Cowingene Mycobacterium Tuberculosis Detection Kit （NATBox）

ORDER INFORMATION

REF

TYPE

PACKAGE

TB01023W

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

IS6110/IS1081

ANALYTICAL SPECIFICITY

Mycobacterium Tuberculosis

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 400 cp/test 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

sputum,tongue swab,urine,BALF,CSF

TYPE

cartridge                               

STORAGE

2-8℃

SHELF LIFE

12months                          

REACTION TIME

75mins                            

DIAGNOSTIC SPECIFICITY

100.00 % (CI95%: 97.78 % – 100.00 %)

DIAGNOSTIC SENSITIVITY

100.00 % (CI95%: 98.12 % – 100.00 %)

APPLIED INSTRUMENTS

mini Ⅱ 

REQUIRED DETECTION CHANNELS

FAM, ROX, CY5