To: All Submitters of Newborn Screening Specimens

NOTICE

To: All Submitters of Newborn Screening Specimens

It has come to our attention that some of the birthing facilities are planning to use a capillary blood collection system that contains heparin as the anticoagulant.

Based on the CLSI document, “MM17-A: Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline” specifically states in Section 8.4.5.2, “As described in Section 5, residual reagent, such as organic solvents, wash buffers and others or residual proteins may not be sufficiently removed during the extraction procedure. The most common interfering substance in the extraction and PCR amplification of gDNA is heparin, and therefore, this reagent should not be used as an anticoagulant.”

As PCR becomes more complex as in the multiplex CFTR assay (method we are using for Cystic Fibrosis screening), the more issues will be encountered.