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|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|
|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
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|
Association between acute, severe hepatitis in small children and Adenovirus infection is currently under…
GeneProof merges with American Laboratory Products Company.