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Switch health question


Cruisingrampy
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18 minutes ago, Cruisingrampy said:

I know its been asked a million times but forgive me i cant find it. Does celebrity allow the switch health test as an approved test

 

 

 

 

If you are referring to the proctored home test kit, no, it's not. Celebrity requires that such tests have FDA emergency use authorization, and the SD Biosensor test device used in the Switch Health kit does not have FDA authorization.

 

That said, there are numerous Canadians who have reported no problem boarding, and as has been pointed out, the results issued by Switch Health are the same for home tests and tests at their airport facilities.

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39 minutes ago, Fouremco said:

If you are referring to the proctored home test kit, no, it's not. Celebrity requires that such tests have FDA emergency use authorization, and the SD Biosensor test device used in the Switch Health kit does not have FDA authorization.

 

That said, there are numerous Canadians who have reported no problem boarding, and as has been pointed out, the results issued by Switch Health are the same for home tests and tests at their airport facilities.


Someone had provided the below link before. Is this not the required FDA approval of the SD Biosensor test device used by Switch in the proctored antigen test? (Sorry, I haven’t looked into this in detail)
 

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The FDA has given approval to one of SD Biosensors devices, but it is not one used by Switch Health. Instead, it is purely a home test kit similar to the BTNX kit handed out freely in Canada. If you look at the summary on the FDA's website, you'll see that it is intended as a serial test kit for people without symptoms. They are to test twice in a three day period and there are no telehealth provisions in the instructions (https://www.fda.gov/media/155126/download). 

 

1870325714_ScreenShot2022-03-14at3_08_57PM.thumb.png.ae07d9de0362b8a216460f99e8d1f646.png

 

Health Canada has approved 9 separate devices manufactured by SD Biosensor, including Switch Health's. Unfortunately, the FDA approval is for a different device.

 

 

 

 

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RCI does have limited testing outside the terminal. While it isn't designed for situations where an existing test is rejected, I'm sure that they could accommodate you.

 

How to Schedule Pre-Cruise Testing Outside the Terminal

Vaccinated guests that need this option should schedule their testing appointment 30 minutes before their selected cruise check-in window. If your desired test time is unavailable, select a time closest after your cruise check-in window. Scheduling your test appointment much earlier than your cruise check-in window does not mean you will be permitted to check-in earlier than scheduled.

Results are delivered within 20 minutes via email. If a guest receives a positive result, they will not be permitted to enter the terminal or sail. 

Appointments for pre-cruise testing outside the terminal open 30 days prior to your sailing date — guests will not be able to book prior to that. To book an appointment for a pre-cruise test outside the terminal, please select the port where your cruise will be departing from.

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3 minutes ago, Fouremco said:

RCI does have limited testing outside the terminal. While it isn't designed for situations where an existing test is rejected, I'm sure that they could accommodate you.

 

How to Schedule Pre-Cruise Testing Outside the Terminal

Vaccinated guests that need this option should schedule their testing appointment 30 minutes before their selected cruise check-in window. If your desired test time is unavailable, select a time closest after your cruise check-in window. Scheduling your test appointment much earlier than your cruise check-in window does not mean you will be permitted to check-in earlier than scheduled.

Results are delivered within 20 minutes via email. If a guest receives a positive result, they will not be permitted to enter the terminal or sail. 

Appointments for pre-cruise testing outside the terminal open 30 days prior to your sailing date — guests will not be able to book prior to that. To book an appointment for a pre-cruise test outside the terminal, please select the port where your cruise will be departing from.

Thanks for that. You wouldnt know whether it was rejected until

you showed at the terminal anyway. You are carrying a negative test with you Nd they would have to reject it.

Edited by tottenhamfc
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Just now, Cruisingrampy said:

Seems bizzare the test is ok to enter a countrt but not board a ship haha. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

I agree. I think some posters are adding complexity because of two different countries protocols. In reality if we can only access Canadian tests which may not be CDC approved it seems to me that if we are allowed in to the States by plane, then it has been defacto approved. The cruiselines I am sure will have flexibility in this regard. 

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There is different wording between the USA Federal flight requirements and the Celebrity cruise ones. The CDC wording for flights is below and has the “OR” wording at the end. The Celebrity website only has the FDA requirement and not the wording that says or the relevant national authority. 

 

  • The test must be a SARS-CoV-2 viral test (nucleic acid amplification test [NAAT] or antigen test) with Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) OR the relevant national authority where the test is administered.

 

As a note though, I have used the Shoppers test for my 3 cruises and the people would not know if it is FDA approved or not. I highly doubt they have memorized a list. They look for your name, the date and negative. I’ll likely just use Shoppers again, as I know it works and it is convenient for me. 

Edited by AlbertaCruisers
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18 hours ago, AlbertaCruisers said:

There is different wording between the USA Federal flight requirements and the Celebrity cruise ones. The CDC wording for flights is below and has the “OR” wording at the end. The Celebrity website only has the FDA requirement and not the wording that says or the relevant national authority. 

 

  • The test must be a SARS-CoV-2 viral test (nucleic acid amplification test [NAAT] or antigen test) with Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) OR the relevant national authority where the test is administered.

 

But to be even more specific, I believe Celebrity (and Royal) only have that FDA requirement listed for self administered telehealth tests. Not for tests that are administered by a pharmacy or medical clinic. 

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Just now, cmich068 said:

 

But to be even more specific, I believe Celebrity (and Royal) only have that FDA requirement listed for self administered telehealth tests. Not for tests that are administered by a pharmacy or medical clinic. 

 

Agreed.  The requirements seem more strict when it is Telehealth.

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As a note, for anyone using the Switch Health Rapid Antigen test to get on a cruise, there were previous notes that the results for the telehealth were the same as for in clinic tests, but it looks like that has changed.  We just did the Switch Health Rapid Antigen test for our flight to Vegas tomorrow and the below wording is now on the results.

 

 

Test Result Wording.JPG

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5 minutes ago, AlbertaCruisers said:

As a note, for anyone using the Switch Health Rapid Antigen test to get on a cruise, there were previous notes that the results for the telehealth were the same as for in clinic tests, but it looks like that has changed.  We just did the Switch Health Rapid Antigen test for our flight to Vegas tomorrow and the below wording is now on the results.

 

 

Test Result Wording.JPG

So what are you suggesting? They are acceptable or not for cruiselines? Does this extra help or hinder ?

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12 minutes ago, tottenhamfc said:

So what are you suggesting? They are acceptable or not for cruiselines? Does this extra help or hinder ?

 

I would suggest that this hinders this test further for use getting on a cruise.  The Celebrity/Royal wording (I haven't looked at others) does not have the wording that would allow a telehealth test approved in Canada, and instead requires FDA approval.  Before, when the results were the same and didn't have that wording, there is a chance that no one would know the difference.  Now, with this wording, I think it may trigger to the people checking the test to get on the ship that since this is telehealth they have to look closer, and the last line suggests it is not FDA approved, as why not add that if it was also FDA approved.

 

As a note, the CDC wording allows for tests approved in the country the test is taken, so I'm not worried abut using this to fly to Vegas tomorrow.

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6 minutes ago, AlbertaCruisers said:

 

I would suggest that this hinders this test further for use getting on a cruise.  The Celebrity/Royal wording (I haven't looked at others) does not have the wording that would allow a telehealth test approved in Canada, and instead requires FDA approval.  Before, when the results were the same and didn't have that wording, there is a chance that no one would know the difference.  Now, with this wording, I think it may trigger to the people checking the test to get on the ship that since this is telehealth they have to look closer, and the last line suggests it is not FDA approved, as why not add that if it was also FDA approved.

 

As a note, the CDC wording allows for tests approved in the country the test is taken, so I'm not worried abut using this to fly to Vegas tomorrow.

I know that HAL and Celebrity also require that proctored self-tests have an FDA emergency use authorization. I imagine most cruiselines have this requirement. Thanks for the heads up on the changed wording.

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In Ontario ...Sailing NCL driving to port Is Shoppers or Costco best for testing????  Anyone have any issues with either ...Need a test for March 27th sailing BUT no test on the way back on the ArriveCan app do we list ports or just NYC Thanks 

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8 minutes ago, kar1996 said:

In Ontario ...Sailing NCL driving to port Is Shoppers or Costco best for testing????  Anyone have any issues with either ...Need a test for March 27th sailing BUT no test on the way back on the ArriveCan app do we list ports or just NYC Thanks 

Either is good. Costco is cheaper, but not all Costco stores offer it. Not all SDM stores either, but many more. Appointments are needed at both in most cases.

 

There will be changes made to the ArriveCAN app. Whether this will mean eliminating the list of all countries visited remains to be seen. As no testing is required, irrespective of your itinerary, I can't see them requiring the additional information, but time will tell.

 

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3 minutes ago, willing292 said:

The manufactures of the switch health rapid antigen test have received FDA approval for emergency use.  The letter of approval is on the FDA website.

The single SD Biosensor device given emergency use authorization by the FDA is not one of the devices used by Switch Health. SD Biosensor has nine devices authorized for emergency use by Health Canada, but those nine do not include the device authorized by the FDA.

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52 minutes ago, Fouremco said:

The single SD Biosensor device given emergency use authorization by the FDA is not one of the devices used by Switch Health. SD Biosensor has nine devices authorized for emergency use by Health Canada, but those nine do not include the device authorized by the FDA.

so, now I'm curious.  what has been authorized for them?  How many ways are there to test for Covid?

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52 minutes ago, willing292 said:

so, now I'm curious.  what has been authorized for them?  How many ways are there to test for Covid?

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.

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