Test Catalog

Test Id : CHRGB

Chimerism-Recipient Germline (Pretransplant), Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating the recipient cells prior to bone marrow transplant

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Complete chimerism analysis requires 3 specimens, under 3 separate orders, for the 3 separate tests listed below. These specimens should be submitted when collected. An interpretive report will be provided once all specimens are received.

 

Pre-Transplant:

-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies

-CHIDB / Chimerism-Donor, Varies

-ADONO / Additional Chimerism Donor (Bill Only), if applicable

 

Post-Transplant:

-CHIMU / Chimerism Transplant No Cell Sort, Varies or CHIMS / Chimerism Transplant Sorted Cells, Varies

 

Billing occurs with the following tests:

Pre-transplant:

-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies

-ADONO / Additional Chimerism Donor (Bill Only), if applicable

 

Post-Transplant:

-CHIMU / Chimerism Transplant No Cell Sort, Varies

-CHIMS / Chimerism Transplant Sorted Cells, Varies

-SORT1 / Chimerism Cell Sort 1 (Bill Only)

-SORT2 / Chimerism Cell Sort 2 (Bill Only)

 

For more information see Chimerism-Recipient Germline Testing Algorithm

Special Instructions
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

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.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Chimerism-Recipient Germline

Aliases
Lists additional common names for a test, as an aid in searching

Chimerism evaluation

Pre transplant evaluation

Transplant analysis

Transplant evaluation

Bone marrow DNA typing

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Complete chimerism analysis requires 3 specimens, under 3 separate orders, for the 3 separate tests listed below. These specimens should be submitted when collected. An interpretive report will be provided once all specimens are received.

 

Pre-Transplant:

-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies

-CHIDB / Chimerism-Donor, Varies

-ADONO / Additional Chimerism Donor (Bill Only), if applicable

 

Post-Transplant:

-CHIMU / Chimerism Transplant No Cell Sort, Varies or CHIMS / Chimerism Transplant Sorted Cells, Varies

 

Billing occurs with the following tests:

Pre-transplant:

-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies

-ADONO / Additional Chimerism Donor (Bill Only), if applicable

 

Post-Transplant:

-CHIMU / Chimerism Transplant No Cell Sort, Varies

-CHIMS / Chimerism Transplant Sorted Cells, Varies

-SORT1 / Chimerism Cell Sort 1 (Bill Only)

-SORT2 / Chimerism Cell Sort 2 (Bill Only)

 

For more information see Chimerism-Recipient Germline Testing Algorithm

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

This test is for the pre-bone marrow transplant evaluation of the recipient specimen.

Shipping Instructions

1. Specimen must arrive within 7 days of collection.

2. Collect and package specimen as close to shipping time as possible.

Necessary Information

The following information is required. Provide either as answers to the Order Questions or on Chimerism Analysis Information (T594) if not ordering electronically. Testing will be delayed if this information is not provided:

Donor:

-Full name and date of birth (DOB)

-If unrelated donor, provide full identification number and date of birth (DOB). If DOB is not provided, an arbitrary date such as 01/01/2020 can be used.

Specimen Type

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
MP007 Donor
MP014 Specimen Type Buccal Swab
EDTA blood
EDTA bone marrow
Extracted DNA

Specimen Required
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. Invert several times to mix blood.

2. Label specimen as blood.

3. Send whole blood specimen in original tube. Do not aliquot.

 

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. Label specimen as bone marrow.

3. Send bone marrow specimen in original tube. Do not aliquot.

 

Specimen Type: Buccal swab

Supplies: Buccal Swab Kit (T543)

Container/Tube: Buccal smear collection kit

Specimen Volume: 2 Cyto-Pak brushes-1 per cheek

Collection Instructions:

1. Patient should rinse out mouth vigorously with mouthwash for approximately 15 seconds.

2. Remove Cyto-Pak brush from container only touching "stick" end. Save container.

3. Using medium pressure, rotate brush several times on inside of cheek.

4. Return brush to container and cap.

5. Repeat steps 2 through 4 on other cheek using second brush.

6. It is important that patient's buccal cells are not contaminated with cells from any other source. Do not touch bristles. Do not brush too vigorously. If blood appears, discard brush and restart collection process.

7. Label each container with patient's name and order number or hospital/clinic number.

Additional Information: It is important that the cells do not dry out during shipping. Ensure that container is tightly sealed.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Blood: 3 mL

Bone marrow/buccal swab: See Specimen Required

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

Gross hemolysis 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

Specimen Type Temperature Time Special Container
Varies Ambient (preferred) 7 days
Refrigerated 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating the recipient cells prior to bone marrow transplant

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Complete chimerism analysis requires 3 specimens, under 3 separate orders, for the 3 separate tests listed below. These specimens should be submitted when collected. An interpretive report will be provided once all specimens are received.

 

Pre-Transplant:

-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies

-CHIDB / Chimerism-Donor, Varies

-ADONO / Additional Chimerism Donor (Bill Only), if applicable

 

Post-Transplant:

-CHIMU / Chimerism Transplant No Cell Sort, Varies or CHIMS / Chimerism Transplant Sorted Cells, Varies

 

Billing occurs with the following tests:

Pre-transplant:

-CHRGB / Chimerism-Recipient Germline (Pretransplant), Varies

-ADONO / Additional Chimerism Donor (Bill Only), if applicable

 

Post-Transplant:

-CHIMU / Chimerism Transplant No Cell Sort, Varies

-CHIMS / Chimerism Transplant Sorted Cells, Varies

-SORT1 / Chimerism Cell Sort 1 (Bill Only)

-SORT2 / Chimerism Cell Sort 2 (Bill Only)

 

For more information see Chimerism-Recipient Germline Testing Algorithm

Clinical Information
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 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. STR 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 be evaluated again for the informative STR regions to identify chimerism and estimate the proportions of donor and recipient cells in the specimen.

 

This test evaluates the recipient specimen prior to bone marrow transplant.

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.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report will be provided under CHIMU / Chimerism Transplant No Cell Sort, Varies or CHIMS / Chimerism Transplant Sorted Cells, Varies. This includes whether chimerism is detected and, if detected, the approximate percentage of donor and recipient cells. Sorted cell analysis permits more detailed evaluation of chimeric status in T-cell and myeloid cell fractions, which can be helpful in clinical management.

 

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

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 of donor cells is 90% or higher, it is reported as 95% donor cells. In rare cases (eg, matched related stem cell transplants), short tandem repeat patterns may be identical (ie, noninformative) and chimeric status cannot be determined with this test. Use of alternative approaches (eg, XY fluorescence in situ hybridization in patients with opposite sex transplants) may be required.

Clinical Reference
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 Bone Marrow Transplantation. Biol Blood Marrow Transplant. 2001;7(9):473-485

2. Tang X, Alatrash G, Ning J, et al: Increasing chimerism following allogeneic stem cell transplantation is associated with longer survival time. Biol Blood Marrow Transplant. 2014 Aug;20(8):1139-1144. doi: 10.1016/j.bbmt.2014.04.003

3. 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

4. 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

Method Description
Describes how the test is performed and provides a method-specific reference

Genomic DNA is extracted using an automated extraction platform and is then used in a commercial GlobalFiler polymerase chain reaction (PCR) Amplification Kit, following the manufacturer's instructions. Briefly, 20 different short tandem repeat (STR) marker regions are amplified in single multiplex PCR using primers labeled with fluorescent tags. The products are analyzed for size and amount using capillary electrophoresis. For the initial sample on any patient, the test is performed on 3 separate DNA samples: donor germline DNA, recipient germline DNA, and recipient post-transplant 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 1999. 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.

 

The sensitivity of this analysis is approximately 5% in a post-transplant specimen (donor and recipient DNA mixed chimerism).(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 May;23[10]:1055-1060; 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; package insert: GlobalFiler PCR Amplification Kit. ThermoFisher Scientific; 08/21/2019)

PDF Report
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.

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.

4 to 8 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Blood/Bone marrow: 2 weeks Extracted DNA: Indefinitely

Performing Laboratory Location
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.

  • 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.

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.

81265-Comparative analysis using Short Tandem Repeat (STR) markers; patient and comparative specimen (e.g., pre-transplant recipient and donor germline testing, post-transplant non-hematopoietic recipient germline [e.g., buccal swab or other germline tissue sample] and donor testing, twin zygosity testing or maternal cell contamination of fetal cells)

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.

Test Id Test Order Name Order LOINC Value
CHRGB Chimerism-Recipient Germline 31208-2
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.
MP007 Donor 44780-5
MP014 Specimen Type 31208-2
83186 Chimerism-Recipient Germline No LOINC Needed

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.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

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.

SI Normal Reports | SI Abnormal Reports