GeneProof Cytomegalovirus (CMV) PCR Kit
GeneProof Cytomegalovirus (CMV) PCR Kit adalah sebuah kit diagnostik molekuler yang digunakan untuk mendeteksi dan mengamplifikasi DNA virus sitomegalovirus (CMV) dalam sampel klinis. Kit ini menggunakan metode Polymerase Chain Reaction (PCR) untuk mendeteksi keberadaan CMV dengan sensitivitas tinggi dan spesifisitas yang baik.
Baca Selengkapnya Minta PenawaranProduk data dan gambar GeneProof Cytomegalovirus (CMV) PCR Kit
Spesifikasi GeneProof Cytomegalovirus (CMV) PCR Kit
Deskripsi
| INDICATION | in vitro diagnostic medical device |
| REGULATORY STATUS | CE IVD |
| INTENDED USER | For professional use in laboratories with trained staff |
| TECHNOLOGY | Real-time PCR |
| TYPE OF ANALYSIS | Qualitative and quantitative |
| TARGET SEQUENCE Specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen |
Specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen |
| ANALYTICAL SPECIFICITY | Human Cytomegalovirus (CMV), 100 % |
|
ANALYTICAL SENSITIVITY (LoD with the probability of 95 %) |
122.594 IU/ml (on CMV NIBSC 09/162, manual extraction GeneProof PathogenFree DNA Isolation Kit) |
|
165.237 IU/ml (on CMV NIBSC 09/162, automatic extraction croBEE 201A Nucleic Acid Extraction Kit) |
|
| DIAGNOSTIC SPECIFICITY | 90.67 % (CI95%: 81.15 % – 95.85 %) |
| DIAGNOSTIC SENSITIVITY | 92.86 % (CI95%: 64.17 % – 99.63 %) |
| LINEAR RANGE | 1010 – 102.5 IU/ml with precision of ± 0.5 log |
|
DYNAMIC RANGE |
1010 – 122.594 cp/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) |
|
1010 – 165.237 cp/ml (using automatic extraction croBEE 201A Nucleic Acid Extraction Kit) |
|
| REPORTING UNITS | IU/ml |
| VALIDATED SPECIMEN | plasma, serum, urine*, whole blood |
| STORAGE | -20 ± 5 °C |
|
VALIDATED EXTRACTION METHOD |
croBEE 201A Nucleic Acid Extraction Kit |
| GeneProof PathogenFree DNA Isolation Kit | |
|
INSTRUMENTS |
croBEE Real-Time PCR System |
| AMPLilab Real-Time PCR System | |
| Applied Biosystems 7300 / 7500 Real-Time | |
| PCR System | |
| AriaMx Real-Time PCR System | |
| BioQuant-96 Real-Time PCR System | |
| CFX Connect™ / CFX96™ / Dx Real-Time PCR | |
| Detection System | |
| LightCycler® 2.0 / 480 | |
| LineGene 9600 / 9600 Plus | |
| Mic qPCR Cycler | |
| QuantStudio™ 3 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 ASSESSMENT |
Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |