Cod FPO 7.3.1 2/ 10
First Romanian rapid tests manufacturer !
Holding the sample dropper vertically, add 5 drops (0.2 ml) of specimen
“See Now” Amphetamine Strip/Cassette Test
without air bubbles into the sample well .
For strip test, immerse the strip into the urine cup and take out the strip
For in vitro Diagnosis Use
after 10 sec. Lay the strip on a flat, clean, dry, non-absorbent surface
Product Code: SN 7.1
Read the results at 10 minutes. Ensure that the background of the test
area is white before interpreting the result
The “See Now” Amphetamine (AMP) Test is a rapid and convenient
INTERPRETATION OF RESULTS
immunochromatographic in vitro assay. It is intended for the qualitative
detection of the presence of AMP and its metabolites in urine at or above the
cutoff level of 1000 ng/ml. The device is designed for professional use.
This assay provides only a preliminary result. Clinical consideration and
professional judgment should be applied to any drug of abuse test result,
particularly in evaluating a preliminary positive result. To obtain a confirmed
analytical result, a more specific alternate chemical method is needed.
Negative SUMMARY OF THE TEST
control and test regions. This indicates
Amphetamine is central nervous system stimulants that produce alertness,
wakefulness, increased energy, reduced hunger, and an overall feeling of well
being. Amphetamine can be taken orally, intravenously, by smoking or by
nasal inhalation. Large doses of Amphetamine could develop tolerances and
physiological dependency and lead to its abuse. Metabolism occurs in the
No visible band at the control region. Repeat with a new test kit. If test still
liver either by deamination or hydroxylation of the aromatic ring.
fails, please contact the distributor with the
Amphetamine is also excreted in the urine unchanged. Both d and L forms of
Note: A faint line at the test region
The “See Now” AMP Test device contains mouse monoclonal
indicates the drug in sample is near the
anti-amphetamine antibody colloidal gold conjugate pre-dried on a pad.
cut-off level for the test. These samples
AMP-BSA conjugates antigen (on test region) and goat anti mouse IgG (on
control region) are coated and immobilized on a reaction membrane. The
principle of the “See Now” AMP Test is a solid phase, competitive inhibition
immuno-chromatographic assay, in which a chemical y labeled drug (drug
conjugate) competes with the drug that may be present in urine, for limited
STORAGE AND STABILITY
antibody binding sites. When the absorbent pad is soaked with urine, the
The test kit can be stored at temperature
urine will migrate via capillary action toward the test window where the test reaction occurs. A negative specimen produces two distinct color bands, one
(2 to 30°C) in the sealed pouch to the date
in the test zone and one in the control zone. A positive specimen produces
of expiration. The test kit should be kept away from direct sunlight, moisture
only one color band in the control zone. To serve as an internal process
control, a control band was designed to indicate that the test is performed
properly. This control line should always be seen after test is completed.
Absence of a colored control line in the control region is an indication of an
FOR IN VITRO DIAGNOSTIC USE ONLY.
Don’t use it after the expiration date.
SPECIMEN COLLECTIONAND STORAGE
• Urine specimen may be col ected at any time in a clean, dry container
• If specimen cannot be assayed immediately, they can be stored at 2-8°C
for up to 72 hours prior to testing or frozen at –20ºC for longer period of
The “See Now”Amphetamine Urinary Test detects amphetamine and its
metabolites in urine at concentrations equal to or greater than 1000 ng/ml.
• Specimens should be equilibrated to room temperature before testing if
A study was conducted with the “See Now” Amphetamine Urinary Rapid Test
• Urine specimens exhibiting visible precipitates should be filtered,
to determine the cross-reactivity of amphetamine-related compounds with
centrifuged, or allowed to settle so that clear aliquots can be obtained for
Table-I Concentration of Morphine-related compounds showing a positive response approximately equivalent to the Morphine cut off set for the test.
TEST PROCEDURE •
Remove the test device from pouch when ready to perform the
test .Label the test device with patient or control identification
Remove the test device from the sealed pouch by tearing at the notch.
Then place the testing device on a level surface
A separate study was conducted to determine the cross-reactivity of non-Amphetamine related compounds with the test at concentrations much higher than normally found in the urine of people using or abusing them. No cross-reactivity was detected with the substances listed in Table II. Table- II Compounds tested and found not to cross-react with the test at a 1000 µg/ml concentration in urine
The following conditions were found not to interfere with the test.
Accuracy of the “See Now” Amphetamine Urinary Test Device has been evaluated. A total of 80 clinic samples tested (40 negative and 40 positive), This study demonstrated that two assays have an overall of 96.3%.
The precision was determined by replicative assays of both positive and negative urine samples with devices from three different production lots. The resultant data indicated no appreciable inter lot variation when testing both positive and negative samples across three different lots of devices.
PREFERRED DRUG LIST CONVERSION TABLE January 2002 BOLD TYPEFACE indicates product is available at the preferred generic copayment tier. CAPS indicates product is available at the preferred brand copayment tier. NON-PREFERRED DRUG PREFERRED ALTERNATIVE Ranitidine 300mg Cimetidine 800mg Famotidine 40mg Cardiovascular Agents – Calcium Channel Blockers Diltiaz