Performance of a lateral flow immunochromatography test for the rapid diagnosis of active tuberculosis in a large multicentre study in areas with different clinical settings and tuberculosis exposure levels

Abstract

Background: Tuberculosis (TB) continues to cause an outsized burden of morbidity and mortality worldwide, still missing efficient and largely accessible diagnostic tools determining an appropriate control of the disease. Serological tests have the potentially to impact TB diagnosis, in particular in extreme clinical settings. Methods:The diagnostic performances of the TB-XT HEMA EXPRESS (HEMA-EXPRESS) immunochromatographic rapid test for active TB diagnosis, based on use of multiple Mycobacterium tuberculosis (MTB) specific antigens, have been evaluated in a large study multicentre TB case-finding study, in populations with different exposure level to TB. A total of 1,386 subjects were enrolled in the six participating centres in Peru: 290 active-TB and 1,096 unaffected subjects. Results:The TB prevalence (overall 20.5%) varied between 4.0% and 41.1% in the different study groups.Overall, the HEMA-EXPRESS test had 30.6% sensitivity (range 3.9-77.9%) and 84.6% specificity (range 51.6-97.3%). A significant inverse correlation between test accuracy (overall 73.5%, range 40.4-96.4%) and TB prevalence in the various study populations was observed (Pearson's r=−0.7985; P=0.05).Conclusions: HEMA-EXPRESS, is rapid and relatively inexpensive test suitable for routine use in TB diagnosis. In low TB prevalence conditions, test performance appears in line with WHO Target Product Profile for TB diagnostics. Performances appear suboptimal in high TB prevalence settings. Appropriate set-up in operative clinical settings has to be considered for novel serological tests for TB diagnosis, particularly for formats suitable for point-of-care use.

An Overview of Experimental Rodent Pathogens: Health Monitoring and Latest Diagnostic Techniques

“…Suitable diagnostic assay selection for transmissible diseases depends on multiple parameters including clinical presentation and endemic pathogens known to circulate within a specific geographic region. Rapid point-of-care PCR [30,31] and lateral flow immunoassays [32,33] as well as more complex PCR (34)(35) and laboratory based antigen capture ELISAs [36,37] can generate a clinically actionable diagnosis in rodent health monitoring. These assays are sensitive, rapid, and relatively inexpensive, making this testing approach ideal for initial diagnostic testing.…”

A highly multiplexed broad pathogen detection assay for infectious disease diagnostics

“…Appropriate diagnostic assay selection for infectious diseases depends on multiple parameters including clinical presentation and endemic pathogens known to circulate within a specific geographic region. Rapid point-of-care PCR [ 1 , 2 ] and lateral flow immunoassays [ 3 , 4 ] as well as more complex PCR [ 5 – 7 ] and laboratory based antigen capture ELISAs [ 8 , 9 ] can generate a clinically actionable diagnosis in patients presenting with an acute febrile illness. These assays are sensitive, rapid, and relatively inexpensive, making this testing approach ideal for initial diagnostic testing.…”

Evaluation of a synthetic peptide for the detection of anti-Mycobacterium tuberculosis curli pili IgG antibodies in patients with pulmonary tuberculosis

“…The lipoarabinomannan (LAM) lateral flow assay [4], another POC test recently recommended by the WHO for use in HIV co-infected patients, has been shown to lack adequate accuracy in highly endemic populations [5]. Lateral flow formats based on other epitopes designed for performance in laboratory settings have not been evaluated in substantial population studies prior to commercialisation [6].…”