BioMedomics COVID-19

Hello

I just reviewed the website.  The test is listed for "research use only not for use in diagnostic procedures".  If the FDA cleared this for use in the US I don't think it would have this disclaimer. 

It is important at this point all testing be performed at a Health Department Laboratory for surveillance purposes.

This may be what a COViD19 test looks like when this initial pandemic dies down(hopefully)...and we run a test similar to the flu. 

Good Question and Good Luck

I've worked POCT in clinic environment since before EID which ended up H1N1  and EID which ended up Ebola. Even before WHO issued 'pandemic' on Wednesday, working with direct care staff in a clinic environment where we are the ones screening is challenging on many levels.

Even our clinic nonlaboratorian Directors send confusing messages, such as saying 'since we are COVID testing centers'...no, no we are not. We are able to perform POC flu and strep which is getting ordered on patients who present with positive screens for symptoms and travel.

We still don't have testing kits in the hospital/lab for COVID19 - we are a state supported university! and no testing kits. We collect and send to state public health dept from what I continue to hear as of this morning on our skype call.

We are screening inhouse with a POC waived Flu test and then if determined to be appropriate, we send out a respiratory viral panel, public health then determines if we send the third swab to the state lab for COVID-19 testing

That's the jest of what we have been doing until we have our own testing in house. We do have a new problem of folks calling wanting COVID19 tests so they can 'go back to work after traveling for spring break'. Sorry no, be symptomatic before you come in.

Today I heard that the transport media for respiratory panel is in short supply (something comes from Italy).

I'm waiting to hear if we are going to put in place a 'drive through'...I guess on the way to stand in line 2 hrs to buy toilet paper and disinfectant wipes (as if they are on the shelves!) folks can swing on in and wait 1 hr in line to get swabbed.

The hoarding going on around here is far worse than the usual 'run buy batteries, milk and bread' as the hurricane or tropical storm approaches and bad decisions are made to hunker down!

We have started running our own Covid-19 test at TriCore. One of our hospitals has set aside a "Respiratory Care Center" to triage patients into the ED. Other sites are setting up tents or drive-through for testing. Even if people probably have more risk at the supermarket or other crowded places, we don't want them to spread to our already sick patients. The Respiratory Care Center has placed a Liat there for flu/RSV testing, and I'm sure we'll see more requests coming. 

The Copan swabs used for a lot of viral testing do come from Italy. I'm hoping we can keep up with demand on any alternate swabs--to say nothing of test kits and other necessities.

Everybody make sure you wash hands, eat right, and get enough sleep! Healthcare workers need to stay healthy!

We were going to move our IDNOW testing to our drive up swab and go clinic we have  but thought we needed to have a CLIA for that address in order to run them at the location.  Does anyone know if that is true?

Is anyone running a Point of Care or in house test for Covid-19 at this time?  If so what test are you using ?  

Our molecular department is running the PCR test.  We are not running this point of care.

We are planning, unboxing it now, to use the Cepheid GeneXpert COVID test in the lab.

Given the scarcity of the kits, that orders for them are being metered *if* you can even get them right now it's my personal believe that making this test POC would be inappropriate at this time.  Tests should be performed on individuals that meet the criteria only.  If it was made POC they would be used on everyone and your supply would be gone very quickly.

My 2 cents.

Jeremy, I agree with  you 100%.  I have had physicians and administration questioning the ability to run a point of care test for Covid so I ask the question.  I may be the POCC but I am also a 40+ years Med Tech and have learned that sometimes you have to go ahead and ask the question to a larger group, to get the powers that be to understand I gave them the appropriate answer in the beginning.  

Everyone have a nice day and stay well!

Could you please explain the way you started your own COVID19 test?   Federal Government provides especial approval during emergency.  Will you be able to get reimbursement from Medicare/Medicaid and other private insurance companies?  How effective would your test?

The FDA just granted Cepheid's molecular-based COVID-19 test as a POCT.  Results obtained in 45 minutes. 

Have any of you been contacted by the company KMG Diagnostics concerning a Covid 19 test?  My Laboratory Manager had a cold call from this company but has not been able to find any information concerning their test platform.