Humanitarian Device. Authorized by Federal law for use in qualitative polymerase chain reaction (PCR) detection of KIT D816V mutational status in patients with aggressive systemic mastocytosis (ASM). The effectiveness of this device for this use has not been demonstrated. Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.
KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) is an in vitro diagnostic test intended for qualitative polymerase chain reaction (PCR) detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis. The KIT D816V mutational assay is indicated as an aid in the selection of ASM patients for whom Gleevec (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.
Assay: Mon, Thu
- Patient Preparation
- The KIT D816V for Gleevec Eligibility in ASM is approved by the FDA as a Humanitarian Use Device for qualitative polymerase chain reaction (PCR) detection of KIT D816V mutational status in patients with aggressive systemic mastocytosis (ASM). Testing must be ordered using the following instructions:
1. The ordering physician must register with the Internal Review Board (IRB) for KIT D816V for Gleevec Eligibility in ASM testing. Go to http://www.aruplab.com/KITD816V to obtain IRB registration online.
2. The test should be ordered using the ARUP test requisition form or via ARUP's web-based ordering interface (available only to existing ARUP clients). The full name of the ordering physician must be included on the ARUP form to ensure timely testing of the specimen. Specimens submitted with incomplete information may delay specimen testing.
3. To send a specimen to ARUP, contact your local hospital/reference lab to determine if they are an ARUP client and can send the specimen. If they cannot send the specimens to ARUP, contact ARUP Client Services at (800) 522-2787 to be directed to an alternative ordering mechanism.
4. Information about the KIT D816V for Gleevec Eligibility in ASM test and IRB registration may be accessed at http://www.aruplab.com/KITD816V.
5. ARUP will receive specimens via usual shipping routes, from designated clients. When the specimen arrives, with an accompanying requisition, the physician's full name will be logged in, if present. If the ordering physician's full name is not present, the specimen is placed on EXCEPT (handled by the Exception Handling services group) after evaluation by the Integrated Oncology and Genetics (IOG) services group. The IOG services group will then attempt to locate the physician for confirmation of IRB registration. Upon confirmation of physician registration, the IOG services group will notify the Molecular Oncology clinical laboratory, and testing will proceed.
- Fresh bone marrow.
- Specimen Preparation
- Transfer 3 mL bone marrow to an EDTA tube. (Min: 1 mL)
- Storage/Transport Temperature
- Unacceptable Conditions
- Whole blood. Paraffin-embedded or clotted specimens.
- Specimen must be received and testing initiated within: Ambient: Unacceptable; Refrigerated: 3 days; Frozen: Unacceptable
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|2013146||KIT D816V Mutation by PCR for GLV in ASM|
- KIT exon 17