The test design, development, and validation are described in Grskovic et al., J Mol Diagn, 2016. Cell-free DNA is purified from plasma collected in Streck cell-free DNA BCT® tubes. Cell-free DNA extracted from plasma is used as the template in a pre-amplification PCR reaction with primer pairs that specifically amplify the genomic regions containing the AlloSure SNPs. The pre-amplification product is used as the template in parallel small-multiplex microfluidic PCR amplification library preparation and next generation sequencing.
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