ASTMH’s Clinical Group members recently submitted questions to CDC inquiring about the pause in testing services by CDC’s Parasitic Diseases Laboratory in the Division of Parasitic Diseases and Malaria (DPDM). In CDC’s ongoing commitment to sharing information with the ASTMH community, CDC provided the following responses April 11, 2022. Updates will be provided as they become available.
(Resource:
Click here for a list of non-CDC options for molecular and serologic testing for parasitic diseases.)
Why the pause for all diagnostic testing operations for parasitic diseases in September 2021?
CDC’s Parasitic Diseases Laboratory in the Division of Parasitic Diseases and Malaria (DPDM)
paused all diagnostic testing operations for parasitic diseases to implement laboratory system improvements. CDC’s laboratories must meet and maintain the highest standards of excellence to serve as the nation’s premier health protection agency and to maintain confidence from our citizens, public health and clinical partners. We are working diligently to implement laboratory improvements to ensure that we can meet these expectations and continue offering high quality diagnostic services.
Will all parasitic tests only available at CDC prior to the pause (before September 2021) be restored at the DPDM laboratory?
Our highest priority is to resume high quality testing operations, as soon as possible, and to offer the same tests that were available before the pause. We are prioritizing diagnostic tests with the greatest public health impact, particularly those assays that are only available at CDC.
Our parasitic diseases laboratory has already restarted (testing resumed on February 24, 2022) serologic testing for Chagas disease and morphologic identification and is on track for phased resumption of remaining diagnostic assays. Our careful and thorough approach reinforces our commitment to quality. Updates will be communicated as information becomes available on our
Diagnosis of Parasitic Diseases website.
Which tests will be discontinued at CDC and why? For each discontinued test, what is the plan to assist clinicians for each parasitic test?
As mentioned, we plan to offer the same tests that were available before the pause. Our Parasitic Diseases Laboratory resumed serologic testing for Chagas disease and morphologic identification on February 24 and is on track for phased resumption of the remaining diagnostic assays. Our careful and thorough approach highlights our commitment to quality and our firm belief that persons at risk of parasitic infections deserve the highest quality laboratory services. Updates will be communicated as information becomes available on our
Diagnosis of Parasitic Diseases website.
DPDM offers consultation regarding other options in the absence of diagnostic testing. Healthcare providers needing assistance with diagnosis or management of suspected cases of parasitic diseases may contact CDC’s Parasitic Diseases Hotline at (404) 718-4745 or e-mail
[email protected].
What is the timeline for each parasitic test to be restored (expected date and order)?
At present, we are unable to share a detailed timeline for additional testing to resume but are working to restart testing as soon as possible in a phased, prioritized approach. We are prioritizing diagnostic tests with the greatest public health impact, particularly those assays that are only available at CDC.
Our Parasitic Diseases Laboratory resumed serologic testing for Chagas disease and morphologic identification on February 24 and is on track for phased resumption of the remaining diagnostic assays. Among the molecular tests, Chagas disease PCR and leishmaniasis PCR are high priorities for resumption.
How were the order (and implicit priority) decided for restoring services for different parasitic tests?
In our planning for phased resumption of testing, we are prioritizing diagnostic tests with the greatest public health impact, particularly those assays that are of limited availability, except at CDC. We are also considering input from clinical and laboratory partners, for example SPHLs and ASTMH, on what tests to prioritize.
Will CDC DPDM parasitic laboratory return to similar volumes for each test (at the level prior to the suspension) or will some tests have a reduced capacity? If so, which tests will be restricted and at what levels of reduced capacity and why?
At present, we are working to resume the testing services that were available prior to the pause and do not anticipate changes in the volume of testing or testing capacity at CDC. Any changes to the test services will be communicated as decisions are made. Updates will be communicated as information becomes available on our Diagnosis of Parasitic Diseases website.
What are the criteria for CDC to provide parasitic testing for clinicians after restoration of services, by test? (Are the criteria the same for all tests or specific to each test? Are the criteria the same as before September 2021 or have the criteria changed? If changed, why were they changed and through what process?)
There is no change in
clinical criteria to request testing. Clinicians are requested to submit their samples through their State Public Health Laboratories. Details on specimen submission are in the CDC Infectious Disease Laboratory Test directory:
Home | Submitting Specimens to CDC | Infectious Diseases Laboratories | CDC .
During a review of CDC’s infectious diseases revised laboratory pre-analytical processes (which encompass the handling of clinical specimens prior to receipt at CDC laboratories, e.g., storage and transport conditions), we identified specimens that we received and determined that they were in unsatisfactory condition for testing. Going forward, we are working to ensure that specimens for testing will be submitted in accordance with the approved criteria.
The CDC
Infectious Disease Test Directory has been revised to clearly specify the requirements for the acceptable collection, storage, preservation and transportation of specimens to be tested. Additionally, specimen acceptance and rejection procedures have been revised. Testing for parasitic diseases will require submitters to receive pre-approval prior to sending specimens and submitters should work with their jurisdictional public health laboratories to coordinate submission. Updated guidance on specimen packing and shipping can be found
here. Please contact
[email protected] for questions.
Can CDC assist in designing a more robust national system or network for parasitic disease testing in the United States to assist clinicians with access to high-quality and timely testing for parasitic diseases?
CDC shares the goal of ensuring high-quality and timely testing for parasitic diseases to support diagnosis and treatment with our clinical partners. We acknowledge there are risks posed by having test services only available from a sole provider and may explore this option in the future.
If desired, clinically warranted and test orders are available, CDC will make every effort to analyze newly collected specimens that comply with the updated pre-analytic requirements detailed in the CDC Infectious Disease
Test Directory.
Can you provide a list of reputable testing sites for parasitic diseases that are outside of CDC?
CDC offers consultation regarding other options in the absence of diagnostic testing at CDC. Healthcare providers needing assistance with diagnosis or management of suspected cases of parasitic diseases may contact CDC’s Parasitic Diseases Hotline at (404) 718-4745 or e-mail
[email protected].
Will samples sent to CDC to be tested before/during the pause still be tested?
Specimens submitted for parasitology testing from September 2021 were held while specimen acceptance criteria were reviewed and updated. Based on revised specimen acceptance criteria, some specimens were determined to be in unsatisfactory condition and testing will not be performed. Specimen rejection reports were issued and received by the appropriate jurisdictional laboratory on or prior to April 4. We apologize for this inconvenience. If desired, clinically warranted and test orders are available, CDC will make every effort to analyze newly collected specimens that comply with the updated pre-analytic requirements detailed in the CDC Infectious Disease
Test Directory.
Is CDC aware of the impact (such as delays in patient diagnosis and/or care, inconvenience) on patient care that has occurred from the suspension of these tests?
CDC recognizes that the medical community and the public rely on our Parasitic Diseases Laboratory for accurate and timely diagnostic services and trust us to maintain first-rate standards. We absolutely hear and understand the concerns and the challenges the pause in testing for parasitic diseases presents for healthcare providers, particularly those treating people at elevated risk for parasitic diseases. We share the goal of ensuring quality testing for parasitic diseases to support diagnosis and treatment with our clinical partners.
Any other thoughts?
We appreciate the patience, support and partnership of our clinical partners. We also appreciate their acknowledgement of the critical role that CDC’s Parasitic Diseases Laboratory serves. We are constantly working to improve and offer outstanding services and are committed and grateful for our ongoing partnership and collaborations.