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

Autor: 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.
Jazyk: angličtina
Zdroj: Diagnostics (Basel, Switzerland) [Diagnostics (Basel)] 2023 Apr 06; Vol. 13 (7). Date of Electronic Publication: 2023 Apr 06.
DOI: 10.3390/diagnostics13071355
Abstrakt: 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.
Databáze: MEDLINE
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