A prostate-specific antigen (PSA) enzyme-linked immunosorbent assay (ELISA) is
a research-only kit that measures the amount of PSA in human serum. The assay is a two-step "sandwich" type assay that uses a
hyperimmune antiserum produced in rabbits.The antiserum is conjugated with horseradish peroxidase and reacts
with the test sample, a monoclonal anti-PSA-HRP conjugate, and a
TMB reagent to develop a blue color. The color intensity is
proportional to the PSA concentration in the sample, and a standard
curve is used to plot the results.
The PSA ELISA test is highly sensitive and specific, and has been
shown to be an efficient method for identifying semen in forensic
casework.The anti-PSA IgG in the test does not cross-react with saliva,
normal blood, female urine, vaginal fluid, or menstrual blood.However, blood samples may occasionally show a non-specific
cross-reaction caused by rheumatoid factors or other heterophilic
antibodies.
The normal range for PSA scores depends on age:
Men in their 40s and 50s
A score greater than 2.5 ng/ml is considered abnormal, with a
median of 0.6 to 0.7 ng/ml
Men in their 60s
A score greater than 4.0 ng/ml is considered abnormal, with a
normal range of 1.0 to 1.5 ng/ml
However, some individuals with PSA levels below 4.0 ng/mL have
prostate cancer, and many with higher levels between 4 and 10 ng/mL
do not. PSA levels can also fluctuate due to various factors.
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