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 Name: Finecare™ Prolactin Rapid Quantitative Test
Catalog No: W246P0001
LOT. NO.： F2461630CAD
EXP. ： 2025/02/09

Characterization: The main physiological function of prolactin (PRL) is to provoke and

maintain female lactation. Pregnancy, sexual intercourse, breast stimulation,
sleep, exercise, stress, estrogen, progesterone and some psychiatric drugs
taking can also make elevated prolactin levels. PRL monitoring can be used
for diagnosis and control the treatment of severe, bacterial infection and
sepsis. PRL Rapid Quantitative Test Cartridge adopts fluorescence
immunoassay technology and is intended for in vitro quantitative
measurement of Prolactin in human whole blood, serum or plasma.

Performance: When sample is added into the sample well of the test, the
fluorescence-labeled detector anti-PRL antibody binds to PRL 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 PRL are captured to anti-PRL antibody that has been immobilized on
test strip. Thus the more PRL antigen is in blood specimen, the more
complexes are accumulated on test strip. Signal intensity of fluorescence of
detector antibody reflects amount of PRL captured and Finecare™ FIA
System shows PRL concentrations in blood specimen. The default results
unit of PRL Rapid Quantitative Test is displayed as XXX ng/mL from
Finecare™ FIA System.

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.