COVID-19 IgG/IgM Rapid Immunodetection Tests

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DPath2000

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Hello,

Does anyone know about these rapid COVID IgG and IgM tests? They look like this.



1586748347424-png.302100


I see a bunch of manufactures online. Some have EUAs not sure about the others. Has anyone had experience with these or familiarity with the manufacturers?



Also, how would you validate something like this?

How would you bill?

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Hello,

Does anyone know about these rapid COVID IgG and IgM tests? They look like this.



1586748347424-png.302100


I see a bunch of manufactures online. Some have EUAs not sure about the others. Has anyone had experience with these or familiarity with the manufacturers?



Also, how would you validate something like this?

How would you bill?


Yeah....there's a bunch of these rushing to market, but they do not have great sensitivity or specificity. Many of the manufacturers are based in China. I would not trust them at this point.


 
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Yeah....there's a bunch of these rushing to market, but they do not have great sensitivity or specificity. Many of the manufacturers are based in China. I would not trust them at this point.



Agreed. I would wait until a known vendor (Abbott, Roche, Ortho, etc) comes up with these tests. There are a lot of unanswered questions with these serology tests.

I have seen in several FB groups and even on the news in Michigan that PCP's are ordering these tests directly and testing their patients and employees. Several of these companies are claiming CLIA-waived status. The only test that is EUA approved is Cellux, however their PI states they can only be run in mod or high complexity laboratories. Therefore (to the best of my knowledge) there are no COVID waived tests on the market at this time.
 
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Members don't see this ad :)
We have several PCPs offering cash only Covid tests in our small town.
Their CLIA certficates show waived tests and PPM.
I don't think there are any waived Covid tests on the market yet.
Perhaps, they think cash only prevents them from moderate complexity rules?

I think we will a big problem nationally with PCPs and COVID testing
I am getting a lot of BS email offers from labs and small manufactures looking to cash in.
 
This looks like a POC device and probably needs FDA approval.

I am wondering if it tells you if your COVID is a boy or a girl.
 
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I'm getting bombarded by these emails. So many people trying to cash in on this tragedy. Perhaps we will go from CLIA'88 to CLIA'20.
 
I got my hands on a batch. the better question is where do I find positive controls to validate? Is anyone selling IgG and IgM serology controls for validation? They are high-complexity and have to be validated as a lab-developed test.
 
Yup know all about these.

I have them.

1.) you need to absolutely validate vs. known acute and recovered sera samples
2.) you need to ensure you know what the results mean, MEANING IgG alone is NOT considered an indicator of immunity
3.) These are HIGH complexity assays. HIGH. Meaning if you lack a high complexity testing license you cannot perform them.
4.) they are cheap as chips, like less than 10 bucks and resolve in minutes so great POC usage in the field.
Almost all vendors for these are IN CHINA. Even if they appear to originate from the US like Healgen, Houston TX are indeed made in Shanghai.

Someone please check my ROUGH Medicare reimbursement guide:
POC Serology Test Reimbursement: $36
Nucleic Acid amp, high throughput: $100
Nucleic Acid amp, rt PCR and isothermal PCR: $280
 
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Quick point about these lateral flow antibody tests for COVID-19. Let's say a test has 97% sensitivity and 97% specificity. Let's say a condition detected by that test has 1% prevalence in the population. The positive predictive value of that test (PPV) is 16%. 4 out of every 5 positive results generated is a false positive.

The FDA-approved Cellex lateral flow assay has something like 93% sensitivity and 97% specificity.

Using a lateral flow immunoassay test for mass screening or testing of asymptomatic individuals for COVID-19 is madness. ELISA is the only way to go.

If you insist on selling these garbage tests include every disclaimer in the book to protect yourself from litigation.
 
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Quick point about these lateral flow antibody tests for COVID-19. Let's say a test has 97% sensitivity and 97% specificity. Let's say a condition detected by that test has 1% prevalence in the population. The positive predictive value of that test (PPV) is 16%. 4 out of every 5 positive results generated is a false positive.

The FDA-approved Cellex lateral flow assay has something like 93% sensitivity and 97% specificity.

Using a lateral flow immunoassay test for mass screening or testing of asymptomatic individuals for COVID-19 is madness. ELISA is the only way to go.

If you insist on selling these garbage tests include every disclaimer in the book to protect yourself from litigation.

What's the specificity of the ELISA?
 
Quick point about these lateral flow antibody tests for COVID-19. Let's say a test has 97% sensitivity and 97% specificity. Let's say a condition detected by that test has 1% prevalence in the population. The positive predictive value of that test (PPV) is 16%. 4 out of every 5 positive results generated is a false positive.

The FDA-approved Cellex lateral flow assay has something like 93% sensitivity and 97% specificity.

Using a lateral flow immunoassay test for mass screening or testing of asymptomatic individuals for COVID-19 is madness. ELISA is the only way to go.

If you insist on selling these garbage tests include every disclaimer in the book to protect yourself from litigation.


EVERYTHING is garbage. Please tell me something that isnt total garbage. The sensitivity of PCR on NP swabs falls off a CLIFF after day 8 post infection!
____________________________________________________________
Gilead's drug just revealed as a scam.
Hydroxychloroq is a scam.
Serology is nowhere near as useful as its being sold as by politicians, we know this.
PCR cannot effectively screen asymptomatic patients or patients post day 8.
Vaccine likely not possible.
___________________________________________________________

Tell me where this story gets better? Someone...anyone...

Tell why the stock market will not be 80% lower once this sinks into?

Tell me how schools will reopen this fall? How 75% of restaurants arent doomed? How retail has basically been obliterated? How Vegas will not go completely belly up??
 
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Quick point about these lateral flow antibody tests for COVID-19. Let's say a test has 97% sensitivity and 97% specificity. Let's say a condition detected by that test has 1% prevalence in the population. The positive predictive value of that test (PPV) is 16%. 4 out of every 5 positive results generated is a false positive.

The FDA-approved Cellex lateral flow assay has something like 93% sensitivity and 97% specificity.

Using a lateral flow immunoassay test for mass screening or testing of asymptomatic individuals for COVID-19 is madness. ELISA is the only way to go.

If you insist on selling these garbage tests include every disclaimer in the book to protect yourself from litigation.

this is what I keep saying; nobody in medicine seems to get this, let alone general public. But at least as the prevalence goes up we'll have incrementally better PPV.
 
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EVERYTHING is garbage. Please tell me something that isnt total garbage. The sensitivity of PCR on NP swabs falls off a CLIFF after day 8 post infection!
____________________________________________________________
Gilead's drug just revealed as a scam.
Hydroxychloroq is a scam.
Serology is nowhere near as useful as its being sold as by politicians, we know this.
PCR cannot effectively screen asymptomatic patients or patients post day 8.
Vaccine likely not possible.
___________________________________________________________

Tell me where this story gets better? Someone...anyone...

Tell why the stock market will not be 80% lower once this sinks into?

Tell me how schools will reopen this fall? How 75% of restaurants arent doomed? How retail has basically been obliterated? How Vegas will not go completely belly up??

Wouldn't the way to get out of this be to not go all-in on either strategy, i.e. not complete shutdown but also not a complete return to normal activity? We need to find a sweet spot that allows us to increase prevalence while at the same time being careful not to completely overwhelm healthcare capacity. If we get to say, 30% prevalence, a serology test with 93% sensitivity has a PPV of ~85%. Then at least you might be able to do somewhat reliable contact tracing until a vaccine is developed. If a vaccine isn't possible, well then...that might be a true doomsday scenario.

EDIT: I screwed up my math...30% prevalence with 93% sensitivity and 97% specificity leads to PPV of ~90%...sample 2x2 table.
 
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I agree the public and alarmingly the average decision making physician are INCOMPETENT on testing. PLUS THE ARROGANCE OF THESE KNOW NOTHING DOCS IS FRIGHTENING.

I WENT SHORT DIS, MAR TODAY!!
 
EVERYTHING is garbage. Please tell me something that isnt total garbage. The sensitivity of PCR on NP swabs falls off a CLIFF after day 8 post infection!
____________________________________________________________
Gilead's drug just revealed as a scam.
Hydroxychloroq is a scam.
Serology is nowhere near as useful as its being sold as by politicians, we know this.
PCR cannot effectively screen asymptomatic patients or patients post day 8.
Vaccine likely not possible.
___________________________________________________________

Tell me where this story gets better? Someone...anyone...

Tell why the stock market will not be 80% lower once this sinks into?

Tell me how schools will reopen this fall? How 75% of restaurants arent doomed? How retail has basically been obliterated? How Vegas will not go completely belly up??

Let me guess. You sense fear and blood in the streets. It is different this time. God that makes me greedy. But, I am 68 and retired. Too late for any grand financial makeover. But, my nest egg is more than enough for my nut which , by now, is quite small ( no debt, no more kids, one house, one wife, no retirement contributions)


Sent from my iPad using Tapatalk
 
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President asked about injecting bleach into patients or using UV light at the press conference last night. That was a pretty good laugh.

He better be planning a "new deal". We are in deep **** for years to come. We will be longing for the pathologist job market pre-covid.
 
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Someone please check my ROUGH Medicare reimbursement guide:
POC Serology Test Reimbursement: $36

Has medicare set the price for the POC serology test reimbursement 86328? I haven't seen it on a fee schedule?
 
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