Chromosomal Microarray, POC FFPE, ClariSure® Oligo‑SNP
Also known as: Products of Conception FFPE, Oligo-SNP Microarray FFPE, CMA, FFPE, Products of Conception Block
Use
Chromosomal Microarray using the ClariSure® Oligo‑SNP platform enables detection of chromosomal deletions, duplications, and regions of homozygosity indicative of uniparental disomy or consanguinity. It is intended for post‑product‑of‑conception evaluation using formalin‑fixed paraffin‑embedded (FFPE) tissue to investigate chromosomal abnormalities in miscarriage specimens or POC samples.
Special Instructions
This is a germline genetic test requiring physician attestation of informed consent if the ordering medical facility is located in specified states (AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD, VT) or if performed in MA. Specimens must be FFPE tissue fixed in 10% neutral buffered formalin with cold ischemic time <1 hour, fixed for 6–72 hours.
Limitations
Not provided explicitly. However, general limitations of CMA apply, such as inability to detect balanced rearrangements, low-level mosaicism, or single‑gene mutations below resolution of the assay.
Methodology
Microarray
Biomarkers
Result Turnaround Time
10-14 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (Fixed (Non-FFPE))
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Preferred: 5×5 mm POC FFPE tissue (minimum 2×3 mm). Other acceptable: five unstained charged slides from FFPE tissue. Specimen must be fixed in 10% neutral buffered formalin; cold ischemic time <1 hour; fixation between 6 and 72 hours.