IVD Technology
Magazine
IVDT Article Index
Originally published September, 1997
NCCLS Issues Test Guidelines
NCCLS has recently issued two new guidelines for manufacturers of alpha-fetoprotein assays and coagulation factor assays, and for clinical laboratory personnel who perform the tests.
Determination of Factor Coagulant Activities; Approved Guideline (NCCLS document H48-A) provides guidance on the performance, quality control, and reporting of one-stage coagulation factor assays based on APTT and PT coagulation tests. The guideline recommends techniques to minimize the effects of sources of error and improve inter- and intralaboratory precision.
Assessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Open Neural Tube Defects; Approved Guideline (NCCLS document I/LA17-A) presents preanalytical and analytical considerations necessary to ensure the reliability of AFP testing during the second trimester of pregnancy.
To order copies of the guidelines, contact NCCLS at 610/688-0100.
