False Negatives in COVID-19 Testing

I left for vacation at the beginning of June thinking “once I get back, all of this COVID stuff will be quieted down.” …Well that wasn’t quite the case and testing for novel Coronavirus has continued to be very important. In fact, this last weekend I was tested by occupational health. It came back negative, but I’m am very enthusiastic to get alternative specimen types validated; those Nasopharyngeal swabs are quite…uncomfortable. Luckily, my test was processed at our institution which gets results back in 24-48 hours. However, with the resurgence around the country, turnaround times are backing up to 7-8 days. One solution has been the widely used IDNOW point of care platform. However, there has been significant concern over false negatives produced by this platform. One reason the sensitivity is different is because this platform performs isothermal amplification of nucleic acid. This method amplifies RNA at a stable temperature instead of cycling the temperature as in real-time PCR.

Colleagues at my institution reflexed any negative IDNOW samples to the m2000 Real-Time PCR assay for SARS-CoV-2 for one month. Within that time, over 500 samples were tested and the IDNOW was found to have missed 21% of positive cases (prevalence rate of 5%)2. One the positive side, it had a 98% negative predictive value, which helped rule out COVID19 infection. However, as prevalence rates are increasing, a high negative predictive value isn’t as important as sensitivity.

One study drew much attention when it claimed the IDNOW had a sensitivity of 52% in a New York City academic institution (Basu)4. However, this seems to be an outlier compared to other studies of this platform: one large multi-center study found positive percent agreement (equivalent of sensitivity when a gold standard test hasn’t been established) of 74%1. The highest PPA of 88%3 for the IDNOW was found in a study that indicated it can be completed in 17 minutes, whereas another quick instrument (but not point of care instrument: Xpert Xpress, 45min) had a PPA of 98%2.

Myself and other colleagues looked more closely at the clinical characteristics of false negative test results on the IDNOW. Overall, we found 82% PPA, and 8 patients with false negative tests. Interestingly, a majority of these patients were tested over 2 weeks after their initial onset of symptoms. The virus is known to be at its highest levels at the beginning of symptom onset. So the test may not be limited, but it should be used in the correct clinical context (< 2weeks from symptom onset). After that time, other RT-PCR based tests are more appropriate.

As clinical laboratorians, we often hear: “the right test for the right patient at the right time.” Now with so many platforms available for use in different contexts, we should help guide clinicians to Choose Wisely.

References

  1. Harrington A et al. Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. JCM 2020. PMID: PMID: 32327448
  2. McDonald et al. Diagnostic Performance of a Rapid Point of Care Test for SARS-CoV-2 in an Urban ED Setting. Academ. Emerg. Med. 2020. PMID: 32492760
  3. Zhen W et al. Clinical Evaluation of Three Sample-To-Answer Platforms for the Detection of SARS-CoV-2. JCM 2020. PMID: 32332061
  4. Basu A et al. Performance of the rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution. BioRxiv 2020.

-Jeff SoRelle, MD is a Chief Resident of Pathology at the University of Texas Southwestern Medical Center in Dallas, TX. His clinical research interests include understanding how the lab intersects with transgender healthcare and improving genetic variant interpretation.

The Laboratory’s Role in Inclusion

“Where do we go from here…chaos or community?” is the question Dr. Martin Luther King, Jr. asked in 1967 before the civil rights riots in the hot summer of 1968.  The query was directed to the nation as it sought to address the racism and pain deeply felt in the daily lives of its African-American citizens.  Over 50 years later, that very same question is asked again as the nation is roiled with civil demonstrations, daily videos of racist behavior, and the seemingly senseless killings of African-American men and women. 

As American culture and the nation evolves, uncomfortable conversations are beginning to occur in healthcare and across the country.  Laboratory administrators and managers may want to reflect on the culture of their laboratory to ensure all voices are heard and that they are creating and supporting an inclusive work environment.

Diversity, inclusivity, and equity are goals healthcare organizations seek to incorporate into their culture to foster a healthy workplace environment and be reflective of the communities they serve.  As with most industries, the laboratory has found itself challenged to improve cross-cultural intelligence and eliminate implicit and unconscious bias.  The scientific community would like to believe it operates and makes decisions based solely on objectivity and facts.  However, everyone is human and prone to perceptions influenced by preconceived beliefs and life experiences. 

In the laboratory, questions involving race relations are pondered and discussed by workers of all creeds and colors.  Historically, laboratorians have viewed themselves as scientists focused strictly on the pursuit of facts, hard data, and helping patients.  However, one would err in thinking the lives of minority lab workers were encased in impenetrable bubbles of logic and reason. Instead, early on in their career (correction—their lives), many minority workers learned to compartmentalize and hide feelings of unfairness and helplessness in their effort to “fit in” and not make others feel uncomfortable.

Laboratory administrators should let employees know that their office is a “safe place” if an employee feels he or she needs to discuss issues affecting how they feel about their work environment. Many employees of color working in predominately white environments may avoid conversations involving race out of fear as being labeled as “one of those.”  However, avoiding difficult conversations does not make the problems go away; in fact, the lack of addressing an issue often creates a more significant problem later on, or the employee simply quits.  One thing managers should be prepared to hear if they are successful in creating a safe space and the employee chooses to talk, harsh truths.

Lab managers can be proactive and ask if the employee has encountered any barriers or obstacles to their success in the healthcare organization.  Minority employees frequently experience microaggressions, favoritism, and racial discrimination.  Discussing feelings may provide a release for the employee, allow the manager to begin to understand, and offer the opportunity for the manager to reflect on their behavior. 

 The diversity of today’s protest marchers provides evidence of the progress America has made toward vanquishing the problems of racism and discrimination.  All colors, creeds, and ethnicities are together expressing their desire to defeat the scourge of racial injustice.  Laboratories are a part of the social community, and minority employees are often reluctant to share anxiety and experiences they feel are race-based.  Lab managers should be reflective and reach out to their employees to let them know their office is a “safe place” to discuss issues openly, including those with racial overtones.  It is only through open and honest dialogue that we can avoid chaos and become the community we seek.

Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ), has been an ASCP Medical Technologist for over 30 years and has been performing CAP inspections for 15+ years. Dr. Elzie provides laboratory quality oversight for four hospitals, one ambulatory care center, and supports laboratory quality initiatives throughout the Sentara Healthcare system.

From Panic to Pandemic: Laboratory Emergency Response Plans

In 2018, Hurricane Florence ripped through the Carolinas causing an immense amount of destruction and taking a record amount of lives in the area. Superstorm Sandy had a devastating impact on New York and New Jersey in October 2012. In Joplin, Missouri, an EF-5 tornado cut a damaging path through town in May 2011, directly hitting the hospital. Severe storms, flooding, and even blizzards are regular events throughout large areas of the United States every year, disrupting normal life and the delivery of services, including healthcare services.

Natural disasters occur frequently, and labs must consider them in their Emergency Response plans. These disasters have consequences for hospitals and laboratories and their operations. Given the wide variety of possible disasters that can affect a laboratory, it may seem impossible to be prepared for every type of event that could occur. Some labs take a reactive approach and create individual plans for different disaster types. For example, a lab manager may decide to create a blizzard response plan after a major winter storm—a plan that is separate from any previously existing lab emergency response plan. That may not work well, and it many plans may become cumbersome for lab staff when the event occurs.

As 2020 has shown us, other types of disasters that are not normally considered can also affect laboratory operations. The COVID-19 pandemic situation has created issues like the reduction of the availability of staff, a need to quickly alter testing platforms, and even major supply acquisition issues. Clearly, pandemic issues need to be considered when looking at lab disaster responses.

The best type of laboratory emergency response plan is a single plan that will enable the laboratory to continue to provide services in a variety of disaster scenarios, including pandemics. The College of American Pathologists (CAP) requires labs to develop an emergency plan which is based on the overall facility’s Hazard Vulnerability Analysis (HVA). The HVA is a risk assessment tool that lists types of disasters that can affect the facility, and it ranks which disaster types are most likely. If you work in an independent lab, you must perform your own HVA and update it every year. In 2020, it would be prudent to quickly add “pandemic” to the list.

There is no need to panic, however. In your plan which has been designed to have an “all hazards” approach, you may find some aspects of pandemic response are already addressed. Fluctuating staffing levels should already be addressed. Be sure the plan discusses how to best utilize staff when fewer people are available. That process may include a reduction in testing or utilizing a reference lab if necessary. In some instances during the pandemic, labs were left with too many staff members once an overall reduction in lab volumes occurred. How can extra staff be used? Can they go to other departments or facilities where needs may exist? There should be a section in the response plan regarding how to handle supply issues. If it is known there is going to be a problem obtaining PPE, reagents, and other supplies, decide what procedures will occur. Stockpiling, finding alternative vendors, and changing the type of supplies purchased are some options.

Once all of the pieces of the updated lab emergency operations procedure is complete, it is important to test the plan for flaws or needed improvements. One thorough method of testing includes the use of a table-top drill or exercise. Present a step-wise disaster scenario to key lab stakeholders and discuss possible responses as the imagined situation unfolds. Be sure to discuss important aspects such as staffing, supplies, communications, and relocation of testing. If the COVID-19 pandemic has led your lab to utilize its emergency response plan, be sure to take the opportunity to review how it is working for your department. Ask lab leaders and staff members if the current plan works- what went well and what needs improvement? This current disaster can help us all to improve our current procedures and keep us ready for the next event.

Is your laboratory emergency operations plan up to date? Does your staff know how to use it or will they panic when a disaster occurs? Has the plan been tested? Now is the time to review what you have and make sure it works for pandemics as well as a wide variety of disaster scenarios.

Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

Practicing Productivity in the time of Pandemic

At this point, you are either somewhat adjusted to working from home (likely taking on new roles and responsibilities while juggling your kids, dog, and spouse), battling COVID on the front lines (caring for patients, providing us with food, or keeping the lights on), or unemployed (yet another victim among a whole host of victims during this extremely trying time). Regardless of where you fall, you have likely been on at least one video conference since January and you will likely be on many more over the next six months. As live, in person meetings of 2500 to 5000 people that we are so used to have come to a screeching halt, the world of associations such as ASCP are carefully and artfully creating virtual experiences that you can be assured will enhance and improve your life but will most definitely be in a virtual format. But the whole world is now experiencing online happy hours, teaching sessions, work meetings, telehealth visits, group therapy sessions, and kid’s birthday parties. Step back from your current situation and ask, “Have I seen MORE or LESS of my friends and peers in the last six months than in the prior year?” That answer is different for each person and carries different emotional baggage. For the constant extrovert who needs that human interaction fuel to spur them on, video conferences may not be hitting the mark. For the ever-quiet introvert who happily recharges among their books and cats and knitting, constantly being required to video chat with people for hours on end may be pushing them toward a steep cliff of insanity. For the “mover and shaker” that loves a problem a minute, thrives in crisis, and gets utter joy out of solving a problem and moving on, facing a day filled with 8 pre-scheduled video conferences or, worse, a day with an empty calendar can be demoralizing. For anyone who had a rhythm to their email usage which involved key time points to check during the day and an internal list of priorities of how to deal with emails on a rolling basis, the extreme uptick in volume of email because everyone is working remotely in the same office (“where is the water cooler chat?”) is dizzying.

It is now July 2020 and we face the uncertainly of what working from home will mean or be or even when it will end (or will we choose this as a permanent solution?). For those of us who have been and continue to report to our work place using social distancing, masks, shift rotations, and the inability to touch anything around us, how can we make this sustainable long-term, do we need to do so, and how do we know when we can end it? For the hundreds of millions of non-laboratorians who are asking, “When will there be a test so we can go back to work?”, the job of the laboratory has long been a mystery but is now suddenly thought to be a miraculous answer to a complex problem of politics, public health, and capitalism. Amidst all of the uncertainty of COVID-19 that we are facing on a continuous basis, the country was already immersed into a “fake news” war between rival political factions that already had the bulk of America either fed up with all new sources, only trusting one “news” source (the bulk of which was political agenda opinion), or simply burying heads in the sand in hopes that this was all just a bad dream. We are halfway through 2020 and the optimists are saying, “It can only get better” and the pessimists are sighing, “what comes next?”. The only people who aren’t complaining are the myriad of investors who didn’t even need a crystal ball to predict the March stock market crash, sold short, and raked in billions—which they then returned to the market buying blue chips at rock bottom (relative) prices to now be showing a 20% return. If only we could all be so lucky?

But there is a light at the end of the tunnel and the sun will come up tomorrow. Nothing lasts forever and this virus will run its course—whether we fight it tooth and nail or ignore it—to a natural conclusion which is harmony within our population. Over the next 6 months, enormous amounts of data on epidemiology, biology, virology, and treatment will emerge. We will learn from our colleagues in Africa what the impacts of early, sustained interventions can do to thwart the virus. Over the next year, vaccines will appear and be available for the population at large. The myriad of tests will have settled around a handful of reliable “winners” that have the sensitivity and specificity we need for each of the valued applications in our systems. The stock markets (and your retirement funds) will have recovered and exceeded pre-COVID-19 levels. However, one aspect of our lives will be permanently changed and that is our dependence and use of video conferencing for the special, the everyday, and the mundane. To that end, let me conclude with some of my (hard earned) lessons from both the last 6 months and the last 20 years of working in global health.

  1. Video conferencing etiquette is a “thing”. Seriously. Tools available to the host can get you so far but nothing says, “we are all in this together” like a team on a video call that is following the rules. Mute yourself when you are not talking. Turn off your computer’s sounds or software that makes frequent sounds. Do not leave your cellphone on your desk on vibrate (computers have great microphones!). If your internet connection is bad, switch off your video. When you are listening, look directly into your webcam (then others feel you are looking directly at them and they feel more connected). Use a virtual background if possible so we do not see your kids making breakfast in the background. Brush your hair (you can totally get away with no pants and not showering but “bed head” is a dead giveaway). Sit within 3 feet of your computer. Rename yourself on the screen if possible, with your full name and organization. Do not take a video call while walking outside.
  2. Your workstation is your productivity cockpit. Make sure it has what you need. In today’s world of multitasking and conferencing, two screens are almost a must. You can use a laptop while traveling but for a home office, having two screens creates a much cleaner canvas to spread out your work, keep resources at your fingertips, take notes while conferencing, etc. Treat your digital workspace like your physical desktop. Keep only what you need on the desktop. File your files in folders you understand and can follow. If your virtual desktop is covered in hundreds of files and icons, your brain is not mentally able to process or prioritize. Use a background picture that sends you to your happy place so that, when you need a break, all windows can be closed, and you can zip to your happy place immediately.
  3. Develop a personal system for communications. Maybe you are a texter, a snapchatter, an emailer, a phone-call-aholic, an instant messenger fiend… Whatever you are comfortable with, the other dozen people you interact with are comfortable with something else. Your team lead may say, “We are using Teams!” or “We are using Basecamp!” or “We are using Sharepoint!” but, let’s face it, it may not fit your style or your work flow. The important thing is to develop a system for whatever communication type you feel most comfortable and work that system to be productive. I have seen the inboxes of people who have 85,000 unopened emails (both personally and professionally) to which I reply, “Delete them!”. If something in those emails was so important, the person will have found another way to contact you. You are never going to read them and, honestly, email just does not work for you. Pick another channel. Texting can work for many people but the organization of texts on a phone and the archiving eventually becomes a challenge such that screen captures or lots of copy/pastes must occur. Whatsapp is a good solution with its archiving function but can still present a permanence problem. Your chosen communication channel is important because it will dictate your productivity style. For example, one of my colleagues takes extensive notes on paper (extensive!) but sometimes takes extensive notes on a tablet. Their work stack (i.e., the collection of items they work through daily) is a combination of pieces of paper and digital notes, but it is disconnected from a communication system. The time required for note translation into understanding and then moving those thoughts to an email, for example, for me would be wasted time. But they remain one of the most productive people I know so this system works for them! Each person must decide what makes them most productive and what keeps them informed and connected; however, a good approach if you are feeling overwhelmed is to use a single system (digital) that moves with you. Microsoft Outlook, Gmail (and calendar), and iCloud all have cross functionality that allow seamless notetaking, email and calendar creation, and file connectivity. Outlooks category function for email can be a massive time saver for the adept user where a preliminary read through of email can allow for classification (for example, I use “Urgent”, “To do – Non-Urgent”, and “Waiting on Reply”) and then priority follow up. At the writing of this blog, I have less than 30 emails in my inbox, all are categorized, and all are calendared for completion.
  4. Go outside and breath. The single most important thing that we can achieve as a society as we emerge from the COVID-19 pandemic is an appreciation for life, freedom, and health and that is difficult to do if you stay in front of your computer for 12 hours a day. More than half a million people have died of COVID-19 and we could have been one of them. Unemployment spike from a flat 4% to more than 14% with many companies, restaurants, and small businesses never planning to reopen. The unfortunate tragedies that continue to befall our black brothers and sisters led to peaceful protests which were then corrupted by riot and ruin across many major cities. Even now, racial and ethnic disparities, especially our Navajo neighbors in the Southwest along with our black communities, cause disproportionately suffering from COVID-19. It is not a time to think, “I’ve been lucky!”. It is a time to say, “What can I do to help today?”And where the help is needed is outside, in your community. Yes, you should wear a mask if you can’t social distance. Be sure to wash your hands frequently. But get out there and be part of the change for the better!
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-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.

A Wave of Testing Advances or Just a Drop in the Bucket?

Hello again everyone and welcome back! Thanks for joining last time in my discussion of social media as an inexhaustible force in professional development. This month…something different…

Yes, indeed, this month’s piece from me to you is a well-deserved break from your regularly scheduled pandemic reading. Consider this your COVID content caesura. Whatever will we discuss without the virus at the forefront of all of our media channels? What then could possibly hold our attention, satisfy our craving for knowledge and professional development, and quench our thirst for lab-driven news?

Liquid biopsies. Obviously. Get it? Thirst? Quench? Yea? I’m sorry, let’s just jump in…

Image 1. This is totally what happens during liquid biopsies, can you guys not visually see DNA? You might need better centrifuges/brighter bulbs—talk about your 10,000 ft. diagnosis, right? (Stock image: Cancer.org)

In my recent social media scroll-binging (which is absolutely normal nowadays, don’t judge) a small story about a published article in JAMA appeared nestled gently between powerful protest content, pandemic virology, and 2020 politics. The article, which was just a small summary of a study in Science that combined liquid biopsy testing with PET-CT imaging to screen and guide interventions for a variety of cancers detected among over 10,000 recruited patients. Detected cancers included anything from solid masses to lymphoma and were found from thyroids to the ovaries. Translation: earlier, more comprehensive detection of malignant neoplasms of all sorts ….*drum-roll, please* ….BY BLOOD TEST! If you’re not impressed with this outright, then don’t fret. This kind of lab testing technology is some Penn & Teller level medical lab science, and I’m very excited about it! I could do a whole talk on this, a professional one, a TEDx one even…scroll to timestamp 4:50:00—of course I’m gonna plug the TEDx talk here. You know me.

Image 2. Remember your A-B-P’s: Always be promoting. Like the TEDx talk I gave, where I talked a bit about liquid biopsies; I don’t know if told you that I did that … (Source: TEDx)

What’s a liquid biopsy anyway?

That’s a great question, I’m glad you asked. Basically, think of it as the pinnacle of precision medicine—the gate key for all diagnoses and prognoses for an individualized treatment regimen based on the principles of known mutagens and detectable proteins and particles. Put plainly, a simple blood test that tests your blood (or other body fluid) for specific biomarkers to clue us in on the presence of an insidious malignancy. What kind of markers? Circulating tumor cells, micro-amounts of relevant RNA, vesicles, modified platelets, and other parts of cells, specific proteins—the list is growing. New concept, right? Not exactly, we’ve known about circulating tumor cells for at least 70 years now (nope, not a typo) but we haven’t been able to accurately hunt for them. We’ve had a concept of this sort of testing since the 70’s but have had a hard time implementing its clinical utility.

Image 3. A clinical lab. Somewhere. Circa 1975. To be a fly on the wall when they decided to skip gas biopsies and jump straight from solid tissue to liquid—what a concept! (Source: Univ. Texas at Austin, College of Health Sciences, historical photo of flu drug development at Memorial Sloan Kettering, NY)

Until the present day. Much like PCR, NGS, MALI-ToF, specialized mass spectrometry, and other awesome tools in our clinical arsenal, the ability is surpassing the paradigm. Whoa—philosophy check: are we moving too fast? Is this a reckless exercise? Should we do more research? No, no, and yes (obviously, always). Liquid biopsies have had pre-Wright brother success in getting airborne, so I’m recruiting all you readers out there to get excited with me and garner interest. Previous limitations might have meant we needed histological diagnosis first—I see you, everyone on the AP side… but these papers I’m showing you all today say basically three things: (1) our technology for liquid biopsy is getting better, (2) we might not need any previous test/section and could use liquid biopsy as a screening tool, (3) combined with imaging studies, this could be highly predictive and clinically useful.

The published study said what…?

Okay, let me show you the papers in the order I saw them: the JAMA article was just a primer in their Biotech Innovations magazine, a summary of an interesting development in liquid biopsies. They referenced the recent study in Science and discussed how 26 of the 10,000 women aged 65-75 were confirmed from liquid biopsy (LB) to imaging with PET-CT and, ultimately, biopsy to conclude. It said that the “blood test combined with the PET-CT had a 99.6% specificity and a 15.6% sensitivity…” with more being detected by LB at follow up. If those numbers triggered you as much as they did me, then of course you would have done what I did and followed the breadcrumbs.

Image 4. (LEFT) the three-tiered method of testing in the Detect-A Science paper and (RIGHT) the nearly 99% specificity of the CancerSEEK liquid biopsy modality in the second referenced Science article.

Que the Science study. In it, the authors presented their three-step testing process, using “Detect-A” LB for baselines. Ultimately 26 cancers in 10 organs were detected by just the blood test; this was out of a total of 96 cancers detected overall in the 10,000 participants either through liquid biopsy, current standards, or other investigative work ups. They did the math and showed that despite a sensitivity of 15.7% for the combined LB and PET-CT, the positive predictive value rose from 5.9% to 40.6% when you combined those two modalities. But the other statistics weren’t as impressive. Back to the JAMA article! The very last line said, “a newer version of the test that has a 99% sensitivity without confirmatory steps is in development…” Okay, now we’re cooking with gas—or testing with liquids—whatever: that’s the holy grail of CP testing 99% sensitivity, 99% specificity! Do tell!

Much ado about liquid—this was less impressive. This last line referenced a Science paper used “CancerSEEK” LB in 1,000 patients with sensitivities from 70-98%, but fantastic 99% specificity. Different panel, different cancers this time. Interesting to note, was that, applied to the specific incidence in the US population for the particular cancers detected by CancerSEEK, the sensitivity was around 55%. And, they managed to keep the cost relatively low at under $500 per test. (Sorry, if a red light just went on while you read this, CMS is probably recording now…) Well, this left me wanting. I’ve read so little about LB’s in recent years, is no one working on them? Well no, I was just busy, there’s tons of stuff out there, silly.

In just the past year alone, the American Journal of Clinical Pathology published 10 pieces on liquid biopsy cases, education, and utility for all kinds of malignancies from cytology to hemepath! AJCP—that’s us guys, it’s happening right here, right now! I told you we’ve got to do a PR run on this stuff and get it out there.

Is this the future? Are we in it now?

I’m happy to report that yes! This is indeed the future, well at least as thought of by the folks that conceptualized liquid biopsies 70 years ago. No hover-cars, or hover-boards, or hover-anything really (not without a lot of tech and work) but we’re closer to small advances in medical diagnostics!

Image 5. Maybe a better conceptual map of what liquid biopsies do. (Source: Gene Quantification)

Nature writer Catherine Alix-Panabieres put it very well when she wrote an Outlook piece this past March. On the one hand, liquid biopsies are a growing clinically useful tool in the synergy of addressing cancer in individualized medicine. On the other hand, we’ve known about this concept and have clearly been working on advancements in this testing technology for decades—it’s about time to come out of the shadow and push into widespread utility, including them in cancer algorithms, and redefining the ways in which cancer work-ups are developed in clinical trials, regulated by safety, and integrated into the toolkit of oncologic diagnostics. In my recent interview with People of Pathology Podcast show-runner, Dennis Strenk, I said we’re not quite ready to replace tissue biopsies yet—but are we close?

When do we go from pushing glass to pushing tubes?

See you next time!

References

Abbasi, J (2020) Blood Test Flags Multiple Cancers in Large Study, JAMA. 2020;323(22):2239. doi:10.1001/jama.2020.9266 → read it here

Alix-Panabieres, C (2020) The future of Liquid Biopsy, Nature 25 Mar 2020 579, S9 doi: 10.1038/d41586-020-00844-5 → read it here

Bai, Y, and Haitao, Z (2018) Liquid biopsy in tumors: opportunities and challenges, Annals of Translational Medicine, 2018 Nov; 6 (Suppl 1): S89, doi: 10.21037/atm.2018.11.31 → read it here

CAP (2020) The ‘Liquid’ Biopsy, College of American Pathologists → read it here

Cohen, J, et al. (2018) Detection and localization of surgically resectable cancers with a multi-analyte blood test, Science 23 Feb 2018; Vol. 359, Issue 6378, pp. 926-930, doi: /science.aar3247 → read it here

Lennon, AM, et al. (2020) Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention, Science doi. 10.1126/science.abb9601 → read it here


-Constantine E. Kanakis MD, MSc, MLS (ASCP)CM is a new first year resident physician in the Pathology and Laboratory Medicine Department at Loyola University Medical Center in Chicago with interests in hematopathology, transfusion medicine, bioethics, public health, and graphic medicine. His posts focus on the broader issues important to the practice of clinical laboratory medicine and their applications to global/public health, outreach/education, and advancing medical science. He is actively involved in public health and education, advocating for visibility and advancement of pathology and lab medicine. Watch his TEDx talk entitled “Unrecognizable Medicine” and follow him on Twitter @CEKanakisMD.

A Resident’s Perspective of SARS-CoV-2 Testing Using the Double Diamond Model of Design Process

During the 2019-2020 residency interview season, I “courted” – no better way to describe those interactions over lunch–several potential co-residents, who were eager to know why I came to University of Chicago (NorthShore) for my residency. My answers and those of my fellow residents would help the candidates determine how high they should rank our program, so I enthusiastically recalled things I liked when I interviewed at NorthShore about a year earlier. I had also recently completed my first microbiology rotation in residency and I had enjoyed seeing all of those factors work synergistically to improve patient health outcomes through improved testing. So passionately, I shared how I fell in love with the physical structure of the department which has almost all the labs and offices one floor, the automation of the labs-especially the core and microbiology labs, the capability and regular expansion of its molecular laboratory, the people and of course, “the feel” about NorthShore.

With these experiences, I looked forward to my second microbiology in March 2020, where I would learn more about the diagnostics of various microorganisms–E. coli: Gram negative short stubby/broad shouldered rods vs. Pseudomonas aeruginosa, Gram negative long slender rods, etc. (Un)fortunately, March came, but the novel coronavirus (SARS-CoV-2) had other plans for my learning. Cases of Coronavirus disease 19 (COVID-19), caused SARS-CoV-2[1] were increasing rapidly in the US, so laboratories, including ours had rapidly implement testing. Rather than have morning rounds and other educational activities where the differential diagnoses of several clinically relevant microorganisms were discussed, we had virtual and in-person meetings discussing what to do about one virus. These continued and by the middle of March, we had become the only non-government lab in Illinois and second in the Midwest that had developed a clinical PCR test for SARS-CoV-2. I was excited to be part of that success, but more so, about learning how we achieved that as a team.

Our approach could be summarized using the Double diamond or 4D model of design process which consists of four phases: Discover, Define, Develop and Deliver (Figure 1).

Figure 1. Double diamond or 4D model of design process which consists of four phases: Discover, Define, Develop and Deliver. Plan Do Study Act (PDSA) is an iterative model of quality improvement embedded in the 4D design process.
  1. In the discover phase, a phase of divergent thought [2] and exploration, we identified from events in China and other parts of the world as well as some other states in the US that the community we care for could potentially be affected by the COVID-19 outbreak.
  2. The next phase- define- is a convergent phase where the problem to be solved, as well as the resources available and resources needed to solve it are delineated [2]. As we transitioned from the discovery to define phases-and recalling the 2009 H1N1 influenza outbreak about 10 years ago- it became evident that an epidemic of a relatively fatal respiratory virus which we knew very little about was heading our way. As clinical laboratory professionals, our objective was to help identify members of the community who had been infected through testing so appropriate steps could be taken to sequester and care for them. Among our available resources was our molecular laboratory, but like most laboratories outside the Centers for Disease Control and Prevention, CDC we lacked the reagents, primers and authorization to run the test.
  3. Develop is the next phase in the process and this is a divergent phase where the team explores and refines potential solution to the issues and selects one[2]. This is often followed by the convergent deliver phase where one of the solutions from the develop phase is implemented. Feedbacks which are used for projects are also received during this phase[2]. But, the outbreak continued to evolve rapidly [3] with briskly increasing positivity rates[4] and some of the solutions we considered would require some time to be implemented and/or have long turnaround times. For instance, since we had a roust molecular laboratory, one option was to develop our assays and test in-house, while another was to send the samples to outside labs where they could be run. Running the tests in-house would have a shorter turnaround time and would be more efficient, which is extremely important considering the severity of COVID-19.
  4. Deliver is the last phase of the process.  We decided to develop a SARS-CoV-2 RT-PCR test at our institution, but we also knew we needed to put logistics and protocols in-place to deliver our solution.  For example, COVID-19 presents with flu-like symptoms but flu is common between December and March[5-7] so it would be impractical to expect to test all patients with flu-like symptoms – at least with the limited resources we had. In any case, it was clear that we would not have an ideal amount of time or information to develop and implement the perfect solution. As such, the revolving and fluid nature of the develop and deliver phases of our response is best depicted using the Plan Do Study Act (PDSA), an iterative model of quality improvement. As shown in Fig. 1, we developed and validated our assay, as well as developed an initial protocol for screening patients and logistics for patient-centered delivery in the “Do” step. Importantly, we also reviewed the effectiveness of these operations, and made necessary changes corresponding in the “Study” and “Act” steps respectively.

The prompt decision to implement in-house COVID-19 testing at NorthShore has proven to be the right one. To date we have tested 75,000 specimens and nearly 20,000 tests have been positive. Success which was possible because of the factors which made me come to NorthShore, amongst others. The LEAN, bright and capacious design of the department limits the innate barriers of hierarchical organizational structure; encouraging seamless horizontal and vertical intradepartmental consultation and collaboration as COVID-19 led us into uncharted territory. Also, having a molecular lab that regularly expands its capability made the decision to test in-house relatively easy. In addition, having an automated microbiology lab made it easier for staff to be flexible and deal with the various demands of testing for a new bug in a pandemic. And of course, the people at NorthShore who are ready to volunteer, take up new roles or change shifts to accommodate the demands of a rapidly evolving pandemic, stay in constant communications and provide feedback, and who make everything else at NorthShore work!

References

  1. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200130-sitrep-10-ncov.pdf?sfvrsn=d0b2e480_2
  2. Council, Design. “Eleven lessons: Managing design in eleven global companies-desk research report.” Design Council (2007).
  3. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html
  4. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200324-sitrep-64-covid-19.pdf?sfvrsn=723b221e_2
  5. https://www.who.int/news-room/q-a-detail/q-a-coronaviruses#:~:text=symptoms
  6. https://www.cdc.gov/flu/symptoms/symptoms.htm
  7. https://www.cdc.gov/flu/about/season/flu-season.htm
  8. Christoff, Patricia. “Running PDSA cycles.” Current problems in pediatric and adolescent health care 48.8 (2018): 198-201.

Adesola Akinyemi, M.D., MPH, is a first year anatomic and clinical pathology resident at University of Chicago (NorthShore). He is interested in most areas of pathology including surgical pathology, cytopathology and neuropathology -and is enjoying it all. He is also passionate about health outcomes improvement through systems thinking and design, and other aspects of healthcare management. Twitter: @AkinyemiDesola

-Erin McElvania, PhD, D(ABMM), is the Director of Clinical Microbiology NorthShore University Health System in Evanston, Illinois. Follow Dr. McElvania on twitter @E-McElvania. 

Unwritten Safety Rules Every Lab Professional Should Know

Many years ago a woman purchased a cup of coffee in a restaurant drive-through. Not having a cup holder available in her car, she placed the cup between her legs to hold the coffee while she reached for money to pay for it. She burned her legs, sued the restaurant, and actually won her court case. Now such restaurants are required to warn customers with signs stating the obvious; “coffee served hot.” Before this regulation came to be, however, many people were aware of the possible danger of placing a hot cup near their skin. Does having a posted sign make customers safer? What about the lab environment? There isn’t an explicit safety regulation written for every action that could create an unsafe situation. So what are a few of the hidden and maybe no-so-obvious things might your staff need to know in order to keep safe?

You can’t chew gum in the laboratory. It’s true, but sadly, it’s not written down anywhere as a regulation. OSHA’s Bloodborne Pathogen standard says that “eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited (in the lab).” It says nothing abut gum, throat lozenges, hard candy, or even chewing tobacco. The unwritten rule is that OSHA is trying to prevent hand-to-face contact while working in an area where infections can be acquired easily this way. There are multiple routes of entry via mucous membranes- a major source of pathogen exposure- your mouth, nose, and eyes. Laboratorians should always keep their hands away from their face when working in the department. These activities are just another opportunity for hand- to-mouth contact. While you might be able to show the safety officer you are putting these things in your mouth outside of the lab, you would not be able to prove that to an inspector, and they will rightly cite you for it. If you need help enforcing this, be on the lookout- by the end of the year there will most likely be a regulatory body that addresses gum chewing directly.

How long should staff wear PPE? During the COVID-19 pandemic, many have asked about the effectiveness of various PPE and have looked for written guidance discussing how long it should be worn. In general, studies show that gloves lose barrier effectiveness in about two hours. Wear them that long if they are not visibly soiled while in use in the lab. Lab coats- disposable or reusable- can be worn for one week in the general lab setting unless something is spilled on them. Once a new coat is worn, the outside is considered contaminated, but that does not mean it cannot be re-used. It is wasteful to change coats every day unless there is a reason to do that (i.e. in a specialty lab where cross-contamination will be an issue). Face shields worn by staff can be reused as well, and they can be cleaned with alcohol-based products for disinfection. Rarely should a wearable face shield or goggles be used only once before disposal.

Mesh shoes are not allowed to be worn by lab personnel. Again, other than in CLSI guidelines, it will be difficult to find that written clearly in lab safety regulations. Laboratory footwear should “be comfortable and cover the entire foot, including the instep and the heel. Because canvas shoes will absorb chemicals or infectious fluids, they are not recommended. Leather or a synthetic, fluid-impermeable material is suggested. OSHA’s PPE standard does insist that employers take measures to protect the feet of employees. In the lab and specimen collection setting, that means footwear needs to protect from biohazard materials, chemicals, and even sharps. Mesh or canvas shoes do not fit the bill, and neither do clog-style shoes (even if they have a heel strap). If you need to, set your lab’s footwear policy through the dress code or maybe the Chemical Hygiene Plan. If staff tells you they can’t find this type of footwear, tell them to look harder. All across this country, hundreds of laboratory employees are wearing the appropriate shoes, and they are available at several different stores.

Often, because these safety rules are “unwritten,” staff will challenge you on them. It can be difficult to try to enforce these important safety measures if you can’t properly educate the staff about why they exist. Be sure to know your regulatory resources, and don’t be afraid to dig deeply into the references to find the answers you seek. Lab leaders can write their own policy, and it can go above and beyond what the regulations state if needed. The safety standard may not be clear and direct, but it these are still important measures to take. Just like that lady may have needed a sign to prevent her from putting hot coffee in her lap, your staff needs clear safety guidance to keep them safe from a lab-acquired injury or exposure. Provide the tools they need to remain happy and healthy members of your lab team.

Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

The Social Medium is the Message

Hello again everyone and welcome back to Lablogatory!

If you read my post last time, I talked about preserving integrity and delivery of our professional duty as laboratorians in the face of both overwhelming pandemic demands as well as working to  advocate for our field as more people realize each day what goes into every single lab result around the world. A run on sentence and a heavy discussion—and it was just in time to celebrate Lab Week 2020!

This time let’s expand on the second topic a bit. Advocacy in our profession and spotlighting our critical roles as pathologists and medical laboratory scientists. As much as you or I might agree that this is proof positive, just from looking at the regular old news media this year, it’s not so easy. But something that’s been quietly creeping higher and higher on the Lab-Med radar this past year or so is now growing faster than it ever has before: Social Media.

The medium you disseminate information on also translates a message about the author/speaker. For me, I was not only staying the course about data-driven testing science regarding COVID, but I took every ad-lib and opportunity to praise the medical laboratory profession. I praised laboratorians for their hard work, and took a minute to say clearly and plainly, that they are indisputably healthcare heroes in this season of notability. In doing so, I found myself addressing a more pressing pandemic: The Path and MLS pipeline problem. We have a serious issue with finding new medical laboratory scientists and medical students to go into our field. The main cause and culprit? Our essential clinical invisibility. As we are much less patient facing than our other colleagues, it’s difficult to expose younger students considering various careers in healthcare to our specialty. Cue Twitter, Facebook, Instagram, LinkedIn, and even TikTok.

Image 1. Throwback to the 2019 ASCP Annual Meeting in Phoenix, AZ. Dr. Kamran Mirza (left), myself, and Dr. Adam Booth (right) are all part of the growing community of pathologists/trainees plugged into the social network to advocate, collaborate, and spotlight our profession. Follow them both on twitter at: @KMirza and @ALBoothMD, they are champions of using social media as an educational connection.

I’ve talked about this before. And, of course, I’m biased: I’m on the official ASCP Social Media Communications Committee and was highly active in previous iterations including the #SoMeTeam as well as ASCP Social Media Ambassadors programs. Anyone who reads my pieces here knows I’m not social media shy—heck, I weaponized my online presence for residency interview season, networking around the clock to get my name and my work out there for programs to notice. Spoilers: it worked really, really well.

(If you’re one of those senior medical students who is preparing to practice the age-old tradition of wiping the internet clean of your presence, consider a 180 turnaround from that plan—at least if you’re applying to pathology…)

So what worked so well for me? Well, first some background. You know I’m on two ASCP committees, CCPD and Social Media. I’ve already told you I’ve been working the social media angles for a while now, at ASCP meetings, sharing content, etc. And I had a super busy, and super rewarding, residency interview season. With rotations and interviews at some amazing places, I was able to both learn a lot about what it is I really want to do and meet folks to talk about it with. All that being said, sometimes things just fall into place. Specifically, a global pandemic happened. …too soon?

I’m not going to rehash the early days of the pandemic for you, or talk about how I became involved on the ground floor of a lot of outreach and education efforts: that was sooo last month, I did that already (read it all here). But what I will talk about is the butterfly effect that each media engagement set into place for me.

Image 2. When everyone’s talking, the loudest microphone gets the audience. When no one’s making sense, the best content wins. Many of the talks and interviews since the very first ones with my friend and colleague Dr. Ajufo set up a cascade of content to answer some serious concerns during these strange times.

In effect, the order of events for me these last few months looked like this:

  • Writing pieces for Lablogatory¸ some based in scientific analysis of testing, some to address public health concerns and education.
  • Making small viral online tid-bits aimed at educating lay people about overall health, avoiding exposure, and what testing means.
  • Social media connection to join the #PathCast lecture series, of which my video has garnered approximately 20,000 individual views and was seen in almost 50 countries.
  • Invitations from CDC-funded training agencies to explain testing considerations, virology details in translational science, and discuss how those most vulnerable to social determinants of health are most inequitably affected by pandemic conditions.
  • Informal features where I was invited to discuss those intersectional tenets of medicine, public health, and socioeconomics with lay persons in a virtual group setting.
  • An interview with Lifehacker magazine’s Vitals section, to answer reddit-style ask-me-anything questions regarding COVID testing online live with open to the public availability.
  • Inclusion in Lifehacker magazine’s online podcast, where I was featured alongside other experts to discuss the effect of the pandemic on many aspects of life from health to finances.
  • An interview with The Endless Files Podcast¸ where I was invited as a content expert to discuss the connections between laboratory data, public health, public policy, and discuss the political climate surrounding coronavirus concerns all over the sociopolitical spectrum.
  • An interview with People of Pathology Podcast which gave me the chance to talk about my individual career path and transition from education about testing to advocacy and representation for our amazing profession.
  • The nomination and selection by my medical school faculty and peers to deliver the student charge at my formal, virtual, medical graduation.
  • …more are on the way!

Why am I listing these things? Is it my misplaced Greek hubris? Maybe. But before I fly too close to the sun, I’m trying to prove a point. That what started out as creating content on social media for health and wellness during a pandemic essentially became a snowball by summer. I was addressing pressingly relevant information during the obvious opportunity to step up and educate. But something else was happening; something I didn’t realize until recently. And whatever it was, I wasn’t getting there alone.

**All of this was made possible by social media recommendations and connections from friends and colleagues!**

PathCast? I was recommended by a pathologist friend on ASCP’s CCPD committee with me. The CDC-funded training? A former grad student friend of mine when I studied at Rush. Lifehacker? Made possible in a public call for content by our favorite medical lab scientist and Lablogatory editor, Kelly Swails. The Endless Files? Reached out to an old political science professor and friend at Loyola. People of Pathology? Social media connections with friends and CLS colleagues in Canada—you want to make things happen? Don’t go at it alone!

Don’t know how to get started in all this social media frenzy? Don’t fret. Basically, here’s a four-step process: make accounts on one or all of your favorite platforms, follow everyone you want to learn more from, share other’s content or your own frequently, and (most importantly) promote others before yourself! There are countless webinars and talks on how to use social media to leverage advocacy and education, just look at some of the greatest pathology teachers on Twitter: @KMirza, @CArnold_GI, @MArnold_PedPath, @RodneyRhode, @HermelinMD, @KreuterMD, @JMGardnerMD, and many, many more. But there’s more than just twitter! Many super talented folks team up to produce lectures, webinars, and even podcasts (check out the brand-spankin’-new PathPod here!)

Just dive in!

Image 3. Virtual graduation, social media outreach. 2-for-1 sale. In my on-screen graduation quote during the conferment of degrees, part of it read “don’t let me be the last pathologist you were friends with…” and during my student address, I implored my classmates and anyone else watching to consider creative, new ways to solve clinical problems. Maybe with new tools, new skills, and a new understanding of interdisciplinary collaboration. I also reminded people that our digital presence can indicate our professional message, as champions of truth in science.

In conclusion, social media is the new (old) heavy hitter in the medical world. Younger med students are getting access to more specialty information than they ever have before, informing and guiding their career choices. Specialists of all kinds share and reshare excellent diamonds of content that galvanize medical discourse everywhere from Twitter to TikTok. What does this do? It closes the gap between professionals across disciplines, shines new spotlights on fields that traditionally got stamped with basement autopsy stereotypes, and creates digestible and understandable bridges for lay people to access our jargon-filled discourse. It only goes up from here.

Post-script: if you haven’t noticed the racially charged, horrible situations adding to the tumultuousness of 2020, there’s another lesson in this. Social media again proves a most-valuable and all-powerful tool to mobilize, demonstrate, collaborate, and unify thoughts, ideas, and causes. I doubt we will ever be free of tragic moments in history, but when we come together as one collective we can use our various platforms to honor heroes, shame wrong doers, celebrate positive change, and highlight systemic failings that might hold us back from true progress, justice, and peace. That includes the medical world, as all things cross at the intersections of human life and human rights.

Thank you for reading! Stay safe, stay well, and continue to practice safe, compassion-informed social distancing. The pandemic isn’t over, and neither is our work.

Until next time!


-Constantine E. Kanakis MD, MSc, MLS (ASCP)CM is a new first year resident physician in the Pathology and Laboratory Medicine Department at Loyola University Medical Center in Chicago with interests in hematopathology, transfusion medicine, bioethics, public health, and graphic medicine. His posts focus on the broader issues important to the practice of clinical laboratory medicine and their applications to global/public health, outreach/education, and advancing medical science. He is actively involved in public health and education, advocating for visibility and advancement of pathology and lab medicine. Watch his TEDx talk entitled “Unrecognizable Medicine” and follow him on Twitter @CEKanakisMD.

COVID-19 Testing Explained

By this point I believe we are all tired of reading and talking about COVID. However based on reading comments on social media, it’s quite clear that there are a lot of misconceptions about COVID testing. For starters COVID-19 is the disease caused by the SARS-CoV-2 virus. So all of the tests we are using to assist in the diagnosis of COVID-19 are really looking for signs that the person was infected with SARS-CoV-2. There are also 3 main categories of tests for SARS-CoV-2 based on the target of the assay: RNA, antigen, and antibody.

Diagnosis of COVID-19 should be based on clinical symptoms, risk of exposure, test results and timeline. The diagnostic tests based on detection of SARS-CoV-2 RNA are the most commonly used and reliable for diagnosis of COVID-19.1 All of these assays are based on amplifying the viral RNA to detect the presence of the RNA. Most assays use some form of PCR to amplify the virus, however because the virus is RNA-based it has to be converted to cDNA with reverse transcriptase PCR before amplification and detection. TMA or transcription-mediated amplification is another chemistry that can be used to amplify the RNA to a detectable level. Both PCR and TMA based assays are very sensitive at detecting the virus especially within the first week after symptoms develop.1,2 Due to the RNA-based nature of the SARS-CoV-2 genome, the mutation rate is anticipated to be high. Most of the RNA-based assays have adopted a strategy to target 2 different areas of the viral genome to prevent missing the presence of the virus due to a mutation in the primer binding site.

A SARS-CoV-2 antigen test received EUA in early May. The test is designed with immunofluorescence-based lateral flow. This type of test is designed to detect SARS-CoV-2 proteins present on the outside of the virus. In general, this class of test is cheaper and faster than RNA-based testing however it is less sensitive (80% clinical sensitivity).3 The clinical specificity of antigen assays is shown to be 100%,3 therefore a positive result is reliable. These tests can be used for screening; however patients with negative results may still need to proceed to testing by an RNA-based method. Antigen based tests is typically more sensitive during the same timeframe when PCR testing is more sensitive, ie earlier in the course of disease.

SARS-CoV-2 antibody tests are the last class of tests. Seroconversion appears to occur within 7-14 days of symptom onset2 or 15-20 days post exposure to the virus.4 There are many different tests to choose from to determine if the patient has previously been exposed to SARS-CoV-2. The assays range from lateral flow cassettes to high throughput chemiluminescent based assays. Some of the SARS-CoV-2 antibody assays detect IgG, IgM, IgA or some combination of the 3 including total antibody without differentiating between the three. The latest studies have shown that some patients develop IgM first, some with IgG, and others had both IgG and IgM develop at the same time.5 Therefore differentiating IgG from IgM is not providing a timeline for acute infection as we have seen in response to other viruses. Although sensitivity and specificity vary widely between manufacturers total antibody detection appears to be more sensitive than IgG or IgM detection alone.4 The FDA recently pulled numerous assays off of the market due to poor performance.

It is important to note that even with the most sensitive and specific antibody test, these tests cannot determine if a patient has protective immunity. Unfortunately we don’t know enough about immunity with regards to COVID yet. Early studies are promising, showing that some level of antibody will likely provide protection from future exposure. We don’t know if there is a threshold of antibody that needs to be present before a patient is immune, will the immunity only decrease the severity and not prevent reinfection, and how long the antibodies are maintained after exposure. These will be important questions to answer before the clinical utility of antibody testing can be realized. Right now the test is useful to determine is a patient was previously exposed to SARS-CoV-2 and is helpful to address epidemiological questions with regards to prevalence of COVID-19 in the community. The antibody test should not be used for diagnosis of current infection due to the delay to seroconvert after exposure.

References

  1. Sethuraman, N., Jeremiah, S. S., & Ryo, A. (2020). Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. doi:10.1001/jama.2020.8259
  2. Wolfel, R., Corman, V. M., Guggemos, W., Seilmaier, M., Zange, S., Muller, M. A., . . . Wendtner, C. (2020). Virological assessment of hospitalized patients with COVID-2019. Nature, 581(7809), 465-469. doi:10.1038/s41586-020-2196-x
  3. Quidel Sofia®2 SARS Antigen FIA. https://www.quidel.com/sites/default/files/product/documents/EF1438900EN00_0.pdf 5/29/2020.
  4. Lou, B., Li, T. D., Zheng, S. F., Su, Y. Y., Li, Z. Y., Liu, W., . . . Chen, Y. (2020). Serology characteristics of SARS-CoV-2 infection since exposure and post symptom onset. Eur Respir J. doi:10.1183/13993003.00763-2020
  5. Long, Q. X., Liu, B. Z., Deng, H. J., Wu, G. C., Deng, K., Chen, Y. K., . . . Huang, A. L. (2020). Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. doi:10.1038/s41591-020-0897-1

-Tabetha Sundin, PhD, HCLD (ABB), MB (ASCP)CM,  has over 10 years of laboratory experience in clinical molecular diagnostics including oncology, genetics, and infectious diseases. She is the Scientific Director of Molecular Diagnostics and Serology at Sentara Healthcare. Dr. Sundin holds appointments as Adjunct Associate Professor at Old Dominion University and Assistant Professor at Eastern Virginia Medical School and is involved with numerous efforts to support the molecular diagnostics field. 

Clinical Laboratory Scientists are Imperative to Patient Education

Medical Laboratory Professionals work behind the screens of the medical industry. The contributions produced by this diligent, dynamic, accuracy-driven teams, provide approximately 70% of diagnostic information. This information is imperative for proper diagnosis and treatment. Due to the nature of laboratory work, laboratory personnels are not visible at the forefront of delivering patient care. Therefore, much of society is unaware of the efforts conducted within other parts of the medical industry.

In November of 2018, I had an experience with an elderly couple that will always remain at the forefront of my mind. I was an evening shift Blood Bank Technical Supervisor at a Trauma Level I hospital housing with more than 1000 beds. The Blood Bank served in/out transfusion-dependent patients, as well as being a transplant institution conducting cardiac, liver, and lung transplants. To say we were busy is an understatement.

We had an outpatient order for an older woman who was accompanied by her husband. Her husband, being her advocate, was known to express his concern regarding an issue concerning his wife. The patient’s two units of blood were delayed and the patient’s husband proceeded to call the blood bank to inquire about the delay. The medical laboratory assistant informing him the order was being worked on was not enough, so he proceeded to hound the nurse. The nurse then proceeded to ask to speak to the supervisor.

Before speaking to the nurse, I got the status of the order and asked the technologist approximately how much longer the wait would be. She explained intital testing had revealed an antibody, and so she followed protocol and informed the nurse there would be a delay in blood products.Completing the workup and finding appropriate blood for the patient is what caused the delay. She was at the last portion of crossmatching the blood, and after my review of the workup, it should be 15 minutes.

I informed the nurse it would be 15 minutes, and she pleaded with me to explain the delay to the patient and her husband. After receiving confirmation from my manager to proceed, I hand-delivered the blood to the outpatient room.

“Perception is reality,” so it is imperative to be aware of all verbal and nonverbal communication when interacting with patients. Therefore, accompanied by the nurse, I entered the room and introduced myself and my position. I explained in layman’s term an ABO Type, antibody screen, and finding suitable blood when an antibody has developed. When I was through, they had an exceptional understanding of concept and turnaround time. The patient and husband were appreciative of my explanation and grateful for my staff. The patient’s husband then asked me about my education and what it entailed for me to hold my position. He was highly impressed and never knew all the science and math courses required to become a medical laboratory scientist. He said it was an opportunity he was going to pass along to his granddaughter, who was interested in science.

The following day, the patient’s husband called and apologized to the staff member he initially spoke with and praised the work we do for all patients. This experience highlighted the importance of training laboratory management when interacting with patients. It is more common for the pathologist or medical director to reach out to patients but there are times, especially on the off-shifts, where a laboratory supervisor or manager may be the best option available.

Being an advocate for the medical laboratory science profession is a means of educating the society of a vital career which impacts all lives. Medical laboratory lrofessionals may be behind the scenes, but to administer treatment, essential laboratory results are required; without the laboratory – you’re guessing.

-Tiffany Channer, MPH, MLS(ASCP)CM honed her skill and knowledge of Blood Banking at Memorial Sloan Kettering Cancer Center in New York, NY, where she completed her 9 year tenure at Memorial Sloan as Blood Bank Educational Lead Medical Technologist III/ Safety Officer. She’s currently working as a Quality Assurance Specialist / Educational Supervisor at Memorial Sloan Kettering Cancer Center. Tiffany was a Top Five 40 under Forty Honoree in 2015 for her dedication and advocacy to education and laboratory medicine.