226: CLSI M100 2026 Updates

Hey there, MicroFriends. Welcome to another episode of Let's Talk Micro. As always, I hope you had a great week. And if this is the first time that you're listening to Let's Talk Micro, we'll thank you for choosing it as one of your podcasts. Okay, let me tell you a little bit about the episode and then we'll go ahead and jump into it. So, as you know, as a micro-biologist, you're familiar with the CLS-I-N100 document, which updates yearly. So in this episode, I am joined by Dr. April Bobernzig to go over the latest updates for this year's 2026 edition. So in the episode, she talks about, you know, which breakpoints were updated, which ones were removed. We also talk about what called the recipe, "Chacomplex". So definitely a great episode if you want to catch up with what the latest updates are. So let's go ahead and listen to it. Hey, micro-friends, as you know, every year, the CLS-I-N100, right, a document that I'm hoping that if you're working on the bench and you're in microbiology, you should be familiar with it. At least know some things and if not, know where it's at, right? But last year, we didn't an episode with the updates. So every year, the M100 releases the new updates. And we thought, you know, it will be a good time to go over them. So just like last year and she's been in the podcast before, I have Dr. A. April Boeman-Shing, joining me. April, welcome back. Thank you. Thanks for having me back this year. I'm excited to talk about this year's updates from the M100. I am the medical director of the Microbiology and Verology Laboratories at Penn State Hershey Medical Center. I also am a member of the CLS-I-Sept Committee on ASC, CLS-I-Sept Committee on susceptibility testing and I co-chair the text and tables working group responsible for updating the M100 document every year. Once again, welcome back and we'll be going over the updates. One thing for those of you listening, and I was telling this to April of camera that she's been a guest twice before. And the first episode, I invite you to check it out. It was an overview of what CLS-I-Sept Committee on the M100 and then she joined us last year for the 2025 update. But one thing I have never asked her, it's her favorite bug. So I am curious and eager to find out what it is. But of course, as you know, we do that at the end. Thank you for your introduction. So let's go ahead and start with a quick overview of what changed this year and the CLS-I-M100. Yes, sure. So we've had a number of breakpoint changes this year. One of the biggest was the addition of the AstraZeneca baby backtam breakpoints for the Inter-Backtales, Inter-Backtural Ellis group. We revised the distribution and MIC breakpoints for immunoclycocides in the acenobacterous species. We made it in addition to the suffixine and septriaxone breakpoints for an ulceria gonorrhea. Previously, there was only susceptible breakpoints, but now we have intermediate and resistant breakpoints due to unroaging resistance throughout the world, not so much here in the U.S. But outside the U.S. We removed the ECVs for the Berclodaria Cepasia complex. We also knew this year we added a breakpoint for trimethypinsolpha and beta-hemolytic strexum, something we'd never had before. Probably one of the biggest updates that's not a breakpoint change or addition was the update to the anaerobic anabigram. This is like all new data, the ulceria in the anabagram, anabagram before was several years old. This is now contemporary data and we added in about five new additional tables with a lot more anaerobic organisms and additional drugs. That's really exciting if you perform anaerobic susceptibility testing or maybe you want to get into anaerobic susceptibility testing and this is a great resource to use for your laboratory. Perfect. And out of this change, all the changes are always important. But sometimes depending on the year, there are some that kind of stand out more than others. I remember last year with Berclodaria Cepasia complex, that was a big thing, completely removal of the breakpoints and I will talk more about that. So for this year, in this edition, a lot of those changes, what do you think will be the biggest impact in clinical microbiology labs? Well, definitely breakpoint change is always have huge impacts on patient care. So your immunoglyca size for the synobacter, certainly something you want to update if you're releasing a doing susceptibility testing for these organisms. Actually, in our lab, we don't even recover too many synobactors, but we do want to be reporting the most up to date breakpoints. So any breakpoint changes that you routinely use and report out, you definitely want to update. And I actually, maybe partial, I'm still very excited about this anoreb antibiotic. It's only March and we've gone into it a couple of times already on the bench to kind of help direct whether or not we're going to work up an organism. We know the patients on Peptizo empirically, but let's look at our antibiotic and see if these bugs that we found in this culture are susceptible to what the patient is currently on and how much we want to work up these anerobs. So I certainly feel like there's a lot you can do with it. And I do know that the Adhock working group who was working on the anoreb antibiotic work really hard and I'm going to be following up with a couple of publications. And I'm sure us an outreach working group at CLSI will probably follow up more on how to use this antibiotic. So from the laboratory perspective, I would be pretty excited about that. You know one thing that some of my bucket list and I wanted to one day because I know like the CLSI has those meetings are twice a year, right? And I think that sometimes they're here in Orlando, which last time they were meeting here, I completely missed them, but hopefully one day. You know, let's thinking about something you mentioned, which is interesting about that you don't recover too much, passing it back during your lab. It's just curious, we get so many an hour or so. It's interesting, right? All the changes between labs and areas, of course. Okay, so one thing that when you look at the M100 tables, right? So when it comes to the entire microbial agents, they're categorized into different tiers for testing and reporting. And I was wondering, you know, for the audience, can you explain what the tiers mean and how labs should use them when deciding which agents to test or report? Yeah, so the tiers were introduced maybe several years ago, but prior to that, we had categories like A, B and C. And those categories have been in the documents since its inception, since the 1970s. And what happened was over the years, our overall profile of in organisms such as E. coli, which were very susceptible, very predictable to certain drug patterns, has really evolved over time. And so the categories that our drugs were in category A, B and C, maybe didn't apply to today's contemporary isolates. And then the fact that we have additional new antimicryls, like many of the new beta-videal lactobase combo inhibitors and agents like Sephitoracol, and we're like, well, where do these newer agents belong in this table? So there was a whole revamp of the table to tiers, one, two, three, and four. Considering if your drugs fall into tiers one and two, that's drugs that are typically on your primary panel, your primary test. So if you were going to bring on just diffusion, you wanted to think about what drugs you'd want to put on your distribution, curvy power plate, you would go to tier one and say, I want all these drugs, and then perhaps a second plate for tier two drugs. But things that are readily available that you have on hand, you can test. And then agents that you maybe don't have a lot of organisms with resistance, or maybe not on formulary, or your volume is just really low and it's not worth bringing on. You might do a send out task, those would fall into your tier three or tier four agents. And so those are really customizable depending upon how much resistance you have. And so if you have a lot more resistance, you may want those beta-videal lactobase inhibitors, which are in tier three on a primary panel and tested right away because you're going to be using them much more frequently than a place that doesn't have a whole lot of resistance. And so you're kind of using the antibiotics for place into the tiers based on what ones we should always have available, which is once we can use secondarily setup or send out to test. And then also you can do cascade reporting based on the tiers. That's very institution-specific. Some institutions want to send out all their antimicrobials because their positions want to see everything. And others have a much more aggressive or active storage of groups. They're like, let's kind of hold back some of these susceptible carbopenoms if my septeraxone is susceptible. I don't need to put out the susceptible neurophenom because they can be treated with the septeraxone per, let's say, an equal line. However, if you're using the septeraxone, you may want to use the septeraxone. If that E. coli is resistant to septic accident and resistant to cephalapine, then you definitely want to release that carbopatum. And then you also want to release probably if that carbopatum is resistant, one of your beta lactamase inhibitor agents, except has ebbac Dam in tier three. So you can kind of cascade across the tier or even within the tier. We recently got a question from someone outside the United States, also trying to interpret these tables. They were really designed for US laboratories and they have to be a little bit more customizable for those outside the US who have different drugs on formulary and maybe different resistance patterns. But you remember that within a group or in a box, you don't have to be resistant to every single organism to cascade over because you're not going to maybe have any kind of end meropenum on your panel. And so to cascade over to a beta lactamase inhibitor, you only really need one of those carbopatums resistant. And then you might want to release another agent. And so just thinking about it's not like an ore nothing. It's definitely sort of a, I would say kind of more customizable approach to the tables. OK. And you know, one thing that you mentioned was some of the changes was regarding Astronom Abibactum. So there are testing recommendations and break points for interebacterialities. Can you talk more about these? So this is a new drug that has activity against the metallobital lactamase enzyme or organisms that have the metallobital lactamases that are of the interebacterial. So it's only for interebacterial to have the MBLs. And this is a great drug because we didn't have a whole lot of options like our septaz EV or any rail. They were not effective against the metallobital lactamase. So now we have this drug that is specific for them or has the ability to inhibit them when they have the metallobital lactamase. So specifically organisms that contain NDM or VIM or IMP. Also what's exciting about this Astronom Abibactum is that it's a little bit more, it's easier to test in the laboratory than say, a syphytical which also has activity against the metallobital lactamase. So it gives us like another option for clinicians. Maybe something we can perform in-house as opposed to sending out the syphytical testing. In our laboratory we recently just brought it on because we are seeing more NDMs than we are KPC now. And so this has been a frequent request. It's also important to note that if your organism is as trinium susceptible, it will be as trinium EV backtams susceptible. But many of those organisms that have the metallobital lactamase also harbor like searing carbon pentemases or ESBLs or oxas. And then that as trinium is going to be resistant. But they'll still remain active to as trinium EV backtams, that EV backtams can now inhibit that searing carbon pentemase allowing only as trinium to now to work. Yeah, thank you for that. And I invite the audience if you're working in a micro issue. We're maybe, but if not, you know, I invite you to read about this. And it's very fascinating, as you mentioned. And one of the things with a-- yeah, when I first learned about astronym, and it's very fascinating. And one thing-- and this is just very nerdy-- but one of the ways that we tested foreign delab was, we did the synergy with astronym. Because then, I've been backtams together with the test eating, which is the drug avicass. And I don't know. It's always such a cool nerdy thing when you see that. It's just completely resistant. And then you do that synergy, and you see the activity. So I think it was a cool nerdy thing. So I just wanted to mention that. OK. One of the other updates was the revisions to the lychocyte breakpoints for asking at a backter species. What prompted this changes? Yes. So these synobacter breakpoints for the whole organism group were set many, many years ago. And as a working group within CLSI, they've been systematically reviewing the different drug classes with a synobacter. And so remember last year, we revised the tetracyclins. And we removed breakpoints for tetracyclin. We updated the minocyclin breakpoint. So now this year, we're systematically looking-- or this current nigger that we published, we were systematically looking at the minocyclicicides. And so we're basically using some contemporary isolates, maybe revising the PKPT data experiments or replying that data to these new isolates, looking at clinical data, clinical failure data, to reassess is this breakpoint that was set many, many years ago still accurate. And in case of the minocyclicicides, they maintain the breakpoints for gentomisand, hovermysand, and amacasin, but lowered it by one dilution. So what we're formally, I believe, 4/8 and 16 for gentomisand, are now 2/4 and 8. And then from amacasin, it was formally 16/32 and 64. And now it's a dilution lower at 18/16 and 32. So just one dilution lower for that. It's a little bit more applicable to today's the synodactyrize that we're recovering in our laboratory. OK, and then speaking of amacasin, one of the changes was the temporary removal of total remising this diffusion breakpoints for as anodactyri and the direct from blur culture testing tables. Just to give the audience a little bit of context and background, can you explain why seagullesize sometimes temporarily removes breakpoints and what laps should do when they encounter this type of changes? Yeah, so we temporarily remove them when we are re-re-re-looking at the data. And the original breakpoints were set on the old to-opermysand distribution diameters, which are correlated to the old to-opermysand breakpoint. And so once the subcommittee accepted the new breakpoints for the standard distribution and amic testing, we knew we had to pull out the direct disk data because we hadn't evaluated it with the new breakpoint or the new distribution diameters. So when we say tabular, it means that it's on our radar. We're currently reviewing the data, looking at the data. But we only vote twice a year for the following year's document. And so if the data is not reviewed during that time period, and at that point, we didn't know what the breakpoint was. And so we couldn't review the data until the breakpoint got approved. And so now this year, we can revise that data set and then put it up for vote so it gets approved in 2026 so that it'll be published in the document 2027. And I think you've seen this also. I think we temporarily moved distribution breakpoints for the NYSERIA, just the distribution because we approved the NYC breakpoints first. And then we have to do the correlation studies to set the new disk diameters. And that data wasn't ready in time for vote. So then we reviewed the data in the following year. So when it says temporary, it just means that we're undergoing review at that moment and just didn't make it in time for that vote for that year. We're basically a year behind in terms of publishing what we're voting on. Yeah. OK. And a little side note for the audience, we're talking about distribution. And something that came to mind when you-- in the lab, it's very typical that we have the stampers, where we have multiple. So we can put many several disks on the medium. And one of the things that's very frustrating is the tech working the bench is when you're going to stamp. And nothing comes out and only half of them come out. So one thing I found out is there's a lock at a long lock position. So before you do anything on your plate, test it. If there's no resistance between unlocking and locking, you should be good to go. If you encounter resistance, that means that you're out of a disk or one of them that's in the wrong position. So just remove them, place them again, lock on lock, unlock on lock. And no resistance, go for it. It will save you headaches. So that's a little tip that I encountered with a trial and error and being frustrating when that happens. I was like, oh, I'm going to say three or four disks come out and then others are stuck there. And it's time consuming, right? And that's time that we don't have. So we're very busy on the bench. So just something to keep in mind. That's a great tip. Right. Yeah. Yeah. Thank you. Yeah. I was doing the quality control weekly. So that's something that I'm like, OK, let me see this. And it was very frustrating that those things. And if you unscrew them and take them apart, you're done. They're very hard to put back together. So something for you to text out there to remember. OK. I mentioned this. And one of the major changes last year was the complete removal of the break points were for vocal de-recipation complex. And we talked about the challenge that many labs face was finding reference labs that could perform the susceptibility testing, right? Using the recommended method. Since that change, how has the situation evolved? And what advice will you give labs when they need susceptibility testing for this organism? So sales fee still recommends the frozen reference for micro delusion method or plate. And we put in the distinction. there that frozen first of the reference, reference brought microdolution because we can buy like lyopolis plates, like our micro scan plates are lyopolis, and our sensitive ones are lyopolis where you just kind of recostitute with chloronic water and then you have a essentially a brought microdolution tray. But that is not the same thing as the actual reference method where the drugs are diluted within the caton and Justin Mueller hitting broth and then usually made in bulk and then frozen. And so the problem was is that who's doing this? Many clinical laboratories don't have the ability to make their own panels in house. And then even our reference laboratories, we found out weren't using the reference brought microdolution method. I do believe you can purchase custom panels from some of distributors, like you customize, make them and ask them about, I don't know how frequent they are, you can purchase them, make them in bulk or purchase them in bulk and stuff. And so am I aware of reference laboratories right now using reference brought microdolution? I don't think, like, I'm unsure. And so that's probably a question I'll have to ask one of my colleagues who works at AREP because I know they were thinking about it. We recently had to send a birchledarius apatia on a patient who was a transplant potential transplant recipient for a heart transplant. And so they had a line infection with birchledarius apatia complex, but not as the apatia. This is like an immunocompromised transplant, you know, about to go on transplant patient. And so we sent theirs out to our reference lab, AREP, at the recost of our infectious disease, doc transplant physician doctor. And we knew we were going to get just back MICs. And it said custom MIC panel, but I don't know what custom is custom because they custom delusions or is it custom because it was frozen. And so I don't know. Luckily our MICs were quite low. What we would expect in this patient, but nothing to use to interpret them. And then, again, we lost the ECVs this year, which was fine because we don't want to be using our ECVs to make clinical determinations anyway. And so I definitely would urge our libertarians out there listening is just kind of contact your, you know, your reference lab. Whatever commercial brush and so that you're using and just ask them what their, what panel they're using for a broth maker for for a delivery, so patient testing. They may be using the sensitizer panel. It actually performs not, not terribly. You know, there is reason publication on it, on its performance. So it's not, it's not the worst case scenario. And we, something we still struggle with because there are patients that truly do need some sort of guidance. I think, you know, in this patient, they were looking for just something to treat their, to eradicate their piece of patient before they went on the heart transplant list. Okay, so let's talk a little bit about quality control. Right. So when it comes to quality control, are there any updates in this edition that laboratories should be aware of? Nothing major like last year we meet major changes in like a frequency testing or performing QC. This one for a clinical lab, maybe the big change is we adjusted the any penum QC range for integrity checks. If you're testing the beta lactam carburel agents, like a lot of times you want to test that QC strain with any penum before testing it with any rel to make sure that that QC strain is indeed resistant to any penum. And so it maintained its resistant plasma. And then you can use it to QC your actual any well-backed and in microbial agent. And so that was one thing. I think that though was just for broth microdolution. So if you're again, you're making home broth microdolution trace something that clinical labs aren't doing. I don't think we adjusted the just diffusion for that range. And then there's some footnote updates that we made. And when you go through the document, whether I guess on the clips or M100 PDF or even online, look for one the overview changes. That way you can kind of quickly review what's been changed in the section. But also we bold every new addition or each addition revision that's new to the document is bolded. So when we update some footnotes, you'll see the footnote will have just the updated bolded language in the footnote. So I kind of take a look at that. Okay. And for this question, you know, I know that maybe you can give like some sort of general answer or because it's been a little complicated. But right. So the M100 is updated yearly as we mentioned. And when we get this changes, right. And I know that sometimes changes come out and people in the lab might feel overwhelmed or maybe not know what to do and things like that. And so when a new addition is released, you know, what steps should microlapse take to review the updates and make any changes and implement them safely in the workflow? I definitely recommend the webinar for sure. That usually comes along with purchase of the document. And now our webinars are recorded. So you can always you have those in live. You can always come back and listen to it. And we recently did a QA session with that. We also within sales eye outreach work in group. We will put out two newsletters, usually like a spring and a fall that will cover any of the new updates in the M100 or just things that are significant that we think our users may want to need to know more information about or be aware of. So if you don't have an opportunity to get on the webinar or read anything from the sales eye website, definitely check out like I said that overview of changes section at the beginning of the document. Take some time to just down with your supervisor, your lead tax. Maybe if you have a pharmacist or ID doctor, I know not everyone has access to a full team to kind of strategize on like what what we what do we need to do first? What's our low hanging fruit? Like I said, if you're an institute that doesn't have isolate, you know, for the last three, four years, we never need to have a synobacter on our anobiogram because we just didn't have enough isolates. And so if you don't have a whole lot of a synobacter, you may not think about doing your immune glycocytes right away. You do have the if you're a capric retina though, I should say you do have a time period that you have to eventually update those break points. But that would be like one of my strategy. Same things like definitely go through your QC. You're doing this diffusion, just diffusion with this diffusion QC ranges. You want to look for any updates there, any bolded highlights, make sure that those are all up to date because that's most important for any of my mature QCs within rate. And trying to think strategize as well as and any sort of questions that come along throughout the year, like if your physicians come to you and say, I want to bring on this new drug, estrogen, new backdamp, then you have the break points and the ability to bring it on if needed. Yeah, and then I always definitely do that. And then I'm always any questions. I always like to say in this podcast, you know, people are always very reachable. So something that I'm you confused and you're unable to answer, you know, even when I got started, I sent like a general email to CLS sign. I got the response really quick and and people like you and others that they just send an email and people are really good about responding and answering questions. So always keep that in mind, even if you can't find the answer, there's a whole network of people out there that are very nice and are willing to help always. So just remember that. Okay. And when he comes to the, you know, I asked this last year and when it comes to the M45, right, which just for real quick for the audience, you know, it has information and organisms like, you know, like microcalacus and lactobacillus, have breakpoints. Right. The talk was that it was coming out this year. Right. Any updates on that? Is it coming out this year or the next year? What can you tell us about that? I know. I've been waiting for this document and it is going to, it is slated to go out in January of 2027. So we have what about nine more months before it comes out, but it is definitely a new and improved. We have some additional organism groups like a Chroma Laptopactor and the pseudomonas non-originosic pseudomonas species are now have their own table at M45. We have some additional breakpoint revisions and a little bit more clarification on when to, you know, always I always go to it like should I be working this up? Yes or no? Should we be sending it out for susceptibility testing? So some additional clarification on that. We have some dis-distribution breakpoints now for arrow copcas. So a lot of great work went into it. And so this one more, not even less than a year now, and it will be coming. And I'm sure it still side will follow up with additional webinars and publications. There's always additional information that we put out throughout the year. And hopefully we can chat about it when it comes out. I mean, like I always, like we've been doing, I mean, I always wait till it comes out. Then you know, see the side does the webinar. And then like, okay, let me reach out and see if we can do an episode for the audience. So as we, you know, as the episode starts coming to a close, you know, any, any closing thoughts, anything that you want to tell the audience or anything else that you want to talk about. Well, I just want to reiterate what you just said is reaching out to CLSI. I'm absolutely, we just, we get customer increase the all year round. So just by emailing, I think customer service, CLSI, the questions get directed to any one of the members in the CLSI subcommittee, depending upon the question. And we always answer via email. So I'm definitely encouraged our users to, you know, send your questions. Or if you see me at a conference, you know, I'm going to welcome to come up and ask questions. I think keeping in mind, we just talked a little bit about the AsinoBacter systematic update. So we just finished up with immunoclyclicides. And now the group is currently looking at SuppleSporin. So that, so kind of be on the lookout for some SuppleSporin changes in that AsinoBacter group next year. I think exciting for me, I always like when we kind of update things that have been in the document for a really long time. And right now we have some working groups working on intrinsic resistance and the definition of intrinsic resistance. So I foresee some changes in that appendix as well. If I can't say if they're going to come in 2027 or the next year, 2028, it depends on how things are presented and get voted on. But definitely some new updates to that, that appendix as well. And then I guess also we're looking at oral SuppleSporins and the Intervectoralis. That's a question that we get quite often, especially, you know, about SuppleSnollin as a serigate for uncomplicated urinary track infections. And the three different organisms and does it apply to all the oral SuppleSporins. It's sometimes we know that our other oral SuppleSporins are used alone, like outside of urinary track infections. And so I definitely think, well, not definitely. I know there's work being done on them and I hope that there'll be some changes in the future to be published. And like I said, I know people we get frequently get questions so adding that. So I'm always exciting stuff going on. Yeah, no, definitely exciting. So for the audience, you know, stay tuned. And as always, it's changes coming on things like that. I will try to keep you updated of what's happening. Okay. As I mentioned, you know, this question always enjoy the answers. And we tend to have a for any number of reasons, you know, we have a favorite bug or least favorite one. And that's also valid, but it's just always a maybe very common is that you work in school with it. And so has some significance. It could be a color pattern or anything. Something with disabilities or mechanism any number of reasons we have that favorite book. So April, what is your favorite bug? This idea is such a hard question. This is like asking a parent who's their favorite child, like as a microbiologist, I love all microbes. And I was like, I don't know what my favorite one is. It probably depends on, you know, the week or what's going on. But I'm going to say this week or actually was last week, we identified our first staff Argentis. And I thought that was really exciting because I've heard about it for a couple years now. And what it was was a staff that just wasn't behaving. So again, we thought of a step where it just wasn't giving us the right Molly ID or like what's wrong with you? You're supposed to be a step or yes. And then finally our tech was like, well, I'm going to try the RUO side of the multi database. And that's when it came out as step, um, staff Argentis. And so I thought that was really exciting. And so, um, you know, staff is, I wouldn't say is my favorite, but it's definitely, um, definitely the most frequently isolated and it can be totally tricky. You know, sometimes it doesn't behave the way it should behave. And so and also keeps me employed if we didn't have staff with caucus species, we wouldn't have microbiologists. So I'm going to give it the not staff general. That's a great and that's that's so exciting. Yeah. Um, having identified that. Yeah, I wonder, yeah, it's just, you know, that's, that's, and I always told the audience this, but yeah, that was the first episode that I did with a guest. Um, back in 2021, it was about, you know, um, the staff always complex. And so it's always, you know, in my radar and that was the first time that I talked to someone about it. So, okay, such a great answer. Well, um, as always, you know, thank you for taking the time. You know, it's been great and I appreciate, you know, you coming over here to update us. Um, of the changes. So thank you for taking the time to be in Les talk, my great. Thank you for having me. My pleasure. Well, there you have it. I hope you enjoyed this episode. I always enjoy sharing this information with you. And, you know, stay tuned when the M45 comes out, the latest edition, which, you know, April said it wasn't next year, 2027. You know, I will do an episode about it. So stay tuned. And hey, I wanted to take a moment to thank you as always for your support and to share with you that Les talk, my career passed 225,000 downloads. And that is of course, thanks to you for downloading episodes and, you know, and sharing them and listening to them. So thank you. And of course, you know, this is always thanks to you for downloading episodes for sharing content. So I am so grateful. And if you're listening to this, hey, you know, go to our socials and make a comment, you know, I want to hear what's your favorite episode, what's your favorite bug or anything that you want to share. 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Thank you so much. You know, thank you for listening for supporting us. I appreciate it. And please, continue bringing that passion to what you do. It's so important. You do such a great work. As always, stay motivated, stay safe, and of course, continue talking, micro until the next time. Bye.