Reply to: Letter to the editor of heliyon re: "Diagnostic evaluation of nCoV-QS, nCoV-QM-N, and nCoV-OM detection kits based on rRT-PCR for detection of SARS-CoV-2 in Ecuador"

Author:

Salinas MarcoORCID,Aguirre Diana,Baldeón Lucy,Pérez-Galarza Jorge

Funder

Universidad Central del Ecuador

Publisher

Elsevier BV

Subject

Multidisciplinary

Reference11 articles.

1. US Food & Drug Administration. Emergency Use Authorization | FDA [Internet]. 2022 [cited 2022 Sep 11]. Available from: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

2. Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: an example of the need of validation studies;Freire-Paspuel;J. Clin. Virol.,2020

3. MiCo BioMed. Veri-Q PCR 316 Coronavirus disease 2019 (COVID-19) nCoV-QS Detection Kit [Internet]. 2021. pp. 1–18. Available from: https://extranet.who.int/pqweb/sites/default/files/documents/eul_0495_188_00_nCoV-QS_EN_IFU_v4.pdf.

4. US Food & Drug Administration. Guidance for Industry and FDA Staff Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests [Internet]. 2007 [cited 2023 Jun 15]. pp. 1–39. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071148.htm.

5. TIB Molbiol. LightMix SarbecoV E-gene plus EAV control [Internet]. 2022 [cited 2022 Sep 11]. Available from: https://www.roche-as.es/lm_pdf/MDx_40-0776_96_Sarbeco-E-gene_V200204_09164154001 (1).pdf.

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