Cowingene HBV/HCV/HIV Detection Kit

ORDER INFORMATION

REF

TYPE

PACKAGE

HG02021X

Liquid

48tests/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

Hepatitis B Virus,Hepatitis C Virus and Human Immunodeficiency Virus

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 100 cp/test 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

fresh serum

TYPE

Liquid                                 

STORAGE

≤-20℃                             

SHELF LIFE

18months                              

REACTION TIME

90mins                               

DIAGNOSTIC SPECIFICITY

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

DIAGNOSTIC SENSITIVITY

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

VALIDATED EXTRACTION METHOD

Cowingene Viral DNA/RNA Column

APPLIED INSTRUMENTS

CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System

QuantStudio™ 3 / 5 Real-Time PCR System

Applied Biosystems 7300 / 7500 Real-Time PCR System

Rotor-Gene™ 3000 / 6000 / Q

SLAN® Real-Time PCR System

MA-9600P/MA-6000 Real-Time Quantitative Thermal Cycler

LightCycler® 480

LineGene 9600 Plus

croBEE™ Real-Time PCR System

Gentier 96E/96R Real-Time PCR System

AriaMx Real-Time PCR System

Mic qPCR Cycler

BioQuant-96 Real-Time PCR System

AMPLilab Real-Time PCR System

REQUIRED DETECTION CHANNELS

FAM, HEX，ROX，CY5