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™ AMH Rapid Quantitative Test

Catalog No: W257P0001
LOT. NO.： F2571510DA
EXP. ： 2024/08/04
Characterization: The Anti-mullerian hormone (AMH) Rapid Quantitative Test along with FIA
System is a fluorescence immunoassay quantitative determination of AMH
level in human whole blood, serum or plasma. Results are used to assess
ovarian reserve function, predict ovarian reactivity and assist in the
diagnosis of polycystic ovary syndrome(PCOS).

Performance: The AMH Rapid Quantitative Test is based on fluorescence immunoassay

technology to quantitatively determine the concentration of AMH in whole
blood, serum or plasma. Add the sample into the sample dilution solution
and mixed. Then add the mixed sample into sample hole of the test
cartridge, it will be combined with the fluorescent labeled AMH antibody on
the marking pad to form reaction complexs. As the complexes migrate on
the nitrocellulose matrix by capillary action, it can be captured by AMH
antibodies that have been immobilized on the detection line of
nitrocellulose membrane. The more AMH in the sample, the more
complexs are accumulated on the detection line, and the signal strength of
fluorescence antibodies reflected the number of objects to be measured.
Signal intensity of detector AMH antibodies reflect the amount of antigens
and are processed in the FIA System to determine the AMH concentration
in blood.

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.