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- Twitter Chat Wrap-Up: Diagnosing COVID-19: What Pathologists Need to Know Now
On March 10, 9pm EST, I took over the @Pathologists Twitter handle to host a Twitter chat about what pathologists need to know about their role in diagnosing and treating patients suspected to have contracted COVID-19.
I was joined by expert guests Bobbi Pritt, MD, FCAP (@ParasiteGal) and Michael Mina, MD, PhD (@michaelmina_lab). The CAP’s Advocacy office (@capdcadvocacy) participated to address any regulatory issues.
Below are some highlights from the hour-long discussion. Also, be sure to scroll to the bottom of this blog to view additional resources related to COVID-19.
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Q1: Curious if anyone has developed in-house testing yet #CapChat
— Sara Jiang, MD (@Sara_Jiang) March 11, 2020
We are finalizing ours #CAPchat
— Nicole D. Riddle, MD (@NRiddleMD) March 11, 2020
UCSF started in-house testing this week. 1 day TAT, about 40/day capacity. #capchat @ekhanafshar
— Vighnesh Walavalkar (@vighnesh_w) March 11, 2020
Unfortunately it's not as simple as developing an LDT, since all tests should be validated according to FDA guidelines and submitted for FDA Emergency Use Authorization prior to being used clinically. This drastically slowed the clinical lab's ability to develope and use LDTs
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
I thought you have 15 days after use to submit to fda- is that not true?
— JL (@newneuron) March 11, 2020
Yes, that is correct. You may begin to use your LDT as soon as it is submitted, but the expectation is that you will submit to the FDA within 15 days through the EUA process.
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
The FDA details its process for Emergency Use Authorization, which includes a 15-day waiver so testing can begin more immediately, for high complexity laboratories here: https://t.co/u4L4ApmXJd.
— CAP Advocacy (@CAPDCAdvocacy) March 11, 2020
A1: The current state, overall, is that the US is lagging behind the world. However, we are now on a trajectory thanks to the FDA opening up clear and accelerated pathways both via the CDC/IDT EUA assays as well as streamlining LDT development #capchat 1/...
— Michael Mina (@michaelmina_lab) March 11, 2020
The availability of the IDT kit under EUA which mirrors the CDC kit has opened up a lot of testing. However, it does not come with a +cntrl which is problematic but we are getting +specimens now so it is less problematic. #capchat 2/...
— Michael Mina (@michaelmina_lab) March 11, 2020
LDTs are coming on line as well and these are taking different shapes - the highest throughput (1000/d) at moment is certainly UW with great effort by @GreningerLab Others are following suit but most will be smaller volumes #capchat 3/...
— Michael Mina (@michaelmina_lab) March 11, 2020
LabCorp’s test is live now as well.
— Rich Davis, PhD, D(ABMM), MLS (@richdavisphd) March 11, 2020
Yes! Quest and UW have and are currently offering testing, and several other labs, including Mayo Clinic, are also close.
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
A1: Many are getting their assays up and running. Many are using the CDC EUA approved assays and are still in the process of validation or just obtaining the reagents. A major hurdle has been + controls but as we know, this will not be a major hurdle for too long
— Michael Mina (@michaelmina_lab) March 11, 2020
Q1: does anyone know what the CDC's approximate turn around time is?
— Rashna Meunier, MD (@RMeunierMD) March 11, 2020
A1: #capchat #COVID19 I am not sure what the experience has been in the past week or two. State laboratory in MA has had a turnaround time of less than a day recently. But as testing volume increases the TAT will be extended if it outstrips capacity - soon. 1/...
— Michael Mina (@michaelmina_lab) March 11, 2020
https://t.co/ey2y0ScZEy
— (@AmyHDeekenMD) March 11, 2020
has been created to monitor available testing in US by @ScottGottliebMD
Q1: I know @UW is doing in house testing for #coronavirus @SuzyDintzis #capchat
— Michael Misialek, MD (@DrMisialek) March 11, 2020
Good evening all, I was curious as to what type of testing is used by @UW and others? If it is RT-PCR, how are primers designed for this? How sensitive and specific have they been shown to be?
— atheiss (@atheiss4) March 11, 2020
A1. @StanfordMed has brought COVID19 testing in house and I believe my residency program @UCLAHealth is set to have it up in the next couple of days. #capchat
— Jason Scapa, MD (@JScapaPathMD) March 11, 2020
A1: #capchat #covid19. In Florida, we send tests to the state lab which will be confirmed by CDC on the highly suspicious pets https://t.co/bB2yZN4Cnx
— Dr. Bui Pathologist (@DrBuiPathology) March 11, 2020
A1: Many are getting their assays up and running. Many are using the CDC EUA approved assays and are still in the process of validation or just obtaining the reagents. A major hurdle has been + controls but as we know, this will not be a major hurdle for too long
— Michael Mina (@michaelmina_lab) March 11, 2020
Whether d US is leading or lagging behind is not d subject of discourse here. Do you hav any workable in-house testing yet. If no, specify clearly. Currently US transparency on COVID19 way better than many countries who claims to hav a lead on d disease bt yet failing woefully
— Peter Obami, MS, BMLS (@PeterObami) March 11, 2020
To add, in the Philippines we also have our own COVID19 testing kits https://t.co/vMYCQ7Mmbq#capchat#COVID19 pic.twitter.com/UfcGsvim9p
— Shu, RMT (@anueru432) March 11, 2020
Another piece of good news is that - after an initial delay - the public health labs for all 50 states are now capable of providing some amount of testing. This will be important for the labs that don't have the ability to bring in high complexity manual PCR assays.
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
Many of the major companies (@RocheDia , @Hologic, @CepheidNews) will apply for EUA in the coming 3-6 (maybe more?) weeks and these will of course open up many new avenues for testing. #capchat
— Michael Mina (@michaelmina_lab) March 11, 2020
@Pathologists What assurance does the public have that tests developed under EUA are properly validated? Is CAP LAP doing any extra oversight on accredited labs running these tests? #capchat
— Ed Uthman (@euthman) March 11, 2020
Excellent point. The FDA has very high standards for validating tests for use with emergency use authorization. If the lab's test submission is found to be problematic, then the FDA will tell the lab to cease testing. The FDA also provided clear guidance for validation.#capchat
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
Also, CAP is looking into ways to quickly offer information on laboratory testing, and hoping to quickly offer a product for proficiency testing
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
What is the protocol of a patient tests positive with an in-house or commercially available test? Do they need a second test to be confirmed by the CDC or state lab? #capchat #covid19
— Lauren Stuart MD,MBA (@DrLaurenStuart) March 11, 2020
At the moment there remains a recommendation for confirmation by CDC/State lab if a positive is resulted. I do not anticipate that this will or can remain in effect for long, particularly as individual labs and industry labs far outstrip state lab/CDC capacity #capchat
— Michael Mina (@michaelmina_lab) March 11, 2020
Is the confirmation just a repeat or different methodology? #capchat
— Michael Misialek, MD (@DrMisialek) March 11, 2020
What the commercial lab tests like Labcorp - do they need to be co firmed as well?
— Rebecca Osgood (@OsgoodRebecca) March 11, 2020
Yes, at this point, results still need to be confirmed by the public health lab or CDC.
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
A2. Stanford uses Reverse Transcriptase PCR methodology. We screen first for the presence of viral RNA encoding the envelope protein, and then confirms the positive result by testing for the gene encoding RNA-dependent RNA polymerase. #capchat
— Jason Scapa, MD (@JScapaPathMD) March 11, 2020
More info here about the @StanfordMed approach to #COVID19 testing. #capchat https://t.co/JjdVgadZAN
— Jason Scapa, MD (@JScapaPathMD) March 11, 2020
Related issue: False negatives have been prominently reported in news; how much should we repeat testing? #CapChat
— Sara Jiang, MD (@Sara_Jiang) March 11, 2020
Good Question! As with all tests, there is a risk for false positive and negative results. At this time, the CDC is requiring confirmatory testing by public health labs for all #COVID-19 laboratory-developed PCR tests
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
I assume that all positive results done by individual labs will have to be reported to the local public health. Who is responsible for reporting this? The labs or the ordering providers?
— Jason Scapa, MD (@JScapaPathMD) March 11, 2020
#capchat #COVID19 At this point, we should anticipate placing less weight on the TAT for CDC and focus more on state lab results and increasingly what will be coming from hospital labs and industry like Quest and LabCorps. Some others too like Avellino labs now FDA approved.
— Michael Mina (@michaelmina_lab) March 11, 2020
#capchat #covid19. Covid19 viral test is PCR based. Washington University, Quest, ARUP, Lab Corp developed these molecular tests. But physician need to ordered them and the tests need to be confirmed by CDC, I was told. https://t.co/SJOmTDWKhd
— Dr. Bui Pathologist (@DrBuiPathology) March 11, 2020
Per New York Gov Cuomo 3/10/20:
— Bill Smith (@ttskbmar) March 11, 2020
CDC has the large amounts of test kits they say they do. But the problem is the CDC "they don't have the capacity to scale to do the actual tests".
5:54 in the video... https://t.co/qxxwjIBVEH
#COVID19 #capchat This is the problem today. The test kits themselves (aka primer/probe mixes) are plentiful - frankly, should not have ever been the limiting reagent. These are fast reagents to produce in bulk. What is limiting are instruments (ABI7500 = low throughput) 1/...
— Michael Mina (@michaelmina_lab) March 11, 2020
#COVID19 #capchat as well as manpower to perform the tests. Of course, molecular virology in the clinical space has largely gone to cartridge based and similar roboticized solutions. So, workforce of clinical micro labs generally not well suited to perform these rtPCR assays 2/..
— Michael Mina (@michaelmina_lab) March 11, 2020
#COVID19 #capchat this is a holdup for many microbiology labs. Instrument availabilty and hands. However, a new twist is a potential problem in everyday reagents - RNA extraction kits are in short supply now. This will be big problem if supply doesn't increase soon.
— Michael Mina (@michaelmina_lab) March 11, 2020
Any insight on how South Korea was able to roll out high volume of testing so fast? Did they choose a different path in regards to QC or validation?
— Dennis Reel (@DennisReel) March 11, 2020
South Korea does not face the same regulatory constraints that the US faces. The need to submit lab-developed tests for emergency use authorization deterred many labs from developing tests, and slowed down those who did.
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
I am wondering what to do about swab collection. Our state lab now wants the NP and OP in one viral transport tube. But we currently collect separately and viracor (our back up lab) has not validated OP swabs. Also all our flu and respiratory panels are validated for NP.
— Cynthia Flynn (@CynthiaFlynn15) March 11, 2020
#COVID19 #capchat We've been discussing this and I feel that NP should be collected for flu/other per usual and additional NP plus an OP should be collected and combined for COVID testing. Some debate on which is better. Can combine for conserving resources as primary goal.
— Michael Mina (@michaelmina_lab) March 11, 2020
#COVID19 #capchat sample handling (i.e. swabs) are BSL2. if someone needs to grow the virus (no clinical micro lab should be doing) then it becomes BSL-3
— Michael Mina (@michaelmina_lab) March 11, 2020
Yes, specimens from patients with suspected #COVID-19 can be safely handled in a BSL-2 environment, but raw clinical respiratory specimens should ideally be opened and manipulated within a certified class II BSC. CDC guidance:https://t.co/uHEur9vo9T #capchat
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
Cynthia, after discussion with the regulatory agencies they have assessed and told us we can test OP swabs since we had validated NP swabs. We will be accepting OP swabs.
— ViracorEurofins (@viracoreurofins) March 11, 2020
#capchat #COVID19 your thoughts about expanding access to testing (and validation process) by developing COVID test strips? (https://t.co/CmiI3KHdUH, apologies link in Chinese)
— Jim (@jimtalksdata) March 11, 2020
I think that having commerically-available real-time RT-PCR test kits will be essential - particularly cartridge-based tests those that can be run on existing instrumentation in the lab. Several companies are working on developing these. #capchat
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
Are you hearing anything about timescale on those, fear is we may be well into worst of it before they are available. #capchat
— Dan Smith (@Dan1763) March 11, 2020
Has anyone seen any results on specimens sent to @Labcorp ? If so, what was the turnaround time? And what kind of pricing are you seeing? #capchat #covid19
— Ed Uthman (@euthman) March 11, 2020
Per report (not my direct experience) we’re getting 3-4 day TAT. No idea on pricing #CAPChat
— Sara Jiang, MD (@Sara_Jiang) March 11, 2020
That's a tough situation. Things should get better quickly as more labs come online with their own tests. #capchat #COVID19
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
We’re working on getting the in-house testing up and running @DukePathDept (no thanks to me-it’s our awesome clin labs team!) #CapChat
— Sara Jiang, MD (@Sara_Jiang) March 11, 2020
Q3: How should pathologists respond when they receive calls from patients and PCPs wondering about how to get tested, particularly from worried patients who are otherwise well, despite not having a definite risk factor? #CAPchat #Covid19 @ParasiteGal @michaelmina_lab
— CAPathologists (@Pathologists) March 11, 2020
Check common things first like flu and other respiratory pathogens!
— Rebecca Osgood (@OsgoodRebecca) March 11, 2020
Any criteria for testing for community spread? #CAPchat #Covid19
— Ric Mendoza (@RMendozaMD) March 11, 2020
Severe cases/deaths with no travel history should, by sheer statistics, suggest the community rate of infection
— Awkward Skeptic (@sjbenson101) March 11, 2020
A4: #COVID19 #capchat This is a really great question. First the laboratory has to work hard to ensure the technicians and staff are, themselves, comfortable in their job. There is, rightly so, a lot of anxiety about all sorts of things - just coming to the hospital for ex 1/n
— Michael Mina (@michaelmina_lab) March 11, 2020
A4: #COVID19 #capchat Assuming the lab staff are properly trained and feel comfortable handling samples, then I think that working closely with the medical directors is absolutely critical to try to be sure everyone is well informed. This will empower the laboratories 2/n
— Michael Mina (@michaelmina_lab) March 11, 2020
A4: #COVID19 #capchat ... and the staff to be able to address crit questions that are going to be asked. People will likely be anxious but one way the lab can alleviate it is to provide sound and truthful answers to when sample results will be available. Simple. effective.
— Michael Mina (@michaelmina_lab) March 11, 2020
A4. I also agree that there should be an extra "hazard pay" especially to laboratory workers in areas where there is risk for the #COVID19#capchat
— Shu, RMT (@anueru432) March 11, 2020
A4: #COVID19 #capchat Interesting and good idea. We've discussed it insofar as O/T pay. But I like the "hazard pay" idea. A bit of a slippery slope - but perhaps one that should be considered. At least in our hospital structure though, that comes through entirely distinct channel
— Michael Mina (@michaelmina_lab) March 11, 2020
#capchat #covid19 My hospital gave us a special grand rounds today on this topic. Interestingly this virus is afraid of heat and humidity which we have a lot in Florida. @Pathologists
— Dr. Bui Pathologist (@DrBuiPathology) March 11, 2020
#capchat #covid19 testing @Pathologists Share what I learned from Moffitt Grand Rounds today by Dr. Greene pic.twitter.com/p76ijfGiNF
— Dr. Bui Pathologist (@DrBuiPathology) March 11, 2020
A4: Open lines of communication are key. We have send out daily updates to staff and provided clear guidance for the safe handling of specimens from patients with suspected #COVID19 #capchat
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
#COVID19 #capchat Completely agree! Any hospital/clinic that hasn't had their ID control teams and pathology teams and admin in the same room should really try to make this happen ASAP.
— Michael Mina (@michaelmina_lab) March 11, 2020
Keeping calm in the lab in the current situation: good communication is essential! #CAPchat #Covid19 @pathologists https://t.co/38TqBSblPS
— Ziad El-Zaatari (@ziad_zaatari) March 11, 2020
Q5: How can we help our clinical colleagues in this emerging situation? #CAPchat #Covid19 @ParasiteGal @michaelmina_lab
— CAPathologists (@Pathologists) March 11, 2020
A5. Lab leadership should do their best to be at the table with other clinical colleagues to develop local testing protocols and ensure that essential testing needs are met. #capchat
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
A5: #COVID19 #capchat At the end of the day, we are laboratories so our reach can only go so far. However, there is a tremendous amount that we can do. The major ways that a clinical microbiology laboratory can help, IMO, are two...1/n
— Michael Mina (@michaelmina_lab) March 11, 2020
A5: #COVID19 #capchat We need to get testing up and running as fast as we can. We can be nimble. Fluid. And careful. We can keep constant communication with ID teams and hospital admin all of whom are wonder "what's taking so long". Communication goes a LONG way 2/n...
— Michael Mina (@michaelmina_lab) March 11, 2020
A5: #COVID19 #capchat We can work hard to figure out what is going to be best in terms of testing tomorrow, 2 weeks, 4 weeks and 2 months from now. And work towards those goals and communicate them. Outside of the lab ppl have little idea why things take a while... 3/n
— Michael Mina (@michaelmina_lab) March 11, 2020
A5: #COVID19 #capchat explaining the hoops that we must address in the lab (in a quick and concise fashion) also goes a very long way.... 4/n
— Michael Mina (@michaelmina_lab) March 11, 2020
A5: #COVID19 #capchat I also think that the clinical microbiology lab can serve as an essential resource to our clinical teams. We can provide the nitty gritty details that either the clinicians don't know to think about or can even help them better understand how to approach 5/n
— Michael Mina (@michaelmina_lab) March 11, 2020
A5: #COVID19 #capchat their patients if they have not been intensely trained. Certainly the major hospitals will have people who are well accustomed to these issues but many smaller hospitals may feel less comfortable. Clinical labs are full of expertise and in my experience 6/n
— Michael Mina (@michaelmina_lab) March 11, 2020
Keep the information regarding lab testing up to date! It’s hard!!! It’s A moving target but our clinical colleagues rely on our information!!!
— Rebecca Osgood (@OsgoodRebecca) March 11, 2020
A5: #COVID19 #capchat at @BrighamWomens the clinical microbiology laboratory MD's and technical staff are all absolutely essential to the proper functioning of our ID clinicians. So, certainly the expertise and staying up to date portion goes a long way too.
— Michael Mina (@michaelmina_lab) March 11, 2020
Are insurance agencies covering the cost for testing? #CAPchat #COVID19
— Ric Mendoza (@RMendozaMD) March 11, 2020
#COVID19 #capchat great question! At moment it remains unclear and testing remains so restricted that it hasn't been THE primary piece. insurance companies will eventually reimburse but whether this will be tomorrow or in a few months+ is variable. 1/n— Michael Mina (@michaelmina_lab) March 11, 2020
#COVID19 #capchat Testing performed at CDC/state laboratories is not being charged a fee. The reagent costs are however of course not particularly expensive. so the real question is whether patients are going to get hit with $1000's bills just for coming in. We do not want 2/n— Michael Mina (@michaelmina_lab) March 11, 2020
Some labs, including mine at Mayo Clinic, are creating easy-access testing points where patients can drive up and get tested - thus limiting exposure to other patients. In this way, the cost for the visit is also limited. #capchat #COVID19— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
My hospital patient population is mostly Medicare, Medicaid, and no-pay, so test cost comes out of operating funds. #capchat— Ed Uthman (@euthman) March 11, 2020
At least we don’t have to worry about that on a per patient basis in U.K., costs of ramping up staffing and equipment are real, but national budget is tommorrow and hopefully we will hear, something about additional £$€— Dan Smith (@Dan1763) March 11, 2020
#COVID19 #capchat dollars to be the barrier to testing. How each hospital deals with this aspect though will be individual. My personal opinion is that there should be some guidance from states (or federal) that anyone wanting to get a test should not have to fear $$$ bills.— Michael Mina (@michaelmina_lab) March 11, 2020
The Medicare program recently released coverage and billing information for COVID-19 tests. More details here in today's Advocacy Update: https://t.co/hbRp5izem9. #capchat— CAP Advocacy (@CAPDCAdvocacy) March 11, 2020
Q8: Can we learn from prior viral diseases, such as Ebola, SARS, MERS, H1N1? #CAPchat #Covid19 @ParasiteGal @michaelmina_lab
— CAPathologists (@Pathologists) March 11, 2020
A8: #COVID19 #capchat Yes. epidemiologically we were at a huge advantage to consider mitigation strategies based on positive experiences of containing SARS for ex. It's not all the same at all, but we weren't starting from scratch.
— Michael Mina (@michaelmina_lab) March 11, 2020
A8: Yes, we have had a lot of outbreaks in the past 15 years! I believe that our institutions become better prepared to address new outbreaks by learning from old ones. For example, some labs created emergency testing facilities during the ebola outbreak. #capchat
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
A8: #COVID19 #capchat Additionally, I certainly hope that we learn a tremendous amount from this experience and use this as an opportunity to build true preparedness protocols at all levels. We have a massive defense department... lets include defense against pandemics to it.
— Michael Mina (@michaelmina_lab) March 11, 2020
It's been a great #capchat on #covid19. Remember that we are an essential part of the clinical team and need to calmly work with our other clinician colleagues and lab staff to develop testing algorithms for our patients. The situation is fluid and changes daily (or hourly!).
— Bobbi Pritt, MD (@ParasiteGal) March 11, 2020
For updated information on COVID-19, please visit CAP.org’s Latest on the Novel Coronavirus (COVID-19).
Ziad M. El-Zaatari, MD, is a fellow in Surgical Pathology and former GU/Renal fellow and AP/CP resident at Houston Methodist Hospital in Houston, Texas. Dr. El-Zaatari is a junior member of the College of American Pathologists’ Digital Content Committee and member and past Chair of the Texas Society of Pathologists’ Digital Content Subcommittee. He can be found on Twitter as @ziad_zaatari.