I've included links to the FDA cleared test database below. The 510(k) data for these combinations of tests have not yet been posted, but all of these tests had been previously cleared as first-tier tests, so those 510(k) data are available.
We also anticipate releasing and MMWR on this topic in the near future.
If you have any additional questions, other people probably have them too, so feel free to ask on this forum. Thanks!
Anna Perea Key Message: FDA has cleared new Lyme disease tests that are easier to use and interpret. CDC recognizes these assays as an acceptable alternative to the existing, CDC-recommended 2-tier test.
What was CDC’s role in this process? CDC provided samples for test validation to the company through CDC’s Lyme Disease Serum Repository. Panels of sera and accompanying clinical and laboratory testing results are available to Lyme disease serological test users and researchers developing novel tests. For information about the repository, see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4187768/.
How is this test better? This test eliminates the subjectivity that’s been associated with Western blot interpretation, it is potentially less costly, and it is less labor intensive.
How much is it and how much are current tests? Please contact Zeus Scientific for details regarding pricing and ordering these tests. Commercial laboratories may also be able to provide pricing information.
How much does it cost compared to the previous testing algorithm? Although first tier tests typically cost less than immunoblots, the final costs will be determined in large part by the labs and the manufacturers.
When will this be available?/How soon can doctors start using this test? Laboratories can use these algorithms as soon as the tests are available for laboratory purchase. Decisions about what tests to offer and when are made on a lab-by-lab basis. This test is not sold directly to consumers.
Why isn’t there a test that is better during very early stages of illness? It has been difficult to develop blood tests that directly detect the bacteria that cause Lyme disease largely because the infection starts in the skin and then quickly moves to other parts of the body, only briefly existing in the bloodstream. Most lab tests rely on blood samples but if the bacteria has already moved out of the bloodstream, they won’t be found.
Why are there still two tests? The combination of the two tests is important to balance sensitivity and specificity.
Is it faster that a Western blot? Typically EIA tests are run more quickly than immunoblots. Individual laboratory result times may vary.
Are Western blots going away? Western blots and immunoblots are still good tests, particularly in later stages of infection. Individual manufacturers will decide which tests they choose to market.
How is this new testing algorithm an improvement over the old two-tier testing? Benefits of the new testing algorithm include:
Objective interpretation of test results
Easier reporting of test results to health care providers and patients
Why would you do two of the same kind of test? The combination of the two tests is important to balance sensitivity and specificity.
Will CDC use this test? CDC will be evaluating these tests for potential use in serologic testing at CDC.
Aren’t all tests FDA cleared? What is the benefit of FDA clearance? When it comes to individual tests performed by a lab, these come in two flavors. First, there are commercially available tests (e.g. test kits) that are sold to multiple labs. Because they are interstate commerce (sold across state lines), these must be cleared by the federal government, specifically the FDA. This clearance includes an evaluation of the clinical sensitivity and specificity of the test and assurance that the test is safe and effective.
The second type of tests are lab-developed “in-house” assays that are used only by the lab that developed them. Laboratories that perform “in-house” assays are certified under the Clinical Laboratory Improvement Amendments (CLIA), which is primarily concerned with the performance of the lab, not the test itself. The critical difference between FDA clearance of a test and CLIA certification of a laboratory is that for CLIA certification there is no requirement for assessing the accuracy with which the test identifies the presence or absence of a clinical condition in a patient.
Catherine M. Brown, DVM, MSc, MPH State Epidemiologist and State Public Health Veterinarian Massachusetts Department of Public Health State Public Health Laboratory 305 South St. Jamaica Plain, MA 02130 617-983-6804
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Anne Kjemtrup
Thank you Anna, A few additional questions: So I am assuming that, as of now, FDA approval of this test will result in discussion at CSTE next year about how it will impact the surveillance case definition? Or are these tests something we should already consider for surveillance? (right now if I saw them I would consider as a first tier test and look for a western blot. )
I see that they have IgM-IgG combination tests, and IgM alone and IgG alone tests. I would also assume that these should therefore be used in the same context as other IgM/IgG tests, e.g. IgM alone is interpretable only within 30 days from onset and the IgG/IgM combo or IgG alone can be interpretable more or less at any time in the disease course. Is that correct do you know?
Thanks as always for your updates and input! Anne
Anne Kjemtrup, DVM, MPVM, PhD Research Scientist III ________________________________________
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At this point, CDC recognizes these assays as an acceptable alternative to the existing, CDC-recommended 2-tier test.
Speaking on my own behalf, I imagine that the CSTE work group will have to decide how to amend the case definition, if that's what they choose. And of course, each state interprets the case definition a bit differently . . .
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Hanna Oltean
Thank you for the info. Are any labs already using these assays? Is there a clear way to differentiate EIAs that have been approved for use as 2-tier versus EIAs that are not approved? With the way lab information is brought in through our ELR system, I am worried about our ability to differentiate specific EIA tests.
Thanks, Hanna
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Anna Perea
I would be surprised if any labs had implemented this new combination of tests yet. However, we do know that some labs have been using other first tier tests in this manner for several years.
I am unfamiliar with the specifics of ELR systems, but I can ask around.
Anna
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Elizabeth Schiffman
Hi Anna,
Do you have any idea on the timeline for that MMWR? This is a big switch, and I anticipate a lot of questions from providers and others around this, so any guidance that CDC can offer will be very helpful!
Anecdotally, based on what I've heard, I think these tests will start to be on offer pretty quickly from the larger commercial labs, so the sooner we are ready, the better.
Hanna, the ELRs are going to be a mess... :(
Elizabeth
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Anna Perea
We're trying to scoot the MMWR along as quickly as possible, but we don't have a date.
But I agree that it shouldn't take too long for labs to implement, especially if they already use these tests.
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Anna Perea
Additional info re: Hanna's question--
Labs will have to verify performance characteristics of the assay in-house, so there is likely to be a delay before the tests are offered clinically. That said, some large commercial labs were involved in generating data for FDA approval, so they may be able to get in-house approval and start offering the modified algorithm fairly quickly.
Catherine M. Brown, DVM, MSc, MPH
State Epidemiologist and State Public Health Veterinarian
Massachusetts Department of Public Health
State Public Health Laboratory
305 South St.
Jamaica Plain, MA 02130
617-983-6804
A few additional questions:
So I am assuming that, as of now, FDA approval of this test will result in discussion at CSTE next year about how it will impact the surveillance case definition? Or are these tests something we should already consider for surveillance? (right now if I saw them I would consider as a first tier test and look for a western blot. )
I see that they have IgM-IgG combination tests, and IgM alone and IgG alone tests. I would also assume that these should therefore be used in the same context as other IgM/IgG tests, e.g. IgM alone is interpretable only within 30 days from onset and the IgG/IgM combo or IgG alone can be interpretable more or less at any time in the disease course. Is that correct do you know?
Thanks as always for your updates and input!
Anne
Anne Kjemtrup, DVM, MPVM, PhD
Research Scientist III
________________________________________
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Speaking on my own behalf, I imagine that the CSTE work group will have to decide how to amend the case definition, if that's what they choose. And of course, each state interprets the case definition a bit differently . . .
Thanks,
Hanna
I would be surprised if any labs had implemented this new combination of tests yet. However, we do know that some labs have been using other first tier tests in this manner for several years.
I am unfamiliar with the specifics of ELR systems, but I can ask around.
Anna
Do you have any idea on the timeline for that MMWR? This is a big switch, and I anticipate a lot of questions from providers and others around this, so any guidance that CDC can offer will be very helpful!
Anecdotally, based on what I've heard, I think these tests will start to be on offer pretty quickly from the larger commercial labs, so the sooner we are ready, the better.
Hanna, the ELRs are going to be a mess... :(
Elizabeth
But I agree that it shouldn't take too long for labs to implement, especially if they already use these tests.
Labs will have to verify performance characteristics of the assay in-house, so there is likely to be a delay before the tests are offered clinically. That said, some large commercial labs were involved in generating data for FDA approval, so they may be able to get in-house approval and start offering the modified algorithm fairly quickly.
Let me know if you have any questions. So far, things have been really quiet, media-wise.
Have a nice weekend!
Anna