دورية أكاديمية
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Clinical Validation of a Colorimetric Loop-Mediated Isothermal Amplification Using a Portable Device for the Rapid Detection of SARS-CoV-2.

التفاصيل البيبلوغرافية
العنوان: Clinical Validation of a Colorimetric Loop-Mediated Isothermal Amplification Using a Portable Device for the Rapid Detection of SARS-CoV-2.
المؤلفون: Raddatz BW; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Rabello FJ; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Benedetti R; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Steil GJ; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Imamura LM; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Kim EYS; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Santiago EB; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Hartmann LF; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Predebon JV; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Delfino BM; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Nogueira MB; Virology Laboratory, Universidade Federal do Paraná (Hospital de Clínicas), Rua General Carneiro, 181-Alto da Glória, Curitiba 80060-900, PR, Brazil., Dos Santos JS; Virology Laboratory, Universidade Federal do Paraná (Hospital de Clínicas), Rua General Carneiro, 181-Alto da Glória, Curitiba 80060-900, PR, Brazil., da Silva BG; Virology Laboratory, Universidade Federal do Paraná (Hospital de Clínicas), Rua General Carneiro, 181-Alto da Glória, Curitiba 80060-900, PR, Brazil., Nicollete DRP; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Almeida BMM; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Rogal SR Jr; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil., Figueredo MVM; Hilab, Rua José Altair Possebom, 800-CIC, Curitiba 81270-185, PR, Brazil.
المصدر: Diagnostics (Basel, Switzerland) [Diagnostics (Basel)] 2023 Apr 06; Vol. 13 (7). Date of Electronic Publication: 2023 Apr 06.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: MDPI AG Country of Publication: Switzerland NLM ID: 101658402 Publication Model: Electronic Cited Medium: Print ISSN: 2075-4418 (Print) Linking ISSN: 20754418 NLM ISO Abbreviation: Diagnostics (Basel) Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Basel, Switzerland : MDPI AG, [2011]-
مستخلص: Quick and reliable mass testing of infected people is an effective tool for the contingency of SARS-CoV-2. During the COVID-19 pandemic, Point-of-Care (POC) tests using Loop-Mediated Isothermal Amplification (LAMP) arose as a useful diagnostic tool. LAMP tests are a robust and fast alternative to Polymerase Chain Reaction (PCR), and their isothermal property allows easy incorporation into POC platforms. The main drawback of using colorimetric LAMP is the reported short-term stability of the pre-mixed reagents, as well as the relatively high rate of false-positive results. Also, low-magnitude amplification can produce a subtle color change, making it difficult to discern a positive reaction. This paper presents Hilab Molecular, a portable device that uses the Internet of Things and Artificial Intelligence to pre-analyze colorimetric data. In addition, we established manufacturing procedures to increase the stability of colorimetric RT-LAMP tests. We show that ready-to-use reactions can be stored for up to 120 days at -20 °C. Furthermore, we validated both the Hilab Molecular device and the Hilab RT-LAMP test for SARS-CoV-2 using 581 patient samples without any purification steps. We achieved a sensitivity of 92.93% and specificity of 99.42% (samples with CT ≤ 30) when compared to RT-qPCR.
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فهرسة مساهمة: Keywords: Point-of-Care; RT-LAMP; SARS-CoV-2; colorimetric; diagnostics
تواريخ الأحداث: Date Created: 20230413 Latest Revision: 20230415
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC10093461
DOI: 10.3390/diagnostics13071355
PMID: 37046573
قاعدة البيانات: MEDLINE
الوصف
تدمد:2075-4418
DOI:10.3390/diagnostics13071355