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| Sample Submission Information |
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| (1) What are the special considerations for sending blood samples for RNA analysis? |
Blood samples must be collected in EDTA (lavender-top) tubes and shipped overnight, as they must be received within 24 hours of collection. Samples must be sent at room temperature.
For samples that require longer than 24 hours for shipping alternative collection and shipment protocols are available. Please contact Customer Service at 888-663-7382 for information.
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| (2) What quality control measures are in place to ensure reliable results? |
To ensure reliable results, MolecularMD has established quality controls at every step of the assay, from blood RNA extraction to re-verification of results before pathologist sign off. For example:
•The Reverse Transcription (RT) efficiency step is measured with three RNA quality controls:
High BCR-ABL levels, mimicking baseline untreated patients
BCR-ABL MMR level
BCR-ABL negative
•PCR efficiency for BCR-ABL and ABL is measured with 6 plasmid quality controls over a 5-log range with:
Quantitation accuracy down to 3 copies of BCR-ABL
•MolecularMD has quality control and quality assurance software with specific restrictions to ensure that correct QC roles and control measurements are performed for all steps in the BCR-ABL quantitation assay.
•MolecularMD has several external programs for QC testing of BCR-ABL quantitation with leading IRIS academic laboratories and professional accreditation agencies such as College of American Pathologists (CAP). The laboratory is also subject to two annual Minimal Residual Disease (MRD) surveys as regulated for proficiency testing by the Centers for Medicare and Medicaid Services (CMS).
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| (3) What types of samples can be tested? |
| Peripheral whole blood, bone marrow, frozen cells or RNA can be tested. Please contact Customer Service at 888-663-7382 if you wish to ship RNA or frozen cells. |
| (4) What is the sample collection protocol? |
| The sample collection protocol is standard phlebotomy. |
| (5) How can I request a sample collection kit? What is the delivery time? |
| To request a sample collection kit, call Customer Service at 888-663-7382. Kits are shipped via ground and take approximately 5 business days to arrive. View our Shipping Guidelines for more information. |
| (6) Can we use our own supplies? What is the protocol for collecting samples without the sample collection kit? |
| Yes, you may use your own supplies. Collect blood in EDTA (lavender-top) tubes and place in a biohazard bag with absorbent material for shipping. Biohazard bags should be packed in bubble wrap and shipped at room temperature for overnight delivery. |
| (7) Will all information I submit and receive remain confidential? |
| Yes, the information will remain confidential. All involved employees have been trained on the requirements of the Health Insurance Portability and Accountability Act (HIPPA). Our database is also HIPAA compliant. |
| (8) Can a patient order BCR-ABL quantitation? |
| No. BCR-ABL quantitation must be ordered by a physician. |
| (9) Do patients need to fast before having blood drawn? |
| No, fasting is not necessary before the blood draw. |
