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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, Byron; Vega-Mariño, Patricio; Velez, Alberto; Castillo, Paulina; Cruz, Marilyn; Garcia-Bereguiain, Miguel Angel.
  • Freire-Paspuel B; One Health Research Group. Universidad de Las Américas. Quito, Ecuador.
  • Vega-Mariño P; Agencia de Regulación y Control de la Bioseguridad y Cuarentena para Galápagos, Puerto Ayora, Ecuador.
  • Velez A; Agencia de Regulación y Control de la Bioseguridad y Cuarentena para Galápagos, Puerto Ayora, Ecuador.
  • Castillo P; Agencia de Regulación y Control de la Bioseguridad y Cuarentena para Galápagos, Puerto Ayora, Ecuador.
  • Cruz M; Agencia de Regulación y Control de la Bioseguridad y Cuarentena para Galápagos, Puerto Ayora, Ecuador.
  • Garcia-Bereguiain MA; One Health Research Group. Universidad de Las Américas. Quito, Ecuador. Electronic address: magbereguiain@gmail.com.
J Clin Virol ; 128: 104454, 2020 07.
Article in English | MEDLINE | ID: covidwho-480203
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ABSTRACT

BACKGROUND:

Several qPCR kits are available for SARS-CoV-2 diagnosis, mostly lacking of evaluation due to covid19 emergency.

OBJECTIVE:

We evaluated nCoV-QS (MiCo BioMed) kit using CDC kit as gold standard.

RESULTS:

We found limitations for nCoV-QS 1) lower sensitivity 2) lack of RNA quality control probe.

CONCLUSIONS:

Validation studies should be implemented for any SARS-CoV-2 RT-qPCR commercial kit to prevent unreliable diagnosis.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Real-Time Polymerase Chain Reaction / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: J.jcv.2020.104454

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Real-Time Polymerase Chain Reaction / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: J.jcv.2020.104454