Test Catalog

Test Id : FMT21

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MaterniT21 Plus

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Overview

Test Catalog

Method Name
A short description of the method used to perform the test

Circulating cell-free DNA is examined from maternal whole blood.

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

MaterniT21 Plus

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

Materni T 21

MaterniT21

Non-Invasive prenatal screening (NIPS)

Non-Invasive Prenatal Testing (NIPT)

Specimen Type
Describes the specimen type validated for testing

WB Streck

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
Z3731 Maternal Height (inches)
Z3732 Maternal Weight (pounds)
Z3733 Gestational age (weeks)
Z3734 Gestational age (days)
Z3735 Method determining gestational age
Z3736 Number of fetuses
Z3737 Increased risk due to

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

**NOTE: Completed Sequenom Test Requisition form is required

A Core Option must be marked on TRF under MaterniT 21 PLUS test

If nothing indicated by client, mark option- Core (chr 21, 18, 13, sex)

 

Preferred evacuated tube: (1)10 mL Streck tube kit (MCL supply number T715).

Absolute minimum collection for analysis: (1) 10 mL in Streck tube

Collection instructions: Draw 1 tube of blood, 10 mL in special Streck tube kit (MCL supply number T715). Ship ambient.

 

REQUIRED:

1. Specimen MUST be received at MCL within 72 hours of collection.

2. Specimen collected NOT less than 9 weeks of gestation

3. Sequenom collection kit (MCL Supply T715)

4. Completed Sequenom Test Requisition form

5. Maternal Height (inches)

6. Maternal Weight (pounds)

7. Gestational Age (weeks)

8. Gestational Age (days)

9. Gestation (Number of fetuses)

10. Increased risk due to

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

10 mL

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
WB Streck Ambient 7 days Streck Black/Tan top

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The MaterniT21 PLUS test analyzes circulating cell-free DNA extracted from a maternal blood sample. The test is indicated for use in pregnant women with increased risk for chromosomal aneuploidy. Validation data on twin pregnancies is limited and the ability of this test to detect aneuploidy in a triplet pregnancy has not yet been validated.

 

DNA test results do not provide a definitive genetic risk in all individuals. Cell-free DNA does not replace the accuracy and precision of prenatal diagnosis with CVS or amniocentesis. These tests are not intended to identify pregnancies at risk for neural tube defects or ventral wall defects.

 

A patient with a positive test result should be referred for genetic counseling and offered invasive prenatal diagnosis for confirmation of test results. A negative test result does not ensure an unaffected pregnancy. While results of this testing are highly accurate, not all chromosomal abnormalities may be detected due to placental, maternal or fetal mosaicism, or other causes. The health care provider is responsible for the use of this information in the management of their patient.

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.

A final report will be provided

 

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

Referral

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.

Upon Receipt

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.

7 to 14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Sequenom Center for Molecular Medicine LLC

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 account representative. 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 LabCorp. It has not been cleared or approved by the Food and Drug Administration. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing and accredited by the College of American Pathologists (CAP).

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.

81420

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
FMT21 MaterniT21 Plus Not Provided
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.
Z3738 Result Not Provided

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

Test Update Resources

Change Type Effective Date
Test Changes - Referral Fee 2023-07-01