FDA Authorizes 15-Minute Antibody Testing Kit

[LiberalArkie]

JUN 25, 2020 | KEVIN KUNZMANN

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Virtality Diagnostics for a rapid coronavirus 2019 (COVID-19) antibody test which detects both IgG and IgM antibodies with 98.5% accuracy.

The diagnostic test, which requires a drop of blood from a finger prick, delivers results in 15 minutes, according to the company.

As an antibody test, it is capable of measuring the body’s immune response and determining whether a person’s body produced an antibody response to SARS-CoV-2 infection—indicating both past exposure to and infection by novel coronavirus.

The Virality test’s efficacy was evidenced in a recent series of trials involving 1500-plus patients from multiple sites in the US. The test exhibited 98.8% specificity for novel coronavirus, and a high sensitivity (94.9%) for patients tested at least 2 weeks from symptom onset.

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https://www.contagionlive.com/news/fda-authorizes-15-minute-antibody-testing-kit

[NurseJackie]

1. Does it provide any valuable information to help control the spread?

Are people who have recovered from Covid now immune?

Could the presence of antibodies indicate the possibility of a "live" and active infection? Or does the test only determine if someone previously had Covid (rather than having it now).

Would this test be a disruption to processing tests that give a better indication of who currently has the virus (for isolation purposes and for contact-tracing purposes)?

[Igel]

3. Not really.

Now, yes. At least for 6 months, possibly longer.

No. It's all past tense.

No. It's a separate thing.


We can breathe and keep our mouths closed at the same time. When eating the salad it's okay for the main course to be in preparation or even on the table.

[uponit7771]

2. The last "15" Min test was a total bust why should anyone believe this one