Amphetamines Assay - Beckman Coulter

 Amphetamines Assay

August 2010

9C052.5D_C

Catalog Number

Product Description

Quantity/ Volume

OSR9C229

9A509UL 9A529UL 9A549UL 9A569UL 9A609UL

Emit ? II Plus Amphetamines Assay OSR9C618 R1 (Antibody/Substrate Reagent 1)

OSR9C648 R2 (Enzyme Reagent 2)

Emit ? Calibrator/Control Level 0* Emit ? Calibrator/Control Level 1 (300)* Emit ? Calibrator/Control Level 2 (500)* Emit ? Calibrator/Control Level 3 (1000)* Emit ? Calibrator/Control Level 5 (2000)*

2 x 33 mL

2 x 16 mL

1 x 14 mL 1 x 14 mL 1 x 14 mL 1 x 14 mL 1 x 14 mL

*Required for calibrating the Emit ? II Plus Amphetamines Assay. Sold separately. To determine the appropriate calibrators required for use, see Table 1.

Note: Reagents and calibrators/controls are shipped ready to use in liquid form. No reconstitution is required.

Note: Reagents 1 and 2 are provided as a matched set. They should not be interchanged with components of kits with different lot numbers.

Note: These reagents are qualified for use with these calibrators only. However, other material may be used for quality control purposes.

Table 1 -- Emit ? Calibrators/Controls for Use in Qualitative or Semiquantitative Analysis

Qualitative Analysis

Semiquantitative Analysis

Desired Cutoff Level

(ng/mL)

Required Concentration of

Cal/Control d-methamphetamine

Level

(ng/mL)

Required Concentration of

Cal/Control d-methamphetamine

Level

(ng/mL)

300 500 1000

Level 0 Level 1 Level 5

Level 0 Level 2 Level 5

Level 0 Level 3 Level 5

0 300 2000

0 500 2000

0 1000 2000

Level 0 Level 1 Level 2 Level 3

Level 0 Level 1 Level 2 Level 3 Level 5

0 300 500 1000

0 300 500 1000 2000

Note: The Emit ? Calibrators/Controls contain the stated concentration of d-methamphetamine listed in Table 1. For any individual cutoff listed, a calibrator/control is used either as a calibrator or as a control when the assay is used for qualitative analysis. When a calibrator/control is used as a calibrator for an individual cutoff level, the other level calibrator/control (above or below it, as listed above) are used as controls. See the Emit ? Calibrator/Control instructions for use.

1 INTENDED USE

The Emit ? II Plus Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL, 500 ng/mL or 1000 ng/mL cutoff (SAMHSA initial test cutoff level).1 The assay is intended for use in the qualitative and semi-quantitative analyses of amphetamines in human urine. These reagents are packaged specifically for use on a variety of AU? Clinical Chemistry Systems.

The Emit ? II Plus Amphetamines Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.2 Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

2 SUMMARY

Amphetamines are central nervous system stimulants that produce wakefulness, alertness, increased energy, reduced hunger, and an overall feeling of well being. The term "amphetamines" refers to a group of drugs that includes d-amphetamine, d-methamphetamine (N-methyl derivative of amphetamine), d,l-amphetamine, methylenedioxyamphetamine (MDA) and methylenedioxymethamphetamine (MDMA).3 Amphetamines can be inhaled, taken orally, intravenously, or by smoking.3

Amphetamines are readily absorbed from the gastrointestinal tract and are then either deactivated by the liver or excreted unchanged in the urine. The relative importance of these elimination modes depends on urinary pH. Amphetamine is metabolized to deaminated (hippuric and benzoic acids) and hydroxylated metabolites. Methamphetamine is partially metabolized to amphetamine, its major active metabolite.3

Amphetamines appear in urine within three hours after any type of administration4 and can be detected by this Emit? assay for as long as 24?48 hours after the last dose.2 The Emit ? II Plus Amphetamines Assay detects both d-amphetamine and d-methamphetamine. The assay also detects d,l-amphetamine, d,l-methamphetamine, l-amphetamine, l-methamphetamine, methylenedioxyamphetamine (MDA), methylenedioxymethamphetamine (MDMA) and methylenedioxyethylamphetamine (MDEA) in human urine (see Table 14). The assay contains monoclonal antibodies and is therefore less subject to interferences from amphetamine-like compounds than assays containing polyclonal antibodies. While interferences are reduced with this assay, like any immunological test, some interfering compounds do exist. For this reason, confirmation of preliminary positive results is always recommended.

Methods historically used for detecting amphetamines in biological fluids include liquid chromatography, gas-liquid chromatography, fluorometry, and enzyme immunoassay.5

While confirmation techniques other than GC/MS may be adequate for some drugs of abuse, GC/MS is generally accepted as a vigorous confirmation technique for all drugs, since it provides the best level of confidence in the result.2

3 METHODOLOGY

The Emit? II Plus Amphetamines Assay is a homogeneous enzyme immunoassay technique used for the analysis of specific compounds in human urine.6 The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

4 REAGENTS

Reagents contain the following substances:

Mouse monoclonal antibodies to d-amphetamine (61 ?g/mL) and d-methamphetamine (10 ?g/mL), glucose-6-phosphate (5.5 mM), nicotinamide adenine dinucleotide (3.5 mM), bovine serum albumin, amphetamines labeled with bacterial G6PDH (0.72 U/mL), Tris buffer, preservatives and stabilizers.

Precautions ? For in vitro diagnostic use

? Reagent 1 contains nonsterile mouse antibodies.

? Reagents 1 and 2 contain nonsterile bovine serum albumin.

? Do not use after expiration date.

? Turbid or yellow reagents may indicate contamination or degradation and must be discarded.

? Contains sodium azide ( ................
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