Cowingene Mycobacterium Tuberculosis Detection Kit
|
ORDER INFORMATION |
REF TYPE PACKAGE |
|||
|
TB01021X Liquid 48tests/kit |
||||
|
TB01022X Lyophilized 48tests/kit |
||||
|
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 |
|||
|
TARGET SEQUENCE |
IS6110/IS1081 |
|||
|
ANALYTICAL SPECIFICITY |
Mycobacterium Tuberculosis |
|||
|
ANALYTICAL SENSITIVITY (LoD with probability 95 %) |
reaches up to 400 cp/test with the probability of 95 % (on DNA control) |
|||
|
EXTRACTION/INHIBITION CONTROL |
PCR inhibition and RNA extraction efficiency control by Internal Control (IC) |
|||
|
REPORTING UNITS |
cp/ml |
|||
|
VALIDATED SPECIMEN |
sputum,tongue swab,urine,BALF,CSF |
|||
|
TYPE |
Liquid Lyophilized |
|||
|
STORAGE |
≤-20℃ 2-30℃ |
|||
|
SHELF LIFE |
18months 18months |
|||
|
REACTION TIME |
75mins 75mins |
|||
|
DIAGNOSTIC SPECIFICITY |
100.00 % (CI95%: 98.34% – 100.00 %) 100.00 % (CI95%: 97.78 % – 100.00 %) |
|||
|
DIAGNOSTIC SENSITIVITY |
100.00 % (CI95%: 96.67 % – 100.00 %) 100.00 % (CI95%: 98.12 % – 100.00 %) |
|||
|
VALIDATED EXTRACTION METHOD |
Cowingene DNA/RNA Extraction kit |
|||
|
APPLIED INSTRUMENTS |
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System |
QuantStudio™ 3 / 5 Real-Time PCR System |
||
|
Applied Biosystems 7300 / 7500 Real-Time PCR System |
Rotor-Gene™ 3000 / 6000 / Q |
|||
|
SLAN® Real-Time PCR System |
MA-9600P/MA-6000 Real-Time Quantitative Thermal Cycler |
|||
|
LightCycler® 480 |
LineGene 9600 Plus |
|||
|
croBEE™ Real-Time PCR System |
Gentier 96E/96R Real-Time PCR System |
|||
|
AriaMx Real-Time PCR System |
Mic qPCR Cycler |
|||
|
BioQuant-96 Real-Time PCR System |
AMPLilab Real-Time PCR System |
|||
|
REQUIRED DETECTION CHANNELS |
FAM, ROX, CY5 |
|||
Download
Choose all
