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- Publisher Website: 10.1016/j.tube.2018.08.008
- Scopus: eid_2-s2.0-85052461846
- PMID: 30205964
- WOS: WOS:000443991700016
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Article: Diagnostic evaluation of an in-house developed single-tube, duplex, nested IS6110 real-time PCR assay for rapid pulmonary tuberculosis diagnosis
Title | Diagnostic evaluation of an in-house developed single-tube, duplex, nested IS6110 real-time PCR assay for rapid pulmonary tuberculosis diagnosis |
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Authors | |
Keywords | Mycobacterium tuberculosis Diagnostic IS6110 Real-time PCR |
Issue Date | 2018 |
Publisher | Elsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/tube |
Citation | Tuberculosis, 2018, v. 112, p. 120-125 How to Cite? |
Abstract | Objective:
To perform a prospective evaluation on the diagnostic performance of an in-house developed, duplex nested IS6110 real-time Polymerase-Chain-Reaction (PCR) assay (IS6110-qPCR assay) for rapid pulmonary TB diagnosis.
Methods:
A total of 503 sputum specimens were prospectively collected from July 2016 to November 2016. Diagnostic accuracy and optimal cut-off Cycle-threshold (Ct) value for IS6110-qPCR assay was determined by Receiver Operating Characteristic (ROC) curve. Using the optimal cut-off Ct, diagnostic performance of IS6110-qPCR assay was assessed with reference to both bacteriological and clinical information. Meanwhile, limit of detection (LOD) was calculated using Mycobacterium tuberculosis H37Rv as reference strain.
Result:
ROC curve analysis of IS6110-qPCR assay showed a high Area Under the Curve (AUC) value (0.948) with optimal Ct value at 24.140. Prospective analysis of IS6110-qPCR assay with cut-off Ct = 24.140 showed a high overall sensitivity and specificity of 97.2% and 99.7%, respectively. No cross reactivity was observed among all non-tuberculous mycobacteria specimens in this study. LOD analysis on MTB-spiked sputum showed an average detection limit of 5.0 CFU/mL at Ct = 23.18 (±SD, 0.57).
Conclusion:
IS6110-qPCR assay is a highly accurate and cost-effective assay developed for primary screening of suspected TB cases, which is particularly suitable for regions with limited resources but high TB burden. |
Persistent Identifier | http://hdl.handle.net/10722/285300 |
ISSN | 2023 Impact Factor: 2.8 2023 SCImago Journal Rankings: 0.605 |
ISI Accession Number ID |
DC Field | Value | Language |
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dc.contributor.author | LEUNG, KSS | - |
dc.contributor.author | SIU, GKH | - |
dc.contributor.author | TAM, KGK | - |
dc.contributor.author | Ho, PL | - |
dc.contributor.author | Wong, SSY | - |
dc.contributor.author | Leung, EKC | - |
dc.contributor.author | Yu, SH | - |
dc.contributor.author | Ma, OCK | - |
dc.contributor.author | Yam, WC | - |
dc.date.accessioned | 2020-08-18T03:52:10Z | - |
dc.date.available | 2020-08-18T03:52:10Z | - |
dc.date.issued | 2018 | - |
dc.identifier.citation | Tuberculosis, 2018, v. 112, p. 120-125 | - |
dc.identifier.issn | 1472-9792 | - |
dc.identifier.uri | http://hdl.handle.net/10722/285300 | - |
dc.description.abstract | Objective: To perform a prospective evaluation on the diagnostic performance of an in-house developed, duplex nested IS6110 real-time Polymerase-Chain-Reaction (PCR) assay (IS6110-qPCR assay) for rapid pulmonary TB diagnosis. Methods: A total of 503 sputum specimens were prospectively collected from July 2016 to November 2016. Diagnostic accuracy and optimal cut-off Cycle-threshold (Ct) value for IS6110-qPCR assay was determined by Receiver Operating Characteristic (ROC) curve. Using the optimal cut-off Ct, diagnostic performance of IS6110-qPCR assay was assessed with reference to both bacteriological and clinical information. Meanwhile, limit of detection (LOD) was calculated using Mycobacterium tuberculosis H37Rv as reference strain. Result: ROC curve analysis of IS6110-qPCR assay showed a high Area Under the Curve (AUC) value (0.948) with optimal Ct value at 24.140. Prospective analysis of IS6110-qPCR assay with cut-off Ct = 24.140 showed a high overall sensitivity and specificity of 97.2% and 99.7%, respectively. No cross reactivity was observed among all non-tuberculous mycobacteria specimens in this study. LOD analysis on MTB-spiked sputum showed an average detection limit of 5.0 CFU/mL at Ct = 23.18 (±SD, 0.57). Conclusion: IS6110-qPCR assay is a highly accurate and cost-effective assay developed for primary screening of suspected TB cases, which is particularly suitable for regions with limited resources but high TB burden. | - |
dc.language | eng | - |
dc.publisher | Elsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/tube | - |
dc.relation.ispartof | Tuberculosis | - |
dc.subject | Mycobacterium tuberculosis | - |
dc.subject | Diagnostic | - |
dc.subject | IS6110 | - |
dc.subject | Real-time PCR | - |
dc.title | Diagnostic evaluation of an in-house developed single-tube, duplex, nested IS6110 real-time PCR assay for rapid pulmonary tuberculosis diagnosis | - |
dc.type | Article | - |
dc.identifier.email | Ho, PL: plho@hku.hk | - |
dc.identifier.email | Wong, SSY: samsonsy@hku.hk | - |
dc.identifier.email | Leung, EKC: edgrmhe@hku.hk | - |
dc.identifier.email | Yam, WC: wcyam@hku.hk | - |
dc.identifier.authority | Ho, PL=rp00406 | - |
dc.identifier.authority | Wong, SSY=rp00395 | - |
dc.identifier.authority | Yam, WC=rp00313 | - |
dc.description.nature | link_to_subscribed_fulltext | - |
dc.description.nature | link_to_subscribed_fulltext | - |
dc.identifier.doi | 10.1016/j.tube.2018.08.008 | - |
dc.identifier.pmid | 30205964 | - |
dc.identifier.scopus | eid_2-s2.0-85052461846 | - |
dc.identifier.hkuros | 312819 | - |
dc.identifier.volume | 112 | - |
dc.identifier.spage | 120 | - |
dc.identifier.epage | 125 | - |
dc.identifier.isi | WOS:000443991700016 | - |
dc.publisher.place | United Kingdom | - |
dc.identifier.issnl | 1472-9792 | - |