CT/NG/MG Multiplex PCR Kit

Manufacturer: 

Technical Features

Specifications:

• Target Sequence: the cryptic plasmid sequence and the 16S rRNA gene for Chlamydia trachomatis/the 16S rRNA gene and porA pseudogene for Neisseria gonorrhoeae/the 16S rRNA gene for Mycoplasma genitalium
• Analytical Specificity: Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium, 100 %
• Analytical Sensitivity (LoD): reaches up to 0.177 cp/µl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control) reaches up to 0.22 cp/µl with the probability of 95 % (on Amplirun® Neisseria gonorrhoeae DNAcontrol), up to 1.129 cp/µl with the probability of 95 % (on Amplirun® Mycoplasma genitalium DNAcontrol) and up to 1.129 cp/µl with the probability of 95 % (on Amplirun® Mycoplasma genitalium DNAcontrol)
• Diagnostic Sensitivity: 97.67%
• Diagnostic Specificity: 96.89%
• Quality management system is certified in compliance with the requirements of the standard ISO 13485 ed.2:2016
• External Quality Assessment:  regularly tested by QCMD and Instand e.V. External Quality Assessment Panels
• Required Detection Channels FAM + HEX + Cy5 + TexRed
• Compatible  with a wide range of Real-time  PCR devices (CFX96™/Dx Real-Time PCR Detection System, Applied Biosystems 7300 / 7500 Real-Time PCR System, Rotor-Gene 3000 /Q κα)
• Stable at -20 ± 5 °C
• The components are stable for a maximum of 3 repeated freezing / thawing cycles
• Regulatory Status CE₁₀₂₃ IVD