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GeneProof Team
Secured by targeting the multicopy sequence of the 16S rRNA gene
Elimination of false-negative results caused by a sequence variation in the cryptic plasmid
Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products
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 |
Indication | in vitro diagnostic medical device |
Intended User | For professional use in laboratories with trained staff |
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 and DNA extraction efficiency control |
Validated Specimen | sperm, swab, 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 |
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 |
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