Commercial MPT64-based tests for rapid identification of Mycobacterium tuberculosis complex: A meta-analysis

Yin, Xiaomao; Hu, Ya-Rong; Zheng, Fuqiang; Hu, Yan‐Wei; Wang, Qian

doi:10.1016/j.jinf.2013.06.009

Cited by 35 publications

(22 citation statements)

References 30 publications

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“…Positive mycobacterial cultures were speciated as Mycobacterium tuberculosis complex or non-tuberculosis complex based on MPT64 rapid antigen test (Standard Diagnostics, Seoul, South Korea). (18) Selection of antibiotics, anti-malarials, and tuberculosis therapy was left to the admitting non-study physicians, as was the determination of additional investigations, such as malaria blood slides and cerebral spinal fluid studies. Decisions regarding transfer to intensive care unit (ICU) and initiation of mechanical ventilation or hemodialysis were likewise left to non-study physicians.…”

Section: Methodsmentioning

confidence: 99%

Simplified Severe Sepsis Protocol

Andrews

Muchemwa

Kelly

et al. 2014

Critical Care Medicine

154

128

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Objective To assess the efficacy of a simple, goal-directed sepsis treatment protocol for reducing mortality in patients with severe sepsis in Zambia. Design Single center non-blinded randomized controlled trial Setting Emergency room, ICU, and medical wards of the national referral hospital in Lusaka, Zambia Patients 112 patients enrolled within 24 hours of admission with severe sepsis, defined as systemic inflammatory response syndrome with suspected infection and organ dysfunction Interventions Simplified Severe Sepsis Protocol (SSSP) consisting of up to 4 liters of intravenous fluids within 6 hours, guided by jugular venous pressure assessment, and dopamine and/or blood transfusion in selected patients. Control group was managed as usual care. Blood cultures were collected and early antibiotics administered for both arms. Measurements and Main Results Primary outcome was in-hospital all-cause mortality. 109 patients were included in the final analysis. 88 (80.7%) were HIV positive. Pulmonary infections were the most common source of sepsis. In-hospital mortality rate was 64.2% in the intervention group and 60.7% in the control group (RR 1.05, 95%CI:0.79-1.41). Mycobacterium tuberculosis complex was isolated from 31 of 82 (37.8%) HIV positive patients with available mycobacterial blood culture results. SSSP patients received significantly more IV fluids in the first 6 hours (2.7 liters vs. 1.7 liters, p=0.002). The study was stopped early because of high mortality rate among patients with hypoxemic respiratory failure in the intervention arm (8/8, 100%) compared with the control arm [7/10, 70%, RR 1.43 (95%CI:0.95-2.14)]. Conclusion Factors other than tissue hypoperfusion probably account for much of the end organ dysfunction in African patients with severe sepsis. Studies of fluid-based interventions should utilize inclusion criteria to accurately capture patients with hypovolemia and tissue hypoperfusion who are most likely to benefit from fluids. Exclusion of patients with severe respiratory distress should be considered when ventilator support is not readily available.

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Section: Methodsmentioning

confidence: 99%

Simplified Severe Sepsis Protocol

Andrews

Muchemwa

Kelly

et al. 2014

Critical Care Medicine

154

128

View full text Add to dashboard Cite

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“…Considering the length of a human scFv of ~ 4.5 nm [37] and the Fc-mediated homodimerisation of scFv-Fc fusions [34,61], sterical inhibition by the capture antibody is possible. The commercially available immunochromatographic assays for MPT64 antigen detection in Mtb cultures are sandwich assays with monoclonal antibodies [62]. The Capilia TB Test Kit [63] uses only one monoclonal antibody for a sandwich assay, indicating multimer detection.…”

Section: Discussionmentioning

confidence: 99%

Novel human recombinant antibodies against Mycobacterium tuberculosis antigen 85B

et al. 2014

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BackgroundTuberculosis is the leading cause of death due to bacterial infections worldwide, mainly caused by Mycobacterium tuberculosis. The antigen 85 complex comprises a set of major secreted proteins of M. tuberculosis, which are potential biomarkers for diagnostic.ResultsIn this work, the first human single chain fragment variable (scFv) antibodies specific for the tuberculosis biomarker 85 B were selected by phage display from naïve antibody gene libraries (HAL7/8). Produced as scFv-Fc in mammalian cells, these antibodies were further characterized and analysed for specificity and applicability in different tuberculosis antigen detection assays. Sandwich detection of recombinant 85 B was successful in enzyme linked immunosorbent assay (ELISA), lateral flow immunoassay and immunoblot. Whereas detection of M. tuberculosis cell extracts and culture filtrates was only possible in direct ELISA and immunoblot assays. It was found that the conformation of 85 B, depending on sample treatment, influenced antigen detection.ConclusionsRecombinant antibodies, selected by phage display, may be applicable for 85 B detection in various assays. These antibodies are candidates for the development of future point of care tuberculosis diagnostic kits. Using 85 B as a biomarker, the antigen conformation influenced by sample treatment is important.

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“…Three commercial ICTs are available that detect MPT64, a secretory protein specific to the M. tuberculosis complex, in liquid and solid cultures. 18,27 These assays are simple to perform, have a turnaround time (TAT) of 30 minutes, and allow rapid identification of M. tuberculosis in positive liquid cultures such as MGIT. A meta-analysis of commercial ICTs reported a pooled sensitivity of 97% (95% CI, 96-97%) and a pooled specificity of 98% (95% CI, 98-99%).…”

Section: Mpt64 Immunochromatographic Testsmentioning

confidence: 99%

Revised guidelines for Australian laboratories performing mycobacteriology testing

2021

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Mycobacteriology laboratories play a key role in tuberculosis (TB) control by providing phenotypic and molecular diagnostics, by performing molecular typing to aid contact tracing, and by supporting research and similar laboratories in Australia’s neighbouring countries where TB is prevalent. The National Tuberculosis Advisory Committee (NTAC) published a set of laboratory guidelines in 2006 aiming to document the infrastructure, equipment, staffing and work practices required for safe high-quality work in Australian mycobacteriology laboratories. These revised guidelines have the same aims and have been through a similar extensive consultative peer-review process involving the Mycobacterium Reference Laboratory (MRL) network, the Mycobacterium Special Interest Group (SIG) of the Australian Society for Microbiology (ASM), and other relevant national bodies. This revised document contains several significant changes reflecting the publication of new biosafety guidelines and tuberculosis standards by various national and international organisations, technology developments – such as the MPT64-based immunochromatographic tests (ICTs) and the Xpert MTB/RIF assay, and updated work practices in mycobacteriology laboratories. The biosafety recommendations affirm the latest Australian/New Zealand Standard 2243.3: 2010 and promote a biorisk assessment approach that, in addition to the risk categorisation of the organism, also considers the characteristics of the procedure being performed. Using this biorisk assessment approach, limited manipulations, such as Ziehl-Neelsen (ZN) microscopy, MPT64 ICTs, and culture inactivation/DNA extraction for molecular testing, may be performed on a positive TB culture in a PC2 laboratory with additional features and work practices. Other significant changes include recommendations on the integration of MPT64 ICTs and novel molecular tests into TB laboratory workflows to provide rapid accurate results that improve the care of TB patients. This revised document supersedes the original 2006 publication. NTAC will periodically review these guidelines and provide updates as new laboratory technologies become available.

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Commercial MPT64-based tests for rapid identification of Mycobacterium tuberculosis complex: A meta-analysis

Cited by 35 publications

References 30 publications

Simplified Severe Sepsis Protocol

Simplified Severe Sepsis Protocol

Novel human recombinant antibodies against Mycobacterium tuberculosis antigen 85B

Revised guidelines for Australian laboratories performing mycobacteriology testing

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