Cowingene Chlamydia Trachomatis and Neisseria Gonorrhoeae Detection Kit (NATBox)

ORDER INFORMATION

REF

TYPE

PACKAGE

ST03013W

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

Chlamydia Trachomatis and Neisseria Gonorrhoeae

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

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

EXTRACTION/INHIBITION CONTROL

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

REPORTING UNITS

cp/ml

VALIDATED SPECIMEN

male urethral swab,female cervical swab,female vaginal swab,urine

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