Press Releases

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS)
Announces New Standard Advantageous to the Field of Prenatal Screening

CLSI/NCCLS document, Maternal Serum Screening; Approved Standard (I/LA25-A), is written for clinical laboratorians who participate in prenatal screening for open neural tube defects and Down syndrome involving AFP, hCG, uE3, DIA, and/or PAPP-A measurements, as well as for clinicians and manufacturers who have a direct interest in the tests. The standard is intended to present necessary considerations: preanalytical, analytical, and postanalytical; and to ensure the reliability of the tests, including the risk calculation, the outcome evaluation, and the accuracy of the information management. If properly applied, the four biochemical determinations (or five, if performing integrated testing with PAPP-A from the first trimester), and the risk calculations can contribute constructively to the field of prenatal screening and to the welfare of pregnant women and the fetus.

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CLSI/NCCLS document, Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (MM9-A), specifies recommendations for all aspects of the sequencing process including specimen collection and handling, isolation of nucleic acid, amplification and sequencing of nucleic acids, and general interpretation and reporting of genotyping results. It is the intent of this document to provide instruction for verifying that the sequence obtained is accurate and suitable for subsequent interpretation; to address general interpretation of the sequence; and to provide quality control/assessment considerations for each step of the process as appropriate.

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