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Rapid Drug Screen

INTENDED USE

'RAPID DRUG SCREEN™' is a one-step, lateral flow immunoassay for the simultaneous detection of five or eight abused substances in urine (each assay occupies a separate channel). 'RAPID DRUG SCREEN' is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels:

'RAPID DRUG SCREEN' is intended for professional use. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS).

'RAPID DRUG SCREEN' provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas-chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method (1). Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used (2). The 'RAPID DRUG SCREEN', for the eight drugs above, has been categorized as moderately complex under the Clinical Laboratory Improvement Act (CLIA 88).

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SUMMARY AND EXPLANATION

Urine-based screening tests for the detection of drugs of abuse range in complexity from simple immunoassay tests to very complex analytical procedures. Over the years the speed and specificity of immunoassays have made them one of the most accepted methods for screening for drugs of abuse in urine. 'RAPID DRUG SCREEN' utilizes the principle of highly specific reactions between antibodies and antigens for the detection of urinary drugs of abuse. 'RAPID DRUG SCREEN' is a rapid, visual, competitive immunoassay for the simultaneous detection of cocaine, opiates, amphetamines, marijuana, barbiturates, benzodiazepines, methamphetamine and PCP in urine. 'RAPID DRUG SCREEN' has been shown to have sensitivity equal to the cut-offs recommended by Substance Abuse Mental Health Services Administration (SAMHSA). The SAMHSA cut-offs are as follows:

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PRINCIPLES OF THE TEST

All of the assays employed in the 'RAPID DRUG SCREEN' are based on the same principle of the highly specific reaction between antigens and antibodies.

Each assay is a one-step immunoassay in which a specially-labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on an antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the 'test' area. The formation of a visible line in the test area occurs when the test is below the cur-off for the drug.

When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the test area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present in all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

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REAGENTS AND MATERIALS SUPPLIED

Each 'RAPID DRUG SCREEN' kit contains:

1. Directions for use.

2. Test Devices: (20 each) Each plastic device contains 8 independent channels for the complete immunoassay for 8 different drugs. Each channel contains a membrane to which are attached 2 absorbent pads. Each lower pad contains the immobilized colloidal gold-antibody complex. Eight different monoclonal antibodies are utilized.

The test line contains a BSA-drug conjugate for each individual analyte, dried in a thin band onto the membrane. A second band (control), containing an appropriate IgG, is placed above the test line on all 8 membranes.

The uppermost absorbent pad acts as a reservoir for the sample after it migrates through the membrane.

3. Test Cup: (20 each) Each polystrene cup is supplied with 2 caps. One cap is fitted with a slot for the insertion of the test card, and a second cap (not slotted) for transport to a confirmation laboratory, if necessary.

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QUALITY CONTROL

It is good laboratory practice to use quality control materials to ensure proper test performance. Quality control specimens are commercially available. When using these control materials, use the same procedures as with a urine specimen. It is recommended to use quality control specimens which have analyte concentrations 25% greater than cut-off. It is recommended to test each shipment of product upon receipt, every 30 days thereafter and if the product had been stored under conditions outside the manufacturer's recommendations. (3)

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LIMITATIONS OF PROCEDURE

The assay is designed for use with human urine only.

'RAPID DRUG SCREEN' is a presumptive screening test. No clinical action should be taken on the basis of this test alone. All positive results must be confirmed by a more definitive procedure such as GC/MS.

There is a possibility that other substances and/or factors not listed may interfere with the test and cause erroneous results, such as technical or procedural errors. Adulterants, such as bleach, acids, aldehydes, salt, etc., added to urine specimens may produce erroneous results. If adulteration is suspected, obtain a fresh sample and re-test.

Results obtained with 'RAPID DRUG SCREEN' cannot be considered conclusive evidence of the use of opiates, marijuana, cocaine, amphetamines, barbiturates, benzodiazepine, methamphetamine or PCP. All positive results should be analyzed using a procedure that is definitive for determining drugs of abuse, i.e. GC/MS.

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RAISING THE BAR

We have recently implemented several refinements that have served to "raise the bar" of precision and accuracy, resulting in a screen that is at today's cutting edge of detection accuracy. As a byproduct of these improvements you may notice a slight reduction of intensity in the test line (second line), indicating a negative finding. As specified in the package insert, we remind you that any evidence of a second line is to be interpreted as a "negative", regardless of completeness or intensity. We also remind you that the test is to be read within 10 minutes of introduction of the test card into the sample. Also please note that overfilling of the specimen jar (above the blue area on the label) may reduce line intensity.

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PERFORMANCE CHARACTERISTICS

AMPHETAMINE

Specific Performance Characteristics

Sensitivity

'RAPID DRUG SCREEN' for amphetamine will be positive at 1000 ng/ml. Known concentrations of d-amphetamine were added to normal, drug-free urine. Ten (10) determinations were made at each serial dilution of the single analyte. Sensitivity is defined as that concentration which produced positive responses in all 10 replicates. At 1000 ng/ml all 10 replicates produced positive responses.

Twenty determinations were done at each serial dilution of clinical specimens containing d-amphetamine. The d-amphetamine concentration at each dilution was quantitated by GC/MS. All 20 of the specimens containing 1000 ng/ml of d-amphetamine produced positive results.

Accuracy (Method of Comparison)

RDS for amphetamines was compared to a commercially available immunoassay ('microLINE', DSSI, Blackwood, N.J.) at a claimed cut-off of 1000 ng/ml. One hundred fifteen (115) clinically metabolized specimens were evaluated by both systems. Of the 115 samples, 75 drug-free specimens were determined negative and 40 were positive by EMIT II. RDS and 'microLINE' correctly identified 114. GC/MS analysis of the positive samples showed amphetamine concentrations of 279 to 24,133 ng/ml. The one discordant sample (EMIT II positive, RDS negative) contained 279 ng/ml of amphetamine and 585 ng/ml of methamphetamine.

Reproducibility

Three clinically metabolized urine samples with amphetamine concentrations of 0 ng/ml, 1,000 ng/ml, and 1,250 ng/ml, as determined by GC/MS were tested. Each sample was tested three times daily, in duplicate, for five consecutive days using 2 lots of RDS for Amphetamine. Concurrence with GC/MS results were obtained.

Endogenous interference and specificity (cross reactivity) studies.

RDS for Amphetamine detects amphetamine in urine. All of the following compounds were added to normal, drug-free urine:

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PCP (phencyclidine)

Specific Performance Characteristics

Sensitivity

RDS for PCP will be positive at 25 ng/ml. Known concentrations of PCP were added to normal,drug-free urine. Ten determinations at each serial dilution of the single analyte were made. Sensitivity is defined as that concentration which produced positive responses in all 10 replicates. At 25 ng/ml of PCP, all 10 produced positive responses.

Clinically metabolized specimens containing PCP were serially diluted. Each dilution was quanitated by GC/MS. Twenty (20) determinations were made at each dilution. All 20 clinical specimens containing 25 ng/ml of PCP produced positive results.

Accuracy (Method of Comparison)

RDS for PCP was compared to a commercially available immunoassay ('microLINE', DSSI, Blackwood, NJ) at a claimed cut-off of 25 ng/ml. One hundred six (106) clinically metabolized specimens were evaluated by both systems. Of the 106 samples, 75 drug-free specimens were found to be negative and 31 assayed as positive by EMIT II. RDS and 'microLINE' correctly identified the 106 specimens. GC/MS analyses of all positive showed a PCP concentration of 19 to 192 ng/ml.

Reproducibility

Reproducibility studies were carried out using commercially available standards. Each individual standard had been diluted in normal, drug-free urine to give the appropriate concentration. Each sample, at each concentration of analyte, was tested three times daily, in duplicate, for 5 consecutive days using 2 different lots of RDS.

PCP

conc. (ng/ml)	#	Results	Precision
0	60	60 neg	>99%
25	60	60 pos	>99%
34	60	60 pos	>99%

Endogenous interference and specificity (cross reactivity) studies.

RDS for PCP also detects high concentrations of the cough suppressant, dextromethorphan. In young children, dextromethorphan overdoses may produce positive results with RDS. However, adults ingesting therapeutic dosages of dextromethorphan should not produce a positive result withy RDS.

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COCAINE (Benzoylecgonine)

Specific performance characteristics

Sensitivity

RDS will be positive for benzoylecgonine at 300 ng/ml. Known concentrations of benzoylecgonine were added to normal, drug-free urine. Ten (10) determinations were done at each serial dilution of the single analyte. Sensitivity is defined as that concentration of benzoylecgonine which produced positive results in all replicates. At 300 ng/ml of benzoyl ecognine, all 10 replicates produced positive results.

Clinically metabolized specimens containing benzoylecgonine were serially diluted. Twenty (20) determinations were made at serial dilution of these clinical specimens. Benzoylecgonine concentration was quantitated by GC/MS. All 20 clinical specimens containing more than 250 ng/ml produced positive results.

Accuracy (Method of Comparison)

RDS for cocaine was compared to a commercially available immunoassay ('microLINE, DSSL, Blackwood, N.J.) for cocaine at a claimed cut-off of 300 ng/ml. One hundred fifteen (115) clinically metabolized specimens were evaluated by both systems. Of the 115 specimens, 75 were found to be drug-free and 40 were determined as positive by EMIT II. RDS and microLINE correctly identified all of the drug-free and all of the positive specimens. GC/MS analysis of the positive samples showed benzoylecgonine concentrations of 249 to >1,000,000 ng/ml.

Reproducibility

Reproducibility studies were carried out using commercially available standards. Each individual standard had been diluted in normal, drug-free urine to give the appropriate concentration. Each sample, at each concentration of analyte, was tested three times daily, in duplicate, for five days using 2 lots of RDS. Concurrence with GC/MS results were obtained.

Benzoylecgonine (Cocaine)

conc. (ng/ml)	#	Results	Precision
0	60	60 neg	>99%
300	60	60 pos	>99%
375	60	60 pos	>99%

Endogenous interference and specificity (cross reactivity) studies.

RDS for cocaine detects benzoylecgonine in urine. All of the following compounds were added to normal, drug-free urine.

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THC (cannabinoids)

Specific Performance Characteristics

Sensitivity

RDS for THC will detect 38-50 ng/ml. Known concentrations of 11-nor-9carboxy-delta-9-THC were added to normal, drug-free urine. Ten (10) determinations were made at each serial dilution of this single analyte. Sensitivity is defined as that concentration of 11-nor-9-carboxy-delta-9-THC which produced positive results in all 10 replicates. At 50 ng/ml of 11-nor-9-carboxy-delta-9-THC, all 10 produced positive results.

Clinically metabolized specimens containing only 11-nor-9-carboxy-delta-9-THC were serially diluted. Twenty (20) determinations were done at each serial dilution. The concentration of 11-nor-9-carboxy-delta-9-THC was quantitated by GC/MS. All clinical specimens containing 50 ng/ml, gave positive results.

Accuracy (Method of Comparison)

RDS for cannabinoids (THC) was compared to a commercially available immunoassay ('microLINE', DSSL, Blackwood, N.J.) at a claimed cut-off 50 ng/ml. One hundred fifteen (115) clinical specimens were evaluated by both systems. Of the 115 samples, 75 were found to be drug-free and 40 tested as positive by EMIT II. RDS correctly identified 74 samples as drug-free. The 1 disparate sample, EMIT II negative and RDS positive, was shown by GC/MS to contain 7 ng/ml of THC. 'microLINE' correctly identified all 75 samples as negative. GC/MS analyses of the 40 positive specimens showed THC concentrations of 39 to 620 ng/ml. All 40 specimens were found to be positive by both RDS and 'microLINE'.

Reproducibility

Reproducibility studies were carried out using commercially available standards. Each individual standard had been diluted in normal, drug-free urine to give the appropriate concentration. Each sample, at each concentration of analyte, was tested three times daily, in duplicate, for 5 days. Concurrence with GC/MS results were obtained.

THC

conc. (ng/ml)	#	Results	Precision
0	60	60 neg	>99%
50	60	60 pos	>99%
75	60	60 pos	>99%

Endogenous interference and specificity (cross reactivity) studies.

RDS for THC detects marijuana metabolites in urine. All of the following compounds were added to normal, drug-free urine.

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OPIATES

Specific Performance Characteristics

Sensitivity

RDS for opiates will detect opiates and opiate metabolites at 300 ng/ml. Known concentrations of morphine-3-glucuronide were added to normal, drug-free urine. Ten (10) determinations were made at each serial dilution of this single analyte. Sensitivity is defined as that concentration of morphine-3-glucuronide which produced positive responses in all 10 replicates. At a concentration of 300 ng/ml of morphine-3-glucuronide, all 10 replicates were positive.

Clinically metabolized specimens containing only morphine were diluted. Twenty (20) determinations were done at each dilution. The concentration of morphine was quantitated by GC/MS. All 20 clinical specimens at 300 ng/ml of morphine produced positive results.

Accuracy (Method of Comparison)

RDS for opiates was compared to a commercially available immunosassay ('microLINE', DSSI, Blackwood, N.J.) at the claimed cut-off of 300 ng/ml. One hundred fifteen (115) clinical specimens were evaluated by both systems. Of the 115 specimens, 75 were found to be drug-free and 40 were positive by EMIT II. RDS and 'microLINE' correctly identified all of the positive and all of the drug-free samples as negative. GC/MS analyses of the 40 positive specimens were shown to contain morphine in concentrations of 353 to >48,000 ng/ml.

Reproducibility

Reproducibility studies were carried out using a commercially available standard. Each individual standard had been diluted in normal, drug-free urine to give the appropriate concentration. Each sample, at each concentration of analyte, was tested three times daily in duplicate for 5 consecutive days. Concurrence with GC/MS results were obtained.

Opiates

conc. (ng/ml)	#	Results	Precision
0	60	60 neg	>99%
300	60	60 pos	>99%
375	60	60 pos	>99%

Endogenous interference and specificity (cross reactivity) studies

RDS for opiates detects morphine and morphine glucuronide in urine. All of the following compounds were added to normal, drug-free urine.

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BENZODIAZEPINE

Specific Performance Characteristics

Sensitivity

'Rapid Drug Screen' for benzodiazepine will be positeve at 300 ng/ml. Known concentrations of oxazepam were added to normal drug-free urine. Ten (10) determinations were made at each dilution of the single analyte. At 300 ng/ml all 10 replicates produced positive responses.

Accuracy (Method of Comparison)

This benzodiazepine assay was compared to a commercially available immunoassay system for benzodiazepines at a cut off of 300 ng/ml for oxazepam. One hundred fifty clinical samples were evaluated by both systems. Both tests identified 74 specimens as positive and 74 specimens as negative. However, RDS showed 2 samples as positive, which the predicate method had determined to have benzodiazepine below the cutoff. These samples were shown by GC/MS to contain 442 ng/ml and 229 ng/ml oxazepam.

Reproducibility

Reproducibility was determined using 3 concentrations levels of oxazepam, 100 ng/ml, 300 ng/ml and 360 ng/ml. These samples were tested for a period of 5 consecutive days using 3 different lots of product. The data shows>99% precision for within run (n=5), within day (n=6), and day to day (n=115) at each concentration.

Endogenous interference and specificity (cross reactivity) studies

'Rapid Drug Screen' for benzodiazepines detects benzodiazepines in urine. All of the following compounds were added to normal drug-free urine.

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BARBITURATES

Specific Performance Characteristics

Sensitivity

The preferred method for confirming the presence or absence of barbiturates in urine is GC/MS. GC/MS specifically detects both the parent compounds or metabolites as an indication of barbiturate use.

No immunoassay that produces a single response in relation to the presence of multiple components in a mixture can reliably quantitate the concentration of these components. 'Rapid Drug Screen' barbiturate test detects several barbiturates. Attempts to establish semi-quantitative concentrations with 'Rapid Drug Screen' are not recommended. The sensitivity of this test to detect barbiturates is at an average concentration of 300 ng/ml.

Accuracy (Method of Comparison)

'Rapid Drug Screen' for barbiturates was compared to a commercially available immunoassay (Syva EMIT II) for barbiturates at a cutoff of 300 ng/ml and the GC/MS method. One hundred forty clinically metabolized samples were evaluated by the the three assay systems. Of the 140 samples, 101 were determined to be negative i.e. contain barbiturate concentrations below the cutoff by EMIT II and GC/MS, while 'Rapid Drug Screen' reported one false positive. All remaining 39 specimens were determined to be positive by EMIT II, GC/MS, and 'Rapid Drug Screen'.

Reproducibility

Three samples with barbiturate (secobarbital) concentrations of 0 ng/ml, 225 ng/ml and 375 ng/ml as determined by GC/MS were tested twice daily, in duplicate, for 5 consecutive days using 'Rapid Drug Screen'. Concurrence with GC/MS results were obtained.

Endogenous interference and specificity (cross reactivity) studies

'Rapid Drug Screen' Barbiturate Test detects barbiturate in urine.

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METHAMPHETAMINE

Specific Performance Characteristics

Sensitivity

'Rapid Drug Screen' Methamphetamine Test detects methamphetamine and all major metabolites of methamphetamine in urine at 1000 ng/ml.

Accuracy (Method of Comparison)

Four hundred fifty four (454) clinically metabolized specimens were tested with RDS Methamphetamine Test and Syva EMIT II. The 256 specimens which contained Methamphetamines below the cutoff tested negative with both systems. Of the 1998 positive specimens as reported by EMIT II, 'Rapid Drug Screen' detected 193. When compared to EMIT II, the relative sensitivity was 97.7%. The relative specificity was 100%. The concordance of the combined data was 98.68%.

Reproducibility

Reproducibility was determined by replicate assays of 3 different patient urine specimens with kits from 3 different production lots. The resultant data indicated 100% precision for the duplicates within each lot and no appreciable inter-lot variation when testing both positive and negative spiked samples across 3 different lots of product.

Endogenous interference and specificity (cross reactivity) studies

'Rapid Drug Screen' Methamphetamine Test detects methamphetamine in urine.

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The following compounds are not detected by RDS at concentrations greater than 100,000 ng/ml:

Acetaminophen
acetyl salicylic acid
amikacin
aspartame
benzoic acid
butacaine
caffeine
camphor
chlorpheniramine
choroquine
cortisone
(-)-dioxyephedrine
diphenhydramine
digitoxin
ecognine
ecognine methylester
(-)-ephedrine
gentisic acid
guaiacol
hippuric acid
indomethacin
ketoprophen
methadone
methylenedioxyethylamine (MDEA)
phenethylamine
phenylpropanol
phenteramine
propanolol
propoxyphenl
pseudoephedrine
quinine
thorazine
urea
uric acid

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Bibliography

1. Urine testing for Drugs of Abuse, National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986.

2. R.C. Baselt, Disposition of Toxic Drugs and Chemicals in Mar, 2nd Ed., Biomedical Publications, Davis Ca., 1982.

3. Federal Register, Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Program, 59, 110 29918-29931 (1994)

Any express or implied warranty offered by American Bio Medical Corporation is contingent upon observance of its published directions with respect to the use of American Bio Medical's diagnostic products. Under no circumstances will American Bio Medica Corporation be liable for any indirect or consequential damages.