Cowingene HPV 16/18Detection Kit ( NATBox)

ORDER INFORMATION

REF

TYPE

PACKAGE

HP09023W

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

TARGET SEQUENCE

L1

ANALYTICAL SPECIFICITY

Human papillomavirus 16, 18

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 100 cp/ml with the probability of 95 % (on HPV DNA control, GeneWell)

EXTRACTION/INHIBITION CONTROL

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

REPORTING UNITS

cp/ml

VALIDATED SPECIMEN

Urine,Cervical Swab

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, VIC, CY5