Abbott Labs: Breakthrough Covid-19 test FDA approved


This is a big deal. 5 minute test results for Covid-19 with 50,000 new tests delivered daily.

Thanks Abbott!


Antibody fest?

This is, of course, exactly what we need. A rapid office based PCR test for covid, similar to the flu tests we have now. However, until they can give the sensitivity and specificity for the test, I will be waiting to use it. A test that gives poor results is worse than no test at all.

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This is so true. I’m not sure how they’d differentiate COVID19 from all the other corona viruses out there, although I am fairly confident they’ve taken that into consideration.

Check with @FairieCyanide, but I think it directly cracks the Covid-19 sphere, then PCRs the RNA chain.

That’s what the release on their website describes. Their reagent binds to a sequence specific to Covid and they run a PCR on that to bring it to detectable levels.


Specific to Corona virus does not differentiate from SARS, MURS, and even the common cold. So you do need to be focusing on segments that are unique to COVID-19.

I would suspect they do the pcr first, then bind a reagent, might not be able to pcr rna with a reagent attached. With time they will get the sensitivity and specificity figures, I tried to access the specs on the web site and they wouldn’t come up. Certainly reason to be optimistic, but the FDA is approving things these days without a lot of data ( which takes time ).

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Here’s all I’ve read about it.

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We have released tests on 2 systems now. This is one and there was another one a week or 2 ago. I can check details. These were from molecular, I work with our ARCHITECT cc and Alinity c instruments. They usually send out company wide emails when stuff release though.


Says that are “targeting COVID-19 RdRp gene.”

All companies are rushing. These products are only approved for use during the pandemic, afterwards everything has to get up to typical FDA regulations. It’s either these tests or to fly completely blind for over a year, to have everything up to typical requirements. I honestly find it to be better to have a rushed tests than nothing at all.


The protocol of the first real-time RT-PCR assays targeting the RNA-dependent RNA polymerase (RdRp), envelope (E), and nucleocapsid (N) genes of SARS-CoV-2 were published on 23rd January 2020. Among these assays, the RdRp assay had the highest analytical sensitivity.



I disagree, you want a test with high specificity if you are in the position of advising a patient if they are safe to visit their elderly parents or a advising a caregiver in a nursing home that they can work. Telling someone they don’t have this illness when they actually do can have some very serious consequences. Since there is currently no treatment available, I find sensitivity to be less important.

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I trust the test far more than I trust your advise, just sayin…

Well thankfully for millions of people the FDA disagrees with you

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I didn’t say the test was bad, in fact, I said something like that is just what we need. However, until we know the sensitivity and specificity we won’t know how useful it will be. A test with low specificity will not be very useful and if it causes people to take actions to further spread the disease it will be worse than no test at all. If you are contemplating visiting someone at risk, and I tell you I have a test that has a 78 % chance ( I am not saying that’s the number, I don’t know the specificity ) of correctly telling you that you are contagious or not, is that worth the risk? Until the sensitivity and specificity are know the test is of limited usefulness.

Wait just a minute, you are weighing the decision of whether you should visit your elderly ancestors, the answer is “NO”.

Realize that you may be carrying a virus that will kill your parents. Leave them alone, make a phone call, let them live!

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There are several very good reasons to remain cautious even after a negative test. This document even says “Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis
for patient management decisions. Negative results must be combined with clinical observations,
patient history, and epidemiological information.”

One good reason is that the virus could mutate enough to not be recognize-able by this test.

New test that some of my IA teammates worked on.


Interesting, as the article that I got this picture from clearly shows IgM while the article says IgG. No matter, serology testing is going to be very useful. You folks at Abbott should be ecstatic as I would guess the market for this test should be approximately 330 million in the US alone. Now I wonder how long it is going to take to process 300 million odd tests, my guess is longer than we want. Tell your teammates thank you.