GeneProof CT/NG/MG Multiplex PCR Kit

CE1023IVD

PRODUCT ADVANTAGES

Learn about our GeneProof CT/NG/MG Multiplex Kit compared to competitors in a clinical study.

MORE INFORMATION WITH LESS SAMPLES

  • PCR Kit detects the most important STI pathogens in a single reaction tube:
  • Chlamydia trachomatis
  • Neisseria gonorrhoeae
  • Mycoplasma genitalium

DETECTS porA MUTANT OF N. GONORRHOEAE

  • Dual target detection of 16S rRNA gene and porA pseudogene

SWEDISH VARIANT OF C. TRACHOMATIS

  • Dual target detection of 16S rRNA gene and cryptic plasmid

HIGH SENSITIVITY

  • Secured by targeting the multicopy sequence of 16S rRNA for all three detected pathogens

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

TECHNICAL SPECIFICATION

Technology real-time PCR
Type of analysis qualitative
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, Vircell)
reaches up to 0.22 cp/μl with the probability of 95 % (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell)
reaches up to 1.129 cp/μl with the probability of 95 % (on Amplirun® Mycoplasma genitalium DNA control, Vircell)
Diagnostic Specificity 96.89 % (CI95%: 93.04% - 98.73%)
Diagnostic Sensitivity 97.67 % (CI95%: 86.20% - 99.88%)
Extraction/Inhibition Control PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version)
Validated Specimen swab, urine
Storage -20 ± 5 °C
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments croBEE Real-Time PCR System*
Applied Biosystems 7500 Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
Mic qPCR Cycler
QuantStudioTM 5 Real-Time PCR System
Rotor-Gene 3000 / Q
Required Detection Channels FAM, HEX, Cy5, Texas Red
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com
Regulatory Status CE1023IVD

* Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof CT/NG/MG Multiplex PCR Kit CNMX/ISEX/025 real-time PCR 25 reactions
GeneProof CT/NG/MG Multiplex PCR Kit CNMX/ISEX/050 real-time PCR 50 reactions
GeneProof CT/NG/MG Multiplex PCR Kit CNMX/ISEX/100 real-time PCR 100 reactions