ID Now

My organization will only allow testing if the site has a BioLevel 2 Safety Hood for preparing the sample. None of my sites have these so we will not be going down this path. I am not unhappy about this. I hate feeling rushed and this is way too important to push it out without the proper time to get everything and everyone ready.

Anastasia

I was told that any POC test submitted to FDA is always moderate complex at first.  Then the company  after doing more studies can resubmit, if they want to market it as waived.

So beware of vendors selling a new product as waived.  Look under FDA listing if they are approved for waived.

In the case of ID Now, it is approved quickly because of the need. An EUA test can be revoked or rejected later if the need is not there anymore. The company has to do more studies to prove the sensitivity, specificity, and accuracy  of the new test before they can sell it as waived or non -waived CLIA classification. The procedure on how to perform the test for ID Now is the same whether it is waived or non-waived.

I am sure all the requirements for non-waived classification  ( I don't think CAP can make a proficiency sample right now for COVID-19) cannot be enforced because of the EUA classification.

If you try to purchase an ID NOW, you will not get one this time.  All the available units are being delivered to hotspots in the US where test is need the most. They are trying to manufacture as fast as possible.

I was just thinking, it  might not be a bad idea to have one of this  if the second wave really happens in the Fall. Bad Karma if we get one. Bad Karma if we don't. 

 I was impressed how easy it was to do the test when they demoed it to me a while back. I still want more information about the test itself, specificity, sensitivity, accuracy, precision, all the required proof of a quality test.

Anyone out there have all the answers to the other tests already on this instrument?   

RE: CLIA Status is determined by the Federal Register. 

CMS designate the CLIA status. FDA just follow the CMS requirements.

BE SAFE everyone.

Do the sample manipulation under the hood.

When CDC first came out with info on COVID-19, it says it is not spread by aerosol only by direct coughing or sneezing.   Now it is proven that the virus stay in aerosol for 3 hours ( watch those who cough or sneeze , have them wear mask- wear mask); 4 hours on copper surface, 24 hours in cardboard, 2-3 hours on plastic and stainless steel.

A negative COVID-19 test does not guarantee one does not have the virus.

Disinfect, disinfect, disinfect before and after testing.

There is a lot of confusion being spread about how a device's CLIA designation is determined.

It IS determined by FDA.  A very clear description of the process is found at https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations

I do not know how or if this applies to EUA though.  Best to call the manufacturer and ask for the CLIA categorization in writing.

Marcia

Pet do you mean under 'emergency use'?

Under emergency use, FDA, as Don said, does not classify under EUA into complexities but if it's not submitted under 'emergency use' and the submission goes normal route, then I do believe that FDA sets the complexities for the testing during it's approval process. Not CMS. I apologize if I misunderstood your post.

I've been privately asked what we are going to do about using ID Now so I'll mention here and sorry I can't respond back to everyone individually.

Between departments, we are in agreement that we'll move ambulatory ID Nows into clinical labs, follow moderate complexity, and not going to add it to the testing menu of the waived ID Now flu and strep we have been performing in our COVID/Respiratory Assessment Centers where there is screening and collection for COVID and POCT for flu and strep. By clinic staff. Of course lab performance of ID Nows will be by med techs.

We are trying to find best option for collection locations (we'd like to stick with NP into viral media for consistency with our LDT and if/when we get reagents for any large lab analyzers - want options for the specimen which we would not have if we chose to use throat or nasal ID Now collections). 

Back to CMS, there is a lot of info now out that CMS has lessened a lot of restrictions, eg opening up care of patients in different settings. That falls into line with the last line in 1st paragraph of the Abbott EUA MIFU that the instrument can be used outside of the clinical laboratory (which doesn't mean it's 'waived' complexity - the manufacturer states in the line before that the testing is moderate/high complexity).

We POCCs are a resilient bunch, we have to be to stay in this field. But we don't get to be that until we are put through trying times. So, 'here we go'... if you are new to POCC, and 'here we go again' if you are ancient like some of us.

Agree, Pet, also if you have been using ID Nows for a while and had put in an addendum or new agreement for more analyzers for additional testing sites, before COVID reagent was released, you may not get them 'now'. I don't know how the 'phasing' method mentioned by Karinna gets calculated but sure believe it.

We had been told to expect ours weeks ago. I don't think we are going to get the additional ones 'ordered' since we have testing sites not seeing face to face (visits) so are able to pull those to use elsewhere. 

Once you "validate" the IDNow Covid19, what is everyone's plan for the frequency of  running QC? 

CAP told me at first that we would have to run QC daily on each machine because it is non-waived.  They also said it did not qualify for an IQCP.  Now they say you can do an IQCP to reduce your QC in order to conserve tests.  If we ran QC on all 5 instruments daily, we would probably not have anything left for patients.  Is anyone writing one?  I have not heard anything lately from Abbott who has been working with CAP to come to an agreement.  I'm sure Joint Commission is the same as it states in CLIA two levels of QC per procedure even.  They didn't want to give guidance though and therefore aren't that much help.

Karla, Did CAP say how many QC had to be run daily?  I wonder if you could do a pos one day and a neg the next?

I've only seen the MIFU statement but not a package insert from a reagent box...let me see if I can get access to one for COVID.

And Adonica, one of the 'good things' about the negative control (from what I understand as a non-molecular specialist!) is that you want to check for false positives and running negative control swabs 'helps' with that.

IN190000 v1.0 ID NOW COVID-19 Test Product Insert IN1 (002).pdf

Above is the package insert for the ID Now COVID-19 test.