【Product
name】
Prostate
Specific
Antigen
(PSA)
Rapid
Quantitative
Test(Fluorescence
immunoassay)
【Package
specification】
25
Tests/kit
【Intended
use】
This
kit
is
used
for
quantitative
determination
of
PSA
in
human
whole
blood,
plasma
and
serum.
Human
prostate-specific
antigen
(PSA)
is
a
serine
protease,
a
single
chain
glycoprotein
with
a
molecular
weight
of
approximately
34,000
daltons
containing
7%
carbohydrate
by
weight.
In
human
serum,
PSA
exists
in
at
least
3
different
forms:
free,
alpha
1-antichymotrypsin
(PSA-ACT)
and
alpha
2-macroglobulin
(PSA-AMG).
Only
free
PSA
and
PSA-ACT
can
be
detected
with
available
immunoassays.
Elevated
serum
PSA
concentrations
have
been
reported
in
patients
with
prostate
cancer,
benign
prostatic
hypertrophy,
prostatitis
or
inflammatory
conditions
of
other
adjacent
genitourinary
tissues.
Also,
increases
in
PSA
to
4-10
ng/mL
are
not
uncommon
among
men
with
benign
prostatic
hyperplasia
(BPH)
or
prostatitis.
The
determination
of
PSA
serum
levels
is
not
only
important
for
the
screening
of
patients
for
prostate
cancer,
but
also
for
monitoring
patients
that
have
been
treated
for
this
disease.
【Inspection
principle】
The
PSA
Rapid
Test
is
a
one-step
chromatographic
sandwich
immunoassay
designed
for
the
quantitative
measurement
of
PSA.
The
PSA
antigen
in
the
sample
was
first
bound
with
the
conjugated
compound
of
fluorescent
labeled
PSA
monoclonal
antibody,
then
moved
and
combined
with
another
PSA
monoclonal
antibody
fixed
on
the
nitrocellulose
membrane,
and
the
double
antibody
sandwich
complex
was
formed
at
the
detection
line
of
the
cellulose
nitrate
membrane.
The
quantitative
detection
results
were
obtained
by
NIR-1000
dry
fluoroimmunoassay
analyser.
【Components】
Name
Quantity
Component
Test
cards
25
It
is
composed
of
fluorescent
pad
(coated
with
fluorescent
labeled
PSA
monoclonal
mouse
antibody),
nitrocellulose
membrane
(coated
with
PSA
monoclonal
mouse
antibody
and
Goat
anti
mouse
IgG
antibody),
absorbent
paper
and
backing
Sample
diluent
25(300μL/tube)
Phosphate
buffer
ID
card
1
With
specific
stand
curve
file
The
components
in
different
batches
of
kits
cannot
be
used
interchangeably.
【Storage
conditions
and
validity】
The
kit
should
be
stored
at
4℃~30℃,
out
of
direct
sunlight.
It
is
valid
for
18
months.
The
test
card
should
be
used
within
15
minutes
after
unsealing
under
the
environment
of
15℃~30℃
and
20%
~
90%
relative
humidity.
The
production
date,
batch
number
and
expiration
date
are
shown
in
the
outer
package
of
the
product.
【Applicable
instruments】
NIR-1000
dry
fluoroimmunoassay
analyser
produced
by
WWHS
Biotech.
Inc.
【Sample
requirements】
1.
Plasma,
serum
and
whole
blood
can
be
used
as
samples.
The
whole
blood
should
be
collected
in
a
tube
containing
heparin,
citrate
or
EDTA
as
the
anticoagulant.
If
the
serum
procedure
is
used,
collect
blood
in
a
tube
without
anticoagulant
and
allow
clotting.
Hemolyzed
samples
should
not
be
used.
2.
Venous
blood
was
collected
according
to
routine
laboratory
methods
to
avoid
hemolysis.
3.
It
is
highly
recommended
to
use
fresh
samples
instead
of
keeping
the
samples
at
room
temperature
for
a
long
time.
After
samples
were
collected,
the
detection
should
be
completed
within
4
hours
at
room
temperature
(15℃~30℃).
The
whole
blood
sample
can
be
stored
at
2℃~8℃
for
24
hours.
Plasma
and
serum
samples
can
be
stored
at
2℃~
8℃
for
7
days,
-20℃for
30
days.
4.
Before
testing,
the
sample
should
return
to
room
temperature
(15℃~30℃).
The
frozen
samples
should
be
completely
thawed,
rewarming
and
mixed
evenly
before
use.
Repeated
freeze-thaw
cycles
should
be
avoided.
【Procedure】
1.
Before
the
test,
please
read
the
instructions
completely.
If
the
test
card
and
sample
are
stored
in
cold
storage,
they
should
be
balanced
at
room
temperature
(15-30)℃
for
not
less
than
30min
before
use.
2.
Start
NIR-1000
dry
fluoroimmunoassay
analyser
according
to
the
instruction
manual
of
the
instrument,
and
carry
out
quality
control
verification
according
to
the
instruction
manual
of
the
instrument(Note:
the
reagent
has
been
calibrated
in
advance,
and
the
calibration
curve
parameters
of
each
batch
of
reagent
have
been
stored
in
the
information
card.
The
information
card
is
inserted
before
use,
so
it
is
not
necessary
to
calibrate
again,
and
the
test
can
be
carried
out
only
after
the
quality
control
is
passed.
Otherwise,
the
cause
should
be
found
out
before
testing.)
3.
Remove
the
test
card
from
the
aluminum
foil
bag
and
use
it
within
15
minutes.
4.
Place
the
test
card
on
a
clean
horizontal
table
and
mark
it
horizontally.
5.
Mix
100
µL
of
patient
sample
with
300µL
of
sample
diluent.
Apply
100
µL
of
diluted
samples
to
the
well
of
the
test
card.
6.
Insert
the
test
card
into
NIR-1000
dry
fluoroimmunoassay
analyser,
read
and
record
the
results
at
10
minutes
after
addition
of
samples,
then
dispose
of
used
test
appropriately.
【Reference
interval】
Healthy
males
are
expected
to
have
serum
PSA
values
below
4ng/mL.
However,as
PSA
levels
increase
with
age,
the
use
of
age-specific
reference
ranges
has
been
suggested
in
order
to
increase
the
sensitivity
in
younger
men
and
increase
the
specificity
in
older
men.
Each
laboratory
must
establish
its
own
normal
ranges
based
on
the
representative
local
population.
【Interpretation
of
results】
1.
This
reagent
is
only
used
for
auxiliary
detection.
If
the
test
results
are
abnormal,
it
should
be
reviewed
in
time
and
judged
in
combination
with
clinical
symptoms.
2.
For
samples
with
PSA
concentration
lower
than
2ng/ml
and
higher
than
100ng/ml,
the
detection
results
are
reported
as
"<
2ng/ml"
and
">
100ng
/ml",
respectively.
【Limitations
of
methods】
1.
This
kit
is
only
used
to
detect
human
plasma/whole
blood
samples
2.
Due
to
the
limitations
of
immunoassay
methods
of
antigen
and
antibody
reaction,
the
results
cannot
be
used
as
the
only
basis
for
clinical
diagnosis,
but
should
be
evaluated
with
all
the
existing
clinical
and
experimental
data.
3.
The
content
of
triglyceride
in
the
sample
shall
not
exceed
15mg/ml,
the
content
of
hemoglobin
shall
not
exceed
5mg/ml,
and
the
content
of
bilirubin
shall
not
exceed
0.5mg/ml,
and
the
relative
deviation
of
the
test
results
shall
not
exceed
±15%.
4.
When
the
concentration
of
PSA
in
the
sample
is
less
than
20000ng/ml,
there
is
no
hook
effect.
5.
HAMA
effect
was
not
produced
when
the
concentration
of
human
anti
rat
in
the
sample
was
less
than
50ng/ml.
6.
When
RF
concentration
in
the
sample
is
less
than
2000IU/ml,
the
relative
deviation
of
the
test
results
is
within
±15%.
【Performance】
1.
Limits
of
detection
No
more
than
0.5ng
/ml.
2.
Accuracy
The
relative
deviation
from
the
target
value
is
within
±15%.
3.
Precision
The
within
and
between
assay
coefficient
of
variations
are
within
15%.
4.
Linear
range
Within
the
linear
range
(2
~
100ng/ml),
the
linear
correlation
coefficient
R≥0.990.
【Note】
1.
This
kit
is
only
used
for
in
vitro
diagnosis.
2.
The
test
card
and
sample
diluent
are
disposable
and
cannot
be
reused.
3.
Please
check
the
integrity
and
validity
of
the
kit
package
before
use,
and
then
open
the
package.
When
it
is
stored
at
low
temperature,
it
should
be
restored
to
room
temperature
(15℃
~
30℃)
before
opening
the
package
for
use.
The
reagents
with
damaged
inner
package
and
beyond
the
validity
period
cannot
be
used.
4.
The
requirements
of
specimen
collection
and
storage
should
be
strictly
observed.
If
the
specimen
is
turbid,
it
should
be
centrifuged
and
discarded
before
use.
5.
The
used
kits
should
be
treated
as
potential
infectious
substances,
and
all
samples,
reagents
and
potential
pollutants
should
be
disinfected
and
treated
according
to
the
relevant
local
regulations.
Sample
Requirements
1.
Plasma,
serum
and
whole
blood
can
be
used
as
samples.
The
whole
blood
should
be
collected
in
a
tube
containing
heparin,
citrate
or
EDTA
as
the
anticoagulant.
If
the
serum
procedure
is
used,
collect
blood
in
a
tube
without
anticoagulant
and
allow
clotting.
Hemolyzed
samples
should
not
be
used.
2.
Venous
blood
was
collected
according
to
routine
laboratory
methods
to
avoid
hemolysis.
3.
It
is
highly
recommended
to
use
fresh
samples
instead
of
keeping
the
samples
at
room
temperature
for
a
long
time.
After
samples
were
collected,
the
detection
should
be
completed
within
4
hours
at
room
temperature
(15℃~30℃).
The
whole
blood
sample
can
be
stored
at
2℃~8℃
for
24
hours.
Plasma
and
serum
samples
can
be
stored
at
2℃~
8℃
for
7
days,
-20℃for
30
days.
4.
Before
testing,
the
sample
should
return
to
room
temperature
(15℃~30℃).
The
frozen
samples
should
be
completely
thawed,
rewarming
and
mixed
evenly
before
use.
Repeated
freeze-thaw
cycles
should
be
avoided.
Applicable
Instrument
WWHS
NIR-1000
dry
fluoroimmunoassay
analyser
Quality
Control
A
procedural
control
is
included
in
the
test.
A
colored
line
appearing
in
the
control
region
(C)
is
the
internal
procedural
control.
It
confirms
sufficient
specimen
volume
and
correct
procedural
technique.
Control
standards
are
not
supplied
with
this
kit;
however,
it
is
recommended
that
a
positive
control
and
a
negative
control
control
be
tested
as
a
good
laboratory
practice
to
confirm
the
test
procedure
and
to
verify
proper
test
performance.
FAQ:
1.
What
is
the
MOQ?
Generally
if
you
choose
the
different
products,
our
minimum
order
qty.
also
will
be
different.
One
sample
available.
2.
What
about
the
delivery
time?
The
goods
need
7-21
work
days
to
be
made
upon
deposit.
3.
Does
your
product
have
any
warranty?
Yes,
we
offer
6
months
limited
warranty
for
our
products.
Damage
due
to
misuse,
ill
treatment
and
unauthorized
modifications
and
repairs
are
not
covered
by
our
warranty.
4.
What's
your
payment
method?
We
usually
accept
the
payment
methods
include
PayPal,
TT,
and
Western
Union.
50%
deposit
in
advance
and
balance
before
shipping.
Buyer
can
choose
which
payment
ways
that
you
accept.
PayPal
is
most
useful
and
safe,
please
don’t
refuse
PayPal
fee
when
you
choose
PayPal.
5.
What's
your
shipping
method?
We
provide
comprehensive
shipping
methods.
For
small
quantity
orders
we
ship
by
DHL
Air-Express,
or
EMS/TNT/UPS/FEDEX
Express
service,
it
is
safe
and
fast.
For
large
quantity
orders
we
ship
by
Air
transportation
or
sea
transportation,
we
can
also
ship
order
to
buyer’s
cargo
agent
in
China.
