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GeneProof Chlamydia trachomatis PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

DUAL TARGET DETECTION

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

HIGH 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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
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

EQA Panels

EQA results

GP_CHT_QCMD_2018_EN
pdf, [130.39 kB]
GP_CHT_QCMD_2018_EN
pdf, [137.5 kB]
GP_CHT_QCMD_C2.2019_EN
pdf, [127.79 kB]
GP_CHT_QCMD_croBEE_2019_EN
pdf, [131.38 kB]
GP_CHT_QCMD_manual_2019_EN
pdf, [130.39 kB]
GP_Instand_06.2018_EN
pdf, [617.11 kB]
GP_Instand_06.2019_EN
pdf, [416.54 kB]
GP_Instand_06.2020_EN
pdf, [323.72 kB]
Choose all

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 C. 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 and DNA extraction efficiency control 
Validated Specimen spermswab, urine
Storage -20 ± 5 °C
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments

ccroBEE 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™ Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Control regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com
Certification CE1023 IVD

* Validated instruments

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_CHT_Advisory Notice_EN_CZ
pdf, [271.73 kB]
GP_CHT_Instruction for Use_CZ
pdf, [189.8 kB]
GP_CHT_Instruction for Use_EN
pdf, [136.51 kB]

Declaration of Conformity

GP_CHT_Declaration of Conformity_CZ
pdf, [317.5 kB]
GP_CHT_Declaration of Conformity_EN
pdf, [318.47 kB]
GP_FQAS EC Certificate_CZ
pdf, [47.46 kB]
GP_FQAS EC Certificate_EN
pdf, [48.26 kB]

MSDS

GP_CHT_Safety Data Sheet_CZ
pdf, [596.25 kB]
GP_CHT_Safety Data Sheet_EN
pdf, [718.73 kB]

Manual

Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_CZ
pdf, [2.13 MB]
Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_EN
pdf, [2.03 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_CZ
pdf, [3.97 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_EN
pdf, [4.04 MB]
AriaMx Real-Time PCR System_CZ
pdf, [2.17 MB]
AriaMx Real-Time PCR System_EN
pdf, [2.14 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_CZ
pdf, [2.37 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [2.2 MB]
croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 2.0_CZ
pdf, [1.85 MB]
LightCycler 2.0_EN
pdf, [1.94 MB]
LightCycler 480/480 Instrument II_CZ
pdf, [2.3 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_CZ
pdf, [4.66 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_CZ
pdf, [2.7 MB]
Mic qPCR Cycler_EN
pdf, [2.6 MB]
QuantStudio 3/5 Real-Time PCR System_CZ
pdf, [2.31 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_CZ
pdf, [2.25 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_CZ
pdf, [1.59 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
StepOne/StepOne Plus Real-Time PCR System_CZ
pdf, [4.37 MB]
StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]

Product Leaflet

GP_CHT_Leaflet_EN
pdf, [135.85 kB]
GP_Poster_EN
pdf, [100.68 kB]
Files are available only for registered users.