A modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings

Abstract We present a prototype for conducting rapid, inexpensive and point-of-care-compatible nucleic acid amplification tests (NAATs) for tuberculosis (TB). The fluorescent isothermal paper-and-plastic NAAT (FLIPP-NAAT) uses paper-based loop mediated isothermal amplification (LAMP) for DNA detecti...

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Autores principales: Navjot Kaur, Joy S. Michael, Bhushan J. Toley
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Lenguaje:EN
Publicado: Nature Portfolio 2019
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Acceso en línea:https://doaj.org/article/2e0d1881f1654d458cc9587e4e3021de
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spelling oai:doaj.org-article:2e0d1881f1654d458cc9587e4e3021de2021-12-02T16:07:53ZA modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings10.1038/s41598-019-51873-82045-2322https://doaj.org/article/2e0d1881f1654d458cc9587e4e3021de2019-10-01T00:00:00Zhttps://doi.org/10.1038/s41598-019-51873-8https://doaj.org/toc/2045-2322Abstract We present a prototype for conducting rapid, inexpensive and point-of-care-compatible nucleic acid amplification tests (NAATs) for tuberculosis (TB). The fluorescent isothermal paper-and-plastic NAAT (FLIPP-NAAT) uses paper-based loop mediated isothermal amplification (LAMP) for DNA detection. The cost of materials required to build a 12-test-zone device is $0.88 and the cost of reagents per reaction is $0.43. An inexpensive imaging platform enables filter-free fluorescence detection of amplified DNA using a cell-phone camera. FLIPP-NAAT can be operated by an untrained user and only requires a regular laboratory incubator as ancillary equipment. All reagents can be dry-stored in the device, facilitating storage and transportation without cold chains. The device design is modular and the assay demonstrated high specificity to Mycobacterium tuberculosis (Mtb), analytical sensitivity of the order of 10 copies of Mtb gDNA, and tolerance to complex samples. The clinical sensitivity and specificity of sputum-based FLIPP NAAT tests were 100% (zero false negatives) and 68.75% (five false positives), respectively (N = 30), using Xpert MTB/RIF assay as the reference standard. FLIPP-NAAT has the potential to provide affordable and accessible molecular diagnostics for TB in low- and middle-income countries, when used in conjunction with an appropriate sample preparation technique. Although demonstrated for the detection of TB, FLIPP-NAAT is a platform technology for amplification of any nucleic acid sequence.Navjot KaurJoy S. MichaelBhushan J. ToleyNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 9, Iss 1, Pp 1-12 (2019)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Navjot Kaur
Joy S. Michael
Bhushan J. Toley
A modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings
description Abstract We present a prototype for conducting rapid, inexpensive and point-of-care-compatible nucleic acid amplification tests (NAATs) for tuberculosis (TB). The fluorescent isothermal paper-and-plastic NAAT (FLIPP-NAAT) uses paper-based loop mediated isothermal amplification (LAMP) for DNA detection. The cost of materials required to build a 12-test-zone device is $0.88 and the cost of reagents per reaction is $0.43. An inexpensive imaging platform enables filter-free fluorescence detection of amplified DNA using a cell-phone camera. FLIPP-NAAT can be operated by an untrained user and only requires a regular laboratory incubator as ancillary equipment. All reagents can be dry-stored in the device, facilitating storage and transportation without cold chains. The device design is modular and the assay demonstrated high specificity to Mycobacterium tuberculosis (Mtb), analytical sensitivity of the order of 10 copies of Mtb gDNA, and tolerance to complex samples. The clinical sensitivity and specificity of sputum-based FLIPP NAAT tests were 100% (zero false negatives) and 68.75% (five false positives), respectively (N = 30), using Xpert MTB/RIF assay as the reference standard. FLIPP-NAAT has the potential to provide affordable and accessible molecular diagnostics for TB in low- and middle-income countries, when used in conjunction with an appropriate sample preparation technique. Although demonstrated for the detection of TB, FLIPP-NAAT is a platform technology for amplification of any nucleic acid sequence.
format article
author Navjot Kaur
Joy S. Michael
Bhushan J. Toley
author_facet Navjot Kaur
Joy S. Michael
Bhushan J. Toley
author_sort Navjot Kaur
title A modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings
title_short A modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings
title_full A modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings
title_fullStr A modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings
title_full_unstemmed A modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings
title_sort modular paper-and-plastic device for tuberculosis nucleic acid amplification testing in limited-resource settings
publisher Nature Portfolio
publishDate 2019
url https://doaj.org/article/2e0d1881f1654d458cc9587e4e3021de
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