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  • One Step Multi-Drug Screening Test

One Step Multi-Drug Screening Test

Usage
The One Step Multi-Drug Screening Test (One Step DOA Test/ One Step Multi-2 DOA Test/ One Step Multi-3 DOA Test/ One Step Multi-4 DOA Test/ One Step Multi-5 DOA Test/ One Step Multi-6 DOA Test/ One Step Multi-7 DOA Test/One Step Multi-8 DOA Test/ One Step Multi-9 DOA Test/ One Step Multi- 10 DOA Test/ One Step Multi- 11 DOA Test/ One Step Multi- 12 DOA Test/ One Step Multi- 13 DOA Test/ One Step Multi- 14 DOA Test) is a rapid, qualitative, competitive lateral flow immunoassay for the detection of DOA and/or their metabolites in human urine. The device allows the detection of multiple drugs, from 1 to 14 indicators, in one simple step. The One Step Multi- Drug Screening Test (One Step DOA Test/ One Step Multi-2 DOA Test/ One Step Multi-3 DOA Test/ One Step Multi-4 DOA Test/ One Step Multi-5 DOA Test/ One Step Multi-6 DOA Test/ One Step Multi-7 DOA Test/ One Step Multi-8 DOA Test/ One Step Multi-9 DOA Test/ One Step Multi- 10 DOA Test/ One Step Multi- 11 DOA Test/ One Step Multi- 12 DOA Test/ One Step Multi- 13 DOA Test/ One Step Multi- 14 DOA Test) is intended to be used by healthcare professionals and trained personnel in professional medical or forensic laboratories. This test is a preliminary screening test and should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). This test is not intended to monitor drug levels, but only used to screen urine for the presence of the drugs as well as their metabolites in human urine at or above the following cut-off concentrations:

 

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Packing specification

Principle of Inspection

The One Step Multi-Drug Screening Test (One Step DOA Test/ One Step Multi-2 DOA Test/ One Step Multi-3 DOA Test/ One Step Multi-4 DOA Test/ One Step Multi-5 DOA Test/ One Step Multi-6 DOA Test/ One Step Multi-7 DOA Test/ One Step Multi-8 DOA Test/ One Step Multi-9 DOA Test/ One Step Multi- 10 DOA Test/ One Step Multi- 11 DOA Test/ One Step Multi- 12 DOA Test/ One Step Multi- 13 DOA Test/ One Step Multi- 14 DOA Test) employs highly sensitive antibodies to selectively detect and identify the following drugs of abuse and/or their metabolites in human urine specimens.

AMPHETAMINES (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% ofAmphetamines are excreted in the urine in unchanged form, with the remainder as hydroxylated and deaminated derivatives. The One Step Multi-Drug Screening Test yields a positive result when the concentration ofAmphetamines in urine is great than or equal to 1000 ng/ml.

BARBITURATES (BAR)

Barbiturates are central nervous system depressants. They are used therapeutically as sedatives, hypnotics, and anticonvulsants. Barbiturates are almost always taken orally as capsules or tablets. The effects resemble those of intoxication with alcohol. Chronic use of barbiturates leads to tolerance and physical dependence. Short acting Barbiturates taken at 400 mg/day for 2-3 months can produce a clinically significant degree of physical dependence. Withdrawal symptoms experienced during periods of drug abstinence can be severe enough to cause death. Only a small amount (less than 5%) of most Barbiturates are excreted unaltered in the urine.

The approximate detection time limits for Barbiturates are:

Short acting (e.g. Secobarbital) 100 mg PO (oral) 4.5 days.

Long acting (e.g. Phenobarbital) 400 mg PO (oral) 7 days.

The One Step Multi-Drug Screening Test yields a positive result when the concentration of Barbiturates (Secobarbital) in urine is great than or equal to 300 ng/ml.

BENZODIAZEPINES (BZO)

Benzodiazepines are medications that are frequently prescribed for the symptomatic treatment of anxiety and sleep disorders. They produce their effects via specific receptors involving a neurochemical called gamma aminobutyric acid (GABA). Because they are safer and more effective, Benzodiazepines have replaced barbiturates in the treatment of both anxiety and insomnia. Benzodiazepines are also used as sedatives before some surgical and medical procedures, and for the treatment of seizure disorders and alcohol withdrawal. Risk of physical dependence increases if Benzodiazepines are taken regularly (e.g., daily) for more than a few months, especially at higher than normal doses. Stopping abruptly can bring on such symptoms as trouble sleeping, gastrointestinal upset, feeling unwell, loss of appetite, sweating, trembling, weakness, anxiety and changes in perception. Only trace amounts (less than 1%) of most Benzodiazepines are excreted unaltered in the urine; most of the concentration in urine is conjugated drug. The detection period for the Benzodiazepines in the urine is 3-7 days. The One Step Multi-DrugScreening Test yields a positive result when the concentration of Benzodiazepines (Oxazepam) is great than or equal to 300 ng/ml.

BUPRENORPHINE (BUP)

Buprenorphine is a semisynthetic opioid analgesic derived from thebaine, a component of opium. It has a longer duration of action than morphine when indicated for the treatment of moderate to severe pain, peri-operative analgesia, and opioid dependence. Low doses buprenorphine produces sufficient agonist effect to enable opioid- addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine carries a lower risk of abuse, addiction, and side effects compared to full opioid agonists because of the “ceiling effect”, which means no longer continue to increase with further increases in dose when reaching a plateau at moderate doses. However, it has also been shown that Buprenorphine has abuse potential and may itself cause dependency. Subutex® , and a Buprenorphine/Naloxone combination product, Suboxone® , are the only two forms of Buprenorphine that have been approved by US FDA in 2002 for use in opioid addiction treatment. Buprenorphine was rescheduled from Schedule V to Schedule III drug just before FDA approval of Suboxone and Subutex. The One Step Multi-Drug Screening Test yields a positive result when the concentration of Buprenorphine in urine is great than or equal to 10 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, 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 exposure. The One Step Multi-Drug Screening Test yields a positive result when the concentration of Cocaine metabolites in urine is great than or equal to 300 ng/ml.

KETAMINE (KET)

Ketamine is a short-acting “dissociative” anesthetic due to its ability to separate perception from sensation. It also has hallucinogenic and painkilling qualities that seem to affect people in very different ways. Ketamine is chemically related to PCP (’Angel Dust’). Ketamine is occasionally administered to people but, more commonly, is used by vets for pet surgery. Generally street K is most often diverted in liquid form from vets’ offices or medical suppliers. Ketamine generally takes 1-5 minutes to take effect. Snorted ketamine takes a little longer at 5- 15 minutes. Depending on how much and how recently one has eaten, oral ketamine can take between 5 and 30 minutes to take effect. The primary effects of ketamine last approximately 30-45 minutes if injected, 45-60 minutes when snorted, and 1-2 hours if used orally. The Drug Enforcement Administration reports that the drug can still affect the body for up to 24 hours. The One Step Multi-Drug Screening Test yields a positive result when the concentration of Ketamine in urine is great than or equal to 1000 ng/ml.

MARIJUANA (THC)

THC (Δ9-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 for3- 10 days after smoking. The main metabolite excreted in the urine is 11-nor-Δ9- tetrahydrocannabinol-9-carboxylic acid ( Δ9-THC-COOH). The One Step Multi-Drug Screening Test yields a positive result when the concentration of 11-nor-Δ9-THC-9 COOH is great than or equal to the 50 ng/ml.

MDMA (ECSTASY)

Methylenedioxymethamphetamine (MDMA), also known as 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. MDMA is not clearly a stimulant, although it has, in common with amphetamine drugs, a capacity to increase blood pressure and heart rate. MDMA 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. MDMA 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 MDMA, occurring in virtually all people who took a reasonable dose of the drug, was to produce a clenching of the jaws. The One Step Multi-Drug Screening Test yields a positive result when the concentration of Methylenedioxymethamphetamine in urine is great than or equal to 500 ng/ml.

METHADONE (MTD)

Methadone is a narcotic analgesic prescribed for the management of moderate to severe pain and for the treatment of Morphine dependence (heroin, Vicodin, Percocet, Morphine). The pharmacology of Oral Methadone is very different from IV Methadone. Oral Methadone is partially stored in the liver for later use. IV Methadone acts more like heroin. In most states you must go to a pain clinic or a Methadone maintenance clinic to be prescribed Methadone. Methadone is a long-acting pain reliever producing effects that last from twelve to forty-eight hours. Ideally, Methadone frees the client from the pressures of obtaining illegal heroin, from the dangers of injection, and from the emotional roller coaster that most opiates produce. Methadone, if taken for long periods and at large doses, can lead to a very long withdrawal period. The withdrawals from Methadone are more prolonged and troublesome than those provoked by heroin cessation, yet the substitution and phased removal of methadone is an acceptable method of detoxification for patients and therapists. The One Step Multi-Drug Screening Test yields a positive result when the concentration of Methadone in urine is great than or equal to 300 ng/ml.

METHAMPHETAMINE (MET, mAMP)

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 ahigh 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 as amphetamine and oxidized and delaminated derivatives. However, 10-20% of Methamphetamine is excreted unchanged. Thus, the presence of the parent compound in the urine indicates Methamphetamine use. The One Step Multi-Drug Screening Test yields a positive result when the concentration of

Methamphetamine is great than or equal to the 1000 ng/ml.

OPIATES (MORPHINE, 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. The One Step Multi- Drug Screening Test yields a positive result when the concentration of Morphine is great than or equal to the 300ng/ml.

PHENCYCLIDINE (PCP)

Phencyclidine, also known as PCP or Angel Dust, is a hallucinogen that was first marketed as a surgical anesthetic in the 1950's. It was removed from the market because patients receiving it became delirious and experienced hallucinations. Phencyclidine is used in powder, capsule, and tablet form. The powder is either snorted or smoked after mixing it with marijuana or vegetable matter. Phencyclidine is most commonly administered by inhalation but can be used intravenously, intra-nasally, and orally. After low doses, the user thinks and acts swiftly and experiences mood swings from euphoria to depression. Self-injurious behavior is one of the devastating effects of Phencyclidine. PCP can be found in urine within 4 to 6 hours after use and will remain in urine for 7 to 14 days, depending on factors such as metabolic rate, user's age, weight, activity, and diet. Phencyclidine is excreted in the urine as an unchanged drug (4% to 19%) and conjugated metabolites (25% to 30%). The One Step Multi-Drug Screening Test yields a positive result when the concentration of Phencyclidine in urine is great than or equal to 25 ng/ml.

TRAMADOL (TRA)

Tramadol is a quasi-narcotic analgesic used in the treatment of moderate to severe pain. It is a synthetic analog of codeine, but has a low binding affinity to the mu-opioid receptors. It has been prescribed off-label for the treatment of diabetic neuropathy and restless leg syndrome. Large doses of Tramadol could develop tolerances and physiological dependency and lead to its abuse. Both Δ(d) and L forms of the isomers are controlled substances. Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% is excreted as metabolites. The major pathways appear to be N- and O- demethylation, glucuronidation or sulfation in the liver. The One Step Multi-Drug Screening Test yields a positive result when the concentration of Tramadol in urine is great than or equal to 200 ng/ml.

TRICYCLIC ANTIDEPRESSANTS (TCA)

TCA (Tricyclic Antidepressants) TCA (Tricyclic Antidepressants) are commonly used for the treatment of depressive disorders. TCA overdoses can result in profound central nervous system depression, cardiotoxicity and anticholinergic effects. TCA overdose is the most common cause of death from prescription drugs. TCAs are taken orally or sometimes by injection. TCAs are metabolized in the liver. Both TCAs and their metabolites are excreted in urine mostly in the form of metabolites for up to ten days. The One Step Multi-Drug Screening Test yields a positive result when the concentration of Tricyclic Antidepressants (Nortriptyline) in urine is great than or equal to 1000 ng/ml.

【TEST PRINCIPLE】

The One Step Multi-Drug Screening Test card is a device composed of 1- 14 chromatographic strips designed to detect 1-14 (as per the device format) individual drugs of abuse. Each strip consists of a sample pad containing antibody-dye colloidal gold conjugate and membrane contains immobilized drug conjugate and control reagent. Urine specimen initially reacts with the antibody-dye colloidal gold conjugate, and then flows onto the strip and migrates through the pads and membrane of the strip by capillary action, to the test area. If sufficient drug is present in urine, it binds with the conjugate, preventing it from binding to the drug conjugate immobilized on the membrane in the test line region (T). Any unbound conjugate continues to migrate through the strip to the control line region (C) where it binds to the control reagent and generates a reddish purple line in the control line region (C). Presence of both a reddish purple quality control line (C) and a reddish purple test line (T) on the strip indicate a negative test result, or the drug concentration is below limit of detection. Presence of only a reddish purple control line (C) on the strip indicates that specific drug has been detected and test result is positive.

Specification packaging

1 Test/Kit, 2 Tests/Kit, 3 Tests/Kit, 4 Tests/Kit, 5 Tests/Kit, 7 Tests/Kit, 10 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit,40 Tests/Kit, 50 Tests/Kit, 100 Tests/Kit.

DOA Test Calibrator Cut-off (ng/ml)
Amphetamine (AMP) D-Amphetamine 1000
Barbiturates (BAR) Secobarbital 300
Benzodiazepines (BZO) Oxazepam 300
Buprenorphine (BUP) Buprenorphine 10
Cocaine (COC) Benzoylecgonine 300
Ketamine (KET) Ketamine 1000
Marijuana (THC) 11-nor-Δ9-THC-9 COOH 50
Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine 500
Methadone (MTD) Methadone 300
Methamphetamine (MET) D-Methamphetamine 1000
Opiates (OPI) Morphine 300
Phencyclidine (PCP) Phencyclidine 25
Tramadol (TRA) Tramadol 200
Tricyclic Antidepressants (TCA) Nortriptyline 1000

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About Kangte

Zhejiang Kangte Biotechnology Co., Ltd

Zhejiang Kangte Biotechnology Co., Ltd. was established in 2001 and is located in Zhejiang Xinchang Provincial High-tech Industrial Park. It is a national high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents. Relying on the pioneering team spirit and scientific management, the company has repeatedly won the national advanced production unit in the in vitro diagnostic industry. 

The company has GMP standard workshops, clean workshops, R&D laboratories, equipped with high-precision testing equipment and fully automatic production equipment. In order to enhance the company's overall R&D strength, it has established a good "production-study-research" cooperative relationship with many colleges and universities. The company has obtained a number of invention patents and utility model patents and has passed ISO9001, ISO14001, ISO13485, and other system certifications. The company currently has more than 100 registered products, covering biochemical, immunological, and other fields, and many of the products have reached the leading domestic level in technology. 

The company adheres to the concept of "integrity, professionalism, efficiency and innovation" to serve customers, and constantly introduces products with higher technological content to provide customers. The company will, as always, position itself in "service technology, professionalism and efficiency, and achieve customers", and work hard to jointly shape the IVD industry and continuously improve the level of human health.

 

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