The free PSA assay is an enzyme-linked immunosorbent assay (ELISA)
for the in vitro quantitative determination of free
prostate-specific antigen (fPSA) in human serum.
Summary
PSA is a 32 kDa single chain glycoprotein serine protease with a
chymotrypsin like speci city produced by the secretory epithelium
of the prostate gland.1 PSA is normally secreted into the seminal
uid and plays a functional role in the cleavage of the seminal
vesicle proteins and the liquefaction of the seminal coagulum.2
Only low levels of PSA are normally present in the blood stream,
and increasing serum concentrations indicate prostatic pathology,
including benign prostatic hyperplasia and cancer of the prostate.
Determination of PSA is now widely used for detection and
management of patients with prostatic cancer and considered as the
superior serological marker for cancer of the prostate.3 PSA has
been shown to form stable complexes with different antiproteases
and the dominating portion of PSA in patient serum occurs in
complex with α1- antichymotrypsin (PSA-ACT).4 However there are
large variations in the relation between Free PSA and PSA ACT
complex between different individuals. A number of studies have
found that the proportion of Free PSA is higher in benign prostatic
disease as compared to prostatic cancer.4,5 The Free PSA EIA is an
assay for specific determination of Free PSA without cross
reactivity with PSA- ACT complex.6
Test principle
Sandwich principle.
Total duration of assay: 80 minutes. • Sample, PSA-specific
antibody coated microwells and enzyme labeled Anti-Free PSA
monoclonal antibody are combined. • During the incubation, Free PSA
presents in the sample is allowed to react simultaneously with the
two antibodies, resulting in the Free PSA molecules being
sandwiched between the solid phase and enzyme-linked antibodies. •
After washing, a complex is generated between the solid phase, the
Free PSA within the sample and enzyme-linked antibodies by
immunological reactions. • Substrate solution is then added and
catalyzed by this complex, resulting in a chromogenic reaction. The
resulting chromogenic reaction is measured as absorbance. • The
absorbance is proportional to the amount of Free PSA in the sample.
Biovantion Inc is independent from international department of
Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro
diagnostic reagents manufacturer engaged in the research,
development, production, and focus on clinical testing for
infectious diseases, such as Hepatitis virus, Noro virus, Parvo
virus test kits, our products include rapid test cassette and Elisa
kits.
All our products have been registered in National Medical Products
Administration of China, in year 2020 we get Certificate of ISO
13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from
SGS. More importantly, we have awarded the registration certificate
from National Medical Products Administration for Diagnostic Kit
for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during
the outbreak in China, and also we developed COVID-19 Antigen test
; Neutralizing Antibody Test, these products selling well all
overthe world
