Evaluation of qPCR on blood and skin microbiopsies, peripheral blood buffy coat smear, and urine antigen ELISA for diagnosis and test of cure for visceral leishmaniasis in HIV-coinfected patients in India: a prospective cohort study

Owen, Sophie ORCID: https://orcid.org/0000-0002-0458-2357, Burza, Sakib, Shiril, Kumar, Verma, Neena, Harshana, Amit, Pandey, Krishna, Cloots, Kristien, Adams, Emily ORCID: https://orcid.org/0000-0002-0816-2835 and Das, Pradeep (2021) 'Evaluation of qPCR on blood and skin microbiopsies, peripheral blood buffy coat smear, and urine antigen ELISA for diagnosis and test of cure for visceral leishmaniasis in HIV-coinfected patients in India: a prospective cohort study'. BMJ Open, Vol 11, Issue 4, e042519.

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Abstract

Introduction:
HIV coinfection presents a challenge for diagnosis of visceral leishmaniasis. Invasive splenic or bone marrow aspiration with microscopic visualisation of Leishmania parasites remains the gold standard for diagnosis of VL in HIV patients. Furthermore, a test-of-cure by splenic or bone marrow aspiration is required as VL-HIV patients are at a high risk of treatment failure. However, there remain financial, implementation and safety costs to these invasive techniques which severely limit their use under field conditions.

Methods and analysis:
We aim to evaluate blood and skin qPCR, peripheral blood buffy coat smear microscopy and urine antigen ELISA as non- or minimally invasive alternatives for diagnosis and post treatment test-of-cure for visceral leishmaniasis in HIV co-infected patients in India, using a sample of 91 parasitologically confirmed symptomatic VL-HIV patients.

Ethics and dissemination:
Ethical approval for this study has been granted by The Liverpool School of Tropical Medicine, The Institute of Tropical Medicine in Antwerp, the University of Antwerp, and the Rajendra Memorial Research Institute of Medical Science in Patna. Any future publications will be published in open access journals.

CTRI Trial registration number: CTRI/2019/03/017908

Item Type:	Article
Subjects:	QU Biochemistry > Genetics > QU 550 Genetic techniques. PCR. Chromosome mapping WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections WC Communicable Diseases > Tropical and Parasitic Diseases > WC 715 Visceral leishmaniasis WR Dermatology > Parasitic Skin Diseases > WR 350 Tropical diseases of the skin. Mucocutaneous leishmaniasis. Leishmaniasis
Faculty: Department:	Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI):	https://doi.org/10.1136/bmjopen-2020-042519
Depositing User:	Cathy Waldron
Date Deposited:	04 May 2021 11:44
Last Modified:	04 May 2021 11:44
URI:	https://archive.lstmed.ac.uk/id/eprint/17573

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