Guangzhou Wondfo Biotech Co., Ltd.

No. 8 Lizhishan Road, Science City, Luogang District, 510663,

Guangzhou, P.R. China
Tel: 86-20-32296083 Fax: 86-20-32296063
Website: en.wondfo.com.cn E-mail: Finecare@wondfo.com.cn

CERTIFICATE OF ANALYSIS
PRODUCT: Finecare™ CRP Rapid Quantitative Test
Catalog No: W201P0008
LOT. NO.： F20118B0DBD
EXP. ： 2025/02/14

Characterization: C-reactive protein (CRP) is synthesized by the liver in response to

interleukin-6 and well known as one of the classical acute-phase reactants
and as a marker of inflammation. CRP Quantitative Test Cartridge adopts
fluorescence immunoassay technology and is intended for in vitro
quantitative determination of C-reactive protein (CRP) in human whole
blood, serum or plasma.

Performance: When sample is added to the sample well of the Test Cartridge, the
fluorescence-labeled detector CRP antibody on the membrane binds to
CRP antigen in blood specimen. As the sample mixture migrates on the
nitrocellulose matrix of test strip by capillary action, the complexes of
detector antibody and CRP are captured to CRP antibody that has been
immobilized on test strip. Thus the more CRP antigen is in blood specimen,
the more complexes are accumulated on test strip. Signal intensity of
fluorescence of detector antibody reflects amount of CRP captured and
FinecareTM FIA Meter shows CRP concentrations in blood specimen. The
default results unit of CRP Test is displayed as XXX mg/L from FinecareTM
FIA Meter.

Package: Packaging procedure strictly follows the production manual and packaging
control is carried out by the quality control system. Inner package: Sealed
pouch contains 1 test. Outer package: kit size of outer package is variable.

Expiry: The device is stable for 24 months from the manufactured date.

Storage: The buffer and test cartridge should be stored at temperature of 4～30℃.

Precaution: The product is offered without warranty for any other specific use than that
specified in the instruction of use.

Product approved and released based on information gained from manufacturer by:

Quality Manager
Guangzhou Wondfo Biotech Co., Ltd.