Cinical considoration and prcfessona!

udgmont should bo appiad to any drug of

abuso lost rosut, particularly when protiminary results are postivo. Positive sults
shou'd be cenfirmed by on stemato mothod such as GCMS
CUALITYCONTROL
1 Each test device has a control band to Ind cate that tho sample volume and
mipration is adequato and that the callcidal gold is dissolving as expected. An
inwalo rosult must bo repoated using a new test device.
2 Positivo and negative, drug free urire controls can ba used to validato raagent
porfarmanco and eslablish test reabilty Comimorcial drug unne controls are
nvailablo, but not provided with this test NIDArecommanded gudelnes or crugs
of abusa scroning indicato controls should contin 0 drug ata lovel ot loss, 20%
abova tho NIDA cuto vaue If control values do notfall ith n the estab ished lmts
assay rosults aro invalid.
EXPECTED RESULTS
Tho Advanced Cuality Naamphotamino Test idantios mesramphetamine and it
mataboltos in human urino at a cutoff cancentaion of 500ngimL The concontraton
o! the drug can no: be determined using this lest Tho test is Intended to sceenurine
to soparato o nogativo result form o prasumpsvo poslbivo rcsul Al positivo resut
rust be contimed using an otemata mobcd, preferaby GCMS.

PERFORMANCE CHARACTERISTICS
The Advanced Qualty Cna Step Methamphe=mino Tost was compared to a
commercially availoblo rocrence screoning method using 230 human urine samples
See Table 1.
Sensltivity
Tho Advanced Quality Ono Step Methamphetamine test is designed for the detection
of Mothamphetamine in human urine 500 ng/mL as suggested for the
imunoassay method Based on the data collected in tthis study, the sensitivity was
142/142 or 1.00
specificity
The Advanced Quaity Ono Step Mathamphotanine tost can specifcaly dotect both
d and Itoms of mothamphetamne and a miture. Tho test has proven posiive win
500 ng-mL or greater concentratons of both Mothamphetamine and
Methylenudovy meth-amphetamine. Using the data presented In Table 1
specificity was calculated to be 133/138 or 1.00.
TABLE 1 Evaluation Summary
AQI+
142
Row Totals
142
138
280
Reference Screen
AO)
133
138
Col. Totals
142
TABLE 2-Compounds which produce a posltive result
Lovel or Concentration
5 uVmL
10 uUmL
500 ngmL
10 ullmL
1 ul/mL
10 ulmL
25 uUmL
50 umL
Compound
d-Amphotamine
4,1-Amphetamine
Mothamphatamine
3,4-Melhylanedioxyamphatamine
e 3,4-Mothytened oxymethamphetamino
Pseudoephedrine
Ephodrine
Phenyl propanolamine (PPA)
TABLE 3 Compounds thal give negativo results
Acetaminophen
Acetilsalicylic Acid
Amikacin
Amltripty no
Meperidina
Methylphenidate
Mathadono
3,4-Methytenodioxyampheta
d-Amphetamine
Ampicillin
Artereno!
Aspartame
Atropine Sulfate
Benzoic Acid
Benzoylecgonine HC
Caffeine
Chlorpheniramine
Chlorpropamazine HC
Cimetidine
-9-THC
11-nor -A-9-carboxy - THC- 9-COoH
Methaqualone
Morphine Glucuronide
Morphine Sulfate
Oxazepanm
Oxycodone
Pendimetrazine
Penicillin G
Pentobarbital
d-Propoxyphene
Hydrochlorothiazide
Deoxyephedrine
Dextromethorphan
Diazepanm
Diethylpropion
Diphenylhydantoin
Doxylamine
Ecgonine HCI
Ecgonine Methyl Ester
Glucose
Histamine
Hydrocodone
Hydromorphone
Indomathacin
Ketoprofen
Levorphanol
Phencyclidine
Phenobarbital
Phentermine
Phenylpropanolamine
L-Phenylephrine
Quinine
Ranitidine
Sodium Salicylate
Tryptophan
Tetracycline
Tetrahydrozoline
Theophyline
Thioridazine
Trifluoperazine

LIMITATIONS OF THE TEST

1.This product is designed to be used for the deteclion of Methamphetamine in human
urine only
2.Although The Advanced Quality One Step Mathamphetamine Test is very accurate
in detecting the level of Methamphetamine in urine, there is a possibility of falso
results due to the presence of interfering substances in the urine
quantitative level of Amphetamine in urine.
specimens, may produce erroneous test results regardless of the analysis method
3.The test is a qualitative screening assay and is not suggested for determining the
4 Adulterants, such as bleach or other strong oxidizing agents, when added to urine
used. If adulteration is suspected, obtain another urine specimen
5.There is the possibility that other substances andfor factors not listed above may
interfere with the test and cause false resuits, e.g. technical or procedural errors