Cowingene Human Leukocyte Antigen B27 Detection Kit (NATBox)

ORDER INFORMATION

REF

TYPE

PACKAGE

HG01023W

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

Exon 2/Exon 3

ANALYTICAL SPECIFICITY

HLA-B*27:01 to B*27:73

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

Whole Blood

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