Velo Multi-Drugs Rapid Test
Catalog Number: VE242002
Package Specification: 20 tests/kit
Kit Content
- Test Devices: 20 pieces test panel individually pouched.
- Package insert: 1 piece attached.
| Test | Calibrator |
| Amphetamine (AMP) | D-Amphetamine |
| Barbiturates (BAR) | Secobarbital |
| Benzodiazepines (BZO) | Oxazepam |
| Cocaine (COC) | Benzoylecgonine |
| Marijuana (THC) | 11-nor-D9-THC-9 COOH |
| Methadone (MTD) | Methadone |
| Methamphetamine (MET) | D-Methamphetamine |
| Methylenedioxymethamphetamine (MDMA) | D, L-Methylenedioxymethamphetamine |
| Opiates/Morphine (MOP) | Morphine |
| Tricyclic Antidepressants (TCA) | Nortriptyline |
Intended Use
Velo Multi-Drugs (2-10 Strips) Rapid Test Panel is a lateral flow chromatographic immunoassay test device for the qualitative detection of following drugs.
Sample Collection and Preparation
Additional Materials Needed (but Not Included in the Kit)
- Timer or stopwatch.
- Specimen collection containers
- Disposable gloves and/or protective clothing
Sample Collection and Preparation
- Velo Multi-Drugs (2-10 Strips) Rapid Test Panel (Urine is intended for use with human urine specimens only).
- Urine collected at any time of the day may be used.
- Turbid specimens should be centrifuged, filtered, or allowed to settle and only the clear supernatant should be used for testing.
- Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Urine specimens may be stored at 2-8°C for up to 2 days. 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.
If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological
Test Procedure
Allow the test panel, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.
- Bring the pouch to room temperature before opening it. Remove the test panel from the sealed pouch and use it as soon as possible.
- Take off the cap outside of the test end. With arrows pointing toward the urine specimen, immerse the test panel vertically into the urine specimen for at least 15-20 seconds. Immerse the test panel to at least the level of the wavy lines on the strip(s), do not pass the arrows on the test panel when immersing the panel. Then close it. see the illustration below.
- Place the test panel 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.
Quality Control
An internal procedural control is included in the test. a colored line appearing in the control line region (C) is an internal valid procedural control, it confirming adequate membrane wicking. Control standards are not supplied with this kit; however, 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.
Results
Interpretation of Results
NEGATIVE: * Two lines appear. One colored line should be in the control line region (C), and another apparent colored line should be in the test line region (T). This negative result indicates that the drug concentration is below the detectable level.
*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 colored line.
POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). This positive result indicates that the drug concentration exceeds 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 cassette. If the problem persists, discontinue using the lot immediately and contact your local distributor.
Specific Characteristics
Positive cutoff reference range
According to the requirements of American drug abuse and mental health service administration (SAMHSA) for the cutoff value of drugs of abuse in urine, the detection threshold is set as following table stated.
| Test | Cut-off |
| Amphetamine (AMP) | 1,000 ng/mL |
| Barbiturates (BAR) | 300 ng/mL |
| Benzodiazepines (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Methamphetamine (MET) | 1,000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Opiates/Morphine (MOP) | 300 ng/mL |
| Tricyclic Antidepressants (TCA) | 1,000 ng/mL |
Sensitivity and Specificity Accuracy
A clinical study was conducted using Velo Multi-Drugs (2-10 Strips) Rapid Test Panel and GC/MS. Testing was performed on 150 pieces positive urine specimens and 150 pieces negative urine specimens previously collected and confirmed by GC/MS. The results indicated that Velo Multi-Drugs (2-10 Strips) Rapid Test Panel has a high sensitivity and specificity as summarized below:
| Positive Agreement | Negative Agreement | Total Results | |
| AMP | 95% | >99% | 98% |
| BAR | 99% | >99% | 100% |
| BZO | 93% | 98% | 95% |
| COC | 96% | >99% | 98% |
| THC | >99% | >99% | >99% |
| MTD | >99% | >99% | >99% |
| MET | >99% | >99% | >99% |
| MDMA | >99% | 99% | 100% |
| OPI/MOP | 99% | 100% | 99% |
| TCA | 97% | >99% | 98% |
Analytical Sensitivity
A piece of drug-free urine was spiked with drugs to the concentrations at ± 50% cut-off and ± 25% cut-off. Each titer was repeated 30 pieces of test. The results are summarized below.
| Drug Conc. | AMP1000 | BAR300 | ||
| (Cut-off range) | POS/+ | NEG/- | POS/+ | NEG/- |
| 0% Cut-off | 0 | 30 | 0 | 30 |
| -50% Cut-off | 0 | 30 | 0 | 30 |
| -25% Cut-off | 7 | 23 | 10 | 20 |
| Cut-off | 21 | 9 | 17 | 13 |
| +25% Cut-off | 29 | 1 | 22 | 8 |
| +50% Cut-off | 30 | 0 | 30 | 0 |
| Drug Conc. | BZO300 | COC300 | ||
| (Cut-off range) | POS/+ | NEG/- | POS/+ | NEG/- |
| 0% Cut-off | 0 | 30 | 0 | 30 |
| -50% Cut-off | 0 | 30 | 0 | 30 |
| -25% Cut-off | 4 | 26 | 0 | 30 |
| Cut-off | 18 | 12 | 21 | 9 |
| +25% Cut-off | 27 | 3 | 23 | 7 |
| +50% Cut-off | 30 | 0 | 30 | 0 |
| Drug Conc. | THC50 | MTD300 | ||
| (Cut-off range) | POS/+ | NEG/- | POS/+ | NEG/- |
| 0% Cut-off | 0 | 30 | 0 | 30 |
| -50% Cut-off | 0 | 30 | 0 | 30 |
| -25% Cut-off | 0 | 30 | 4 | 26 |
| Cut-off | 9 | 21 | 14 | 16 |
| +25% Cut-off | 13 | 17 | 26 | 4 |
| +50% Cut-off | 30 | 0 | 30 | 0 |
| Drug Conc. | MET1000 | MDMA500 | ||
| (Cut-off range) | POS/+ | NEG/- | POS/+ | NEG/- |
| 0% Cut-off | 0 | 30 | 0 | 30 |
| -50% Cut-off | 0 | 30 | 0 | 30 |
| -25% Cut-off | 6 | 24 | 7 | 23 |
| Cut-off | 12 | 18 | 15 | 15 |
| +25% Cut-off | 29 | 1 | 24 | 6 |
| +50% Cut-off | 30 | 0 | 30 | 0 |
| Drug Conc. | MOP300 | TCA1000 | ||
| (Cut-off range) | POS/+ | NEG/- | POS/+ | NEG/- |
| 0% Cut-off | 0 | 30 | 0 | 30 |
| -50% Cut-off | 0 | 30 | 0 | 30 |
| -25% Cut-off | 2 | 28 | 4 | 26 |
| Cut-off | 20 | 10 | 16 | 14 |
| +25% Cut-off | 27 | 3 | 26 | 4 |
| +50% Cut-off | 30 | 0 | 30 | 0 |
Analytical Specificity
The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by Velo Multi-Drugs (2-10 Strips) Rapid Test Panel at 5 minutes.
AMP
| Compounds | Conc. ng/ml |
| d-Amphetamine | 1,000 |
| d,l-Amphetamine | 3,000 |
| l-Amphetamine | 50,000 |
| d,l-3,4-Methylenedioxyamphetamine (MDA) | 2,000 |
BAR
| Compounds | Conc. ng/ml |
| Secobarbital | 300 |
| Alphenal | 150 |
| Amobarbital | 300 |
| Aprobarbital | 200 |
| Butabarbital | 75 |
| Butalbital | 2,500 |
| Butethal | 100 |
| Cyclopentobarbital | 600 |
| Pentobarbital | 300 |
| Phenobarbital | 100 |
BZO
| Compounds | Conc. ng/ml |
| Oxazepam | 300 |
| Alprazolam | 196 |
| Bromazepam | 1,562 |
| Chlordiazepoxide | 1,562 |
| Clobazam | 98 |
| Clonazepam | 781 |
| Clorazepate | 195 |
| Delorazepam | 1,562 |
| Desalkylflurazepam | 390 |
| Diazepam | 195 |
| Estazolam | 2,500 |
| Flunitrazepam | 390 |
| α-Hydroxyalprazolam | 1,262 |
| d,l-Lorazepam | 1,562 |
| RS-Lorazepam glucuronide | 156 |
| Midazolam | 12,500 |
| Nitrazepam | 98 |
| Norchlordiazepoxide | 195 |
| Nordiazepam | 390 |
| Temazepam | 98 |
| Triazolam | 2,500 |
COC
| Compounds | Conc. ng/ml |
| Benzoylecgonine | 300 |
| Cocaine | 782 |
| Cocaethylene | 12500 |
| Ecgonine | 3200 |
THC
| Compounds | Conc. ng/ml |
| 11-nor-9-THC-9 COOH | 50 |
| Cannabinol | 20,000 |
| 11-nor-8-THC-9 COOH | 30 |
| 8-THC | 15,000 |
| 9-THC | 15,000 |
MTD
| Compounds | Conc. ng/ml |
| Méthadone | 300 |
| Doxylamine | 50.000 |
MET
| Compounds | Conc. ng/ml |
| d-Methamphetamine | 1,000 |
| p-Hydroxymethamphetamine | 30,000 |
| Mephentermine | 50,000 |
| l-Methamphetamine | 8,000 |
| d,l-3,4-Methylenedioxymethamphetamine (MDMA) | 2,000 |
MDMA
| Compounds | Conc. ng/ml |
| d,l-3,4-Methylenedioxymethamphetamine (MDMA) | 500 |
| d,l-3,4-Methylenedioxyamphetamine (MDA) | 3,000 |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 300 |
MOP
| Compounds | Conc. ng/ml |
| Morphine | 300 |
| Codeine | 300 |
| Ethylmorphine | 6250 |
| Hydrocodone | 50000 |
| Hydromorphone | 3,125 |
| Levorphanol | 1,500 |
| 6-Monoacetylmorphine (6-MAM) | 400 |
| Morphine 3-b-D-glucuronide | 1,000 |
| Norcodeine | 6,250 |
| Normorphine | 100,000 |
| Oxycodone | 30,000 |
| Oxymorphone | 100,000 |
| Procaine | 150,000 |
| Thebaine | 6,250 |
TCA
| Compounds | Conc. ng/ml |
| Nortriptyline | 1,000 |
| Amitriptyline | 1,500 |
| Clomipramine | 12,500 |
| Desipramine | 200 |
| Doxepin | 2,000 |
| Imipramine | 400 |
| Maprotiline | 2,000 |
| Nordoxepin | 1,000 |
| Promazine | 1,500 |
| Promethazine | 25,000 |
| Trimipramine | 3,000 |
Cross-Reactivity
A study was conducted to determine the cross-reactivity of the test with compounds in either drug- free urine or positive urine. The following compounds show no cross-reactivity when tested with Velo Multi-Drugs (2-10 Strips) Rapid Test Panel at a concentration of 100 μg/mL.
| Non Cross-Reacting Compounds | ||
| 4-Acetamidophenol | Ethyl alcohol | Orphenadrine |
| Acetone | Ethyl-p-aminobenzoate | Oxalic acid |
| Acetophenetidin | Etodolac | Oxolinic acid |
| Acetylsalicylic acid | Famprofazone | Oxymetazoline |
| Albumin | Fenoprofen | Papaverine |
| alpha-Naphthaleneacetic Acid | Fluoxetine | Pemoline |
| Aminopyrine | Furosemide | Penicillin |
| Amoxapine | Gentisic acid | Pentazocine |
| Amoxicillin | d-Glucose | Phenelzine |
| Ampicillin | Guaiacol Glyceryl Ether | Pheniramine |
| ApoAmphetamine | Hemoglobin | Phenothiazine |
| Ascorbic acid | Hydralazine | Prednisolone |
| Aspartame | Hydrochlorothiazide | Prednisone |
| Atropine | Hydrocortisone | d,l-Propanolol |
| Benzilic acid | o-Hydroxyhippuric acid | Quinacrine |
| Benzoic acid | 3-Hydroxytyramine | Quinidine |
| Benzydamine | Ibuprofen | Quinine |
| Brompheniramine | Iproniazid | R(-) Deprenyl |
| Caffeine | Isoproterenol | Riboflavin |
| Cannabidiol | Isoxsuprine | Salicylic acid |
| Chloral Hydrate | Kanamycin | Serotonin |
| Chloramphenicol | Ketoprofen | Seroquel |
| Chloroquine | Labetalol | Sertraline |
| Chlorothiazide | Lidocaine | Sodium Chloride |
| Chlorpromazine | Lindane | Sulfamethazine |
| Chlorprothixene | Lithium | Sulindac |
| Cholesterol | Loperamide | Tetracycline |
| Cimetidine | l-Thyroxine | Tetrahydrocortison-3-acetate |
| Clonidine | Meperidine | Tetrahydrozoline |
| Cortisone | Meprobamate | Theophylline |
| Creatinine | Methaqualone | Thiamine |
| Deoxycorticosterone | Methoxyphenamine | Thioridazine |
| Dextromethorphan | Methylphenidate | Tolbutamide |
| Diclofenac | Metoprolol | Trans-2-phenylcyclopropylamine |
| Dicyclomine | N-Acetylprocainamide | Trazodone |
| Diflunisal | Nalidixic acid | Triamterene |
| Digoxin | Nalorphine | Trifluoperazine |
| 4-Dimethylaminoantipyrine | Naproxen | Trimethoprim |
| Diphenhydramine | Niacinamide | d,l-Tryptophan |
| 5,5-Diphenylhydantoin | Nifedipine | d,l-Tyrosine |
| EMDP | Nimesulide | Uric acid |
| Erythromycin | Norethindrone | Verapamil |
| β-Estradiol | Noscapine | Zomepirac |
| Estrone-3-sulfate | d,l-Octopamine | —– |
Limitation of the Procedure
- Velo Multi-Drugs (2-10 Strips) Rapid Test Panel 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.
- There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
- 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.
- A positive result does not indicate level or intoxication, administration route or concentration in urine.
- 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.
- The test does not distinguish between drugs of abuse and certain medications.
- A positive result may be obtained from certain foods or food supplements.
Storage and Safety
Storage
- Velo Multi-Drugs (2-10 Strips) Rapid Test Panel should be stored between 2-30°C and the shelf life is 24 months.
- If stored refrigerated, ensure that the pouched device is brought to room temperature before opening.
- Do not freeze the kit.
Warnings
- Read the package insert completely before using the product. The instructions must be followed carefully as not doing so may result in inaccurate results.
- Velo Multi-Drugs (2-10 Strips) Rapid Test Panel is for diagnostic use only.
- Perform test at room temperature.
Precautions
- Velo Multi-Drugs (2-10 Strips) Rapid Test Panel is for professional use only.
- The package insert instructions must be followed to ensure optimum test performance.
- The used test device should be discarded according to local regulations.
Handling Precautions
- Do not use if the kit box safety seal is absent, damaged or broken.
- Do not use any device if the pouches have been perforated.
- Each device is for single use only.
- Do not use the kit past the expiration date (this date is printed on the kit box).
- Adequate lighting is required to read the test results.
- The result should be read immediately after the end of the 5 minutes incubation time following the addition of specimen and wash buffer solution. Results should not be read after 10 minutes.