Cowingene Cytomegalovirus Detection Kit （NATBox）

ORDER INFORMATION

REF

TYPE

PACKAGE

NI01023W

mini Ⅱ

24tests/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

ANALYTICAL SPECIFICITY

Cytomegalovirus

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 100 cp/ml 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

peripheral blood,fresh peripheral blood,frozen peripheral blood

TYPE

cartridge                                

STORAGE

2-8℃

SHELF LIFE

12months                        

REACTION TIME

52mins  

DIAGNOSTIC SPECIFICITY

100.00 % (CI95%:97.33% – 100.00 %)

DIAGNOSTIC SENSITIVITY

100.00 % (CI95%:96.52% – 100.00 %)

APPLIED INSTRUMENTS

mini Ⅱ

REQUIRED DETECTION CHANNELS

FAM, CY5