Cowingene MRSA/SA Detection Kit (NATBox)

ORDER INFORMATION

REF

TYPE

PACKAGE

HG06013W

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

Methicillin-resistant Staphylococcus aureus

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 300 cp/ml with the probability of 95 % (on DNA control, GeneWell)

EXTRACTION/INHIBITION CONTROL

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

REPORTING UNITS

cp/ml

VALIDATED SPECIMEN

CSF, Plasma, Urine, Whole blood

TYPE

cartridge                               

STORAGE

2-8℃                             

SHELF LIFE

18months                              

REACTION TIME

90mins                               

DIAGNOSTIC SPECIFICITY

100.00 % (CI95%: 97.32 % – 100.00 %)     

DIAGNOSTIC SENSITIVITY

100.00 % (CI95%: 96.56 % – 100.00 %)    

APPLIED INSTRUMENTS

mini II

REQUIRED DETECTION CHANNELS

FAM, HEX，ROX，CY5