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26554 Invitae Twin NIPS (chr 13, 18, 21) (71002)

Invitae Twin NIPS (chr 13, 18, 21) (71002)
Test Code: TNIPSSO
Useful For

​​Invitae Non-invasive Prenatal Screening (NIPS) for Twin Pregnancies analyzes whether a pregnancy is at increased risk for the chromosomal disorders listed below. Testing can be performed at a minimum of 10 weeks gestation.

All NIPS reports include analysis of chromosomes 13, 18, and 21 and assess the risk of the following trisomies:

  • Trisomy 13 (Patau syndrome)
  • Trisomy 18 (Edwards syndrome)
  • Trisomy 21 (Down syndrome)
​Y chromosome analysis can also be included to determine if at least one twin is male. However, the presence of the Y chromosome cannot differentiate between one male twin or two male twins. To include predicted fetal sex prediction (Y chr only) in your order, please select the add-on.
Specimen Requirements

​Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
​Whole blood
 Two ​10 mL black & tan top streck cfDNA tube (in Invitae NIPS kit)
​20 mL
14 mL (7 mL per tube) ​
Collection Processing Instructions

​Minimum gestational age of 10 weeks 0 days

Gently invert tubes at leaset 10 times immediately after draw. 

Ship samples same day or next day. Collected samples must be received within 6 days of collection.

Specimen Stability Information

Specimen TypeTemperatureTime
​Whole Blood
​Ambient
​48 hours
Rejection Criteria

Frozen specimen

Kit past expiration date

Interference

​Many factors, both maternal (maternal blood transfusion, surgery, organ transplant, immunotherapy, neoplasm, or mosaicism) and pregnancy-related (vanishing twin, fetal demise, confined placental mosaicism, true fetal mosaicism, uniparental disomy, and polyploidy), can affect the results. NIPS is intended for screening purposes only, thus false negative and false positive results occur. This analysis does not assess the risk for other conditions, including but not limited to birth defects, open spine or ventral wall defects, intellectual disability, single gene disorders, or chromosomal abnormalities other than those listed above. ​

Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation

​Invitae
​Monday through Friday
​3 to 10 days
Cell-free nucleic acid extraction from maternal blood, DNA sequencing and analysis of sequenced regions. 
Reference Lab
Test Information

The Invitae Twin NIPS is validated to detect trisomies of chromosomes 13, 18 and 21 and the presence of chromosome Y for twin pregnancies at a minimum gestational age of 10 weeks 0 days. NIPS relies on the presence of fragments of cell-free placental and maternal DNA in maternal blood to assess the risk of an affected pregnancy. Many factors, both maternal (maternal blood transfusion, surgery, organ transplant, immunotherapy, neoplasm, or mosaicism) and pregnancy-related (vanishing twin, fetal demise, confined placental mosaicism, true fetal mosaicism, uniparental disomy, and polyploidy), can affect the results. NIPS is intended for screening purposes only, thus false negative and false positive results occur. This analysis does not assess the risk for other conditions, including but not limited to birth defects, open spine or ventral wall defects, intellectual disability, single gene disorders, or chromosomal abnormalities other than those listed above. The PPV and NPV calculations reported do not take into account additional clinical information such as previous screening results, positive family history or abnormal ultrasound findings. It is the duty of the healthcare provider to interpret these results in the context of the patient's clinical and family history and to recommend genetic counseling and additional testing when appropriate. This test was developed and its performance characteristics determined by Invitae. It has not been cleared or approved by the FDA. 

Reference Range Information

Interpretive report

Classification
This test was developed and its performance characteristics determined by Invitae.  It has not been cleared or approved by the US Food and Drug Administration.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.
Ordering Applications
Ordering ApplicationDescription
​Cerner
​​Invitae Twin NIPS (chr 13, 18, 21) (71002)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements

​Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)
​Whole blood
 Two ​10 mL black & tan top streck cfDNA tube (in Invitae NIPS kit)
​20 mL
14 mL (7 mL per tube) ​
Collection Processing

​Minimum gestational age of 10 weeks 0 days

Gently invert tubes at leaset 10 times immediately after draw. 

Ship samples same day or next day. Collected samples must be received within 6 days of collection.

Specimen Stability Information

Specimen TypeTemperatureTime
​Whole Blood
​Ambient
​48 hours
Rejection Criteria

Frozen specimen

Kit past expiration date

Interference

​Many factors, both maternal (maternal blood transfusion, surgery, organ transplant, immunotherapy, neoplasm, or mosaicism) and pregnancy-related (vanishing twin, fetal demise, confined placental mosaicism, true fetal mosaicism, uniparental disomy, and polyploidy), can affect the results. NIPS is intended for screening purposes only, thus false negative and false positive results occur. This analysis does not assess the risk for other conditions, including but not limited to birth defects, open spine or ventral wall defects, intellectual disability, single gene disorders, or chromosomal abnormalities other than those listed above. ​

Useful For

​​Invitae Non-invasive Prenatal Screening (NIPS) for Twin Pregnancies analyzes whether a pregnancy is at increased risk for the chromosomal disorders listed below. Testing can be performed at a minimum of 10 weeks gestation.

All NIPS reports include analysis of chromosomes 13, 18, and 21 and assess the risk of the following trisomies:

  • Trisomy 13 (Patau syndrome)
  • Trisomy 18 (Edwards syndrome)
  • Trisomy 21 (Down syndrome)
​Y chromosome analysis can also be included to determine if at least one twin is male. However, the presence of the Y chromosome cannot differentiate between one male twin or two male twins. To include predicted fetal sex prediction (Y chr only) in your order, please select the add-on.
Reference Range Information

Interpretive report

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation

​Invitae
​Monday through Friday
​3 to 10 days
Cell-free nucleic acid extraction from maternal blood, DNA sequencing and analysis of sequenced regions. 
Reference Lab
For billing questions, see Contacts
Classification
This test was developed and its performance characteristics determined by Invitae.  It has not been cleared or approved by the US Food and Drug Administration.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.
For most current information refer to the Marshfield Laboratory online reference manual.