AMP-COC-MET-THC-OPI Panel Test

                                                       One Step Drug Screen Test Card

【Package Insert for Multi Drug Screen Test Cards】

 

This Instruction Sheet is for testing of any combination of Amphetamine, Cocaine, Marijuana, Methamphetamine, Opiates.

 

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

For healthcare professionals including professionals at point of care sites.

 

For in vitro diagnostic use only.

INTENDED USE

The One Step Drug Screen Test Card is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations:

Test	Calibrator	Cut-off
Amphetamine (AMP)	D-Amphetamine	500 ng/mL
Cocaine (COC)	Benzoylecgonine	150 ng/mL
Marijuana (THC)	11-nor-Δ9-THC-9 COOH	50 ng/Ml
Methamphetamine (MET)	D-Methamphetamine	500 ng/mL
Opiates ( OPI )	Opiates	2000 ng/mL

 

The configurations of the One Step Multi-Drug Screen Test Card come with any combination of the above listed drug analytes. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

SUMMARY

The One Step Drug Screen Test Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of specific drugs in urine.

AMPHETAMINE (AMP)

Amphetamine is a Schedule II controlled 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 behavior. 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 One Step Drug Screen Test Card yields a positive result when Amphetamines in urine exceed 500 ng/mL.

COCAINE (COC)

Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic. Initially, it brings about extreme energy and restlessness while gradually resulting in tremors, over-sensitivity and spasms. In large amounts, cocaine causes fever, unresponsiveness, and difficulty in breathing and unconsciousness.

Cocaine is often self-administered by nasal inhalation, intravenous injection and free-base smoking. It is excreted in the urine in a short time primarily as Benzoylecgonine^1,2. Benzoylecgonine, a major metabolite of cocaine, has a longer biological half-life (5-8 hours) than cocaine (0.5-1.5 hours), and can generally be detected for 24-48 hours after cocaine exposure².

The One Step Drug Screen Test Card yields a positive result when the cocaine metabolite in urine exceeds 150 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).

MARIJUANA (THC)

THC (D⁹--tetrahydrocannabinol) is the primary active ingredient in cannabinoids (marijuana). When smoked or orally administered, it produces euphoric effects. Users have impaired short term memory and slowed learning. They may also experience transient episodes of confusion and anxiety. Long term relatively heavy use may be associated with behavioral disorders. The peak effect of smoking marijuana occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette. Elevated levels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days after smoking. The main metabolite excreted in the urine is 11-nor-D⁹-tetrahydrocannabinol-9-carboxylic acid (D⁹-THC-COOH).

The One Step Drug Screen Test Card yields a positive result when the concentration of marijuana in urine exceeds 50 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA). ³

METHAMPHETAMINE (MET)

Methamphetamine is an addictive stimulant drug that strongly activates certain systems in the brain. Methamphetamine is closely related chemically to amphetamine, but the central nervous system effects of Methamphetamine are greater. Methamphetamine is made in illegal laboratories and has a high potential for abuse and dependence. The drug can be taken orally, injected, or inhaled. 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 Methamphetamine include increased blood pressure and cardiac arrhythmias. More acute responses produce anxiety, paranoia, hallucinations, psychotic behavior, and eventually, depression and exhaustion.

The effects of Methamphetamine generally last 2-4 hours and the drug has a half-life of 9-24 hours in the body. Methamphetamine is excreted in the urine primarily as amphetamine and oxidized and deaminated derivatives. However, 10-20% of Methamphetamine is excreted unchanged. Thus, the presence of the parent compound in the urine indicates Methamphetamine use. Methamphetamine is generally detectable in the urine for 3-5 days, depending on urine pH level.

The One Step Drug Screen Test Card yields a positive result when the Methamphetamine in urine exceeds 500 ng/mL.

OPIATE(OPI)

Opiate refers to any drug that is derived from the opium poppy, including the natural products, morphine and codeine, and the semi-synthetic drugs such as heroin. Opioid is more general, referring to any drug that acts on the opioid receptor.

Opioid analgesics comprise a large group of substances which control pain by depressing the central nervous system. Large doses of morphine can produce higher tolerance levels, physiological dependency in users, and may lead to substance abuse. Morphine is excreted unmetabolized, and is also the major metabolic product of codeine and heroin. Morphine is detectable in the urine for several days after an opiate dose (1).

The One Step Drug Screen Test Card yields a positive result when the concentration of opiate exceeds the 2000 ng/mL cut-off level.

PRINCIPLE

The One Step Drug Screen Test Card is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody.

During testing, a urine specimen migrates upward by capillary action. A drug, 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 the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region.

A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-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 colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

REAGENTS

The test contains a membrane strip coated with drug-protein conjugates (purified bovine albumin) on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody specific to Amphetamine, Cocaine, THC, Methamphetamine , or Opiate.

PRECAUTIONS

• For healthcare professionals including professionals at point of care sites.
• For in vitro diagnostic use only. Do not use after the expiration date.
• The test panel should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
• The used test card should be discarded according to federal, state and local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at 2-30°C. The test strip is stable through the expiration date printed on the sealed pouch. The test strips must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

SPECIMEN COLLECTION AND PREPARATION

Urine Assay

The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.

Specimen Storage

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.

MATERIALS

Materials Provided

• Test cards
• Package insert

Materials Required But Not Provided

• Specimen collection container
• Timer
• External controls

DIRECTIONS FOR USE

Allow the test card, urine specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test card from the sealed pouch and use it as soon as possible. Remove the cap from the end of the test card. With arrows pointing toward the urine specimen, immerse the strip(s) of the test card vertically in the urine specimen for at least 10-15 seconds. Immerse the test card to at least the level of the wavy lines on the strip(s), but not above the arrow(s) on the test card. See the illustration below.
2. Place the test card on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The results should be read at 5 minutes. Do not interpret results after 10 minutes.

 

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

 

NEGATIVE:* Two lines appear. One red line should be in the control region (C), and another apparent red or pink line adjacent should be in the test region (T). This negative result indicates that the drug concentration is below the detectable level.

*NOTE: The shade of red in the test line region (T) will vary, but it should be considered negative whenever there is even a faint pink line.

POSITIVE: One red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the drug concentration is above the detectable level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact your local distributor.

 

QUALITY CONTROL

A procedural control is included in the test. A red line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

LIMITATIONS

1. The One Step Drug Screen Test Card provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. ^3,4,7
2. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.
4. A Positive result does not indicate level or intoxication, administration route or concentration in urine.
5. A Negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.
6. Test does not distinguish between drugs of abuse and certain medications.
7. A positive test result may be obtained from certain foods or food supplements.

PERFORMANCE CHARACTERISTICS

Accuracy

 

A side-by-side comparison was conducted using the One Step Single Drug Test Strip and commercially available drug rapid tests. Testing was performed on approximately 300 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive 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
COC	Benzoylecgonine
THC	11-nor-D9-tetrahydrocannabinol-9-carboxylic acid
MET	Methamphetamine
OPI	Morphine, Codeine

 

The following results are tabulated from these clinical studies:

 

%Agreement with Commercial Kit

	AMP	COC	THC	MET	OPI
Positive Agreement	97%	95%	98%	98%	100%
Negative Agreement	100%	>99%	100%	100%	99%
Total Results	98%	98%	99%	99%	<99%

 

%Agreement with GC/MS

	AMP	COC	THC	MET	OPI
Positive Agreement	97%	96%	97%	99%	100%
Negative Agreement	95%	>90%	88%	94%	97%
Total Results	96%	93%	91%	96%	98%

 

Forty (40) clinical samples for each drug were run using each of The One Step Single Drug Test Strip by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

Precision

 

A study was conducted at three physician offices by untrained operators using three different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens, containing drugs at the concentration of ± 50% and ± 25% cut-off level, was labeled, blinded and tested at each site. The results are given below:

 

AMPHETAMINE (AMP)

Amphetamine conc. (ng/mL)	n per site	Site A		Site B		Site C
		-	+	-	+	-	+
0	15	15	0	15	0	15	0
250	15	15	0	15	0	14	1
375	15	13	2	11	4	11	4
625	15	6	9	4	11	4	11
750	15	2	13	1	14	1	14

 

 

COCAINE (COC)

Benzoylecgonine conc. (ng/mL)	n per site	Site A		Site B		Site C
		-	+	-	+	-	+
0	15	14*	0	15	0	15	0
75	15	14	1	15	0	14	1
112.5	15	4	11	5	10	8	7
187.5	15	0	15	0	15	0	15
225	15	0	15	0	15	1	14

*Note: One invalid result was obtained.

 

MARIJUANA (THC)

11-nor-D9 -THC-9-COOH conc. (ng/mL)	n per site	Site A		Site B		Site C
		-	+	-	+	-	+
0	15	15	0	15	0	15	0
25	15	15	0	15	0	14	1
37.5	15	9	6	14	1	9	6
62.5	15	2	13	0	15	0	15
75	15	0	15	0	15	0	15

 

 

METHAMPHETAMINE (MET)

Methamphetamine conc. (ng/mL)	n per site	Site A		Site B		Site C
		-	+	-	+	-	+
0	15	15	0	15	0	15	0
250	15	15	0	14	1	13	2
375	15	11	4	10	5	10	5
625	15	8	7	4	11	6	9
750	15	1	14	1	14	0	15

 

OPIATE (OPI)

Opiates conc. (ng/mL)	n per site	Site A		Site B		Site C
		-	+	-	+	-	+
0	15	15	0	15	0	15	0
1000	15	13	2	13	2	15	0
1500	15	3	12	7	8	10	5
2500	15	0	15	1	14	0	15
3000	15	0	15	0	15	0	15

 

Analytical Sensitivity

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

Drug concentration		AMP		COC
Cut-off Range	n	-	+	-	+
0% Cut-off	30	30	0	30	0
-50% Cut-off	30	30	0	30	0
-25% Cut-off	30	30	0	30	0
Cut-off	30	18	12	4	26
+25% Cut-off	30	1	29	0	30
+50% Cut-off	30	0	30	0	30

 

Drug Concentration		THC		MET		OPI
Cut-off Range	n	-	+	-	+	-	+
0% Cut-off	30	30	0	30	0	30	0
-50% Cut-off	30	30	0	30	0	30	0
-25% Cut-off	30	12	18	30	0	30	0
Cut-off	30	1	29	18	12	13	17
+25% Cut-off	30	1	29	1	29	4	26
+50% Cut-off	30	0	30	0	30	0	30

Analytical Specificity

The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by One Step Drug Screen Test Card at 5 minutes.

AMPHETAMINE (AMP)	ng/mL
D-Amphetamine	500
D,L-Amphetamine sulfate	15,000
L-Amphetamine	25,000
(±)3,4-Methylenedioxyamphetamine	1,000
Phentermine	1,500
COCAINE (COC)
Benzoylecgonine	150
Cocaine HCl	390
Cocaethylene	6,500
Ecgonine HCl	16,000
MARIJUANA (THC)
11-nor-D9 -THC-9 COOH	50
Cannabinol	20,000
11-nor-D8-THC-9 COOH	30
D8 -THC	15,000
D9 -THC	15,000
METHAMPHETAMINE (MET)
D-Methamphetamine	500
r-Hydroxymethamphetamine	15,000
L-Methamphetamine	4,000
(±)-3,4-Methylenedioxymethamphetamine	1,000
Mephentermine	25,000
OPIATES(OPI)
Morphine	2,000
Codeine	2,000
Ethylmorphine	5,000
Hydrocodone	12,500
Hydromorphone	5,000
Levophanol	75,000
6-Monoacetylmorphine	5,000
Morphine 3-b-D-glucuronide	2,000
Norcodeine	12,500
Normorphone	50,0000
Oxycodone	25,000
Oxymorphone	25,000
Procaine	150,000
Thebaine	100,000

Effect of Urinary Specific Gravity

Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.000-1.037) were spiked with drugs at 50% below and 50% above cut-off levels respectively. The One Step Drug Screen Test Card was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.

Effect of the Urinary pH

The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine was tested with One Step Drug Screen Test Card. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.

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 Cocaine, Barbiturates, Benzodiazepine, Amphetamine, Methamphetamine, Marijuana, Methadone, Opiate, Phencyclidine or Tricyclic Antidepressant. The following compounds show no cross-reactivity when tested with One Step Drug Screen Test Card at a concentration of 100 mg/mL.

Non Cross-Reacting Compounds

Acetaminophen	Maprotiline
Acetophenetidin	MDE
N-Acetylprocainamide	Meperidine
Acetylsalicylic acid	Meprobamate
Aminopyrine	Methoxyphenamine
Amitryptyline
Amoxicillin	Methyphenidate Nalidixic acid
Ampicillin	Naloxone
L-Ascorbic acid	Naltrexone
	Naproxen
Apomorphine	Niacinamide
Aspartame	Nifedipine
Atropine	Norethindrone
Benzilic acid	D-Norpropoxyphene
Benzoic acid	Noscapine
Benzphetamine	DL-Octopamine
Bilirubin	Oxalic acid
(±) – Brompheniramine
Caffeine	Oxolinic acid
Cannabidiol	Oxymetazoline
Chloralhydrate	Papaverine
chlorph	Penicillin-G
Chlorothiazide	Pentazocine hydrochloride
(±) – Chlorpheniramine	Perphenazine
Chlorpromazine	Phenelzine
Chlorquine	Trans-2-phenylcyclo-propylamine
Cholesterol	hydrochloride
Clomipramine	L-Phenylephrine
Clonidine	b-Phenylethylamine
Cortisone	Phenylpropanolamine
(-) Cotinine	Prednisolone
Creatinine	Prednisone
Deoxycorticosterone	Promazine
Dextromethorphan	Promethazine
Diclofenac	DL-Propranolol
Diflunisal	D-Propoxyphene
Digoxin	D-Pseudoephedrine
Diphenhydramine	Quinacrine
Doxylamine	Quinidine
Ecgonine methylester	Quinine
(-) -Ψ-Ephedrine	Ranitidine
b-Estradiol	Salicylic acid
Estrone-3-sulfate	Serotonin
Ethyl-p-aminobenzoate	Sulfamethazine
[1R,2S] (-) Ephedrine	Sulindac
(L) – Epinephrine
Erythromycin	Tetracycline
Fenoprofen	Tetrahydrocortisone, 3-acetate
Furosemide	Tetrahydrocortisone 3-
Gentisic acid	(b-D-glucuronide)
Hemoglobin	Tetrahydrozoline
Hydralazine	Thiamine
Hydrochlorothiazide	Thioridazine
Hydrocortisone	DL-Tyrosine
O-Hydroxyhippuric acid	Tolbutamide
p-Hydroxyamphetamine	Triamterene
3-Hydroxytyramine	Trifluoperazine
Ibuprofen	Trimethoprim
Imipramine	Trimipramine
Iproniazid	Tryptamine
(±) – Isoproterenol	DL-Tryptophan
Isoxsuprine	Tyramine
Ketamine	Uric acid
Ketoprofen	Verapamil
Labetalol	Zomepirac
Loperamide