Hi Will,
It is true that NAATs are not FDA approved for self-swab; however, the NAAT itself was only approved by the FDA for testing of extra-genital GC/CT in May of 2019. FDA approval arrived 10 years after the CDC recommendations began for extragenital testing. This is the natural history of it.
2009: MMWR where the CDC started to first recommend extra genital screening for GC/CT:
MMWR Morb Mortal Wkly Rep. 2009 Jul 10;58(26):716-9.
2010: CDC changed the treatment guidelines for GC secondary to developing quinolone resistance.
2011: Ken Mayer published
Clinical Infectious Diseases, Volume 53, Issue suppl_3, 15 December 2011, Pages S79–S83, https://doi.org/10.1093/cid/cir696 and
Luckily, providers kept doing extra genital screenings because we now have data on how many infections we were actually missing prior to extra-genital screening and it is quite scary. My guess is that it likely will not come unless there is a lot of pressure from the community.
At my LGBTQ practice in Connecticut we have been doing "express STI" testing for about 18 months and as I'm sure you have experience, the uptake is spectacular. However, we did send all of the uninsured sample to the state labs and received a reminder letter from the STI prevention chief that the swabs are not FDA approved for self-collection.
Quest will absolutely take the swabs back from the patient if you mail them the labeled swabs and instructions on how to do the test, the same ones you probably use. It is great, because for TelePrEP the patient just returns the swabs to Quest when they go for their routine labs.
The FDA approval again is a tricky business for this test, but pointing out the long history and benefit of doing the test is often beneficial when discussing the issue.
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A.C Demidont, DO AAHIVS
Principal Medical Scientist, HIV Prevention
Medical Affairs, East (CT,MA,RI,NH,VT,ME and Upstate NY)
Email:
ac.demidont@gilead.comcell: 203.299.6076
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Original Message:
Sent: 04-16-2020 19:21
From: William Sharp
Subject: Telemedicine and HCV- Telemedicine and other Conditions
Hello All -
Our clinic has been allowing patients to self collect GCC swabs (oral/rectal) for some time now. Now with Covid-19 our clinic is doing all virtual visits and our patients are going to lab locations closer to where they live (not in our clinic as it is currently closed). We are learning and getting push back from our lab leadership that self collection of GCC swabs is only approved by the FDA for vaginal collection (not oral or rectal). The labs are now refusing to give swabs to directly to patients to self collect oral and rectal specimens. The patients need to schedule visits with a provider for collection purposes. We know self collection is a common and patient preferred practice (for many). Any thoughts on how to approach this or is there some FDA regulation that we are missing that would allow self collection?
Any feedback would be greatly appreciated.
Will Sharp, APRN-CNP AAHIVS
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William Sharp
Orono MN
Original Message:
Sent: 04-02-2020 10:16
From: Gary Spinner
Subject: Telemedicine and HCV- Telemedicine and other Conditions
Hi Lucy
Attached are the protocols I drafted. If others look at this and have modifications, please let me know. I just tried to make it as easy as possible to provide the same needed services for STI treatment and prevention and PrEP access, while minimizing the the need for patients to come to clinic. They obviously need to go to the lab for lab tests and dropping off self swab specimens, or to get injectables in clinic when warranted, but otherwise the services are virtual.
Gary
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Gary F. Spinner PA,MPH,AAHIVS
Southwest Community Health Center
Bridgeport, CT
gspinner@swchc.org
Gary.spinner@aya.yale.edu
Original Message:
Sent: 04-01-2020 12:22
From: lucy efobi
Subject: Telemedicine and HCV- Telemedicine and other Conditions
Thank you so much Mr. Gary, I am actually a newbie in the world of HIV treatment and I am pleased to be part of this community. I really do not have an answer to your question but it is quite interesting how you had developed a telemedicine protocol with PrEP and STI and I wondering if you can share that with me. I am currently working in an HIV clinic, seeing patients with diagnoses of HIV, STI's, STD's, and PrEP. Any information to help me deliver adequate care to my patients will be greatly appreciated.
Thanks
Lucy Efobi, DNP, FNP-BC
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lucy efobi
Linden NJ
Original Message:
Sent: 03-31-2020 07:29
From: Gary Spinner
Subject: Telemedicine and HCV- Telemedicine and other Conditions
Hi All,
How quickly practice has changed for so many of us. I am working from home using telemedicine. I have written two telemedicine protocols for PrEP and STI screening for my community health center.
Having just "seen" two new HCV monoinfected patients whose laboratory evaluations are pending, I am wondering if any of you might have telemedicne protocols that you are using for treatment of patients with HCV- feel free to respond to other conditions as well- in treating patients that you will not be able to put a hand on.
As a hotspot for Covid-19, where I practice, patient care still needs to go on. Routine testing for diagnostic imaging is more difficult in my setting at the present time, although I believe I can still get ultrasonography- though not elastography. Differentiating patients with compensated vs decompensated cirrhosis is certainly the most crucial diagnostic decision point, and laboratory and serum markers are available for this of course.
Have any of you been using telemedicine and treating patients with HCV that you have never personally seen in real life?
Thanks for sharing your stories and experience.
Gary
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Gary F. Spinner PA,MPH,AAHIVS
Southwest Community Health Center
Bridgeport, CT
gspinner@swchc.org
Gary.spinner@aya.yale.edu
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