AMP/BAR/BZO/COC/MOP/THC Test Panel
Intended Use
The one step AMP/BAR/BZO/COC/MOP/THC Test Panel is a lateral flow chromatographic immunoassay for the detection of Amphetamine, Barbiturates, Cocaine, Methamphetamine, Opiate and Marijuana in human urine.
|
Test |
Calibrator |
Cutoff |
|
AMP |
Amphetamine |
1000ng/ml |
|
BAR |
Barbiturates |
300ng/ml |
|
BZO |
Benzodiazepines |
300ng/ml |
|
COC |
Cocaine |
300ng/ml |
|
MOP |
Morphine (Opiate) |
300ng/ml |
|
THC |
Marijuana |
50ng/ml |
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.
Principle
AMP/BAR/BZO/COC/MOP/THC Test Panel has been designed to detect Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Morphine and Marijuana through visual interpretation of color development in the strip. The membrane was immobilized with Drug antigens conjugates on the test region, and the sample pad was pre-coated with colored anti- drugs antibodies colloidal gold conjugates. After specimens were added, the gold-conjugates move along the membrane chromatographically by capillary action and antibodies get to the test region. If there is no drug molecule in the urine the antibody gold conjugate would attach to the drug conjugate to form a visible line. Therefore, the formation of a visible precipitant in the test region occurs when the urine is negative for the drug. If Amphetamine, Barbiturates, Cocaine, Methamphetamine, Opiate and Marijuana are present in the urine, the drug antigen competes with the immobilized drug conjugate on the test region for limited antibody sites. In case of sufficient concentration of the drug, it fills the limited antibody binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate to the drug conjugate zone on the test region. Therefore, absence of the colored band on the test region indicates a positive result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
Kit Components
| Test Panels | Disposable pipettes | Packaging Insert |
Materials Required but Not Provided
| Timer | Specimen collection container |
Precautions
★ For professional in vitro diagnostic use only.
★ Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
★ This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
★ Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
★ Read the entire procedure carefully prior to performing any tests.
★ Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
★ Humidity and temperature can adversely affect results.
★ The used testing materials should be discarded in accordance with local, state and/or federal regulations.
Storage and Stability
✽ The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
✽ The test must remain in the sealed pouch until use.
✽ Do not freeze.
✽ Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.
Specimen Collection and Storage
✔ The AMP/BAR/BZO/COC/MOP/THC Test Panel is intended only for use with human urine specimens.
✔ Collected urine specimens must be put in clear and dry containers. Ensure that a sufficient quantity of the specimen is collected to allow submerging the dipping area of the strip.
✔ Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 48 hours. For long term storage, specimens should be kept below -20°C.
✔ Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
✔ Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.
Procedure
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1.Remove the panel from its sealed pouch and use it as soon as possible. To obtain a best result, the assay should be performed within one hour.
2.Collect the urine in a urine cup, insert the test panel into the urine and make sure the urine do not pass the max line.
3.The result should be read at 5 minutes. Do not interpret the result after 20 minutes.
Precautions for Use
POSITIVE RESULT:
|
* A colored band appears in the control band region (C) and another colored band appears in the T band region. |
| NEGATIVE RESULT:
|
One colored band appears in the control band region (C). No band appears in the test band region (T). |
| INVALID RESULT:
|
Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
Note
1.The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered negative. Besides, the concentration level can not be determined by this qualitative test.
2.Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
Quality Control
★ Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique.
★ External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance
Limitations of the Test
1.The AMP/BAR/BZO/COC/MOP/THC Test Panel is for professional in vitro diagnostic use, and should be used for the qualitative detection of morphine and other opiates only.
2.The AMP/BAR/BZO/COC/MOP/THC Test Panel provides only a quantitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method.
3.Please take the specificity and the cross reactivity into account for evaluation
4.A positive result with any of the tests indicates the presence of a drug/metabolite only, and does not indicate or measure intoxication.
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.There is a possibility that technical or procedural errors as well as other substances and factors not listed may interfere with the test and cause false results.
7.The test is designed for use with human urine only. Due to absence of ions and other components in pure water the usage or pure water for test could lead to false or invalid results.
8.Foods and tea containing poppy products (the origin of opiates) may also produce a positive result.
9.The test does not distinguish between drugs of abuse and certain medications.
Performance Characteristics
Analytical Sensitivity
A drug-free urine pool was spiked with drugs at the following concentrations: +/- 25%, +/- 50% and cutoff. The data are summarized below:
|
Percent of Cut-off |
n |
AMP |
BAR |
BZO |
|||
|
- |
+ |
- |
+ |
- |
+ |
||
|
0 |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-50% |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-25% |
30 |
23 |
7 |
28 |
2 |
30 |
0 |
|
Cut-off |
30 |
9 |
21 |
4 |
26 |
3 |
27 |
|
+25% |
30 |
1 |
29 |
0 |
30 |
0 |
30 |
|
+50% |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
|
Percent of Cut-off |
n |
COC |
MOP |
THC |
|||
|
- |
+ |
- |
+ |
- |
+ |
||
|
0 |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-50% |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-25% |
30 |
30 |
0 |
27 |
3 |
30 |
0 |
|
Cut-off |
30 |
4 |
26 |
5 |
25 |
7 |
23 |
|
+25% |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
|
+50% |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
Analytical Specificity
The following table lists compounds that are positively detected in urine by the AMP One Step Amphetamine Test Strip (Urine) at 5 minutes.
| Related Compound | Concentration (ng/mL) |
| AMP | |
| D-Amphetamine | 1,000 |
| D,L-Amphetamine sulfate | 3,000 |
| L-Amphetamine | 50,000 |
| (±) 3,4-MethylenedioxyAmphetamine | 2,000 |
| Phentermine | 3,000 |
| BAR | |
| Secobarbital | 300 |
| Amobarbital | 300 |
| Alphenol | 150 |
| Aprobarbital | 200 |
| Butalbital | 2,500 |
| Butethal | 100 |
| Cyclopentobarbital | 600 |
| Pentobarbital | 300 |
| Butabarbital | 75 |
| Phenobarbital | 100 |
| BZO | |
| Alprazolam | 125 |
| Bromazepam | 625 |
| Chlordiazepoxide | 2,500 |
| Clobazam | 63 |
| Clonazepam | 2,500 |
| Clorazepate dipotassium | 3,330 |
| Delorazepam | 2,500 |
| Desalkylflurazepam | 250 |
| Diazepam | 250 |
| Estazolam | 5,000 |
| Flunitrazepam | 375 |
| (±) Lorazepam | 1,250 |
| RS-Lorazepam glucuronide | 1,250 |
| Midazolam | 100,000 |
| Nitrazepam | 25,000 |
| Norchlordiazepoxide | 250 |
| Nordiazepam | 500 |
| Oxazepam | 300 |
| Sulindac | 100,000 |
| Temazepam | 63 |
| Triazolam | 5,000 |
| COC | |
| Benzoylecgonine | 300 |
| Cocaine HCl | 780 |
| Cocaethylene | 12,500 |
| MOP | |
| Codeine | 300 |
| Ethylmorphine | 6,250 |
| Hydrocodone | 50,000 |
| Hydromorphone | 3,125 |
| Levophanol | 1,500 |
| 6-Monoacethylmorphine | 400 |
| Morphine | 300 |
| Morphine 3-b-D-glucuronide | 1,000 |
| Norcodeine | 6,250 |
| Normorphone | 100,000 |
| Oxycodone | 30,000 |
| Oxymorphone | 100,000 |
| Procaine | 15,000 |
| Thebaine | 6,250 |
| THC | |
| 11-nor-Δ9-THC-9-COOH | 50 |
| 11-nor-Δ8-THC-9-COOH | 50 |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 20000 |
| Δ8-Tetrahydrocannabinol | 15000 |
| Δ9-Tetrahydrocannabinol | 20000 |
| Cannabinol | 20000 |
| Cannabidiol | 100000 |
The following compounds yielded negative results up to a concentration of 100 µg/mL:
|
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 |
|
Ampicillin |
Hydrochlorothiazide |
Phencyclidine |
|
L-Ascorbic acid |
Hydrocodone |
Phenelzine |
|
Apomorphine |
Hydrocortisone |
Phenobarbital |
|
Aspartame |
p-HydroxyAmphetamine |
L-Phenylephrine |
|
Atropine |
O-Hydroxyhippuric acid |
Brompheniramine |
|
Benzilic acid |
3-Acetate |
Phenylpropanolamine |
|
Benzoic acid |
Acetaminophen |
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 |
|
Chloramphenicol |
Levorphanol |
Quinine |
|
Chlordiazepoxide |
Loperamide |
Ranitidine |
|
Chlorothiazide |
Maprotiline |
Salicylic acid |
|
(±) Chlorpheniramine |
Meperidine |
Secobarbital |
|
Chlorpromazine |
Meprobamate |
Nalorphine |
|
Chlorquine |
Methadone |
Iproniazid |
|
Cholesterol |
D-methAmphetamine |
Sulfamethazine |
|
Clomipramine |
(L)-methAmphetamine |
Sulindac |
|
Clonidine |
Methoxyphenamine |
Temazepam |
|
Cocaine hydrochloride |
Tetrahydrocortisone, |
Tetracycline |
|
Codeine |
Phentermine |
Acetone |
|
Cortisone |
L-Epinephrine |
(-)-ψ-Ephedrine |
|
(-) Cotinine |
b-Phenylethylamine |
(-) Y Ephedrine |
|
Creatinine |
Methylphenidate |
Chlorpheniramin |
|
Deoxycorticosterone |
(1R,2S)-(-)-Ephedrine |
Tetrahydrozoline |
|
Dextromethorphan |
D,L-Amphetamine sulfate |
Thebaine |
|
Diazepam |
Nalidixic acid |
Thiamine |
|
Diclofenac |
Naloxone |
Thioridazine |
|
Diflunisal |
Naltrexone |
Tolbutamine |
|
Digoxin |
Naproxen |
Triamterene |
|
Diphenhydramine |
Niacinamide |
Trifluoperazine |
|
Doxylamine |
Nifedipine |
Trimethoprim |
|
Ecgonine hydrochloride |
Norcodein |
D,L-Propranolol |
|
Ecgonine methylester |
Norethindrone |
D, L-Tryptophan |
|
(IR,2S)-(-)-Ephedrine |
D-Norpropoxyphene |
Tyramine |
|
L-Ephedrine |
Noscapine |
D, L-Tyrosine |
|
(-)-ψ- Ephedrine |
D,L-Octopamine |
Uric acid |
|
Erythromycin |
Oxalic acid |
Verapamil |
|
b-Estradiol |
Oxazepam |
Zomepirac |
|
Cocaethylene |
(±) - 3,4-Methylenedioxy- |
(±)-Brompheniramine |
|
(±) Isoproterenol |
amphetamine |
3-Acetate |
|
Morphine Sulfate |
(±) - 3,4-Methylenedioxy |
D,L-Tyrosine |
|
Tolbutamide |
methmphetamine |
3-(b-D-glucuronide) |
|
(±) - Chlorpheniramine |
Quinacrine |
MDE |
|
(-) -ψ-Ephedrine |
Dicyclomine |
Tryptamine |
|
[1R,2S] (-) Ephedrine |
Mehentermine |
D,L-Tryptophan |
|
L - Epinephrine |
D/L-Propranolol |
L-Ψ-Ephedrine |
|
Quindine |
Buspirone |
Aspirin |
|
Chloroquine |
D-Amphetamine |
L-Amphetamine |
|
Phenolbarbital |
D,L-Amphetamine |
Pheniramine |
|
Nimesulide |
Creatin |
Phenothiazine |
|
b-Hydroxynorephedrtne |
Dexbrompheniramine |
Phenylethylamine |
|
D/L-Tryptophan |
D/L-Octopamine |
Quinjdin |
|
Tetrahydrocortisone |
Dopamine |
Ranitidin |
|
propylamine |
Ethanol |
Riboflavine |
|
(±) -Brompheniramine |
3-(b-D glucuronide) |
Glucose |
|
Chloroquin |
(+/-)-Isoproterenol |
Sodium Chloride |
|
L-Epinephrine |
Albumin |
Thioridazin |
|
Theophylline |
Lidocaine |
Trifluoperazin |
|
D/L-Chloropheniramine |
Amitriptylin |
Trimethobenzamid |
|
Imipramin |
3-acetate |
Vitamin C |
|
(-)Isoproterenol |
D/L-Tyrosine |
Benzocaine |
|
(±) -Isoproterenol |
Trazodone |
Coffeine |
|
Trans-2- phenylcyclopropylamine |
p-Hydroxy-methAmphetamine |
Guaiacol Glyceryl Ether |
|
Tetrahydrocortisone 3 (b-D glucuronide) |
4-Dimethylaminoantipyrine |
(+/-)-Chlorpheniramin |
|
(+)3,4-Methylenedioxy-amphetamine |
Morphine-3-b-D glucuronide |
Morphine-3-b-D-glucuronide |
|
Trans-2-phenylcyclo-propylamine hydrochloride |
3,4-Methylenedioxyethyl-Amphetamine |
(+) 3,4-Methylenedioxy-methAmphetamine |
|
Tetrahydrocortisone 3 (b-D glucuronide) |
Pentazocine hydrochloride |
Tetrahydrocortisone, 3 Acetate |
|
Serotonin (5-Hydroxytyramine) |
(+) 3,4-Methylenedioxy-amphetamine |
Literature References
1.Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, Biomedical Publications, 1982.
2.Urine Testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA), Research Monograph 73, 1986.
3.Thomas L. eds., Labor und Diagnose, 6. ed., TH-Books Verlags gesellschaft, Frankfurt, 2005
4.Fed. Register, Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs, 53, 69, 11970, 1988.
5.McBay, A.J. Clin. Chem. 33, 33B-40B, 1987.
