Cowingene Influenza A/B Detection Kit (NATBox)

ORDER INFORMATION

REF

TYPE

PACKAGE

RP06023W

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

Influenza A/B Virus

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 400 cp/ml with the probability of 95 % (on RNA control)

EXTRACTION/INHIBITION CONTROL

PCR inhibition and RNA extraction efficiency control by Internal Control (IC)

REPORTING UNITS

cp/ml

VALIDATED SPECIMEN

Nasopharyngeal Swab

TYPE

cartridge                               

STORAGE

2-8℃                               

SHELF LIFE

12months                              

REACTION TIME

75mins                                

DIAGNOSTIC SPECIFICITY

100.00 % (CI95%: 97.57 % – 100.00 %)      

DIAGNOSTIC SENSITIVITY

100.00 % (CI95%: 96.37 % – 100.00 %)      

APPLIED INSTRUMENTS

mini Ⅱ

REQUIRED DETECTION CHANNELS

FAM,ROX, CY5