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GeneProof Chlamydia trachomatis PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

HIGH SENSITIVITY

  • Secured by targeting the multicopy sequence of the 16S rRNA gene
  • Dual target detection of the 16S rRNA gene and a cryptic plasmid

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other PCR kits from the STI Panel in one workflow

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

RELIABLE DETECTION OF SWEDISH VARIANT OF CHLAMYDIA TRACHOMATIS

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

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

 

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/100 real-time PCR 100 reactions

Product Leaflet

Product Leaflet

; GP_STI_Panel_Leaflet_EN
pdf, [1.42 MB]
; GP_CHT_Leaflet_EN
pdf, [121.03 kB]
; GP_Poster_EN
pdf, [100.68 kB]
Choose all

EQA Panels

EQA results

; GP_STI II_QCMD_11_2022_EN
pdf, [228.53 kB]
; GP_STI I_QCMD_11_2022_EN
pdf, [261.07 kB]
; GP_CT_croBEE_QCMD_9_2022
pdf, [130.58 kB]
; GP_CT_ QCMD_9_2022
pdf, [129.55 kB]
; GP_CHT_QCMD_05_22_EN_02
pdf, [127.76 kB]
; GP_CHT_QCMD_05_22_EN_01
pdf, [126.74 kB]
; GP_CHT_QCMD_09_21_EN_02
pdf, [133.66 kB]
; GP_CHT_QCMD_09_21_EN_01
pdf, [134.65 kB]
; GP_CTNG_QCMD_09_21_EN_02
pdf, [139.59 kB]
; GP_CTNG_QCMD_09_21_EN_01
pdf, [138.43 kB]
; GP_CHT_Instand_06_21_EN
pdf, [901.17 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Intended User For professional use in laboratories with trained staff
Regulatory Status CE1023IVD
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) 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 201A Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments

croBEE Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AMPLilab
AriaMx Real-Time PCR System
BioQuant-96
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
DTlite Real-Time PCR System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ 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

Instructions for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_CHT_Advisory Notice_EN_CZ
pdf, [271.73 kB]
; GP_CHT_Advisory_Notice_05_22_EN
pdf, [450.59 kB]
; GP_CHT_Instruction_for_Use_EN
pdf, [211.72 kB]
; GP_CHT_Instruction_for_Use_ES
pdf, [214.83 kB]
; GP_CHT_Instruction_for_Use_FR
pdf, [255.3 kB]

Declaration of Conformity

; GP_CHT_Declaration_of_Conformity_EN
pdf, [618.97 kB]
; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [58.14 kB]

MSDS

; GP_CHT_Safety_Data_Sheet_EN
pdf, [275.03 kB]

Publications

; GP_STI_publications_08_22_EN
pdf, [204.33 kB]

PCR Template

; GP_Chlamydia trachomatis_Mic
micassay, [21.95 kB]
; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Manual

; AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; LightCycler 2.0_EN
pdf, [1.8 MB]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.