Analytical and Clinical Evaluation of Two RT-qPCR SARS-CoV-2 Diagnostic Tests with Emergency Use Authorization in Ecuador

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  • 1 One Health Research Group, Universidad de Las Americas, Quito, Ecuador;
  • 2 Instituto Nacional de Salud Pública e Investigación Leopoldo Izquieta Pérez, Guayaquil, Ecuador

Dozens of RT-qPCR kits are available in the market for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) or at least by a responsible agency of their country of origin, but many of them lack proper evaluation studies because of COVID-19 pandemic emergency. We evaluated the clinical performance of two commercially available kits in South America, the 2019-nCoV kit (Da An Gene, Guangzhou, China) and GenomeCoV19 kit (ABM, Richmond, Canada), for RT-qPCR SARS-CoV-2 diagnosis using the FDA EUA 2019-nCoV CDC kit (IDT, Coralville, IA) as gold standard. We found striking differences among clinical performance and analytical sensitivity in both kits; whereas the 2019-nCoV kit (Da An Gene) has a limit of detection of 2,000 copies/mL and 100% of sensitivity, the GenomeCoV19 kit (ABM) has a poor sensitivity of 75% and a limit of detection estimated to be over 8.000 copies/mL. The GenomeCoV19 kit (ABM) lacks clinical use authorization in Canada; however, the 2019-nCoV kit (Da An Gene) is authorized by the Chinese CDC. Our results support that only SARS-CoV-2 diagnosis kits with clinical use authorization from their country of origin should be exported to developing countries lacking proper evaluation agencies to avoid a deep impact of the COVID-19 pandemic due to unreliable diagnosis.

Author Notes

Address correspondence to Miguel Angel Garcia-Bereguiain, One Health Research Group, Universidad de Las Américas, Campus Queri, Calle José Queri S/N, Quito, Ecuador. E-mail: magbereguiain@gmail.com

Financial support: This study was funded by Universidad de Las Americas (Quito, Ecuador).

Acknowledgments: We thank Dr Tannya Lozada from “Dirección General de Investigación de la Universidad de Las Américas” and also the authorities from Universidad de Las Américas for logistic support making SARS-CoV-2 diagnosis possible.

Authors’ addresses: Byron Freire-Paspuel and Miguel Angel Garcia-Bereguiain, One Health Research Group. Universidad de Las Americas, Quito, Ecuador, E-mails: byron.freire.paspuel@udla.edu.ec and magbereguiain@gmail.com. Alfredo Bruno and Alberto Orlando, Instituto Nacional de Salud Pública e Investigación Leopoldo Izquieta Pérez, Guayaquil, Ecuador, E-mails: alfredobrunoc@yahoo.es and aorlado@hotmail.com.

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