Abstract
BackgroundExtrapulmonary tuberculosis (EPTB) is a diagnostic challenge. An immunochemistry-based MPT64 antigen detection test (MPT64 test) has reported higher sensitivity in the diagnosis of EPTB compared with conventional methods. The objective of this study was to implement and evaluate the MPT64 test in routine diagnostics in a low-resource setting.MethodsPatients with presumptive EPTB were prospectively enrolled at Mnazi Mmoja Hospital, Zanzibar, and followed to the end of treatment. Specimens collected were subjected to routine diagnostics, GeneXpert® MTB/RIF assay and the MPT64 test. The performance of the MPT64 test was assessed using a composite reference standard, defining the patients as tuberculosis (TB) cases or non-TB cases.ResultsPatients (n = 132) were classified as confirmed TB (n = 12), probable TB (n = 34), possible TB (n = 18), non-TB (n = 62) and uncategorized (n = 6) cases. Overall, in comparison to the composite reference standard for diagnosis, the sensitivity, specificity, positive predictive value, negative predictive value and accuracy of the MPT64 test was 69%, 95%, 94%, 75% and 82%, respectively. The MPT64 test performance was best in TB lymphadenitis cases (n = 67, sensitivity 79%, specificity 97%) and in paediatric TB (n = 41, sensitivity 100%, specificity 96%).ConclusionsWe show that the MPT64 test can be implemented in routine diagnostics in a low-resource setting and improves the diagnosis of EPTB, especially in TB lymphadenitis and in children.
Highlights
Despite efforts to develop new diagnostic tools for tuberculosis (TB), the diagnosis of extrapulmonary TB (EPTB) remains a challenge
The MPT64 test performance was best in TB lymphadenitis cases (n = 67, sensitivity 79%, specificity 97%) and in paediatric TB (n = 41, sensitivity 100%, specificity 96%)
We show that the MPT64 test can be implemented in routine diagnostics in a low-resource setting and improves the diagnosis of Extrapulmonary tuberculosis (EPTB), especially in TB lymphadenitis and in children
Summary
Despite efforts to develop new diagnostic tools for tuberculosis (TB), the diagnosis of extrapulmonary TB (EPTB) remains a challenge. The various clinical presentations of EPTB are nonspecific, and the disease is often paucibacillary leading to low sensitivities of routine diagnostic methods such as; acid-fast bacilli (AFB) microscopy [1,2,3] and culture [1, 4, 5]. Most nucleic acid amplification tests show better sensitivity, but are complex, expensive, technically demanding and prone to contamination, limiting their use in low-resource diagnostic settings [7,8,9,10]. The objective of this study was to implement and evaluate the MPT64 test in routine diagnostics in a low-resource setting
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