Qualitative DNA Test for Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) - Vietnam Registration 2402895ĐKLH/BYT-HTTB

The NeuMoDx CT/NG Assay, as performed on the NeuMoDx™ 96 Molecular System and the NeuMoDx™ 288 Molecular System, is a qualitative in vitro amplification test for the direct detection and differentiation of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The test uses real-time polymerase chain reaction (PCR) to detect the DNA of Chlamydia trachomatis and Neisseria gonorrhoeae in vaginal swab specimens obtained by the clinical physician, self-obtained vaginal swab specimens (obtained in the clinical setting), and cervical swab specimens, all of which are obtained using polyester-tipped swabs coated with plastic in a common transport medium (Universal Transport Medium, UTM-RT®, Copan Diagnostics, CA, USA or BD™ Universal Viral Transport System, BD™ UVT, Becton, Dickinson and Company, MD, USA or equivalent), cervical swab specimens obtained in PreservCyt® Solution (Hologic, Inc, MA, USA) and urine specimens from male and female patients. The NeuMoDx™ CT/NG Assay is used to aid in the diagnosis of urogenital infections caused by Chlamydia and Gonococcus in symptomatic and asymptomatic individuals.