Accuracy of rapid point-of-care serological tests for leprosy diagnosis: a systematic review and meta-analysis

• Published in: Memórias do Instituto Oswaldo Cruz Vol. 117; p. e220317
• Main Authors: Romero, Carmen Phang, Castro, Rodolfo, do Brasil, Pedro Emmanuel A, Pereira, Daniella R, Pinheiro, Roberta Olmo, Toscano, Cristiana M, de Oliveira, Maria Regina Fernandes
• Format: Journal Article
• Language: English; Portuguese
• Published: Brazil Instituto Oswaldo Cruz, Ministério da Saúde 01.01.2022; Fundação Oswaldo Cruz (FIOCRUZ)
• Subjects: accuracy; diagnosis; Drug Therapy, Combination; Humans; Leprostatic Agents; leprosy; Leprosy - diagnosis; Mycobacterium infections; PARASITOLOGY; point-of-care; Point-of-Care Systems; Sensitivity and Specificity; Serologic Tests; systematic review; TROPICAL MEDICINE; leprosy; accuracy; diagnosis; Mycobacterium infections; systematic review; point-of-care
• ISSN: 0074-0276; 1678-8060; 1678-8060
• DOI: 10.1590/0074-02760220317

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. This systematic review aims to evaluate the accuracy of rapid point-of-care (POC) tests for diagnosis of leprosy. 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. 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. 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.