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VALIDATION AND EVALUATION OF RT-PCR REAL-TIME IN-HOUSE TEST TO DETECTION OF SARS-CoV-2 USING SPECIFIC RdRp GENE AND GAPDH ENDOGEN CONTROL.

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Title: VALIDATION AND EVALUATION OF RT-PCR REAL-TIME IN-HOUSE TEST TO DETECTION OF SARS-CoV-2 USING SPECIFIC RdRp GENE AND GAPDH ENDOGEN CONTROL.
Authors: Rojas-Serrano, Nancy1 (AUTHOR) nrojass@ins.gob.pe, Lope-Pari, Priscila1 (AUTHOR), Huaringa-Nuñez, Maribel1 (AUTHOR), Marques Simas, Paulo Vitor2,3 (AUTHOR), Palacios-Salvatierra, Rosa1 (AUTHOR), Balbuena-Torres, Johanna1 (AUTHOR), Caceres Rey, Omar Alberto4 (AUTHOR), Padilla-Rojas, Carlos4 (AUTHOR)
Source: Revista Peruana de Medicina Experimental y Salud Pública. 2021, Vol. 38 Issue 4, p595-600. 6p. 1 Diagram, 2 Charts, 1 Graph.
Abstract: The present work validated and evaluated a duplex real-time RT-PCR using specific primers and probes for genes RdRp from SARS-CoV-2 and GAPDH from humans; the latter was used as an endogenous control in all reactions. We evaluated the specificity, the sensitivity, the robustness, the reproducibility, the repeatability, the comparability, and the limit of detection. The predictive positive and negative values (PPV and PNV, respectively) and all the parameters evaluated using our duplex real-time RT-PCR was 100%. The detection limit was 100 copies/µL according to the acceptance criteria established for the validation of this protocol. Our duplex real-time RT-PCR demonstrated to be a good alternative for the diagnosis of COVID-19; in addition, this PCR was used adequately in suspicion of COVID-19, allowing it to control the number of false-negatives. [ABSTRACT FROM AUTHOR]
Copyright of Revista Peruana de Medicina Experimental y Salud Pública is the property of Instituto Nacional de Salud (Peru) and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: <searchLink fieldCode="JN" term="%22Revista+Peruana+de+Medicina+Experimental+y+Salud+Pública%22">Revista Peruana de Medicina Experimental y Salud Pública</searchLink>. 2021, Vol. 38 Issue 4, p595-600. 6p. 1 Diagram, 2 Charts, 1 Graph.
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  Data: The present work validated and evaluated a duplex real-time RT-PCR using specific primers and probes for genes RdRp from SARS-CoV-2 and GAPDH from humans; the latter was used as an endogenous control in all reactions. We evaluated the specificity, the sensitivity, the robustness, the reproducibility, the repeatability, the comparability, and the limit of detection. The predictive positive and negative values (PPV and PNV, respectively) and all the parameters evaluated using our duplex real-time RT-PCR was 100%. The detection limit was 100 copies/µL according to the acceptance criteria established for the validation of this protocol. Our duplex real-time RT-PCR demonstrated to be a good alternative for the diagnosis of COVID-19; in addition, this PCR was used adequately in suspicion of COVID-19, allowing it to control the number of false-negatives. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Revista Peruana de Medicina Experimental y Salud Pública is the property of Instituto Nacional de Salud (Peru) and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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