IVD SYSTEMS & AUTOMATED CLINICAL DIAGNOSTIC ANALYSERS
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EASY Line

New Line for Rapid Diagnostic Tests

Rapid Test Product Information & Purchase Order

Method & Sample Line Product Package Info
Drug of Abuse EASY Line EASY Line Amphetamine Test (Cassette) Tests per Package: 30
Urine Code: 20002-1 Package Format: Cassette (3mm)
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  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

Please pay attention to the revision of the document that must be the same as the revision reported in the box label.
In case of discrepancy please contact our Customer Care e-mail: info@adaltis.net.

* Other document related to the product available at Documentation Centre and it is accessible for Adaltis distributors/partners after registration only.

EASY Line Amphetamine Test is a chromatographic immunoassay for the qualitative detection of Amphetamine (AMP) and AMP metabolites in human urine at the cut-off 1000 ng/mL concentrations. This assay provides only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to AMP test result, particularly when preliminary positive results are obtained. This one step test is very sensitive and only takes about 5 minutes.

Test results are read visually without any instrument. For “in vitro” diagnostic use only.

EASY Line Amphetamine Test is a competitive immunoassay utilizing highly specific reactions between antibodies and antigens for the detection of AMP and AMP metabolites in human urine.

EASY Line Amphetamine Test is a rapid urine screening test that utilizes monoclonal antibodies to selectively detect elevated levels of AMP in urine without  instrument.

Amphetamine is a Schedulecontrolled substance available by prescription (Dexedrine®) and is also available on the illicit market. Amphetamines are a class of potent sympathomimetic agents with therapeutic applications. They are chemically related to the human body’s natural catecholamines: epinephrine and norepinephrine. Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power. Cardiovascular responses to Amphetamines include increased blood pressure and cardiac arrhythmias. More acute responses produce anxiety, paranoia, hallucinations, and psychotic behaviour. The effects of Amphetamines generally last 2-4 hours following use, and the drug has a half-life of 4-24 hours in the body. About 30% of Amphetamines are excreted in the urine in unchanged form, with the remainder as hydroxylated and deaminated derivatives.

The Multiple Drugs of Abuse Rapid Test yields a positive result when Amphetamines in urine exceed 1.000 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).

EASY Line Amphetamine Test is an immunoassay based on the principle of competitive binding.

AMP may be present in the urine specimen compete against AMP conjugate for binding sites on it’s specific antibody.

During testing, a urine specimen migrated upward by capillary action. AMP, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with AMP-protein conjugate and a visible coloured line will show up in the test line region of the AMP strip. The presence of AMP above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the coloured line will not from in the test line region.

AMP-positive urine specimen will not generate a coloured line in the specific test line region of the strip because of AMP competition, while negative urine specimen will generate a line in the test line region because of the absence of drug competition.

To serve as a procedural control, a coloured line will always appear at the control line region, including that proper volume of specimen has been added and membrane wicking has occurred.

The kit contains reagents for 30 tests in cassette (code 20002-1).

Individually packed test devices (cassette)

30

Number of tests

30

Code

20002-1

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Amphetamine Test and other commercially available rapid drug tests. Testing was performed on 120 samples per drug type. All the presumptive positive and negative results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested.

Test

Compounds Contributed to the Totals of GC/MS

AMP

Amphetamine

%Agreement with GC/MS

 

AMP

Positive Agreement

98%

Negative Agreement

100%

Total Results

99%

%Agreement with commercial kit

 

AMP

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

Forty (40) clinical samples for AMP were run using each strip contained within EASY Line Amphetamine Test by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the untrained operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

*Note: TCA was based on HPLC data.

Reproducibility

Reproducibility studies were carried out using commercially available standards. Each standard was diluted in normal, AMP-free urine to give the appropriate concentration. Each specimen, at each concentration of analyte, was tested four times daily, in duplicate, for five consecutive days. A total of 40 determinations were made at each concentration. The results are given below:

Amphetamine conc.(ng/mL)

Total number of Determinations

Result

Precision

No drug present

40

40 negative

>99%

500

40

40 negative

>99%

750

40

40 negative

>99%

1000

40

40 positive

>99%

1500

40

40 positive

>99%

Analytical Sensitivity

A drug-free urine pool was spiked with drugs at concentrations listed. The results are summarized below.

Drug concentration Cut-off Range

n

AMP

-

+

0%Cut-off

10

10

0

-50%Cut-off

10

10

0

-25%Cut-off

10

10

0

Cut-off

10

0

10

+25%Cut-off

10

0

10

+50%Cut-off

10

0

10

Analytical Specificity

The following table lists the concentration of compounds (ng/mL) that were detected positive in urine by AMP Rapid Test at a read time of 5 minutes

d-amphetamine

1,000

D,1-amphetamine

1,000

1-amphetamine

20,000

Phentermine

1,250

(+/-)-Methylenedioxyamphetamine (MDMA)

1,500

Cross-Reactivity

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or drug positive urine containing Amphetamine. The following compounds show no cross-reactivity when tested with EASY Line Amphetamine Test at concentrations of 100 µg/mL

Non Cross-Reacting Compound

*Parent compound only; metabolizes into amphetamine and methamphetamine in the body.

Acetaminophen

Ketamine

Acetophenetidin

Ketoprofen

N-Acetylprocainamide

Labetalol

Acetylsalicylic acid

Loperamide

Aminopyrine

Meperidine

Amoxicillin

Meprobamate

Ampicillin

Methoxyphenamine

L-Ascorbic acid

Methylphenidate

Apomorphine

Naloxone

Aspartame

Naltrexone

Atropine

Naproxen

Benzilic acid

Niacinamide

Benzoic acid

Nifedipine

Benzphetamine*

D-Norpropoxyphene

Bilirubin

Noscapine

D/L-Brompheniramine

D/L-Octopamine

Caffeine

Oxalic acid

Cannabidol

Oxymetazoline

Chloralhydrate

Papaverine

Chloramphenicol

Penilillin-G

Chlorothiazide

Pentazocine hydrochloride

D/L-Chloropheniramine

Perphenazine

Chlorpromazine

Phenelzine

Chloroquine

Trans-2-phenylcyclo-prophlamine hydrochloride

Chloesterol

L-Phenylephrine

Clonidine

β-Phenylephrine

Cortisone

Phenylpropanolamine

L-Cotinine

Prednisolone

Creatinine

Prednisone

Deoxycorticosterone

D/L-Propranolol

Dextromethorphan

D-Propoxyphene

Diclofenac

D-Pseudoephedrine

Diflunisal

Quinine

Digoxin

Quindine

Diphenhydramine

Ranitidine

Ecgonine methyl ester

Salicylic acid

L-ψ-Ephedrine

Serotonin

b-Estradiol

Sulfamethazine

Estrone-3-sulfate

Sulindac

Ethyl-p-aminobenzoate

Teracycline

[1R,2S](-) Ephedrine

Tetrahydrocortisone 3-acetate

L(-)-Epinephrine

Tetrahydrocortisone 3 (b-D-glucuronide)

Erythromycin

Tetrahydroaoline

Fenoprofen

Thiamine

Fruosemide

Thioridazine

Gentisic acid

D/L-Tyrosine

Hemoglobin

Tolbutamide

Hydralazine

Triamterene

Hydrochlorothiazide

Trifluoperazine

Hydrocortisone

Trimethoprim

O-Hydroxyhippuric acid

Tryptamine

p-Hydroxyamphetamine

D/L-Tryptophan

p-Hydroxytyramine

Tyramine

Ibuprofen

Uric acid

Iproniazid

Verapamil

D/L-lsoproterenol

Zomepirac

Isoxsuprine

 

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