Principle:
The DOA Test Device is an immunoassay
based on the principle of competitive
binding. The drug of abuse which may
be present in the urine specimen compete
against the drug conjugate for binding
sites on the antibody.
During testing, a urine specimen migrates
upward by capillary action. The drug
of abuse, if present in the urine
specimen below the cutoff value, will
not saturate the binding sites of
antibody coated particles in the test
device. The antibody coated particles
will then be captured by immobilized
the drug conjugate and a visible colored
line will show up in the test line
zone. The colored line will not form
in the test line zone if the drug
of abuse level is at or above the
cutoff value because it will saturate
all the binding sites of antibodies.
To serve as a procedural control,
a colored line will always appear
at the control line zone if the test
has been performed properly.
Interpretation
of Results:
Positive:
One purple-pink line appears in the
control line zone (C). No line appears
in the test line zone (T). This positive
result indicates that the drug of
abuse concentration is at or above
the detectable level (cutoff value).
Negative:
Two lines appear. One purple-pink
line should be in the control line
zone (C), and another apparent purple-pink
or pink line should be in the test
line zone (T). This negative result
indicates that the drug of abuse concentration
is below the detectable level (cutoff
value).
Invalid:
Control line fails to appear. Insufficient
specimen volume or incorrect procedure
techniques are the most likely reasons
for control line failure. Review the
procedure and repeat the test using
a new test device. If the problem
persists, discontinue using the device
immediately and contact your local
distributor.
Note:
The shade of purple-pink in the Test
line zone (T) will vary, but it should
be considered negative whenever there
is even a faint pink line.
Drug of abuse:
Methamphetamine |
Cutoff
value: |
500
ng/mL |
Morphine |
Cutoff
value: |
300
ng/mL |
THC |
Cutoff
value: |
50
ng/mL |
Cocaine |
Cutoff
value: |
300
ng/mL |
Methamphetamine/Morphine |
Cutoff
value: |
500
ng/mL 300 ng/mL |
Methamphetamine/THC |
Cutoff
value: |
500
ng/mL 50 ng/mL |
|