タイトルまたは説明

[INTENDED USE]
The 'NeoPlexTM RB*8 Detection Kit' is a qualitative in vitro test for the simultaneous detection and confirmation of
eight (8) respiratory infection causing pathogens including Streptococcus pneumonia (SP), Mycoplasma
pneumoniae (MP), Chlamydophila pneumonia (CP), Legionella pneumoniae (LP*), Haemophilus influenza (HI),
Bordertella pertussis (BP), Bordetella parapertussis(BPP), Moraxella catarrhalis(MC) from human nasopharyngeal
swab and sputum specimens based on multiplex Real-time polymerase chain reaction (PCR) assay. This test is
intended for professional use.
* LP target is only applied to sputum specimen

[PRINCIPLE OF ASSAY]
'NeoPlexTM RB*8 Detection Kit' is based on two major processes, isolation of DNA from specimens and multiplex
real-time amplification. RI-causing pathogens DNA is extracted from specimens, amplified in multiplex real-time
PCR and detected using fluorescent reporter dye probes specific for RI-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)
-QIAamp DSP DNA Mini Kit (QIAGEN, Cat No.****4) or equivalent DNA extraction kit