Assessment of the SD Bioline Ag MPT64 Rapid™ and the MGIT™ TBc identification tests for the diagnosis of tuberculosis

Gaillard, Tiphaine; Fabre, M.; Martinaud, Christophe; Vong, Rithy; Brisou, P.; Soler, C.

doi:10.1016/j.diagmicrobio.2010.12.011

Cited by 33 publications

(25 citation statements)

References 6 publications

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“…The results presented above reveal that SD BIOLINE TB Ag MPT64 RAPID ® identification had 100% sensitivity and specificity for the strains, compared with conventional methods, demonstrating excellent agreement. These results are similar to those observed by other studies (Abe et al 1999, Fabre et al 2010, Gaillard et al 2011, Marzouk et al 2011. Likewise, in an earlier multicenter study, Hasegawa et al (2002) reported a notably high specificity for MPB64 using the ICA slide test kit.…”

supporting

confidence: 90%

“…In this case, conventional techniques for the diagnosis of MTB should be recommended if clinical symptoms and microbiological criteria are suggestive for TB. No positive signal was observed for any NTM bacilli or M. bovis BCG in this study, which agrees with most previous studies (Hasegawa et al 2002, Park et al 2009, Fabre et al 2010, Gaillard et al 2011. In terms of the specificity, a few false positives were reported with some strains of Mycobacterium marinum and M. flavescens (Abe et al 1999), though Park and Lee (2003) and Gaillard et al (2011) did not report any false positives for these species when evaluating the SD MPT64.…”

supporting

confidence: 90%

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Validation of an immunochromatographic assay kit for the identification of the Mycobacterium tuberculosis complex

Toihir

Rasolofo

Andrianarisoa

et al. 2011

Mem. Inst. Oswaldo Cruz

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Tuberculosis (TB) is a bacterial disease caused by organisms of the Mycobacterium tuberculosis complex (MTC). The definitive diagnosis of TB depends on the isolation and identification of the etiologic agent. Clinical identification of mycobacteria remains difficult and timeconsuming. Cultures in specific media can result not only in M. tuberculosis (MTB) growth but also growth of nontuberculous mycobacteria (NTM). Therefore, the analysis of cultured colonies should be able to discriminate between MTB and NTM to confirm MTB specifically. Commercial diagnostic methods employ molecular biological tests to provide quick and specific tests for the identification of MTC, but false positive results cannot be excluded and these tests remain costly in terms of specialised equipment, labour and time (Wang 2006). MPT64, a 24 kDa secretory protein, is one of the major antigens from TB bacteria. Recently, MPT64 has been shown to differentiate the MTC from other bacterial species (Tomiyama et al. 1997, Abe et al. 1999, Hasegawa et al. 2002. Standard Diagnostics, Inc (SD) (Yongin, Korea) developed the SD BIOLINE TB Ag MPT64 RAPID ® test, which is a simple and rapid assay using a mouse monoclonal anti-MPT64 antibody that is able to discriminate between MTC and NTM by immunochromatography. The purpose of this study was to evaluate the utility of the SD BIOLINE TB Ag MPT64 RAPID ® test for the routine identification of mycobacteria in Madagascar.A total of 171 MTB and NTM strains were used for this study (Table I). Eleven samples of the H37Rv strain were used as standard controls. Clinical strains of MTB (88) and NTM (5) were isolated from clinical specimens and cultured on the Löwenstein Jensen (LJ) medium following decontamination and liquefaction procedures (Tison & Carbonelle 1972, Kent & Kubica 1985. Samples were inoculated in LJ medium and incubated at 37ºC for growth for several weeks. For Mycobacterium bovis (15 isolates) and NTM (14 isolates), strains from the mycobacteria unit collection were inoculated in 8 mL of Dubos medium and incubated at 37ºC for one week (for NTM) or three weeks (for M. bovis). Two hundred microlitres of each culture was inoculated in LJ medium and incubated at 37ºC. M. bovis strains (15) and NTM strains (3 of Mycobacterium chelonae, 2 of Mycobacterium avium, 2 of Mycobacterium intracellularae, 2 of Mycobacterium flavescens, 1 of Mycobacterium peregrinum, 1 of Mycobacterium vaccae, 1 of Mycobacterium aurum, 1 of Mycobacterium xenopi and 1 of Mycobacterium mucogenicum), after cultivation in Dubos media, were applied to the immunochromatography test slide directly without any manipulation.Mycobacteria strains were identified by their growth rate, colonial morphology, pigmentation, testing for urease, semi-quantitative catalase, heat-stable catalase, nitrate reduction and Tween 80 hydrolysis (David et al. 1989). In this study, 10 strains of M. bovis BCG (Pasteur) were used as a negative control for the MPT64 antigen as reported by Li et al. (1993). Other microorganism isolates (bacteria and fungi) ...

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supporting

confidence: 90%

supporting

confidence: 90%

Validation of an immunochromatographic assay kit for the identification of the Mycobacterium tuberculosis complex

Toihir

Rasolofo

Andrianarisoa

et al. 2011

Mem. Inst. Oswaldo Cruz

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“…No positive bands were observed for any NTM bacilli in this study as reported in previous studies [5]. Few authors although have reported false positive results when evaluating for MPT64 antigen [5,17,19]. Usage of SD MPT64 antigen has not reported any false positive among the NTM species as reported by Toihir et al, [20].…”

Section: Discussionsupporting

confidence: 61%

Rapid Immunochromatographic Test for the Identification and Discrimination of Mycobacterium tuberculosis Complex Isolates from Non-tuberculous Mycobacteria

Shenoy

Mukhopadhyay

2014

JCDR

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“…Meta-analyses of the data, including data from the current study, demonstrated high sensitivity and specificity for all 3 tests, with high positive and negative predictive values for clinical isolates tested (Table 3). There was no evidence that sensitivities and specificities differed between tests even when we confined the meta-analysis to studies that used 16S rRNA sequencing or two or more independent, validated reference methods (4, 12, 16-18 (4)(5)(6)33). The mpb64 gene was sequenced for 27 of 53 (51%) clinically independent isolates for which the MPT64 ICT gave a false-negative result, and a mutation was demonstrated in 23 (85%) of those 27 isolates (12,16,17,20,22,33 Our data and meta-analysis demonstrate noninferiority of MGIT TBcID to LPA for MTBC detection and similar high sensitivities and specificities of 3 commercial MPT64 assays across a range of geographical locations.…”

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confidence: 99%

Performance of the MGIT TBc Identification Test and Meta-Analysis of MPT64 Assays for Identification of the Mycobacterium tuberculosis Complex in Liquid Culture

et al. 2011

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Rapid MPT64-based immunochromatographic tests (MPT64 ICTs) have been developed to detect Mycobacterium tuberculosis complex (MTBC) in culture. We demonstrated the noninferiority of one commercial MTP64 ICT, the MGIT TBc identification (TBcID) test, to GenoType line probe assays for MTBC identification in positive MGIT cultures. Meta-analysis of MPT64 ICT performance for identification of MTBC in liquid culture confirmed similar very high sensitivities and specificities for all three commercial MPT64 assays for which sufficient data were available.Early tuberculosis case detection underpinned by qualityassured bacteriology is a cornerstone of the WHO Stop TB strategy (32). WHO has endorsed wider implementation of liquid mycobacterial culture in high-burden countries to improve diagnostic sensitivity and culture turnaround times (29-31). However, rapid and accurate identification of Mycobacterium tuberculosis in positive cultures is essential for translating these benefits into earlier diagnosis and treatment for patients-particularly as liquid culture is associated with isolation of more nontuberculous mycobacteria (NTM) (2, 31). Conventional biochemical identification methods are slow, requiring subculture onto solid media, and cost and limited laboratory capacity preclude nucleic acid amplification tests (NAAT) in low-resource settings. Rapid immunochromatographic tests (ICT) that detect the M. tuberculosis complex (MTBC) MPT64 protein are cheaper and simpler to use and thus may have an important role in these and other settings. We compared one MPT64 ICT, the MGIT TBc identification test (TBc ID; Becton Dickinson, Sparks, MD), with the GenoType MTBC and Mycobacterium CM/AS line probe assays (LPA; Hain Lifescience Gmbh, Nehren, Germany) and present a meta-analysis of MPT64 assay performance for MTBC identification in liquid culture.Between August 2009 and June 2011, clinical samples from two Kenyan hospitals were processed using the MGIT 960 system (BD Diagnostics, Sparks, MD) and standard protocols (3, 27). Ziehl-Neelsen (ZN)-stained smears from positive cultures were examined for acid-fast bacilli (AFB), and an aliquot was inoculated onto blood agar to detect contamination (defined as growth after 48 h of incubation at 37°C). Further aliquots from AFB-positive cultures were used to perform TBcID and LPA according to manufacturers' instructions. When results were discordant, we repeated both tests, performed the Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA) using the original specimen and culture broth, and reviewed the clinical notes. Assuming an LPA sensitivity of 99% (8) and a smallest acceptable true difference (delta) of 5%, a sample size of 83 MTBC isolates was required to demonstrate the noninferiority of TBcID to the LPA with 90% power.TBcID and LPA results were concordant for 208 (83 MTBC and 125 non-MTBC isolates; 99%) of 210 AFB-positive cultures (kappa ϭ 0.98; 95% confidence interval [CI], 0.84 to 1.0),

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Assessment of the SD Bioline Ag MPT64 Rapid™ and the MGIT™ TBc identification tests for the diagnosis of tuberculosis

Cited by 33 publications

References 6 publications

Validation of an immunochromatographic assay kit for the identification of the Mycobacterium tuberculosis complex

Validation of an immunochromatographic assay kit for the identification of the Mycobacterium tuberculosis complex

Rapid Immunochromatographic Test for the Identification and Discrimination of Mycobacterium tuberculosis Complex Isolates from Non-tuberculous Mycobacteria

Performance of the MGIT TBc Identification Test and Meta-Analysis of MPT64 Assays for Identification of the Mycobacterium tuberculosis Complex in Liquid Culture

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