Analytical sensitivity and clinical performance of "COVID-19 RT-PCR Real TM FAST (CY5) (ATGen, Uruguay) and "ECUGEN SARS-CoV-2 RT-qPCR" (UDLA-STARNEWCORP, Ecuador)": High quality-low cost local SARS-CoV-2 tests for South America

Dozens of commercial RT-qPCR kits for SARS-CoV-2 detection are available with or without Emergency Use Authorization (EUA) by FDA or other regulatory agencies. We evaluated the clinical performance of two SARS-CoV-2 RT-PCR kits designed and produced in South America, "COVID-19 RT-PCR Real TM FA...

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Published in:PLoS neglected tropical diseases 2022-04, Vol.16 (4), p.e0010082
Main Authors: Freire-Paspuel, Byron, Morales-Jadan, Diana, Zambrano-Mila, Marlon, Perez, Franklin, Garcia-Bereguiain, Miguel Angel
Format: Article
Language:English
Subjects:
Biology and life sciences
Brazil
Carbocyanines
Coronaviruses
COVID-19
COVID-19 - diagnosis
Detection
Ecuador - epidemiology
Genes
Humans
Infectious diseases
Medicine and health sciences
Nucleotide sequence
Pandemics
PCR
People and places
Performance evaluation
Polymerase chain reaction
Public health
Quality
Quality control
Quality standards
Regression analysis
Research and Analysis Methods
Reverse Transcriptase Polymerase Chain Reaction
RNA, Viral - analysis
RNA, Viral - genetics
SARS-CoV-2 - genetics
Sensitivity analysis
Sensitivity and Specificity
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Specificity
Tests
Tropical diseases
Uruguay
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cited_by cdi_FETCH-LOGICAL-c577t-9e672a913f1f692124764807c2db348f010ead6da849b325e78aa77852ce34853
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description Dozens of commercial RT-qPCR kits for SARS-CoV-2 detection are available with or without Emergency Use Authorization (EUA) by FDA or other regulatory agencies. We evaluated the clinical performance of two SARS-CoV-2 RT-PCR kits designed and produced in South America, "COVID-19 RT-PCR Real TM FAST (CY5)" (ATGen, Uruguay) and "ECUGEN SARS-CoV-2 RT-qPCR" (UDLA-STARNEWCORP, Ecuador), for RT-qPCR SARS-CoV2 detection using "TaqMan 2019-nCoV Assay Kit v1" (Thermofisher, USA) as a gold standard technique. We report a great clinical performance and analytical sensitivity for the two South American kits with sensitivity values of 96.4 and 100%, specificity of 100% and limit of detection in the range of 10 copies/uL of RNA extraction. "COVID-19 RT-PCR Real TM FAST (CY5)" and "ECUGEN SARS-CoV-2 RT-qPCR" kits are reliable SARS-CoV-2 tests made in South America that have been extensively used in Uruguay, Argentina, Brazil, Bolivia and Ecuador. These locally produced SARS-CoV-2 tests have contributed to overcome supply shortages and reduce diagnosis cost, while maintaining the high quality standards of FDA EUA commercially available kits. This approach could be extended for other diagnostic products to improve infectious diseases surveillance at middle and low income countries beyond COVID-19 pandemic.
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source Publicly Available Content Database; PubMed Central; Coronavirus Research Database
subjects Biology and life sciences
Brazil
Carbocyanines
Coronaviruses
COVID-19
COVID-19 - diagnosis
Detection
Ecuador - epidemiology
Genes
Humans
Infectious diseases
Medicine and health sciences
Nucleotide sequence
Pandemics
PCR
People and places
Performance evaluation
Polymerase chain reaction
Public health
Quality
Quality control
Quality standards
Regression analysis
Research and Analysis Methods
Reverse Transcriptase Polymerase Chain Reaction
RNA, Viral - analysis
RNA, Viral - genetics
SARS-CoV-2 - genetics
Sensitivity analysis
Sensitivity and Specificity
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Specificity
Tests
Tropical diseases
Uruguay
title Analytical sensitivity and clinical performance of "COVID-19 RT-PCR Real TM FAST (CY5) (ATGen, Uruguay) and "ECUGEN SARS-CoV-2 RT-qPCR" (UDLA-STARNEWCORP, Ecuador)": High quality-low cost local SARS-CoV-2 tests for South America
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