Aptima CMV Quant Assay

The Aptima CMV Quant Assay is an in vitro nucleic acid amplification test using real-time transcription-mediated amplification (TMA) technology to quantify human cytomegalovirus (CMV) DNA in EDTA plasma on the Panther/Panther Fusion system. It is intended to aid in managing solid-organ and hematopoietic stem cell transplant patients, including assessing viral response to anti-CMV therapy, but is not intended for screening CMV in blood or blood products.

The subject device is identical to the predicate device in intended use, organisms detected, specimen types, analyte (CMV DNA genotypes 1-4), technology (real-time TMA), platform (Panther/Panther Fusion), and software. The only addition is a new protocol for pre-treating plasma specimens flagged as invalid (ML2 flag) with proteinase K before retesting, which enables recovery of valid results for samples with abnormally high globulin proteins.

The assay is standardized to the 1st WHO International Standard for human cytomegalovirus (NIBSC code: 09/162). No other consensus standards (ISO, IEC, ASTM) are cited in this summary.

The device is substantially equivalent because it uses the same technology, platform, assay methodology, and clinical indication as the predicate device approved in 2022. The proteinase K pre-treatment protocol is a specimen handling modification that does not change the core assay performance—validation data from the NIH demonstrate that proteinase K treatment eliminates ML2 invalid results (from 0.87% to 0%) while maintaining CMV quantification accuracy. This modification only provides a means to rescue previously failed specimens and does not negatively impact safety or effectiveness.