The DOI matches its Crossref record; 12 of the 12 references it cites were found in a registry or an index.
Detection of Mycobacterium tuberculosis by EasyNAT Diagnostic Kit in Sputum Samples from Tanzania
Open accessAbstract
The EasyNAT assay was evaluated for the detection of tuberculosis in sputum smears from presumptive pulmonary tuberculosis (TB) patients in an African high-TB and high-HIV setting. The sensitivity of the EasyNAT assay was 66.7%, and the specificity and positive predictive value were 100% for the culture-positive patients. The sensitivity was only 10% in the smear-negative and culture-positive patients.
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The suboptimal limit of detection of EasyNAT probably explains its poor sensitivity in this paediatric study, where low density of mycobacteria is expected in lymph nodes.
“Sensitivity in these studies was further reduced when only smear-negative but culture-positive pulmonary TB cases were tested (59.8 and 10 %) which indicates a suboptimal limit of detection that probably could explain the poor sensitivity with our paediatric patients, where low density of mycobacteria is expected in lymph nodes.”
From Evaluation of Xpert® MTB/RIF and Ustar EasyNAT™ TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study (2016) · cites this paper as [41]
The passage labeled Abstract reports 10% EasyNAT sensitivity in smear-negative, culture-positive sputum samples and attributes the low detection rate to bacillary DNA below the assay’s detection limit. The paper does not study paediatric patients or lymph-node samples, so it does not establish that this mechanism explains the citing study’s poor sensitivity. (LLM, conf=0.86)
Experimental — accuracy not yet measuredUntil now, EasyNAT has only been evaluated for the detection of pulmonary TB in adults.
“Until now, EasyNAT, a manual assay based on isothermal cross-priming amplification, has only been evaluated for the detection of pulmonary TB in adults [40, 41].”
From Evaluation of Xpert® MTB/RIF and Ustar EasyNAT™ TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study (2016) · cites this paper as [41]
The study description (section labeled Abstract; page unavailable) evaluates EasyNAT using sputum from presumptive pulmonary TB patients, and the reported mean age is 40.5 years. The copy does not establish that all participants were adults or that EasyNAT had only been evaluated in adults for pulmonary TB. (LLM, conf=0.78)
Experimental — accuracy not yet measuredTwo studies reported sensitivity for M. tuberculosis detection against culture of 84.1% and 66.7%, and specificity of 97.8% and 100%, for EasyNAT.
“These two studies reported sensitivity for M. tuberculosis detection against culture of 84.1 and 66.7 %, and specificity of 97.8 and 100 %.”
From Evaluation of Xpert® MTB/RIF and Ustar EasyNAT™ TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study (2016) · cites this paper as [41]
Sensitivity in prior EasyNAT studies was further reduced when only smear-negative but culture-positive pulmonary TB cases were tested (59.8% and 10%), indicating a suboptimal limit of detection.
“Sensitivity in these studies was further reduced when only smear-negative but culture-positive pulmonary TB cases were tested (59.8 and 10 %) which indicates a suboptimal limit of detection that probably could explain the poor sensitivity with our paediatric patients, where low density of mycobacteria is expected in lymph nodes.”
From Evaluation of Xpert® MTB/RIF and Ustar EasyNAT™ TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study (2016) · cites this paper as [41]
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Citations
Cites
Global tuberculosis report (2014)
Gabbasova, L. A., & Who, E. R. E. (2014) · Cited by 12,702
Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review
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Pai, N. P., Vadnais, C., Denkinger, C. M., Engel, N., & Pai, M. (2012) · PLoS Medicine · doi:10.1371/journal.pmed.1001306 · Cited by 597
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Cross Priming Amplification: Mechanism and Optimization for Isothermal DNA Amplification
Xu, G., Hu, L., Zhong, H., et al. (2012) · Scientific Reports · doi:10.1038/srep00246 · Cited by 217
Cross-Priming Amplification for Rapid Detection of Mycobacterium tuberculosis in Sputum Specimens
Fang, R., Li, X., Hu, L., You, Q., Li, J., Wu, J., Xu, P., Zhong, H., Luo, Y., Mei, J., et al. (2009) · Journal of Clinical Microbiology · doi:10.1128/jcm.01528-08 · Cited by 167
Spectrum of clinical disease in a series of 135 hospitalised HIV-infected patients from north India
Sharma, S., Kadhiravan, T., Banga, A., Goyal, T., Bhatia, I., & Saha, P. (2004) · BMC Infectious Diseases · doi:10.1186/1471-2334-4-52 · Cited by 154
Mitarai, S., Okumura, M., Toyota, E., Yoshiyama, T., Aono, A., Sejimo, A., Azuma, Y., Sugahara, K., Nagasawa, T., Nagayama, N., et al. (2011) · The International Journal of Tuberculosis and Lung Disease · doi:10.5588/ijtld.10.0629 · Cited by 126
Nucleic acid testing for tuberculosis at the point-of-care in high-burden countries
Niemz, A., & Boyle, D. S. (2012) · Expert Review of Molecular Diagnostics · doi:10.1586/erm.12.71 · Cited by 74
Challenges to the global control of tuberculosis
Chiang, C., Weezenbeek, C. V., Mori, T., & Enarson, D. A. (2013) · Respirology · doi:10.1111/resp.12067 · Cited by 65
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Bholla, M., Kapalata, N., Masika, E., Chande, H., Jugheli, L., Sasamalo, M., Glass, T. R., Beck, H.-P., & Reither, K. (2016) · BMC Infectious Diseases · doi:10.1186/s12879-016-1578-z · Cited by 31
“Until now, EasyNAT, a manual assay based on isothermal cross-priming amplification, has only been evaluated for the detection of pulmonary TB in adults [40, 41].”
MethodSelf-citation
Metadata
- Authors
- Mhimbira, F. A., Bholla, M., Sasamalo, M., Mukurasi, W., Hella, J. J., Jugheli, L., & Reither, K.
- Affiliations
- Ifakara Health Institute (TZ)
- Venue
- Journal of Clinical Microbiology
- Publisher
- American Society for Microbiology
- Published
- 2015-04
- Volume
- 53
- Issue
- 4
- Pages
- 1342-1344
- ISSN
- 0095-1137 (ISSN-L)
- 1098-660X
- PMC
- PMC4365259
- OpenAlex
- W1975783957
- Cited by
- 17
- References
- 12
- Citations by year
- 2026: 1 · 2023: 3 · 2022: 1 · 2020: 1 · 2019: 1 · 2018: 4 · 2017: 2 · 2016: 2 · 2015: 2
- FWCI
- 2.60
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Microbiology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Utah Science Technology and Research
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (131192)
- European and Developing Countries Clinical Trials Partnership
- Topics
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Health Sciences › Medicine › Infectious Diseases › Infectious Diseases and Tuberculosis
- Health Sciences › Medicine › Epidemiology › Mycobacterium research and diagnosis
- Keywords
- Mycobacterium tuberculosis, nucleic acid amplification tests, tuberculosis diagnosis, sputum smear microscopy, pulmonary tuberculosis, HIV coinfection, diagnostic sensitivity, culture-positive tuberculosis, Tanzania
- MeSH terms
- Bacteriological Techniques, Humans, Mycobacterium tuberculosis, Predictive Value of Tests, Reagent Kits, Diagnostic, Sensitivity and Specificity, Sputum, Tanzania, Tuberculosis, Pulmonary
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