The test consists of a small device that requires only 10 microlitres of patient serum or
plasma, or 20 microlitres of whole blood, to be loaded into a receptacle, alongside an
included buffer, which then mixes with viral S protein fragments and migrates along
the device to an area of immobilized capture antibodies. If virus specific IgG or IgM is
present, conjugates are formed, which show up as a distinctive red band on the
device.
Clinical validation studies have been completed by the manufacturer according to
Administrative Measures for Registration of In-vitro Diagnostic Reagents.
They will have to test it on infected people here, this is a huge gamble, it sounds very much like the shonky kits that screwed over Spain to me
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