Chlamydia trachomatis Variants Escaping Detection in the Aptima Combo 2 Assay in the United States.

ABSTRACT:

Background

The Aptima Combo 2 (AC2) assay manufactured by Hologic, Inc., detects Neisseria gonorrhoeae and/or Chlamydia trachomatis (CT) in urogenital and extragenital specimens by targeting either a 16S rRNA (N. gonorrhoeae) or 23S rRNA (CT) region. In 2019, a mutation (C1515T) in the 23S rRNA region was reported to cause false-negative/equivocal results in specimens collected in Finland. Specimens containing this variant (Fl-nvCT) were also discovered internationally. Working with specimens submitted to a large commercial laboratory, we sought to determine if this variant was also present in the United States.

Methods

A subset (n = 401) of specimens tested with the AC2 assay collected during a 5-week period in late 2019/early 2020 were evaluated using an updated AC2 assay.

SUBMITTER: Katz SS 

PROVIDER: S-EPMC9133125 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature