Test Details
Methodology
Real-time quantitative PCR analysis to identify mitochondrial depletion
Result Turnaround Time
14 - 28 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
Diagnostic testing
Special Instructions
This assay currently is not available in New York state.
Limitations
This assay does not detect single nucleotide variants (SNVs), small indels and large deletions. False positive or false negative results may occur for reasons that include homologous regions, blood transfusions, bone marrow transplantation, tissue-specific heteroplasmy, mislabeled samples or erroneous representation of family relationships. Low levels of heteroplasmy may not be reliably detected. Interpretation of the clinical significance of gene variations is limited by information about the variant that is available at the time of reporting and by the quality and quantity of clinical information provided with the sample. The interpretation of the clinical significance of variants may change.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Whole blood or extracted DNA (from blood only)
Volume
Whole blood: 4 mL or extracted DNA: contact MNG Genetic Services 844-664-8378 (844-MNGTEST)
Minimum Volume
Whole blood: 2 mL or extracted DNA: contact MNG Genetic Services 844-664-8378 (844-MNGTEST)
Container
Whole blood: lavender-top (EDTA) tube or extracted DNA: contact MNG Genetic Services 844-664-8378 (844-MNGTEST)
Collection Instructions
Whole blood: standard phlebotomy or extracted DNA: contact MNG Genetic Services 844-664-8378 (844-MNGTEST)
Stability Requirements
• Room temperature: 14 days
• Refrigerated: 30 days
• Frozen: do not freeze
Storage Instructions
Maintain specimen at room temperature or refrigerate at 4°C. Do not freeze.
Causes for Rejection
Frozen or hemolyzed specimen; quantity not sufficient for analysis; improper container