GeneProof Chlamydia trachomatis PCR Kit

CE1023 IVD

PRODUCT DETAIL

Learn about a clinical evaluation of GeneProof Chlamydia trachomatis PCR Kit to our competitors.

DUAL TARGET DETECTION

  • Dual target detection of the 16S rRNA gene and a cryptic plasmidHIGH

SENSITIVITY

  • Secured by targeting the multicopy sequence of the 16S rRNA gene

RELIABLE DETECTION OF SWEDISH VARIANT OF C. TRACHOMATIS

  • Elimination of false-negative results caused by a sequence variation in the cryptic plasmid

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 multi-copy sequence and the 16S rRNA gene for C. trachomatis
Analytical Specificity Chlamydia trachomatis, including mutations with deletions in cryptic plasmid (including Swedish variant), 100 %
Analytical Sensitivity (LoD) reaches up to 0.075 cp/μl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control, Vircell)
Diagnostic Specificity 99.21 % (CI95 % : 99.07 % - 99.34 %)
Diagnostic Sensitivity 100 % (CI95 % : 99.58 % - 100 %)
Extraction/Inhibition Control PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version)
Validated Specimen spermswab, 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 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
DTlite Real-Time PCR System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus

Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessement regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com
Regulatory Status CE1023 IVD for in vitro Diagnostic Use

 * Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Chlamydia trachomatis PCR Kit CHT/ISEX/025 real-time PCR 25 reactions
GeneProof Chlamydia trachomatis PCR Kit CHT/ISEX/050 real-time PCR 50 reactions
GeneProof Chlamydia trachomatis PCR Kit CHT/ISEX/100 real-time PCR 100 reactions