>Chaparro-Sánchez, Alberto</creatorcontrib><creatorcontrib>Andrade-Villanueva, Jaime</creatorcontrib><creatorcontrib>González-Hernández, Luz Alicia</creatorcontrib><creatorcontrib>Cruz-Martínez, Sofia</creatorcontrib><creatorcontrib>Flores-Barrientos, Oscar</creatorcontrib><creatorcontrib>Gaytán-Martínez, Jesús Enrique</creatorcontrib><creatorcontrib>Magaña-Aquino, Martín</creatorcontrib><creatorcontrib>Cervantes-Sánchez, Axel</creatorcontrib><creatorcontrib>Olivas-Martínez, Antonio</creatorcontrib><creatorcontrib>Araujo-Meléndez, Javier</creatorcontrib><creatorcontrib>Del Rocío Reyes-Montes, María</creatorcontrib><creatorcontrib>Duarte-Escalante, Esperanza</creatorcontrib><creatorcontrib>Frías-De León, María Guadalupe</creatorcontrib><creatorcontrib>Ramírez, José Antonio</creatorcontrib><creatorcontrib>Taylor, María Lucia</creatorcontrib><creatorcontrib>de León-Garduño, Alfredo Ponce</creatorcontrib><creatorcontrib>Sifuentes-Osornio, José</creatorcontrib><title>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</title><title>PLoS neglected tropical diseases</title><addtitle>PLoS Negl Trop Dis</addtitle><description>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. 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. 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.</description><subject>Accuracy</subject><subject>Acquired immune deficiency syndrome</subject><subject>AIDS</subject><subject>Analysis</subject><subject>Antigens</subject><subject>Aspartate aminotransferase</subject><subject>Biology and Life Sciences</subject><subject>Biopsy</subject><subject>Bleeding</subject><subject>Body weight</subject><subject>Body weight loss</subject><subject>Bone marrow</subject><subject>Care and treatment</subject><subject>Cholecystitis</subject><subject>Consortia</subject><subject>Deoxyribonucleic acid</subject><subject>Diagnosis</subject><subject>Diagnostic systems</subject><subject>Diarrhea</subject><subject>Disease</subject><subject>DNA</subject><subject>Enzyme immunoassay</subject><subject>Enzymes</subject><subject>Epididymitis</subject><subject>Ethical standards</subject><subject>Ethics</subject><subject>Ferritin</subject><subject>Fever</subject><subject>Fungal infections</subject><subject>Fungi</subject><subject>Heart</subject><subject>Hemoglobin</subject><subject>Histopathology</subject><subject>Histoplasmosis</subject><subject>HIV</subject><subject>HIV patients</subject><subject>Human immunodeficiency virus</subject><subject>Immunoassay</subject><subject>Immunoassays</subject><subject>Laboratories</subject><subject>Lesions</subject><subject>Leukocytes (neutrophilic)</subject><subject>Lymphadenopathy</subject><subject>Markers</subject><subject>Medical testing products</subject><subject>Medicine and Health Sciences</subject><subject>Mycosis</subject><subject>Observers</subject><subject>Pancreatitis</subject><subject>Pancytopenia</subject><subject>Patients</subject><subject>Physiological aspects</subject><subject>Platelets</subject><subject>Polymerase chain reaction</subject><subject>Prostate</subject><subject>Protocols</subject><subject>Research and Analysis Methods</subject><subject>Skin diseases</subject><subject>Spleen</subject><subject>Splenomegaly</subject><subject>Testing</subject><subject>Tropical diseases</subject><subject>Tuberculosis</subject><subject>Ulcers</subject><subject>Urine</subject><subject>Weight 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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</title><author>Martínez-Gamboa, Areli ; Niembro-Ortega, María Dolores ; Torres-González, Pedro ; Santiago-Cruz, Janeth ; Velázquez-Zavala, Nancy Guadalupe ; Rangel-Cordero, Andrea ; Crabtree-Ramírez, Brenda ; Gamboa-Domínguez, Armando ; Reyes-Gutiérrez, Edgardo ; Reyes-Terán, Gustavo ; Lozano-Fernandez, Víctor Hugo ; Ahumada-Topete, Víctor Hugo ; Martínez-Ayala, Pedro ; Manríquez-Reyes, Marisol ; Ramírez-Hinojosa, Juan Pablo ; Rodríguez-Zulueta, Patricia ; Hernández-León, Christian ; Ruíz-Quiñones, Jesús ; Rivera-Martínez, Norma Eréndira ; Chaparro-Sánchez, Alberto ; Andrade-Villanueva, Jaime ; González-Hernández, Luz Alicia ; Cruz-Martínez, Sofia ; Flores-Barrientos, Oscar ; Gaytán-Martínez, Jesús Enrique ; Magaña-Aquino, Martín ; Cervantes-Sánchez, Axel ; Olivas-Martínez, Antonio ; Araujo-Meléndez, Javier ; Del Rocío Reyes-Montes, María ; Duarte-Escalante, Esperanza ; Frías-De León, María Guadalupe ; Ramírez, José Antonio ; Taylor, María Lucia ; de León-Garduño, Alfredo Ponce ; Sifuentes-Osornio, José</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c624t-d3c053c0936cc324a277a8979a6742f1f79e6230982544d68d590f2cc07f1ae03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Accuracy</topic><topic>Acquired immune deficiency syndrome</topic><topic>AIDS</topic><topic>Analysis</topic><topic>Antigens</topic><topic>Aspartate aminotransferase</topic><topic>Biology and Life Sciences</topic><topic>Biopsy</topic><topic>Bleeding</topic><topic>Body weight</topic><topic>Body weight loss</topic><topic>Bone marrow</topic><topic>Care and treatment</topic><topic>Cholecystitis</topic><topic>Consortia</topic><topic>Deoxyribonucleic acid</topic><topic>Diagnosis</topic><topic>Diagnostic systems</topic><topic>Diarrhea</topic><topic>Disease</topic><topic>DNA</topic><topic>Enzyme immunoassay</topic><topic>Enzymes</topic><topic>Epididymitis</topic><topic>Ethical standards</topic><topic>Ethics</topic><topic>Ferritin</topic><topic>Fever</topic><topic>Fungal infections</topic><topic>Fungi</topic><topic>Heart</topic><topic>Hemoglobin</topic><topic>Histopathology</topic><topic>Histoplasmosis</topic><topic>HIV</topic><topic>HIV patients</topic><topic>Human immunodeficiency virus</topic><topic>Immunoassay</topic><topic>Immunoassays</topic><topic>Laboratories</topic><topic>Lesions</topic><topic>Leukocytes (neutrophilic)</topic><topic>Lymphadenopathy</topic><topic>Markers</topic><topic>Medical testing products</topic><topic>Medicine and Health Sciences</topic><topic>Mycosis</topic><topic>Observers</topic><topic>Pancreatitis</topic><topic>Pancytopenia</topic><topic>Patients</topic><topic>Physiological aspects</topic><topic>Platelets</topic><topic>Polymerase chain reaction</topic><topic>Prostate</topic><topic>Protocols</topic><topic>Research and Analysis Methods</topic><topic>Skin diseases</topic><topic>Spleen</topic><topic>Splenomegaly</topic><topic>Testing</topic><topic>Tropical diseases</topic><topic>Tuberculosis</topic><topic>Ulcers</topic><topic>Urine</topic><topic>Weight loss</topic><topic>Yeasts</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Martínez-Gamboa, Areli</creatorcontrib><creatorcontrib>Niembro-Ortega, María Dolores</creatorcontrib><creatorcontrib>Torres-González, Pedro</creatorcontrib><creatorcontrib>Santiago-Cruz, Janeth</creatorcontrib><creatorcontrib>Velázquez-Zavala, Nancy Guadalupe</creatorcontrib><creatorcontrib>Rangel-Cordero, Andrea</creatorcontrib><creatorcontrib>Crabtree-Ramírez, Brenda</creatorcontrib><creatorcontrib>Gamboa-Domínguez, Armando</creatorcontrib><creatorcontrib>Reyes-Gutiérrez, 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Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PLoS neglected tropical diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Martínez-Gamboa, Areli</au><au>Niembro-Ortega, María Dolores</au><au>Torres-González, Pedro</au><au>Santiago-Cruz, Janeth</au><au>Velázquez-Zavala, Nancy Guadalupe</au><au>Rangel-Cordero, Andrea</au><au>Crabtree-Ramírez, Brenda</au><au>Gamboa-Domínguez, Armando</au><au>Reyes-Gutiérrez, Edgardo</au><au>Reyes-Terán, Gustavo</au><au>Lozano-Fernandez, Víctor Hugo</au><au>Ahumada-Topete, Víctor Hugo</au><au>Martínez-Ayala, Pedro</au><au>Manríquez-Reyes, Marisol</au><au>Ramírez-Hinojosa, Juan Pablo</au><au>Rodríguez-Zulueta, Patricia</au><au>Hernández-León, Christian</au><au>Ruíz-Quiñones, Jesús</au><au>Rivera-Martínez, Norma Eréndira</au><au>Chaparro-Sánchez, Alberto</au><au>Andrade-Villanueva, Jaime</au><au>González-Hernández, Luz Alicia</au><au>Cruz-Martínez, Sofia</au><au>Flores-Barrientos, Oscar</au><au>Gaytán-Martínez, Jesús Enrique</au><au>Magaña-Aquino, Martín</au><au>Cervantes-Sánchez, Axel</au><au>Olivas-Martínez, Antonio</au><au>Araujo-Meléndez, Javier</au><au>Del Rocío Reyes-Montes, María</au><au>Duarte-Escalante, Esperanza</au><au>Frías-De León, María Guadalupe</au><au>Ramírez, José Antonio</au><au>Taylor, María Lucia</au><au>de León-Garduño, Alfredo Ponce</au><au>Sifuentes-Osornio, José</au><au>Gonzalez, Angel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>PLoS neglected tropical diseases</jtitle><addtitle>PLoS Negl Trop Dis</addtitle><date>2021-03-01</date><risdate>2021</risdate><volume>15</volume><issue>3</issue><spage>e0009215</spage><epage>e0009215</epage><pages>e0009215-e0009215</pages><issn>1935-2735</issn><issn>1935-2727</issn><eissn>1935-2735</eissn><abstract>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. 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. 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.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33684128</pmid><doi>10.1371/journal.pntd.0009215</doi><orcidid>https://orcid.org/0000-0002-0905-0835</orcidid><orcidid>https://orcid.org/0000-0002-0505-6340</orcidid><orcidid>https://orcid.org/0000-0002-2279-1558</orcidid><orcidid>https://orcid.org/0000-0003-2640-2916</orcidid><orcidid>https://orcid.org/0000-0002-3160-8698</orcidid><orcidid>https://orcid.org/0000-0001-5395-6418</orcidid><orcidid>https://orcid.org/0000-0003-2613-4878</orcidid><orcidid>https://orcid.org/0000-0003-1948-655X</orcidid><orcidid>https://orcid.org/0000-0001-5094-7890</orcidid><orcidid>https://orcid.org/0000-0002-4609-4415</orcidid><orcidid>https://orcid.org/0000-0002-1983-0384</orcidid><orcidid>https://orcid.org/0000-0001-9822-3496</orcidid><orcidid>https://orcid.org/0000-0002-7163-0566</orcidid><orcidid>https://orcid.org/0000-0002-6315-7860</orcidid><orcidid>https://orcid.org/0000-0003-2779-0068</orcidid><orcidid>https://orcid.org/0000-0001-9584-1360</orcidid><orcidid>https://orcid.org/0000-0002-6716-1234</orcidid><orcidid>https://orcid.org/0000-0002-3866-9995</orcidid><orcidid>https://orcid.org/0000-0001-5011-5939</orcidid><orcidid>https://orcid.org/0000-0002-2587-1123</orcidid><orcidid>https://orcid.org/0000-0002-3773-613X</orcidid><orcidid>https://orcid.org/0000-0002-9545-2522</orcidid><orcidid>https://orcid.org/0000-0002-3723-333X</orcidid><oa>free_for_read</oa></addata></record>
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subjects Accuracy
Acquired immune deficiency syndrome
AIDS
Analysis
Antigens
Aspartate aminotransferase
Biology and Life Sciences
Biopsy
Bleeding
Body weight
Body weight loss
Bone marrow
Care and treatment
Cholecystitis
Consortia
Deoxyribonucleic acid
Diagnosis
Diagnostic systems
Diarrhea
Disease
DNA
Enzyme immunoassay
Enzymes
Epididymitis
Ethical standards
Ethics
Ferritin
Fever
Fungal infections
Fungi
Heart
Hemoglobin
Histopathology
Histoplasmosis
HIV
HIV patients
Human immunodeficiency virus
Immunoassay
Immunoassays
Laboratories
Lesions
Leukocytes (neutrophilic)
Lymphadenopathy
Markers
Medical testing products
Medicine and Health Sciences
Mycosis
Observers
Pancreatitis
Pancytopenia
Patients
Physiological aspects
Platelets
Polymerase chain reaction
Prostate
Protocols
Research and Analysis Methods
Skin diseases
Spleen
Splenomegaly
Testing
Tropical diseases
Tuberculosis
Ulcers
Urine
Weight loss
Yeasts
title 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
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