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BigE1960

02/04/21 1:30 PM

#97482 RE: TedJ #97481

Thanks Ted. I jumped right to the EUA authorization list for the serology tests and read the EUA letters for those with "Lateral Flow, Fingerstick Whole Blood." Partly because that was where the Xiamen test was and how it was described. (And of course they use gold particles.) I had no way of knowing for sure if any of the EUA's I reviewed covered the QD test advertised on the Medek website and that is why I used "might just be."

I'll go back and screen the quantitative ones. According to the Medek page the test has authorization, so I'd assume it must be on the list.
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BigE1960

02/04/21 2:05 PM

#97484 RE: TedJ #97481

While I haven't read it completely, it sounds similar to this from Sanofi:

LATERAL FLOW IMMUNOASSAY STRIP DEVICE

It mentions a commercial reader from opTricon GmbH.

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Jamis1

02/04/21 2:15 PM

#97486 RE: TedJ #97481

Doing a little Google snooping, I found some of these items while looking for the "True-Dot" name.

Shenzhen Kingfocus Biomedical Engineering Co., Ltd. True-Dot™ Novel Coronavirus (2019-nCoV) IgM/IgG Rapid Antibody Detection Kit (Quantum Dot Immunochromatography)


http://blog.rapidmicromethods.com/2020/03/overview-of-current-covid-19-diagnostic.html

Device: MAGLUMI 2019-nCoV IgM/IgG
Company: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Indication: Qualitative detection and differentiation of immunoglobulin
(IgM) and immunoglobulin G (IgG) to SARS-CoV-2 in human
serum and serum in separating gel tubes (SST) using the
MAGLUMI 2000 series fully-automated chemiluminescence
immunoassay analyzer. Intended for use as an aid in identifying
individuals with an adaptive immune response to SARS-CoV-2,
indicating recent or prior infection. Emergency use of this test is
limited to authorized laboratories



https://www.fda.gov/media/142230/download

http://www.king-focus.com/en/