Cowingene Poliovirus Ⅰ/Ⅱ/Ⅲ Detection Kit （NATBox）

ORDER INFORMATION

REF

TYPE

PACKAGE

NI07023W

mini Ⅱ

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

ANALYTICAL SPECIFICITY

Poliovirus 1/2/3

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

Feces

TYPE

cartridge                            

STORAGE

2-8℃

SHELF LIFE

12months                       

REACTION TIME

75mins                            

DIAGNOSTIC SPECIFICITY

100.00 % (CI95%: 97.27 % – 100.00 %)

DIAGNOSTIC SENSITIVITY

100.00 % (CI95%: 97.56 % – 100.00 %)

APPLIED INSTRUMENTS

mini Ⅱ

REQUIRED DETECTION CHANNELS

FAM, HEX，ROX，CY5