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A multicenter study of Cross-Priming Amplification for tuberculosis diagnosis at peripheral level in China
Open accessAbstract
Cross-Priming Amplification (CPA) has been shown to rapidly and effectively detect Mycobacterium tuberculosis (MTB) in sputum samples under isothermal conditions. However, no performance data exist from peripheral-level tuberculosis (TB) clinics in tuberculosis-endemic countries. We conducted a clinical trial at four county-level TB clinics in China to evaluate the effectiveness of the CPA assay. TB suspects were continuously enrolled by a clinician at each clinic. Following informed consent, each patient provided two sputum specimens (spot and morning sputum). Sputum samples were tested by smear microscopy, solid culture and CPA. The National TB reference laboratory (NTRL) collected all culture positive strains and performed 16S-23S rDNA internal transcribed spacer (ITS) sequence analysis for strain identification. Solid culture was used as the gold standard to evaluate the effectiveness of CPA in detecting MTB. A total of 2200 TB-suspected patients were enrolled at the four county-level TB clinics. Compared to solid culture, the sensitivity and specificity of the CPA test for MTB detection within this group was 84.1% (95%CI, 79.5-88.6) and 97.8% (95%CI, 97.1-98.5), respectively, and the sensitivity in smear-negative cases was 59.8% (95%CI, 49.8-69.8). The test failure rate of CPA was 0.8% (32/3918), significantly lower than the 1.7% (106/6138) culture contamination rate.
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“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 [40]
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“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 [40]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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 [40]
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“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 [40]
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References 18 · Cited by 29
Research works printed but not linked: 1
- Kong, 2007, New isothermal molecular diagnostics platforms, IVD Technol, 13, 35
Metadata
- Authors
- Ou, X., Song, Y., Zhao, B., Li, Q., Xia, H., Zhou, Y., Pang, Y., Wang, S., Zhang, Z., Cheng, S., Liu, C., & Zhao, Y.
- Affiliations
- Chinese Center For Disease Control and Prevention (CN)
- Chinese PLA General Hospital (CN)
- Corresponding author
- Liu, Changting
- Zhao, YanLin
- ORCID
- Venue
- Tuberculosis
- Publisher
- Elsevier BV
- Published
- 2014-07
- Volume
- 94
- Issue
- 4
- Pages
- 428-433
- ISSN
- 1472-9792 (ISSN-L)
- OpenAlex
- W2027623011
- Cited by
- 29
- References
- 18
- Citations by year
- 2024: 1 · 2023: 4 · 2022: 2 · 2021: 2 · 2020: 1 · 2019: 4 · 2018: 7 · 2016: 2 · 2015: 5 · 2014: 1
- FWCI
- 1.87
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Tuberculosis (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Chinese Anti-Tuberculosis Association
- Topics
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
- Health Sciences › Medicine › Epidemiology › Mycobacterium research and diagnosis
- Keywords
- cross-priming amplification, Mycobacterium tuberculosis detection, tuberculosis diagnosis, isothermal amplification, smear-negative tuberculosis, sputum, sensitivity and specificity, culture contamination, China
- MeSH terms
- Ambulatory Care Facilities, Feasibility Studies, Humans, Mass Screening, Mycobacterium tuberculosis, Pilot Projects, Reagent Kits, Diagnostic, Sensitivity and Specificity, Sputum, Tuberculosis, Pulmonary, Bacterial Typing Techniques, Nucleic Acid Amplification Techniques, DNA, Intergenic, Cross-Priming
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