View Insert - NC.S. THC

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					                                                                      particles in the test strip. The antibody coated particles will then be   1.   Bring the pouch to room temperature before opening it.
                NC.S. THC                                             captured by immobilized Marijuana 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 Marijuana level is above
                                                                                                                                                     Remove the test strip from the sealed pouch and use it as soon
                                                                                                                                                     as possible.
                                                                      50 ng/mL because it will saturate all the binding sites of anti-          2.   With arrows pointing toward the urine specimen, immerse
                    One Step                                          Marijuana antibodies.                                                          the test strip vertically in the urine specimen for at least
            Marijuana Test Strip (Urine)                              A drug-positive urine specimen will not generate a colored line                10-15 seconds. Do not pass the maximum line (MAX) on
                                                                      in the test line region because of drug competition, while a drug-             the test strip when immersing it. See the illustration below.
                  Package Insert                                      negative urine specimen or a specimen containing a drug
                                                                                                                                                3.   Place the test strip on a non-absorbent flat surface, start
                  (Catalog Number: DTH-101)                           concentration less than the cut-off will generate a line in the test
                                                                      line region.                                                                   the timer and wait for the red line(s) to appear. The
A rapid, one step test for the qualitative detection of THC           To serve as a procedural control, a colored line will always                   result should be read at 5 minutes. Do not interpret the
metabolites in human urine.                                           appear at the control line region indicating that proper volume of             result after 10 minutes.
For professional in vitro diagnostic use only.                        specimen has been added and membrane wicking has occurred.
                       INTENDED USE                                                               REAGENTS
The THC One Step Marijuana Test Strip (Urine) is a rapid              The test strip contains mouse monoclonal anti-Marijuana
                                                          9
chromatographic immunoassay for the detection of 11-nor-∆ -           antibody-coupled particles and Marijuana-protein conjugate. A
THC-9 COOH (THC metabolite) in human urine at a cut-off               goat antibody is employed in the control line system.
concentration of 50 ng/mL.
This assay provides only a preliminary analytical test result.                                 PRECAUTIONS
A more specific alternate chemical method must be used in             •    For professional in vitro diagnostic use only. Do not use
order to obtain a confirmed analytical result. Gas                         after the expiration date.
chromatography/mass spectrophotometry (GC/MS) is the                  •    The test strip should remain in the sealed pouch until use.
preferred confirmatory method. Clinical consideration and             •    All specimens should be considered potentially hazardous
professional judgment should be applied to any drug of                     and handled in the same manner as an infectious agent.
abuse test result, particularly when preliminary positive             •    The used test used strip should be discarded in a proper
results are used.                                                          biohazard container after testing.
                           SUMMARY                                                      STORAGE AND STABILITY
        9
THC (∆ - tetrahydrocannabinol) is the primary active ingredient       The kit can be stored at room temperature or refrigerated (2-30°C).                     INTERPRETATION OF RESULTS
in cannabinoids (Marijuana). When smoked or orally                    The test strip is stable through the expiration date printed on the                      (Please refer to the illustration above)
administered, it produces euphoric effects. Users have impaired       sealed pouch. The test strip must remain in the sealed pouch until
short term memory and slowed learning. They may also                  use. DO NOT FREEZE. Do not use beyond the expiration date.                NEGATIVE:* Two lines appear. One red line should be in the
experience transient episodes of confusion and anxiety. Long                                                                                    control region (C), and another apparent red or pink line should
term relatively heavy use may be associated with behavioral                 SPECIMEN COLLECTION AND PREPARATION
                                                                                                                                                be in the test region (T). This negative result indicates that the
disorders. The peak effect of smoking Marijuana occurs in 20-30                                   Urine Assay                                   Marijuana concentration is below the detectable level of 50
minutes and the duration is 90-120 minutes after one cigarette.       The urine specimen must be collected in a clean and dry container.        ng/mL.
Elevated levels of urinary metabolites are found within hours of      Urine collected at any time of the day may be used. Urine                 * NOTE: The shade of red in the test region (T) may vary, but it
exposure and remain detectable for 3-10 days after smoking. The       specimens exhibiting visible precipitates should be centrifuged,          should be considered negative whenever there is even a faint pink line.
main metabolite excreted in the urine is 11-nor-∆9-                   filtered, or allowed to settle to obtain a clear supernatant for
tetrahydrocannabinol-9-carboxylic acid (∆9-THC-COOH).                                                                                           POSITIVE: One red line appears in the control region (C).
                                                                      testing.                                                                  No line appears in the test region (T). This positive result indicates
The THC One Step Marijuana Test Strip (Urine) is a rapid urine
screening test that can be performed without the use of an                                     Specimen Storage                                 that the Marijuana concentration is above the detectable level of 50
instrument. The test utilizes a monoclonal antibody to                Urine specimens may be stored at 2-8°C for up to 48 hours prior to        ng/mL.
selectively detect elevated levels of Marijuana in urine. The THC     testing. For prolonged storage, specimens may be frozen and stored        INVALID: Control line fails to appear. Insufficient
One Step Marijuana Test Strip (Urine) yields a positive result when   below -20°C. Frozen specimens should be thawed and mixed before           specimen volume or incorrect procedural techniques are the
the concentration of Marijuana in urine exceeds 50 ng/mL. This is     testing.                                                                  most likely reasons for control line failure. Review the
the suggested screening cut-off for positive specimens set by the                              MATERIALS                                        procedure and repeat the test with a new test strip. If the
Substance Abuse and Mental Health Services Administration                                                                                       problem persists, discontinue using the test kit immediately
(SAMHSA, USA). 1                                                                              Materials Provided                                and contact your local distributor.
                          PRINCIPLE                                   •    Test strips
                                                                                                                                                                    QUALITY CONTROL
                                                                      •    Package insert
The THC One Step Marijuana Test Strip (Urine) is a rapid                                                                                        A procedural control is included in the test. A red line appearing
chromatographic immunoassay based on the principle of                              Materials Required But Not Provided                          in the control region (C) is considered an internal procedural
competitive binding. Drugs which may be present in the urine          •    Specimen collection container                                        control. It confirms sufficient specimen volume and correct
specimen compete against the drug conjugate for binding sites on      •    Timer                                                                procedural technique.
the antibody.                                                                                                                                   Control standards are not supplied with this kit; however it is
During testing, a urine specimen migrates upward by capillary                             DIRECTIONS FOR USE
                                                                                                                                                recommended that positive and negative controls be tested as
action. Marijuana, if present in the urine specimen below 50          Allow the test strip, urine specimen, and/or controls to                  good laboratory testing practice to confirm the test procedure
ng/mL, will not saturate the binding sites of the antibody coated     equilibrate to room temperature (15-30°C) prior to testing.               and to verify proper test performance.
                            LIMITATIONS                                    and 0 ng/mL. The result demonstrates 100% accuracy at 50%               Benzoic acid            Ketoprofen                D,L-Propanolol
                                                                           above and 50% below the cut-off concentration. The data are             Benzoylecgonine         Labetalol                 D-Propoxyphene
1.      The THC One Step Marijuana Test Strip (Urine) provides             summarized below:
        only a quantitative, preliminary analytical result. A                                                                                      Benzphetamine           Levorphanol               D-Pseudoephedrine
        secondary analytical method must be used to obtain a                                                                   Visual Result       Bilirubin               Loperamide                Quinidine
                                                                                                   Percent of
        confirmed         result.      Gas       chromatography/mass      THC Concentration         Cut-off        n                               Brompheniramine         Maprotiline               Quinine
                                                                              (ng/mL)                                      Negative     Positive
        spectrophotometry (GC/MS) is the preferred confirmatory                                                                                    Caffeine                Meprobamate               Ranitidine
        method.1,2                                                                0                    0          30          30           0       Cannabidiol             Methadone                 Salicylic acid
2.      It is possible that technical or procedural errors, as well as           25                   50%         30          30           0       Chloralhydrate          Methoxyphenamine          Secobarbital
        other interfering substances in the urine specimen may                  37.5                  75%         30          12           18      Chloramphenicol         (+) 3,4-Methylenedioxy-   Serotonin (5-
        cause erroneous results.                                                 50                  Cut-off      30          1            29      Chlordiazepoxide        amphetamine               Hydroxytyramine)
3.      Adulterants, such as bleach and/or alum, in urine specimens             62.5                 125%         30          1            29      Chlorothiazide          (+) 3,4-Methylenedioxy-   Sulfamethazine
        may produce erroneous results regardless of the analytical               75                  150%         30          0            30
                                                                                                                                                   (±) Chlorpheniramine    methamphetamine           Sulindac
        method used. If adulteration is suspected, the test should be                          Analytical Specificity                              Chlorpromazine          Methylphenidate           Temazepam
        repeated with another urine specimen.                              The following table lists compounds and their respective                Chlorquine              Methyprylon               Tetracycline
4.      A positive result does not indicate level of intoxication,         concentrations in urine that yield a positive result in the THC         Cholesterol             Morphine-3-β-D-           Tetrahydrocortisone, 3
        administration route or concentration in urine.                    One Step Marijuana Test Strip (Urine) at 5 minutes.                     Clomipramine            glucuronide               Acetate
5.      A negative result may not necessarily indicate drug-free                                                                                   Clonidine               Nalidixic acid            Tetrahydrocortisone 3 (β-
        urine. Negative results can be obtained when drug is                     Compound                           Concentration (ng/mL)
                                                                            Cannabinol                                     20,000                  Cocaine hydrochloride   Nalorphine                D glucuronide)
        present but below the cut-off level of the test.                                                                                           Codeine                 Naloxone                  Tetrahydrozoline
6.      Test does not distinguish between drugs of abuse and                        8
                                                                            11-nor-∆ - THC-9 COOH                            30
                                                                                                                                                   Cortisone               Naltrexone                Thebaine
        certain medications.                                                        9
                                                                            11-nor-∆ -THC-9 COOH                             50                    (-) Cotinine            Naproxen                  Thiamine
            PERFORMANCE CHARACTERISTICS                                     ∆ -THC
                                                                             8
                                                                                                                           15,000                  Creatinine              Niacinamide               Thioridazine
                                                                            ∆ -THC
                                                                             9
                                                                                                                           15,000                  Deoxycorticosterone     Nifedipine                D, L-Thyroxine
                              Accuracy
A three way side-by-side comparison was conducted using the THC One                                   Precision                                    Dextromethorphan        Norcodein                 Tolbutamine
Step Marijuana Test Strip (Urine) and a leading commercially available     A study was conducted at 3 physician’s offices by untrained             Diazepam                Norethindrone             Triamterene
THC rapid test. Testing was performed on specimens previously collected    operators using 3 different lots of product to demonstrate the          Diclofenac              D-Norpropoxyphene         Trifluoperazine
from subjects presenting for Drug Screen Testing. Presumptive positive     within run, between run and between operator precision. An              Diflunisal              Noscapine                 Trimethoprim
results were confirmed by GC/MS. The following results were tabulated:     identical panel of coded specimens containing, according to             Digoxin                 D,L-Octopamine            Trimipramine
             Method             Other THC Rapid Test           Total       GC/MS, no THC, 25% THC above and below the cut-off, and                 Diphenhydramine         Oxalic acid               Tryptamine
                                                                           50% THC above and below the 50 ng/mL cut-off was provided               Doxylamine              Oxazepam                  D, L-Tryptophan
     THC One         Results     Positive   Negative          Results
                                                                           to each site. For the specimens below the 25 % cut-off                  Ecgonine                Oxolinic acid             Tyramine
        Step         Positive      140         0                140                                                                                Ecgonine methylester    Oxycodone                 PrD, L-Tyrosine
     Test Strip      Negative       3         157               160
                                                                           concentration, the 3 sites demonstrated 98% agreement with
                                                                           each other. For the –25% to +25% cut-off specimens, the 3 sites         (-) Y Ephedrine         Oxymetazoline             Uric acid
          Total Results            143        157               300        demonstrated 83% agreement with each other. For specimens               Erythromycin            p-Hydroxy-                Verapamil
     % Agreement with this                                                 above the 25% cut-off concentration, the 3 sites demonstrated           β-Estradiol             methamphetamine           Zomepirac
                                   98%            100%         99%                                                                                 Estrone-3-sulfate       Papaverine
         Rapid Test Kit                                                    94% agreement with each other. For all results, the 3 sites were
When compared to GC/MS at 50 ng/mL, the following results                  found to have a 91% agreement with each other.                          Ethyl-p-                Penicillin-G
were tabulated:                                                                                    Cross-Reactivity                                                          BIBLIOGRAPHY
             Method                     GC/MS                Total         A study was conducted to determine the cross-reactivity of the test
                    Results       Positive   Negative       Results        with compounds in either drug-free urine or Marijuana positive           1.   Hawwks RL, CN Chiang. Urine Testing for Drugs of
     THC One
                                                                           urine. The following compounds show no cross-reactivity when                  Abuse. National Institute for Drug Abuse (NIDA), Research
       Step         Positive        118         22            140                                                                                        Monograph 73, 1986
     Test Strip     Negative         4         156            160
                                                                           tested with the THC One Step Marijuana Test Strip (Urine) at a
                                                                           concentration of 100 µg/mL.                                              2.   Baselt RC. Disposition of Toxic Drugs and Chemicals in
          Total Results             122        178            300                                                                                        Man. 2nd Ed. Biomedical Publ., Davis, CA. 1982; 488
                                                                                           Non Cross-Reacting Compounds
       % Agreement with
                                   97%           88%          92%         4-Acetamidophenol      Fenoprofen               Pentazocine
      GC/MS at 50 ng/mL
When compared to GC/MS at 25 ng/mL, the following results
                                                                          Acetophenetidin        Furosemide               Pentobarbital                       Nova Century Scientific Inc.
                                                                          N-Acetylprocainamide   Gentisic acid            Perphenazine
were tabulated:                                                                                                                                                        5026 South Service Road
                                                                          Acetylsalicylic acid   Hemoglobin               Phencyclidine
          Method                         GC/MS               Total        Aminopyrine            Hydralazine              Phenelzine                                 Burlington, Ontario L7L 5Y7
  THC One         Results        Positive    Negative       Results       Amitryptyline          Hydrochlorothiazide      Phenobarbital                                  Tel: 1-800-615-5072
    Step          Positive         135          5             140         Amobarbital            Hydrocodone              Phentermine                                    Fax: 1-800-639-9006
  Test Strip      Negative          6          154            160         Amoxicillin            Hydrocortisone           L-Phenylephrine                           E-mail: info@novacentury .com
       Total Results               141         159            300         Ampicillin             O-Hydroxyhippuric acid   β-Phenylethlamine                         Web Site: www.novacentury.com
                                                                          Ascorbic acid          3-Hydroxytyramine        β-Phenyllethylamine
 % Agreement with GC/MS
                                  96%           97%           96%         D,L-Amphetamine        Ibuprofen                Phenylpropanolamine
        at 25 ng/mL                                                                                                                                                                                      No.: R015098-02
                                                                          L-Amphetamine          Imipramine               Prednisolone
                    Analytical Sensitivity                                Apomorphine            Iproniazid               Prednisone                                                                           Eff Date:
                                                                          Aspartame              (-) Isoproterenol        Procaine                                                                       0402
A drug-free urine pool was spiked with 11-nor-∆9-
Tetrahytrocannabinol-9-carboxylic acid at the following                   Atropine               Isoxsuprine              Promazine
concentrations: 75 ng/mL, 62.5 ng/mL, 37.5 ng/mL, 25 ng/mL,               Benzilic acid          Ketamine                 Promethazine

				
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