1. Clinical Validation of a Colorimetric Loop-Mediated Isothermal Amplification Using a Portable Device for the Rapid Detection of SARS-CoV-2
- Author
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Bruna W. Raddatz, Felipe J. Rabello, Rafael Benedetti, Gisleine J. Steil, Louise M. Imamura, Edson Y. S. Kim, Erika B. Santiago, Luís F. Hartmann, João V. Predebon, Bruna M. Delfino, Meri B. Nogueira, Jucélia S. dos Santos, Breno G. da Silva, Diego R. P. Nicollete, Bernardo M. M. de Almeida, Sergio R. Rogal, and Marcus V. M. Figueredo
- Subjects
RT-LAMP ,colorimetric ,SARS-CoV-2 ,Point-of-Care ,diagnostics ,Medicine (General) ,R5-920 - Abstract
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.
- Published
- 2023
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