Cowingene HPV 15 E6/E7 Gene mRNA Detection Kit

ORDER INFORMATION

REF

TYPE

PACKAGE

HP05021X

Liquid

48tests/kit

HP05022X

Lyophilized

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

TARGET SEQUENCE

E6/E7 Gene mRNA

ANALYTICAL SPECIFICITY

16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66 and 68

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 500 cp/ml with the probability of 95 % (on HPV DNA control, GeneWell)

EXTRACTION/INHIBITION CONTROL

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

REPORTING UNITS

cp/ml

VALIDATED SPECIMEN

Urine,Cervical Swab

TYPE

Liquid                                  Lyophilized

STORAGE

≤-20℃                                  2-30℃

SHELF LIFE

18months                                18months

REACTION TIME

75mins                                  75mins

DIAGNOSTIC SPECIFICITY

100.00 % (CI95%: 97.57 % – 100.00 %)       100.00 % (CI95%: 97.27 % – 100.00 %)     

DIAGNOSTIC SENSITIVITY

100.00 % (CI95%: 96.37 % – 100.00 %)       100.00 % (CI95%: 97.56 % – 100.00 %)

VALIDATED EXTRACTION METHOD

Nucleic Acid Extraction Kit

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, CY5