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16th March 2020  Editorial by: Paul Carton

CE-Marked COVID-19 IgM/IgG Lateral-Flow Kit Provides Results in 10-minutes


Image: Courtesy of ERA-BIO

A 10-minute sample-to-result lateral-flow assay, which has 95% sensitivity and specificity for the primary and secondary antibodies produced in our serum for SARS-CoV-2 has received CE-marking. SARS-CoV-2, which is the causative agent of COVID-19 that causes acute pneumonia in infected individuals, has been detected by laboratories across the world, mainly by using nucleic acid testing (NAT) methods. 

However, in regards to nucleic acid testing, laboratories and skilled technicians are necessary to carry out the procedures, often in Biosafety Laboratories (BSL) of levels 3 & 4. But in this time of crisis, where rapid results are a must and drive-thru testing centres, if possible, can be set-up, instruments that can deliver point-of-care testing must be the way forward. 

These two kits, from ERA-BIO (Era Biology Group), can detect specific IgM, which is produced by the body 3-6 days after infection and also IgG, which is produced >8 days after infection. 

The tests do not require molecular trained personnel to use them, nor a laboratory.



Date Published: 16th March 2020

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