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One Step Methamphetamine Test Device Package Insert

One Step Methamphetamine Test Device Package Insert

One Step  Methamphetamine Test Device Package Insert

Product Details:

Place of Origin: CHINA
Brand Name: SPAN
Certification: ISO CE
Model Number: RA0517

Payment & Shipping Terms:

Minimum Order Quantity: 100 tests
Price: Negotiated
Packaging Details: 20tests/box
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 1000000 pcs per month
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Detailed Product Description
Package: 20tests/box Specificity: 100%
Sensitivity: 100%

MET

One Step

Methamphetamine Test Device

Package Insert

 

A rapid, one step test for the qualitative detection of Methamphetamines in human urine.

 

For healthcare professionals including professionals at point of care sites

 

For professional in vitro diagnostic use only.

 

INTENDED USE

 

The MET One Step Methamphetamine Test Device is a lateral flow chromatographic immunoassay for the detection of Methamphetamines in human urine.

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

 

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 1,000 ng/mL.

 

 

PRINCIPLE

 

The MET One Step Methamphetamine Test Device is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Methamphetamines, if present in the urine specimen below 1,000 ng/mL, will not saturate the binding sites of the antibody coated particles in the test device. The antibody- coated particles will then be captured by immobilized Methamphetamine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Methamphetamine level exceeds 1,000 ng/mL because it will saturate all the binding sites of anti-Methamphetamine antibodies.

A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region.

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 device contains mouse monoclonal anti-Methamphetamine antibody-coupled particles and Methamphetamine-protein conjugate. A goat antibody is employed in the control line system.

 

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 device 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 device 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 device is stable through the expiration date printed on the sealed pouch. The test device 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 particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.

 

Specimen Storage

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

 

MATERIALS

 

Materials Provided

  • Test devices
  • Disposable specimen droppers
  • Package insert

Materials Required But Not Provided

  • Specimen collection container
  • Timer
  • External controls

DIRECTIONS FOR USE

Allow the test device, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.

  1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
  2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100ml) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.
  3. Wait for the colored line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

One Step  Methamphetamine Test Device Package Insert

 

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

 

NEGATIVE:* Two lines appear. One colored line should be in the control region (C), and another apparent colored line should be in the test region (T). This negative result indicates that the Methamphetamine concentration is below the detectable level (1,000 ng/mL).

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

 

POSITIVE: One colored line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Methamphetamine concentration exceeds the detectable level (1,000 ng/mL).

 

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 device. 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 colored 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 MET One Step Methamphetamine Test Device 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. 1,2
  2. It is possible 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 cutoff level of the test.
  6. Test does not distinguish between drugs of abuse and certain medications.

 

PERFORMANCE CHARACTERISTICS

 

Accuracy

A side-by-side comparison was conducted using the MET One Step Methamphetamine Test Device and a leading commercially available MET rapid test. Testing was performed on 300 clinical specimens. Ten percent of the specimens employed were either at –25% or +25% level of the cut-off concentration of 1,000 ng/mL Methamphetamine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Method Other MET Rapid Test Total Results
MET One Step Test Device Results Positive Negative
Positive 140 0 140
Negative 6 154 160
Total Results 146 154 300
% Agreement with this commercial kit 96% >99% 98%
 

 

When compared at 1,000 ng/mL cut-off with GC/MS, the following results were tabulated:

Method GC/MS Total Results
MET One Step Test Device Results Positive Negative
Positive 131 9 140
Negative 5 155 160
Total Results 136 164 300
% Agreement with GC/MS Analysis 96% 95% 95%
 

 

Eighty (80) of these sMETles were also run using the MET One Step Methamphetamine Test Device by an untrained operator at a different site. Based on GC/MS data, the operator obtained a statistically similar Positive Agreement, Negative Agreement and Overall Agreement rate as the laboratory personnel.

 

Analytical Sensitivity

A drug-free urine pool was spiked with Methamphetamine at the following concentrations: 0 ng/mL, 500 ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250 ng/mL and 1,500 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:

MET Concentration (ng/mL) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
500 -50% 30 30 0
750 -25% 30 23 7
1,000 Cutoff 30 9 21
1,250 +25% 30 1 29
1,500 +50% 30 0 30
 

 

Analytical Specificity

The following table lists compounds that are positively detected in urine by the MET One Step Methamphetamine Test Device at 5 minutes.

Compound Concentration (ng/mL)
d-Methamphetamine 1,000
d,l-Methamphetamine sulfate 3,000
l-Methamphetamine 50,000
(±) 3,4-MethylenedioxyMethamphetamine 2,000
Phentermine 3,000
 

 

Precision

A study was conducted at 3 physician’s offices by untrained operators using 3 different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens containing no Methamphetamine, 25% Methamphetamine above and below the cut-off and 50% Methamphetamine above and below the 1,000 ng/mL cut-off was provided to each site.

Methamphetamine concentration (ng/mL) n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
500 15 14 1 13 2 15 0
750 15 11 4 7 8 5 10
1,250 15 2 13 0 15 1 14
1,500 15 1 14 1 14 1 14
 

 

Effect of Urinary Specific Gravity

 

Fifteen (15) urine sMETles of normal, high, and low specific gravity ranges were spiked with 500 ng/mL and 1,500 ng/mL of Methamphetamine respectively. The MET One Step Methamphetamine Test Device was tested in duplicate using the fifteen neat and spiked urine sMETles. 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 Methamphetamine to 500 ng/mL and 1,500 ng/mL. The spiked, pH-adjusted urine was tested with the MET One Step Methamphetamine Test Device in duplicate. 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 Methamphetamine positive urine. The following compounds show no cross-reactivity when tested with the MET One Step Methamphetamine Test Device at a concentration of 100 mg/mL.

 

Non Cross-Reacting Compounds

 

4-Acetamidophenol Estrone-3-sulfate Oxolinic acid
Acetophenetidin Ethyl-p-aminobenzoate Oxycodone
N-Acetylprocainamide Fenfluramine Oxymetazoline
Acetylsalicylic acid Fenoprofen Papaverine
Aminopyrine Furosemide Penicillin-G
Amitryptyline Gentisic acid Pentazocine
Amobarbital Hemoglobin Pentobarbital
Amoxicillin Hydralazine Perphenazine
METicillin Hydrochlorothiazide Phencyclidine
Ascorbic acid Hydrocodone Phenelzine
Apomorphine Hydrocortisone Phenobarbital
Aspartame p-HydroxyMethamphetamine l-Phenylephrine
Atropine O-Hydroxyhippuric acid b-Phenylethlamine
Benzilic acid p-Hydroxy-methMethamphetamine Phenylpropanolamine
Benzoic acid Prednisolone
Benzoylecgonine 3-Hydroxytyramine Prednisone
Benzphetamine Ibuprofen Procaine
Bilirubin Imipramine Promazine
Brompheniramine (-) Isoproterenol Promethazine
Caffeine Isoxsuprine d,l-Propanolol
Cannabidiol Ketamine d-Propoxyphene
Cannabinol Ketoprofen d-Pseudoephedrine
Chloralhydrate Labetalol Quinidine
ChlorMEThenicol Levorphanol Quinine
Chlordiazepoxide Loperamide Ranitidine
Chlorothiazide Maprotiline Salicylic acid
(±) Chlorpheniramine Meperidine Secobarbital
Chlorpromazine Meprobamate Serotonin (5-Hydroxytyramine)
Chlorquine Methadone
Cholesterol d-methMethamphetamine Sulfamethazine
Clomipramine (l)-methMethamphetamine Sulindac
Clonidine Methoxyphenamine Temazepam
Cocaine hydrochloride 3,4-Methylenedioxyethyl-Methamphetamine Tetracycline
Codeine Tetrahydrocortisone, 3 Acetate
Cortisone (+) 3,4-Methylenedioxy-methMethamphetamine
(-) Cotinine Tetrahydrocortisone 3 (b-D glucuronide)
Creatinine Methylphenidate
Deoxycorticosterone Morphine-3-b-D-glucuronide Tetrahydrozoline
Dextromethorphan Thebaine
Diazepam Nalidixic acid Thiamine
Diclofenac Naloxone Thioridazine
Diflunisal Naltrexone Tolbutamine
Digoxin Naproxen Triamterene
Diphenhydramine Niacinamide Trifluoperazine
Doxylamine Nifedipine Trimethoprim
Ecgonine hydrochloride Norcodein Trimipramine
Ecgonine methylester Norethindrone d,l-Tryptophan
(IR,2S)-(-)-Ephedrine d-Norpropoxyphene Tyramine
l-Ephedrine Noscapine d,l-Tyrosine
(-) Y Ephedrine d,l-Octopamine Uric acid
Erythromycin Oxalic acid Verapamil
b-Estradiol Oxazepam Zomepirac
 

 

BIBLIOGRAPHY

 

  1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed. Biomedical Publ., Davis, CA. 1982; 488
  2. Hawwks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986

 

 

 

 

 

 

Printed in China

 

DN: 1150044903

Eff. Date: 2005-07-05

 

 

 

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.

 

Our mission:

 

  • Always best of all and always pay attention to innovation.
  • Special customized service tightly following customers’ requests.
  • Integrated excellent quality, competitive prices and super service together.

 

 

Span Biotech Ltd.

Add: 6A, Unit 5, Building 3, Sunshine Aloha, Bantian Industrial Park, Banxuegang Road , Longgang Shenzhen 518129

Tel:+86-755-89589611

E-mail: info@spanbio.com

 

 

 

Contact Details
SPAN BIOTECH LTD.

Contact Person: Ms. Anna Lee

Tel: 86-755-89589611

Fax: 86-755-89580096

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