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(for at least one location)
Rochester, MN
Describes the nature of a clinical study. Types include:
The purpose of this study is to obtain serum from patients with certain rare immunobullous diseases (e.g., paraneoplastic pemphigus, laminin-332 pemphigoid) to replenish a source of positive control for our clinical testing (e.g., Mayo test codes PNPAB, RSBV).
To verify the performance characteristics of anti-Paraneoplastic Pemphigus (PNP) serum and validate its use as a positive control in PNP test.
Serum from patients with PNP will be used for a positive control for the PNP test upon successful validation.
Background:
For various rare immunobullous diseases, detection of a circulating autoantibody is necessary for accurate diagnosis. As a CLIA requirement, every clinical test run requires positive and negative controls for quality control. Currently, we use either archived sera or commercially available sera from patients with known relevant immunobullous diseases as a structural integrity positive control of rat bladder or transfected cells, which are the substrates for these indirect immunofluorescence tests.
While we have no difficulty locating negative control sera, it is challenging to source positive control sera, due to the rarity of these diseases. Specifically, commercial positive control serum is no longer available for purchase and only limited archived material is available.
Study statuses change often. Please contact us for help.
Open for enrollment