Switch health question

[willing292]

13 hours ago, Fouremco said:

The Device Identifier for the FDA authorization is 9901-NCOV-10G.

 

The Health Canada authorizations are for these devices:

9901-NCOV-06G

9901-NCOV-04G

9901-NCOV-03G

09COV37H

09COV36D

9901-C-NCOV-01G

9901-NCOV-01G

C-NCOV-01G

Q-NCOV-01G

 

As you can see, different devices.

 

How many ways are there to test for Covid? I've no idea.

I don't mean to be a pest, but do you have any idea why the FDA wouldn't approve the rapid antigen from switch health?  Just curious.

[tottenhamfc]

21 minutes ago, willing292 said:

I don't mean to be a pest, but do you have any idea why the FDA wouldn't approve the rapid antigen from switch health?  Just curious.

I am using it as have many others. If they reject it at the port I am sure they have provisions to test. I think we are overthinking this with technicalities. Thus far I have not heard of anyone getting turned away with the requisite details that they are looking for. It makes no sense that one can travel across the border but not get on a ship being fully vaxxed, boosted in some cases and NEGATIVE. 

 

Edited March 18, 2022 by tottenhamfc

[broberts]

29 minutes ago, willing292 said:

I don't mean to be a pest, but do you have any idea why the FDA wouldn't approve the rapid antigen from switch health?  Just curious.

 

Since the product is sold in Canada, it could be as simple as Swithchealth not submitting the product for an EUA. Both the test components and the proctoring have to be approved.

 

[Fouremco]

49 minutes ago, willing292 said:

I don't mean to be a pest, but do you have any idea why the FDA wouldn't approve the rapid antigen from switch health?  Just curious.

In all probability because SD Biosensor hasn't applied to the FDA for authorization, not because it was rejected. They may be focussing on the Canadian market through Switch Health for proctored home self test kits.

 

23 minutes ago, broberts said:

 

Since the product is sold in Canada, it could be as simple as Swithchealth not submitting the product for an EUA. Both the test components and the proctoring have to be approved.

 

Exactly, although I believe you'll find that the submission for an EUA is made by the manufacturer, not the distributor. That's the case in the US, and I believe it holds true for Canada for submissions to Health Canada.

[jflood]

41 minutes ago, tottenhamfc said:

I am using it as have many others. If they reject it at the port I am sure they have provisions to test. I think we are overthinking this with technicalities. Thus far I have not heard of anyone getting turned away with the requisite details that they are looking for. It makes no sense that one can travel across the border but not get on a ship being fully vaxxed, boosted in some cases and NEGATIVE. 

 

 

[jflood]

What day are you cruising? We fly tomorrow  to ft Lauderdale and cruise Monday. If you are cruising before us can you confirm if it works? what are your plans if they turn you away?

[larryt1976]

1 hour ago, jflood said:

What day are you cruising? We fly tomorrow  to ft Lauderdale and cruise Monday. If you are cruising before us can you confirm if it works? what are your plans if they turn you away?

Can you please let us know also if there was any issues 

[willing292]

We aren’t cruising for another 2 weeks, and are going to use it. The days of free testing in the USA may be over, since the US government started giving out free ones for home use.  I found a lab that charges $225 US, and gives results with 2 hours max, and will use it as a back up if needed.  I’ll be happy to share my experience when i return.

[WorkerBee74]

Suggest you take a look at this thread if you’re worried about comments regarding Switch Health and Celebrity in this one. Several posters report no problem boarding Celebrity with Switch rapid - one post goes as far as posting the FDA approval letter for the device used. I feel like speculation is occurring and unnecessarily worrying people vs real life experiences by this who had no problems.  Switch is probably the biggest provider of tests in the country right now so I’m quite sure they’ve already seen a bunch down there - on every cruise line  

 

Edited March 18, 2022 by WorkerBee74

[tottenhamfc]

11 minutes ago, WorkerBee74 said:

Suggest you take a look at this thread if you’re worried about comments regarding Switch Health and Celebrity in this one. Several posters report no problem boarding Celebrity with Switch rapid - one post goes as far as posting the FDA approval letter for the device used. I feel like speculation is occurring and unnecessarily worrying people vs real life experiences by this who had no problems.  Switch is probably the biggest provider of tests in the country right now so I’m quite sure they’ve already seen a bunch down there - on every cruise line  

 

Exactly. People are looking for a problem that doesn't exist. Asking an RCL rep on the booking desk is really looking for an additional problem. How on earth would they know what tests are acceptable. 

Edited March 19, 2022 by tottenhamfc

[broberts]

11 minutes ago, WorkerBee74 said:

Suggest you take a look at this thread if you’re worried about comments regarding Switch Health and Celebrity in this one. Several posters report no problem boarding Celebrity with Switch rapid - one post goes as far as posting the FDA approval letter for the device used. I feel like speculation is occurring and unnecessarily worrying people vs real life experiences by this who had no problems.  Switch is probably the biggest provider of tests in the country right now so I’m quite sure they’ve already seen a bunch down there - on every cruise line  

 

 

There is a recent post somewhere in this section that reports, with an image, Swithchealth has added wording to the test report to indicate the test was done by the client and monitored remotely. This may change things.

[tottenhamfc]

1 minute ago, broberts said:

 

There is a recent post somewhere in this section that reports, with an image, Swithchealth has added wording to the test report to indicate the test was done by the client and monitored remotely. This may change things.

The issue is that the test is acceptable to get into the States. The cruiseline is lagging in its presentation. This by no means rejects the test. Lets just get one response from a successful cruiser to confirm. The rest is pure fear and speculation that it is unacceptable.

[broberts]

2 minutes ago, tottenhamfc said:

The issue is that the test is acceptable to get into the States. The cruiseline is lagging in its presentation. This by no means rejects the test. Lets just get one response from a successful cruiser to confirm. The rest is pure fear and speculation that it is unacceptable.

 

No, the issue is between the letter of regulation and actual practice. I understand that many may not have a problem. I'm not willing to bet my vacation on what is usual vs the fine print.

[tottenhamfc]

55 minutes ago, broberts said:

 

No, the issue is between the letter of regulation and actual practice. I understand that many may not have a problem. I'm not willing to bet my vacation on what is usual vs the fine print.

My point was that you are not going to get an accurate answer from RCL customer service. I will have a gentleman's bet that Switch Health will qualify for a cruise on RCL and Celebrity. They have the facility to test you at the port if need be. They are not going to reject a test that has met the requirements to get into the USA. Common sense says that this is an oversight on the printed copy. If truth be known the cruiselines would do away with testing in a heartbeat if they could. I am going To use Switch and will report back mid April. When are you travelling and what test are you banking on?

Edited March 19, 2022 by tottenhamfc

[WorkerBee74]

1 hour ago, broberts said:

 

There is a recent post somewhere in this section that reports, with an image, Swithchealth has added wording to the test report to indicate the test was done by the client and monitored remotely. This may change things.

 

Why? Do you have something to the contrary from a cruise line that proctored tests are not allowed?  They most certainly are.

[Fouremco]

This issue really isn't complicated. A number of cruiselines state that for a proctored home test to meet their requirements, the test kit must have an FDA EUA.

 

While there is one SD Biosensor device approved by the FDA, the device sold by Switch Health is not that device. Consequently, the Switch Health kit does not meet the cruiseline requirements. Those are the facts.

 

Their requirements notwithstanding, cruiselines make little or no apparent effort to verify that the test kit used is FDA approved. Consequently, there have been many Canadians successfully using Switch Health. As Switch Health lab airport test results and Switch Health proctored test results until very recently used the same format, it's quite possible that the check in staff didn't even realize that it was a proctored home test. With the home kit results now using a different report, it's possible that they will receive greater scrutiny.

 

If a passenger's Switch Health result is not accepted, it is unlikely that they would be refused boarding as there are test facilities at the port. In a worse case scenario, the ship has test capability. However, there is no guarantee that they will help you out when you have not followed their requirements.

 

As long everyone understands the potential risk involved, however small it might be, then there isn't a problem. However, there have been a few erroneous posts recently stating that the Switch Health home test kits have FDA approval. Those posts providing false information should continue to be challenged. Cruise Critic's strength lies in providing accurate, factual information upon which passengers can make decisions. 

[Fouremco]

6 minutes ago, WorkerBee74 said:

 

Why? Do you have something to the contrary from a cruise line that proctored tests are not allowed?  They most certainly are.

Proctored tests are definitely allowed, if they have FDA authorization. The Switch Health proctored tests do not.

[WorkerBee74]

36 minutes ago, Fouremco said:

Proctored tests are definitely allowed, if they have FDA authorization. The Switch Health proctored tests do not.

 

At this point I feel like you are being alarmist for the sake of being alarmist... or right... or something. The reason certain tests would not be approved by the FDA has to do with their minimum sensitivity.  Health Canada has literally approved certain tests by applying minimum standards set by... the FDA.  https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing/antigen.html

 

Getting down to the model numbers not being listed one by one on the website?  This is going against the spirit of pre-cruise testing.  SD Biosensor applied and has received EAU for their at-home device.  Just because American cruise companies are listing American test providers like Abbott is the same reason they'd talk about Dunkin Donuts vs Tim Hortons.  Cruise lines are not looking for a reason like this tiny print you are somehow finding to deny boarding, they are looking for people who took their own test at home with no-one watching, people who tested too early, and people who don't have a test at all.  If they're accepting easily forged wallet cards from Americans saying they've been vaccinated, you can be pretty sure they'll accept a Switch Health test.  They have absolutely seen Switch Health tests before - many times.

 

https://www.fda.gov/media/155123/download

 

Edited March 19, 2022 by WorkerBee74

[broberts]

19 minutes ago, WorkerBee74 said:

 

At this point I feel like you are being alarmist for the sake of being alarmist... or right... or something. The reason certain tests would not be approved by the FDA has to do with their minimum sensitivity.  Health Canada has literally approved certain tests by applying minimum standards set by... the FDA.  https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing/antigen.html

 

Getting down to the model numbers not being listed one by one on the website?  This is going against the spirit of pre-cruise testing.  SD Biosensor applied and has received EAU for their at-home device.  Just because American cruise companies are listing American test providers like Abbott is the same reason they'd talk about Dunkin Donuts vs Tim Hortons.  Cruise lines are not looking for a reason like this tiny print you are somehow finding to deny boarding, they are looking for people who took their own test at home with no-one watching, people who tested too early, and people who don't have a test at all.  If they're accepting easily forged wallet cards from Americans saying they've been vaccinated, you can be pretty sure they'll accept a Switch Health test.  They have absolutely seen Switch Health tests before - many times.

 

https://www.fda.gov/media/155123/download

 

 

From the Royal Caribbean FAQ. Emphasis is in the original text. People ignore cruise line requirements at the risk of being denied boarding. The risk may be small, but it exists.

 

Telehealth Testing for Cruises Departing from U.S. Ports including San Juan, Puerto Rico

For fully vaccinated guests as young as 5 who are cruising from U.S. ports, we accept self-administered COVID-19 tests taken under live video supervision.

Telehealth self-tests taken at home must meet these requirements:

• Per U.S. CDC guidance, only vaccinated guests may present self-administered telehealth COVID-19 test results at the terminal to satisfy the pre-cruise testing requirement.
• The test must have Emergency Use Authorization from the U.S. FDA.
• The self-test process must happen under live supervision on a video call with a telehealth representative.
• The telehealth provider must issue you a result document that includes all the necessary information.
• International guests sailing from the U.S. are able to complete their testing using telehealth test kits, providing the kit has been authorized for use by the U.S. FDA. Telehealth test kits obtained internationally that do not meet this requirement will not be accepted. International guests can arrange to have F.D.A.-approved test kits shipped to the U.S. address where they’ll be staying before their cruise and complete their test prior to departing for the cruise terminal using a U.S. PayPal address to complete the purchase.

 

[tottenhamfc]

22 minutes ago, broberts said:

 

From the Royal Caribbean FAQ. Emphasis is in the original text. People ignore cruise line requirements at the risk of being denied boarding. The risk may be small, but it exists.

 

Telehealth Testing for Cruises Departing from U.S. Ports including San Juan, Puerto Rico

For fully vaccinated guests as young as 5 who are cruising from U.S. ports, we accept self-administered COVID-19 tests taken under live video supervision.

Telehealth self-tests taken at home must meet these requirements:

• Per U.S. CDC guidance, only vaccinated guests may present self-administered telehealth COVID-19 test results at the terminal to satisfy the pre-cruise testing requirement.
• The test must have Emergency Use Authorization from the U.S. FDA.
• The self-test process must happen under live supervision on a video call with a telehealth representative.
• The telehealth provider must issue you a result document that includes all the necessary information.
• International guests sailing from the U.S. are able to complete their testing using telehealth test kits, providing the kit has been authorized for use by the U.S. FDA. Telehealth test kits obtained internationally that do not meet this requirement will not be accepted. International guests can arrange to have F.D.A.-approved test kits shipped to the U.S. address where they’ll be staying before their cruise and complete their test prior to departing for the cruise terminal using a U.S. PayPal address to complete the purchase.

 

Not that this is cruiseline related but it is linked as a form of travel accceptable for entry into the USA. this is from the Air Canada website that accepts the Switch Health accreditation. Surely it is in lockstep with all travel into the States. The key is being vaxxed IMHO and showing that a test has been monitored to prove its authenticity. I think this really is overthinking and possibly fear mongering from some posters. Cruiselines do not want to deny passengers who are triple vaxxed and tested within the requisite timeline. I can assure you that they do not have a cheatsheet of accredited test numbers at hand. 
 

 

All travellers regardless of their vaccination status must have an original printed or electronic negative COVID-19 viral test result (NAAT: RT-PCR, RT-LAMP, TMA, NEAR, HDA, SDA, CRISPR, or Antigen: Rapid, Viral, Antigen Chromatographic Digital Immunoassay, Antigen Chemiluminescence Immunoassay, or Antigen Lateral Flow Fluorescence). The test must be taken a maximum of 1 day before the first scheduled departure time in the flight itinerary (if a flight is at 1 pm on a Friday, travellers could board with a COVID-19 negative test that was taken any time on the prior Thursday). Test results must include the traveller's full name and at least one other identifier such as date of birth or passport number. The test must also clearly state that the results are "negative," SARS-CoV-2 RNA not detected," SARS-CoV-2 antigen not detected," or "COVID-19 not detected." A test marked "invalid" is not acceptable.
 

Edited March 19, 2022 by tottenhamfc

[tottenhamfc]

So the question really is, are these antigen tests that Air Canada/Aeroplan are selling/approving eligible for entry into the USA. I say they are so they must have approval.  First sentence implies that in addition to have vaccinated status a multitude of testing options are available. 

Edited March 19, 2022 by tottenhamfc

[broberts]

2 hours ago, tottenhamfc said:

So the question really is, are these antigen tests that Air Canada/Aeroplan are selling/approving eligible for entry into the USA. I say they are so they must have approval.  First sentence implies that in addition to have vaccinated status a multitude of testing options are available. 

 

There is no reason to think that the CDC or cruise lines will use the same criteria for entering the country and boarding a cruise ship. In fact cruise lines are known to exceed government requirements from time to time. (Consider the issue of requiring passports valid for 6 months beyond end of voyage.)

 

The Swithchealth AC/Aeroplan test kit is approved by Health Canada and so it is acceptable for entry into the US. Apparently the kit does not have an FDA EUA and so some cruise lines may not accept it.

 

[tottenhamfc]

8 hours ago, broberts said:

 

There is no reason to think that the CDC or cruise lines will use the same criteria for entering the country and boarding a cruise ship. In fact cruise lines are known to exceed government requirements from time to time. (Consider the issue of requiring passports valid for 6 months beyond end of voyage.)

 

The Swithchealth AC/Aeroplan test kit is approved by Health Canada and so it is acceptable for entry into the US. Apparently the kit does not have an FDA EUA and so some cruise lines may not accept it.

 

For RCL

 

Telehealth Testing for Cruises Departing from U.S. Ports including San Juan, Puerto Rico

For fully vaccinated guests as young as 5 who are cruising from U.S. ports, we accept self-administered COVID-19 tests taken under live video supervision.

Telehealth self-tests taken at home must meet these requirements:

• Per U.S. CDC guidance, only vaccinated guests may present self-administered telehealth COVID-19 test results at the terminal to satisfy the pre-cruise testing requirement.
• The test must have Emergency Use Authorization from the U.S. FDA.
• The self-test process must happen under live supervision on a video call with a telehealth representative.
• The telehealth provider must issue you a result document that includes all the necessary information.
• International guests sailing from the U.S. are able to complete their testing using telehealth test kits, providing the kit has been authorized for use by the U.S. FDA. Telehealth test kits obtained internationally that do not meet this requirement will not be accepted.International guests can arrange to have F.D.A.-approved test kits shipped to the U.S. address where they’ll be staying before their cruise and complete their test prior to departing for the cruise terminal using a U.S. PayPal address to complete the purchase

Switch Health website FAQ

 

 

Who manufactures your COVID-19 RT-LAMP Home Collection Kits?

 

Our kits are manufactured by Lucira Health, a medical technology company with the first and only FDA, EUA, and HC authorized single-use molecular test for at-home use. This disposable test kit, known as the Lucira Check It COVID-19 Test Kit, is able to detect DNA and RNA of infectious diseases, like COVID-19. Lucira Check It COVID-19 Test Kits provide PCR quality molecular accuracy in 30 minutes 

[Fouremco]

13 hours ago, WorkerBee74 said:

 

At this point I feel like you are being alarmist for the sake of being alarmist... or right... or something. The reason certain tests would not be approved by the FDA has to do with their minimum sensitivity.  Health Canada has literally approved certain tests by applying minimum standards set by... the FDA.  https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing/antigen.html

 

Getting down to the model numbers not being listed one by one on the website?  This is going against the spirit of pre-cruise testing.  SD Biosensor applied and has received EAU for their at-home device.  Just because American cruise companies are listing American test providers like Abbott is the same reason they'd talk about Dunkin Donuts vs Tim Hortons.  Cruise lines are not looking for a reason like this tiny print you are somehow finding to deny boarding, they are looking for people who took their own test at home with no-one watching, people who tested too early, and people who don't have a test at all.  If they're accepting easily forged wallet cards from Americans saying they've been vaccinated, you can be pretty sure they'll accept a Switch Health test.  They have absolutely seen Switch Health tests before - many times.

 

https://www.fda.gov/media/155123/download

 

LOL. So presenting facts is alarmism in your view?

 

BTW, the link you have provided to the FDA website is not for the test kit sold be Switch Health. This is exactly the type of disinformation that begs challenging.

 

[tottenhamfc]

Just now, Fouremco said:

LOL. So presenting facts is alarmism in your view?

 

BTW, the link you have provided to the FDA website is not for the test kit sold be Switch Health. This is exactly the type of disinformation that begs challenging.

 

I am presenting the fact that the antigen is not FDA approved