For Wieslab and all International Ordering Physicians and Patients:
In a recently published article in the Journal of Neuroimmunology, Hesselmark and Bejerot enrolled 53 patients using the Cunningham Panel, in which they concluded “Clinical use of the Cunningham Panel in diagnosing PANS or PANDAS is not supported by this study.”
After reading their study methods, we learned that they collected patients’ blood specimens in invalid collection tubes (Gold top), which contain both a clot activator and a serum gel separator. Blood samples drawn in tubes other than the required Glass Red Top 1 tubes (which have no clot activators, no anticoagulants, no preservatives and no serum separator gel) are rejected for testing by Moleculera Labs.
We do not accept serum collected from blood drawn in containers other than Glass Red Top 2, as data shows interference in the Cunningham Panel assay results. We brought these concerns to the author’s attention, which resulted in the publication of a Corrigendum 3 in the Journal of Neuroimmunology. Unfortunately, the corrigendum referred to a recommendation rather than what is a requirement for the use of glass red top tubes (as specified above).
The Cunningham Panel is clinically validated only for the use of specimens drawn in glass red top tubes. These collection tubes are included in each test kit sent within the U.S., and collection instructions are clearly stated in requisitions for international orders. Our research has shown that blood drawn in tubes other than glass red top tubes yield sporadically unpredictable, and sometimes irreproducible, results with some patient samples. It is unclear at this time what the mechanism of interference is and/or binding properties of the clot activator and serum separator gel in the Gold Top tubes. Since the five-assay Cunningham Panel includes antigen-binding and antibody cell stimulation, there may be more than one mechanism of interference, as results can be increased or decreased in collection tubes with additives. Since the Cunningham Panel has been validated only with glass collection tubes with no additives, as an accredited clinical laboratory we can only accept specimens that are collected in validated collection containers.
We have since learned that all of the Hesselmark et al. specimens in their study were drawn in gold top tubes. Had Moleculera been aware of this, all those specimens would have been rejected. Not all laboratories are able to validate assays in multiple collection tubes, so it is uncertain why the study was performed using an invalid collection tube. We have since offered to work together with the researchers to conduct an additional study utilizing the validated collection tube. We have additional concerns with the Hesselmark and Bejerot study as there was no laboratory evidence that all patients in their control group were infection-free. Since PANDAS/PANS is believed to be a result of an infection-triggered autoimmune response, patients with these disorders may have multiple, and often sub-clinical infections revealed upon appropriate laboratory testing. There is no indication that such testing was performed in the control group. This could be an additional source of test result confusion.
The research of Dr. Madeleine Cunningham and the research conducted in conjunction with other institutions 1-16 has clearly demonstrated that the Cunningham Panel biomarker targets are associated with autoimmune neuropsychiatric disorders such as PANDAS/PANS and other neuropsychiatric conditions. We welcome the opportunity to collaborate in well-designed and well-controlled studies to better characterize the clinical utility of these biomarkers in autoimmune neuropsychiatric disorders.
Should you have further questions or wish to order the Cunningham Panel, please connect with:
You may also contact us at Moleculera Labs by email at email@example.com or by calling (405) 239-5250. We will be happy to answer your questions and address any concerns that you may have.