Title
Accuracy of rapid point-of-care serological tests for leprosy diagnosis: a systematic review and meta-analysis
Date Issued
01 January 2022
Access level
open access
Resource Type
journal article
Author(s)
Castro R.
Do Brasil P.E.A.
Pereira D.R.
Pinheiro R.O.
Toscano C.M.
de Oliveira M.R.F.
Fundação Oswaldo Cruz-Fiocruz
Publisher(s)
Fundacao Oswaldo Cruz
Abstract
BACKGROUND Leprosy is a chronic infectious disease, still endemic in many countries that may lead to neurological, ophthalmic, and motor sequelae if not treated early. Access to timely diagnosis and multidrug therapy (MDT) remains a crucial element in the World Health Organization’s strategy to eliminate the disease as a public health problem. OBJECTIVES This systematic review aims to evaluate the accuracy of rapid point-of-care (POC) tests for diagnosis of leprosy. METHODS Searches were carried out in electronic databases (PubMed, EMBASE, CRD, Cochrane Library and LILACS) in April 2021 for patients with suspicion or confirmatory diagnostic of leprosy, classified in multibacillary (MB) or paucibacillary (PB) cases, performing rapid POC serological tests compared to clinical evaluation, smear microscopy and immunohistochemistry analysis. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2). A meta-analysis was undertaken to generate pooled estimates of diagnostic parameters, presenting sensitivity, specificity and diagnostic odds ratio (DOR) values. The review protocol was registered at PROSPERO, CRD # 42014009658. FINDINGS From 893 potentially relevant references, 12 articles were included reporting 16 diagnostic tests accuracy studies with 5395 individuals enrolled. Meta-analysis of NDO-LID and PGL-I tests data in MB patients showed sensitivity and specificity [95% confidence interval (CI)] of 0.83 (0.71-0.91), 0.91 (0.72-0.97); and 0.92 (0.86-0.96), 0.93 (0.78-0.98); respectively, with high heterogeneity among the studies. MAIN CONCLUSIONS Our results can inform policymakers regarding the possibility of implementing accurate, rapid POC tests for leprosy in public health services, especially within primary health care.
Volume
117
Language
English
OCDE Knowledge area
Biotecnología médica
Ingeniería médica
Subjects
Scopus EID
2-s2.0-85128141477
PubMed ID
Source
Memorias do Instituto Oswaldo Cruz
ISSN of the container
00740276
DOI of the container
10.1590/0074-02760220317
Sponsor(s)
CMT receive scientific productivity scholarship from CNPq (#308010/2018-3), CPR have received a scholarship from Project Actions to Support Regulatory Governance of Products Subject to Health Surveillance, a technical cooperation established between the National Health Surveillance Agency (Anvisa) and Fiocruz Bras?lia through the Evidence Program for Health Policies and Technologies (PEPTS).
Sources of information:
Directorio de Producción Científica
Scopus