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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Enterovirus PCR Kit | EV/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Enterovirus PCR Kit | EV/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 and semiquantitative |
Target sequence | specific single copy 5‘ UTR RNA sequence |
Analytical Specificity | Enterovirus A-D, 100 % |
Analytical Sensitivity (LoD) |
reaches up to 158.34 cp/μl with the probability of 95 % (on Amplirun® Enterovirus 68 RNA control, Vircell) |
Diagnostic Specificity | 100.00% (CI95%: 93.75% - 100.00%) |
Diagnostic Sensitivity | 93.75% (CI95%: 90.63% - 96.88%) |
Reporting Units | cp/μl |
Extraction/Inhibition Control |
PCR inhibition and RNA extraction efficiency control |
Validated Specimen | CSF, stool*, swab |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree RNA Isolation Kit NucleoSpin® RNA Stool |
Instruments |
croBEE Real-Time PCR System** |
Required Detection Channels | FAM, HEX |
External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
Certification | CE IVD |
*Only in combination with NucleoSpin® RNA Stool or croBEE NA16 Nucleic Acid Extraction System
** Validated instruments
+420 543 211 679
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+420 730 176 222
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Association between acute, severe hepatitis in small children and Adenovirus infection is currently under…
GeneProof merges with American Laboratory Products Company.