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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Chlamydia pneumoniae PCR Kit | CHP/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Chlamydia pneumoniae PCR Kit | CHP/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 | specific conservative DNA sequence of a single-copy ompA gene |
Analytical Specificity | C. pneumoniae, 100 % |
Analytical Sensitivity (LoD) | reaches up to 0.647 cp/μl with the probability of 95% |
Diagnostic Specificity | 100% (CI95%: 97.50% - 100.00%) |
Diagnostic Sensitivity | 98.81% (CI95%: 92.62% - 99.94%) |
Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
Validated Specimen | BAL, sputum, swab |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Instruments |
croBEE 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 for in vitro Diagnostic Use |
*Validated instruments
+420 543 211 679
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GeneProof merges with American Laboratory Products Company.