Pooled Testing Approved by FDA

[csodjd]

This may be the breakthrough Hawaii has been looking for in terms of travel-related COVID testing.

The FDA has approved the Quest Diagnostics test for "pooled" testing of up to 4 samples at a time. So, imagine, your family of up to four gets tested all in one test. If it comes back negative it means none of you are infected. If it is positive, it means one of you is, and you're family probably isn't coming to Hawaii! (They they test the individual samples and determine who the infected one is.) When infection rates are < 10% it's easy to see how this hugely increases testing capacity and may quickly reduce test result wait times. Hawaii has already said they will be implementing it in Hawaii to increase their ability to test asymptomatic patients.

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

FDA issued first emergency authorization for sample pooling in COVID-19 diagnostic testing to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test.

www.fda.gov

A new COVID-19 testing method shows promise as the state prepares to implement it

The new method is called pooling, and up to 4 patients can be cleared at once.

www.hawaiinewsnow.com

 

[1Kflyerguy]

I had heard this was in the works a few weeks back. Glad to see its coming online.. This has to help improve the testing backlog.

 

[JIMinNC]

The link below about what the airline industry is pushing for transatlantic travel makes me wonder if something like that could also possibly work for Hawaii.

Airlines call for testing to restore transatlantic travel

It seems like the key for travel testing is to separate it from the medically-necessary testing workflows. You don't want a travel test to delay a test for a symptomatic person and if travel tests are prioritized behind medically-necessary testing, the 72-hour (or whatever) time frame can't be met, which would defeat the purpose of travel testing.

The travel industry has an incentive to develop these kinds of protocols, so a public/private partnership focused purely on travel testing would seem sensible. At least initially, the daily testing needs might not be that huge as long-distance travel will likely be depressed for quite some time. So, maybe a dedicated process with a dedicated lab or labs of some kind could work? Just theorizing here.

One obvious issue is while a joint effort could establish a travel-only lab or labs, this dedicated travel testing process would be competing for the same limited testing supplies as the medical testing, so that might be a big hurdle. But looking for creative solutions is something we should do.

 

[csodjd]

The link below about what the airline industry is pushing for transatlantic travel makes me wonder if something like that could also possibly work for Hawaii.

Airlines call for testing to restore transatlantic travel

It seems like the key for travel testing is to separate it from the medically-necessary testing workflows. You don't want a travel test to delay a test for a symptomatic person and if travel tests are prioritized behind medically-necessary testing, the 72-hour (or whatever) time frame can't be met, which would defeat the purpose of travel testing.

The travel industry has an incentive to develop these kinds of protocols, so a public/private partnership focused purely on travel testing would seem sensible. At least initially, the daily testing needs might not be that huge as long-distance travel will likely be depressed for quite some time. So, maybe a dedicated process with a dedicated lab or labs of some kind could work? Just theorizing here.

One obvious issue is while a joint effort could establish a travel-only lab or labs, this dedicated travel testing process would be competing for the same limited testing supplies as the medical testing, so that might be a big hurdle. But looking for creative solutions is something we should do.

I believe the most important group to be tested are those that have no symptoms but have been exposed to someone with symptoms or confirmed disease. This goes to the heart of pandemic containment.

Those with symptoms will likely be treated with the assumption they have it no matter what a test shows. It's useful to confirm, but won't change the care. If O2 is below 94 they're going to admit and whatever the test shows isn't going to change anything. It's, in my view, MOST important that testing be directed to stopping the spread of the disease and less important that it be directed to diagnosing symptomatic patients.

That said, there are a lot of reasons for testing. Saving economies and industries is a valid reason. An effective FEDERAL/National strategy would help.

 

[JIMinNC]

I believe the most important group to be tested are those that have no symptoms but have been exposed to someone with symptoms or confirmed disease. This goes to the heart of pandemic containment.

Those with symptoms will likely be treated with the assumption they have it no matter what a test shows. It's useful to confirm, but won't change the care. If O2 is below 94 they're going to admit and whatever the test shows isn't going to change anything. It's, in my view, MOST important that testing be directed to stopping the spread of the disease and less important that it be directed to diagnosing symptomatic patients.

That said, there are a lot of reasons for testing. Saving economies and industries is a valid reason. An effective FEDERAL/National strategy would help.

Valid point. I guess I would restate the point I was trying to make as maybe “tests for medical reasons” rather than specifically saying symptomatic. It just seems that someone wanting to travel somewhere would generally be considered lower priority than testing for contact tracing or other primarily medical reasons.

 

[Dean]

This may be the breakthrough Hawaii has been looking for in terms of travel-related COVID testing.

The FDA has approved the Quest Diagnostics test for "pooled" testing of up to 4 samples at a time. So, imagine, your family of up to four gets tested all in one test. If it comes back negative it means none of you are infected. If it is positive, it means one of you is, and you're family probably isn't coming to Hawaii! (They they test the individual samples and determine who the infected one is.) When infection rates are < 10% it's easy to see how this hugely increases testing capacity and may quickly reduce test result wait times. Hawaii has already said they will be implementing it in Hawaii to increase their ability to test asymptomatic patients.

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

FDA issued first emergency authorization for sample pooling in COVID-19 diagnostic testing to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test.

www.fda.gov

A new COVID-19 testing method shows promise as the state prepares to implement it

The new method is called pooling, and up to 4 patients can be cleared at once.

www.hawaiinewsnow.com

One point of order is that NONE of the Covid tests are FDA approved. They are FDA allowed under the Emergency Use Authorization. Four at a time likely won't help much, They need to be able to do 10-20 at a time to make much dent in the turn around time and backlogs.

 

[csodjd]

Valid point. I guess I would restate the point I was trying to make as maybe “tests for medical reasons” rather than specifically saying symptomatic. It just seems that someone wanting to travel somewhere would generally be considered lower priority than testing for contact tracing or other primarily medical reasons.

No doubt. But if testing becomes as available as it SHOULD be, that's not an issue. We (everyone) needs a good reliable quick test. With high sensitivity and specificity, and low false results. Sounds easy.

 

[Dean]

No doubt. But if testing becomes as available as it SHOULD be, that's not an issue. We (everyone) needs a good reliable quick test. With high sensitivity and specificity, and low false results. Sounds easy.

The antigen tests will never get there, it'll take a PCR to do so. I don't see PCR fitting those criteria for some time. Our 2-3 day turn arounds a month or so ago have turned into 7-9 day turn around lately simply because of volume which is where a reasonable pooled testing would come in.

 

[louisianab]

No doubt. But if testing becomes as available as it SHOULD be, that's not an issue. We (everyone) needs a good reliable quick test. With high sensitivity and specificity, and low false results. Sounds easy.

Re reliability : The issues I've been seeing with the testing I run (Cepheid and IDNow) is that half the time, the collector or self-collections don't get done correctly. Like the nasopharyngeal not being put all the way up or the nares ones not being held against each side for the 3-5 seconds or whatever the approval says. Collectors want to be "nice" so they try to do it without discomfort. So then they call and ask if they really have to do x,y,z to collect and then you know it's going to be negative because they don't want to do it or are not trained well enough in collections.

 

[csodjd]

Re reliability : The issues I've been seeing with the testing I run (Cepheid and IDNow) is that half the time, the collector or self-collections don't get done correctly. Like the nasopharyngeal not being put all the way up or the nares ones not being held against each side for the 3-5 seconds or whatever the approval says. Collectors want to be "nice" so they try to do it without discomfort. So then they call and ask if they really have to do x,y,z to collect and then you know it's going to be negative because they don't want to do it or are not trained well enough in collections.

I'm skeptical of self-test negatives for that very reason.

 

[Dean]

Re reliability : The issues I've been seeing with the testing I run (Cepheid and IDNow) is that half the time, the collector or self-collections don't get done correctly. Like the nasopharyngeal not being put all the way up or the nares ones not being held against each side for the 3-5 seconds or whatever the approval says. Collectors want to be "nice" so they try to do it without discomfort. So then they call and ask if they really have to do x,y,z to collect and then you know it's going to be negative because they don't want to do it or are not trained well enough in collections.

The LabCorp self testing states to rotate the q tip all the way around in both sides then place in the liquid media. We've done this a lot and we observe patients doing so. My experience actually watching patients doing so is that they are routinely meeting the testing requirements. With PCR the Roche produced testing that Labcorp does is over 99% in both sensitive and specificity. Abbott's test is basically the same. Antigen tests are not nearly as helpful with a lot of false negatives and occasional false positives. This is true for other antigen tests as well like flu, strep and RSV. Strep antigen tests are usually mid 80 to low 90% predictive compared to a throat culture but RSV & Flu are barely 60% in most situations. Likely the number one reason for false negatives with PCR is people testing too early, with the Antigen tests it's testing early and the limitations of the test.

 

[Luanne]

New Mexico just announced that several of their testing sites will only test now for those with Covid symptoms, or those who have been exposed to someone with Covid. No, so testing for travel, at least at this point. They are cutting back on testing due to the overwhelming number of tests they are processing.

 

[controller1]

We live in one of three COVID-19 hot spots the Federal government chose for free testing for anyone desiring one regardless of the lack of symptoms. They wanted to do 60,000 tests in 12 days. After the lackluster response through four days we decided to get tested. We were tested Tuesday of last week and received our results Monday. Negative.