Cowingene Borrelia Burgdorferi Detection Kit （NATBox）

ORDER INFORMATION

REF

TYPE

PACKAGE

NI06023W

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

Borrelia Burgdorferi

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 400 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

Plasma, serum, whole blood, CSF,urine and tick

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