ID Now

Listening to the Monday CDC-sponsored COVID-19 call. FDA just stated that the direct swab is the only acceptable specimen for now and the FDA site will be updated to reflect that information.

When we did our own quick validation, we got false negatives from vtm samples. At that time we made the decision that the ID NOW could only use "dry" swabs. We now have to let various departments know which method to collect/transport on a daily basis, depending on our inventory levels. For example-all stat ED or tent specimens are "dry" while routine in house are vtm.  It is a challenge.

So for those that are using the ID NOW COVID-19 test- are you using an IQCP?

Hello All,

Please see the below for the ID-NOW  - it is my understanding that the EUA for near patient testing was granted to the analyzer a few days ago.  Patient Care settings =  waived test.

This is directly from CAP website (FAQ regarding COVID-19 Testing) -

"For EUA tests authorized for use in a patient care setting, perform quality control following the manufacturer's instructions, at minimum. The FDA deems these tests to be CLIA waived tests. No IQCP is required."

Hopefully this helps.

You are correct Amanda.  The FDA clarified it.  If it is approved for use under EUA for POC setting, then it is a CLIA waived test. 

When I have a copy of the Abbott ID Now COVID MIFU (after the EUA 'done'/over/ceases) which states it's waived complexity testing, I will believe it. 

IDNOW received FDA EUA for COVID for high, moderate and waived setting.

• W - authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests, and deemed to be CLIA waived for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance.

Were you able to get IDNOW COVID kits?

Peggy,

I wouldn't put this type of test or analyzer in a Point of Care Testing under normal circumstances!  Currently, we are using our 1 analyzer (given to us by our Department of Health) in the laboratory.  Processing the specimens under the hood. Infection Prevention, Laboratory and Medical Director are working on algorithms for where specimens are being tested: DOH, LabCorp, EPlex, ID NOW.

In my opinion, when there is a vaccine for COVID this platform will go back to flu, strep and maybe COVID in the point of care setting.

Happy Lab Week...:)

We been using it for 2 years.  Pros, 15 minute TAT for flu and 6 minutes for strep (2nd gen). Cons you can only run one test at time.  If you’re a busy practice you should get as many as your space allows. If you’re adding COVID you’ll need several just for that test, especially when flu season comes around.  

If you don’t have BSL2 hood, You add an  N95, goggles face shields and a biohazard shields. To routine PPE.

As per the CDC 

“For procedures with a high likelihood to generate aerosols or droplets, use either a certified Class II Type A1 or A2 BSC or additional precautions to provide a barrier between the specimen and personnel. Examples of these additional precautions include personal protective equipment (PPE), such as a surgical mask or face shield, or other physical barriers, like a splash shield; centrifuge safety cups; and sealed centrifuge rotors to reduce the risk of exposure to laboratory personnel” 

We use foam swabs too.

Yes it is waived

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

Check again it is listed as H,M,W.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

I’m looking for BSC for our point of care lab. We don’t have a lot of room a portable BSC would be great.  Can you tell me, where you got yours.  

thank you,

Ramona