AneuCare Silver
| Test Code | ANI001 |
|---|---|
| Test Summary | The AneuCare® test screens for Down (trisomy 21), Edwards (trisomy 18), and Patau (trisomy 13) syndromes |
| Turn Around Time | 10 days |
| Acceptable Sample Types | Whole Blood (EDTA) |
| NY Approved | No |
| Accreditations | CAP , ISO 15189 (NABL) |
*TAT starts after the sample and all required sample information is received at the processing laboratory.
**The CPT codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association, and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party.
This testing service has not been cleared or approved by the U.S. Food and Drug Administration. Testing services may not be licensed in accordance with the laws in all countries. The availability of specific test offerings is dependent upon laboratory location.
**The CPT codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association, and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party.
This testing service has not been cleared or approved by the U.S. Food and Drug Administration. Testing services may not be licensed in accordance with the laws in all countries. The availability of specific test offerings is dependent upon laboratory location.
This test is not available in your region Japan, please select your nearest laboratory to request more information.
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Test Code:
ANI001
Test Description
The AneuCare® test is the only fetal aneuploidy screening platform to enable targeted cfDNA analysis without PCR amplification. Instead, the system directly captures target fragments and labels them for counting. Unlike complex sequencing-based platforms, Easy System enables cost-efficient, high-performance screening for fetal aneuploidies (T13, T18 and T21) using standard microplates, eliminating the need for DNA sequencing, microarrays or microfluidics.
Indications for Testing
Any pregnant woman who wants to know whether there is a risk that the baby carries a chromosomal condition such as Down Syndrome can be screened using the AneuCare® test. Pretest counseling is advised before testing.
Condition Description
Prenatal screening is offered to pregnant women because all pregnancies have a small chance for a genetic disorder, regardless of maternal age, family history, or personal health. Know more about the AneuCare® test, a simple and accurate test to know your baby’s risk for Down, Edwards and Patau Syndrome accurately.
Test Methods and Limitations
Performed without PCR amplification and unlike other complex sequencing-based NIPTs, the AneuCare® test directly captures target chromosomal fragments and labels them for high-yield counting which enables high-performance screening for fetal aneuploidies at an affordable price. The AneuCare® test is processed on Revvity Omics' cfDNA screening platform that enables targeted cfDNA analysis without PCR amplification. Instead, the system directly captures target fragments and labels them for counting. Unlike complex sequencing-based platforms,This system also enables cost-efficient, high-performance screening for fetal aneuploidies (T13, T18 and T21) using standard microplates, eliminating the need for DNA sequencing, microarrays or microfluidics.
Detailed Sample Requirements
Whole Blood (EDTA)
| Collection Container(s) | EDTA (purple top) |
|---|---|
| Collection | Infants (< 2-years): 2 to 3 mL; Children (>2-years): 3 to 5 mL; Older children and adults: Minimum 5mL. The blood tube should be inverted several times immediately after blood collection to prevent coagulation. |
| Sample Condition | Store at ambient temperature. Do not refrigerate or freeze. |
| Shipping | Ship overnight at ambient temperature ensuring receipt within 5-days of collection. |
| Special Sample Instructions | Clotted or hemolyzed samples are not accepted. |