Multiple-type neonatal pathogen nucleic acid IVD, control
Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with neonatal disease, in a clinical specimen using a nucleic acid technique (NAT). Microorganisms detected may include, but are not limited to, Group B Streptococcus/Streptococcus agalactiae (GBS), Listeria monocytogenes, Escherichia coli (E. coli), cytomegalovirus, Staphylococcus aureus, Chlamydia trachomatis and Ureaplasma urealyticum/parvum.