COVID-19 Saliva-Based Rapid Diagnostic Test Uses RT-LAMP Technology and Portable Reader-Analyzer to Deliver Results in 30 Minutes
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By LabMedica International staff writers Posted on 30 Apr 2021 |
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A rapid molecular test based on RT-LAMP technology and requiring minimal equipment enables detection of the SARS-CoV-2 virus, making it possible to diagnose COVID-19 from saliva samples from symptomatic subjects or contact cases.
C4Diagnostics (Marseille, France) has announced the CE marking and commercialization of C4Covid-19 Human for the rapid diagnostic of COVID-19 from a saliva sample. Based on RT-LAMP technology, which is close to RT-PCR, it requires minimal equipment, namely a portable reader-analyzer (compact and with a working autonomy of 24 hours), and the result is delivered in less than 30 minutes (from sampling to reporting of results). The test makes it possible to detect COVID-19 in humans anywhere, with an internal control and two targets genes (in accordance with the recommendations of the WHO and the HAS), with a saliva sample. The performance of the test was calculated upon a large scale clinical trial of 1,320 participants that demonstrated a sensitivity of 86% and specificity of 97.5%.
“The CE marking of our C4Covid-19 Human test is great news as it offers new perspectives to control the disease spread with painless immediate diagnosis. It is also a significant milestone for C4Diagnostics as C4Covid-19 Human is our first in vitro diagnostic product to be CE marked and on the market for a medical use. We have overcome the usual limitations of LAMP technology and of saliva samples to offer a kit with performances close to those of RT-PCR analysis on nasopharyngeal swabs,” stated Younes Lazrak, CEO of C4Diagnostics.
“C4Covid-19 Human is the result of our team's hard work and dedication, but also of extensive collaborations with our partners. Already adopted by our first target customers, the C4Covid-19 Human test is being marketed with a gradual and controlled increase in production to rapidly meet the need in France, Europe, as well as in the Middle East and North Africa,” commented Thomas Tran, Managing Director at C4Diagnostics.
Related Links:
C4Diagnostics
C4Diagnostics (Marseille, France) has announced the CE marking and commercialization of C4Covid-19 Human for the rapid diagnostic of COVID-19 from a saliva sample. Based on RT-LAMP technology, which is close to RT-PCR, it requires minimal equipment, namely a portable reader-analyzer (compact and with a working autonomy of 24 hours), and the result is delivered in less than 30 minutes (from sampling to reporting of results). The test makes it possible to detect COVID-19 in humans anywhere, with an internal control and two targets genes (in accordance with the recommendations of the WHO and the HAS), with a saliva sample. The performance of the test was calculated upon a large scale clinical trial of 1,320 participants that demonstrated a sensitivity of 86% and specificity of 97.5%.
“The CE marking of our C4Covid-19 Human test is great news as it offers new perspectives to control the disease spread with painless immediate diagnosis. It is also a significant milestone for C4Diagnostics as C4Covid-19 Human is our first in vitro diagnostic product to be CE marked and on the market for a medical use. We have overcome the usual limitations of LAMP technology and of saliva samples to offer a kit with performances close to those of RT-PCR analysis on nasopharyngeal swabs,” stated Younes Lazrak, CEO of C4Diagnostics.
“C4Covid-19 Human is the result of our team's hard work and dedication, but also of extensive collaborations with our partners. Already adopted by our first target customers, the C4Covid-19 Human test is being marketed with a gradual and controlled increase in production to rapidly meet the need in France, Europe, as well as in the Middle East and North Africa,” commented Thomas Tran, Managing Director at C4Diagnostics.
Related Links:
C4Diagnostics
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