ArticlePLoS neglected tropical diseases2022
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.
Article in PLoS neglected tropical diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Assessing Different PCR Master Mixes for Ultrarapid DNA Amplification: Important Analytical Parameters.Diagnostics (Basel, Switzerland) · 2024Article
- Development and Optimization of a Multiplex Real-Time RT-PCR to Detect SARS-CoV-2 in Human Samples.International journal of microbiology · 2024Article
- COVID-19: the possibility, ways, mechanisms, and interruptions of mother-to-child transmission.Archives of gynecology and obstetrics · 2023Review
- The quality of commercial SARS-CoV-2 nucleic acid tests in Ecuador: lessons from COVID-19 pandemic for advancing social equity through microbiology.Frontiers in cellular and infection microbiology · 2023Article
- Droplet digital PCR application for the detection of SARS-CoV-2 in air sample.Frontiers in public health · 2023Article
- Coinfection of SARS-CoV-2 with other respiratory pathogens in outpatients from Ecuador.Frontiers in public health · 2023Article
- High SARS-CoV-2 infection rates and viral loads in community-dwelling individuals from rural indigenous and mestizo communities from the Andes during the first wave of the COVID-19 pandemic in Ecuador.Frontiers in medicine · 2023Article
- Fast, cheap and sensitive: Homogenizer-based RNA extraction free method for SARS-CoV-2 detection by RT-qPCR.Frontiers in cellular and infection microbiology · 2023Article
- Rapid and ultrasensitive detection of SARS-CoV-2 spike protein based on upconversion luminescence biosensor for COVID-19 point-of-care diagnostics.Materials & design · 2022Article
- High rates of SARS-CoV-2 infection in funeral home workers in Ecuador: Is it an occupational risk for COVID-19?Frontiers in public health · 2022Article
- Clinical Performance of Three Commercial SARS-CoV-2 Rapid Antigen Tests for Community-Dwelling Individuals in a Tropical Setting.Frontiers in cellular and infection microbiology · 2022Article
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDozens 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.
objectiveWe 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.
resultsWe 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.
conclusions"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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