COVID-19 Testing Where And When It's Needed Most

Abbott has received emergency use authorization from the U.S. Food and Drug Administration for a point-of-care molecular test for detection of COVID-19 with results in 13 minutes or less.

What makes this test so different is where it can be used: outside the four walls of a traditional hospital such as in the physicians’ office or urgent care clinics.

And, unlike tests running on larger lab equipment, the new Abbott ID NOW COVID-19 test runs on Abbott’s ID NOW™ platform—a lightweight box (the size of a small toaster) that can sit in a variety of locations.

Because of its small size, it can be used in more non-traditional places where people can have their results in a matter of minutes, not hours or days, bringing a new testing technology to combat the novel coronavirus.

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[pba]

Abbott response on YouTube comments is just impressive. From old to new videos. GREAT COMPANY 👏👍

[samadhankarandikar]

Every country needs this Rapid and Reliable test, very well done Abbott.Yes we all human race in severe critical horrible situation, but we can eradicate it .You shows ray of hope.🙏🇮🇳

[NE-pzku]

FDA FAQ page is the only place that deems this CLIA waived however, FDA does not CLIA categorize tests authorized under EUA. Instead the settings in which an EUA authorized test may be used are described in the Letter of Authorization.
The letter does not clarify it as being a waived test it reads authorized labs that are moderate/ high complexity and for patient settings outside a clinical laboratory. These patient settings do not default to CLIA waived.

So the FAQ page has no legitimacy in my opinion that it is categorized CLIA waived, the laboratory community needs a formal statement and decision from CMS. Not just an email from them to read the FAQ FDA page.
Also, we need to look at why this test is so much faster. The biggest difference is how the RNA is pulled out of the protein coat. It’s kind of like cracking an egg, you need to break open the protein, but without damaging the RNA inside. The Abbott point-of-care test pulls the RNA differently from the gold standard Roche rt-PCR, in the Abbott it occurs all inside the instrument. It’s way faster, but it is not entirely clear whether it is better at separating out the RNA without damaging it. This causes LOD issues. There is very little publicly available data on what is called “limit of detection” LOD– that’s how many copies of the virus need to be in the sample before it will give a positive result. The lower the limit of detection, the earlier in the infection process the virus can be detected. This is why this new test will be less sensitive. The Abbott instrument per package insert has an LOD of 125 genome equivalents per ml. A gold standard RT-PCR has an LOD of 3.1 GE/ml. This is why the POC instrument will have many false negatives, it’s the ability to detect as low as 3.1 viral particles vs a required 125 viral particles for the Abbott.

[jerryites]

How many ID NOW instruments are located in the U.S? What is the manufactured
output daily of the ID now instrument?

[joannastars]

Thank you!!! Please make as many of these as possible and also take home rapid nasopharyngeal/nasopharynx tests patients can do at home later on this year to stop this horrible wave of death our nation is facing from this virus. Thank you Abbott for getting this out so well!!! =)

[tjo]

Does the ID Now have any sensitivity/ specificity numbers ?

[HernanHH]

More than Amazing job Abbott. I hope you get the money you need to scale this and help humanity. May God Bless your team and the other teams that are working hard.

[dixon]

What I am really interested in is what it tests for? And what is the efficacy?

[ihyland]

hey Abbott what is the costs vs rapdi tests Im/IgG? And the efficiency?

[OdeeOz]

_Are the test kits reusable for this device? _*_If so, can we get data/information about how to sterilize for re-usage?_*

I'm already buying call options for this ABT and buying put options for SPY! I can't wait for over the next 2 weeks will be great...$...$$...$$$...$$$$

[razorgg]

So what is the reliability, false + /- rate? how does it compare with the serologic test, by Hardy Diagnostics for Ig G, and M, , are they complementary in some way? Is there going to be some population testing beyond those who are sick, or symptomatic and to study, contacts, , when they turn positive, is there a lag where they are negative but infected? When will this make it across the country to provide some more information so we are not flying blind?

[MrKnierli]

Similar to the technique they have for influenca testing

[redpillrobo]

you should give the manufacturing license to everybody

[heyesy]

If it works as well as my Freestyle Libre then your onto a winner.
I have every confidence in Abbott.

[Hahahahah]

Je veux une résoudre au probléme de l'application de freestyle librelink la description sur le gmail de l'application, please dés que le possibel mon appareil de mesurer le taux de glucose est damagée et merci

[kayodekay]

Great job, Abbott. America needs it first considering all circumstances. But once you decide to ship to other countries, pls. do not forget Togo, one of the poorest country in West Africa. Think of the people not the politicians or government. Diabetes Care West Africa says once again, thank you for