タイトルまたは説明

[INTENDED USE]
The 'NeoPlexTM STI*7 Detection kit' is a qualitative in vitro test for the simultaneous detection and confirmation of
seven (7) sex-transmitted infection (STI)-causing pathogens including C.trachomatis(CT), N.gonorrhoeae(NG),
M.hominis(MH), M.genitalium(MG), T.vaginalis(TV), U.urealyticum(UU) and U.parvum(UP) from urine (male) or
vaginal swab (female) specimens.

[PRINCIPLE OF ASSAY]
'NeoPlexTM STI*7 Detection kit' is based on two major processes, isolation of DNA from specimens and multiplex
real-time amplification. STI-causing pathogens DNA is extracted from the specimens, amplified in multiplex real-time
PCR and detected using fluorescent reporter dye probes specific for STIs-causing pathogens DNA and Internal
Control. Internal Control (IC) serves as an amplification control for each individually processed specimen and to
identify possible reaction inhibition.

[Additional required equipment and materials]
-CFX*6 real-time PCR detection system (BioRad, Inc., Cat No. *******-IVD) or equivalent
*0.2 ml *-Tube PCR Strips without Caps, low profile, white (BioRad, Inc., Cat No. TLS***1)
-Optical Flat *-Cap Strips for PCR Tubes (BioRad, Inc., Cat No. TCS***3)
-Multiplate™ **-Well PCR Plates, low profile, unskirted, white (BioRad, Inc., Cat No. MLL***1)
-QIAamp DSP DNA Mini Kit (QIAGEN, Cat No.****4)) or equivalent DNA extraction kit
-Pipettes set
-Micro Centrifuge