| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
Test Id : CHIMU
Chimerism Transplant No Cell Sort, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Determining the relative amounts of donor and recipient cells in a specimen
An indicator of bone marrow transplant success
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Initial Chimerism Testing:
Complete chimerism analysis requires 3 specimens. These specimens should be submitted when collected. An interpretive report will be provided once all specimens are received.
-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies
-CHIDB / Chimerism-Donor, Varies
-CHIMU / Chimerism Transplant No Cell Sort, Varies
See Chimerism-Recipient Germline Testing Algorithm in Special Instructions.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
Method Name
A short description of the method used to perform the test
A short description of the method used to perform the test
Polymerase Chain Reaction (PCR) Amplification/Capillary Electrophoresis
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Yes
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Lists a shorter or abbreviated version of the Published Name for a test
Chimerism Transplant No Cell Sort
Aliases
Lists additional common names for a test, as an aid in searching
Lists additional common names for a test, as an aid in searching
Bone Marrow DNA Typing Transplant Eval., Post-Transplant
Bone Marrow Post-Trans Eval
Bone Marrow Transplantation
Chimerism Evaluation
Transplant Analysis
Transplant Evaluation
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Initial Chimerism Testing:
Complete chimerism analysis requires 3 specimens. These specimens should be submitted when collected. An interpretive report will be provided once all specimens are received.
-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies
-CHIDB / Chimerism-Donor, Varies
-CHIMU / Chimerism Transplant No Cell Sort, Varies
See Chimerism-Recipient Germline Testing Algorithm in Special Instructions.
Specimen Type
Describes the specimen type validated for testing
Describes the specimen type validated for testing
Varies
Ordering Guidance
This test is for the post-bone marrow transplant evaluation of the donor specimen. For post-bone marrow transplant testing to determine the relative amounts of donor and recipient cells, see CHIMS / Chimerism Transplant Sorted Cells, Varies.
Additional Testing Requirements
Complete chimerism analysis also requires submission of CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies and CHIDB / Chimerism-Donor, Varies specimens. These tests must be ordered on both the pre and donor specimens under separate order numbers. While the 3 specimens do not need to be submitted at the same time, the CHRGB and CHIDB specimens must be received before this test can be performed.
Shipping Instructions
Specimen must arrive within 7 days (168 hours) of collection. Collect and package specimen as close to shipping time as possible.
Necessary Information
The following information is required:
1. Pertinent clinical history
2. Specimen source
3. Donor identifier and donor date of birth
4. Donor date of collection
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| MP026 | Specimen Type |
Peripheral Blood Bone Marrow |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Submit only 1 of the following specimens:
Specimen Type: Blood
Container/Tube:
Preferred: Lavender top (EDTA)
Acceptable: Yellow top (ACD)
Specimen Volume: 4 mL
Collection Instructions:
1. Only 1 tube is required.
2. Invert several times to mix blood.
3. Send specimen in original tube. Do not aliquot.
4. Label specimen as blood.
Specimen Type: Bone marrow
Container/Tube:
Preferred: Lavender top (EDTA)
Acceptable: Yellow top (ACD)
Specimen Volume: 2 mL
Collection Instructions:
1. Invert several times to mix bone marrow.
2. Send specimen in original tube. Do not aliquot.
3. Label specimen as bone marrow.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
Forms
1. Chimerism Analysis Information Sheet (T594) in Special Instructions.
2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
Blood: 3 mL
Bone Marrow: 2 mL
Lesser volumes may be acceptable, depending on white cell count.
Call 800-533-1710 or 507-266-5700 with questions.
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Moderately to severely clotted | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | 7 days | PURPLE OR PINK TOP/EDTA |
| Refrigerated | 7 days | PURPLE OR PINK TOP/EDTA |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Determining the relative amounts of donor and recipient cells in a specimen
An indicator of bone marrow transplant success
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Initial Chimerism Testing:
Complete chimerism analysis requires 3 specimens. These specimens should be submitted when collected. An interpretive report will be provided once all specimens are received.
-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies
-CHIDB / Chimerism-Donor, Varies
-CHIMU / Chimerism Transplant No Cell Sort, Varies
See Chimerism-Recipient Germline Testing Algorithm in Special Instructions.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Patients who have had donor hematopoietic cells infused for the purpose of engraftment (ie, bone marrow transplant recipients) may have their blood or bone marrow monitored for an estimate of the percentage of donor and recipient cells present. This can be done by first identifying unique features of the donor's and the recipient's DNA prior to transplantation and then examining the recipient's blood or bone marrow after the transplantation procedure has occurred. The presence of both donor and recipient cells (chimerism) and the percentage of donor cells are indicators of transplant success.
Short tandem repeat (STR) sequences are used as identity markers. STRs are di-, tri-, or tetra-nucleotide repeat sequences interspersed throughout the genome at specific sites. There is variability in STR length among people and the STR lengths remain stable throughout life, making them useful as identity markers. Polymerase chain reaction is used to amplify selected STR regions from germline DNA of both donor and recipient. The lengths of the amplified fragment are evaluated for differences (informative markers). Following allogeneic hematopoietic cell infusion, the recipient blood or bone marrow can again be evaluated for the informative STR regions to identify chimerism and estimate the proportions of donor and recipient cells in the specimen.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
An interpretive report will be provided.
Interpretation
Provides information to assist in interpretation of the test results
Provides information to assist in interpretation of the test results
An interpretive report will be provided, which defines unique features of the donor's cells.
It is most useful to observe a trend in chimerism levels. Clinically critical results should be confirmed with 1 or more subsequent specimens.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Sensitivity varies with the proportions of donor and recipient cells in the specimen. For this reason, results are reported as approximate and rounded to the nearest 5% or 10%, depending on the calculated percentage of donor cells. For example, if the percent donor is 10% or less, it is reported as 5% donor cells. If the percent donor cells are 90% or greater, it is reported as 95% donor cells. In rare cases (eg, matched related stem cell transplants), short tandem repeat (STR) patterns may be identical (ie, noninformative) and chimeric status cannot be determined with this test.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
Recommendations for in-depth reading of a clinical nature
1. Antin JH, Childs R, Filipovich AH, et al: Establishment of complete and mixed donor chimerism after allogenic lymphohematopoietic transplantation: recommendations from a workshop at the 2001 Tandem Meetings of the International Bone Marrow Transplant Registry and the American Society of Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2001;7:473-485
2. Tang X, Alatrash G, Ning J, et al: Increasing chimerism following allogeneic stem cell transplantation is associated with longer survivial time. Biol Blood Marrow Transplant. 2014 August;20(8):1139-1144. doi: 10.1016/j.bbmt.2014.04.003
3. Ludeman MJ, Zhong C, Mulero JJ, et al: Developmental validation of GlobalFiler PCR amplification kit: a 6-dye multiplex assay designed for amplification of casework samples. Int J Legal Med. 2018 Nov;132(6):1555-1573. doi: 10.1007/s00414-018-1817-5
4. Tyler J, Kumer L, Fisher C, Casey H, Shike H: Personalized chimerism test that uses selection of short tandem repeat or quantitative PCR depending on patient's chimerism status. J Mol Diagn. 2019 May;21(3):483-490. doi: 10.1016/j.jmoldx.2019.01.007
5. Lion T, Watzinger F, Preuner S, et al: The EuroChimerism concept for a standardized approach to chimerism analysis after allogeneic stem cell transplantation. Leukemia. 2012 Aug;26(8):1821-1828. doi: 10.1038/leu.2012.66
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
Method Description
Describes how the test is performed and provides a method-specific reference
Describes how the test is performed and provides a method-specific reference
Genomic DNA is extracted from blood or bone marrow aspirate samples using an automated extraction machine and used in a commercial kit GlobalFiler PCR Amplification KIT following the manufacturer's instructions. Briefly, 20 different short tandem repeat (STR) marker regions are amplified in single multiplex polymerase chain reaction (PCR) using primers labeled with fluorescent tags. The products are analyzed for size and amount using capillary electrophoresis on a genetic analyzer. For the initial sample on any patient, the test is performed on 3 separate DNA samples: donor germline DNA, recipient germline DNA, and recipient posttransplant sample for chimerism determination. The STR profile of the germline samples is used to identify markers that can distinguish between the donor and recipient. Based on these profiles, the percentage of donor and recipient DNA is then determined in the post-transplant sample using the assumptions and calculations outlined in Thiede et al. Subsequent samples for chimerism evaluation do not need to be accompanied by samples for donor and recipient germline evaluation, as the profiles from the initial testing are kept on file for comparison.(Package insert: GlobalFiler PCR Amplification Kit. User Guide. Applied Biosystems; 2019; Thiede C, Florek M, Bornhauser M, et al: Rapid quantification of mixed chimerism using multiplex amplification of short tandem repeat markers and fluorescence detection. Bone Marrow Transplant. 1999;23:1055-1060)
The sensitivity of this analysis is approximately 5% in a posttransplant specimen (donor and recipient DNA mixed chimerism).
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Indicates whether the report includes an additional document with charts, images or other enriched information
No
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
4 to 8 days following receipt of Pre and Donor Specimens
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
DNA 3 months
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Indicates the location of the laboratory that performs the test
Rochester
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
81267-Chimerism (engraftment) analysis, post hematopoietic stem cell transplantation specimen, includes comparison to previously performed baseline analyses, without cell selection
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| CHIMU | Chimerism Transplant No Cell Sort | 34574-4 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| MP026 | Specimen Type | 31208-2 |
| 37313 | Final Diagnosis | 34574-4 |
Test Setup Resources
Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
Normal and Abnormal sample reports are provided as references for report appearance.
SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.