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 Buprenorphine Test (Strip) Tests per Package: 50
Urine Code: 20010-2 Package Format: Strip (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 Buprenorphine Test is a chromatographic immunoassay for the qualitative detection of Buprenorphine (BUP) and BUP metabolites in human urine at the cut-off 10 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 BUP 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 Buprenorphine Test is a competitive immunoassay utilizing highly specific reactions between antibodies and antigens for the detection of BUP and BUP metabolites in human urine.

EASY Line Buprenorphine Test is a rapid urine screening test that utilizes monoclonal antibodies to selectively detect elevated levels of BUP in urine without the of an instrument.

Methylenedioxymethamphetamine (ecstasy) is a designer drug first synthesized in 1914 by a German drug company for the treatment of obesity. Those who take the drug frequently report adverse effects, such as increased muscle tension and sweating. MSMA is not clearly a stimulant, although it has, in common with amphetamine drugs, a capacity to increase blood pressure and heart rate. BUP does produce some perceptual changes in the form of increased sensitivity to light, difficulty in focusing, and blurred vision in some users. Its mechanism of action is thought to be via release of the neurotransmitter serotonin. BUP may also release dopamine, although the general opinion is that this is a secondary effect of the drug (Nichols and Oberlender, 1990). The most pervasive effect of BUP, occurring in virtually all people who took a reasonable dose of the drug, was to produce a clenching of the jaws.

EASY Line Buprenorphine Test is an immunoassay based on the principle of competitive binding. BUP may be present in the urine specimen compete against BUP conjugate for binding sites on its specific antibody.

During testing, a urine specimen migrated upward by capillary action. BUP, 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 BUP-protein conjugate and a visible coloured line will show up in the test line region of the BUP strip. The presence of BUP 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.

BUP-positive urine specimen will not generate a coloured line in the specific test line region of the strip because of BUP 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 50 tests in strip (code 20010-2). 

Individually packed test devices (strip)

50

Number of tests

50

Code

20010-2

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Buprenorphine Test and other commercially available rapid BUP Test. 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

Bup

Buprenorphine

%Agreement with GC/MS

 

BUP

Positive Agreement

95.7%

Negative Agreement

98%

Total Results

96.7%

 %Agreement with commercial kit

 

BUP

Positive Agreement

98.6%

Negative Agreement

99%

Total Results

99.2%

Forty (40) clinical samples for BUP were run using each strip contained within EASY Line Buprenorphine 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, BUP-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:

Buprenorphine conc. (ng/mL)

Total number of Determinations

Result

Precision

No drug present

40

40negative

>99%

5

40

40negative

>99%

7.5

40

40negative

>99%

10

40

40positive

>99%

15

40

40positive

>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

BUP

-

+

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

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 Buprenorphine. The following compounds show no cross-reactivity when tested with BUP Rapid 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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