Energy Guide

The CLIA Screen Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for
qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine,
Methylenedioxymethamphetamine, Methamphetamine, Morphine, Methadone, Opiate, Oxycodone,
Phencyclidine, Propoxyphene, Notriptyline and Cannabinoids in human urine at specified cutoff level.
Configurations of the CLIA Screen Multi-Drug Urine Test Cup can consist of any combination of the above
listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method should be used in
order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The test may yield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and
secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription
use or abuse of these drugs.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result,
particularly when the preliminary result is positive.
The multi-drug device may be combined with the adulteration control (Creatinine (CR), Glutaraldehyde (GLU),
Nitrite (NI), pH, Specific Gravity (S.G.), Oxidants (OXI), and/or Pyridium Chlorochromate (PCC)) for the
determination of diluted or adulterated urine specimens. The adulteration control is an important pre-screening
test for drug-testing. (The adulteration tests are optional, customers can distinguish them from the pouch
label).
This package insert applies to both multi-drug cups with and without the adulteration. Therefore, some
information on the performance characteristics of the product may not be relevant to your test. Please refer to
the labels on the pouch and the prints on the test cup to identify which drugs are included in your t
est.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
WHAT IS CLIA SCREEN MULTI-DRUG URINE TEST CUP?
The CLIA Screen Multi-Drug Urine Test Cup is an immunochromatographic assay for the qualitative determination of
multiple drugs in human urine. It is intended for over-the-counter and for prescription use.
The test is intended for over-the-counter (OTC) use as the first step in a two step process to provide
consumers with information concerning the presence or absence of the above stated drug in a urine sample.
Information regarding confirmatory testing – the second step in the process, along with the materials for
shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive
result, the second step in the process, is not provided.
WHAT IS THE CUT-OFF VALUE AND APPROXIMATE DETECTION TIME?
Drug(Identifier) Calibrator Cut-off level
Minimum
detection
time
Maximum
detection
time
Amphetamine (AMP)
d-Amphetamine
1000 ng/mL
2-7 hours
1-2 days
Secobarbital (BAR)
Secobarbital
300 ng/mL
2-4 hours
1-4 days
Buprenorphine (BUP) Buprenorphine
10 ng/mL
4 hours
1-3 days
Oxazepam (BZO)
Oxazepam
300 ng/mL
2-7 hours
1-2 days
Cocaine (COC)
Benzoylecgonine
300 ng/mL
1-4 hours
2-4 days
Methylenedioxymethampheta
mine (MDMA)
3,4-Methylenedioxymetha
mphetamine HCl (MDMA)
500 ng/mL 2-7 hours 2-4 days
Methamphetamine
(MET/mAMP)
D(+)-Methamphetamine
1000 ng/mL 2-7 hours 2-4 days
Morphine (MOP)
Morphine
300 ng/mL
2 hours
2-3 days
Methadone (MTD)
Methadone
300 ng/mL
3-8 hours
1-3 days
Opiate (OPI)
Morphine
2000 ng/mL
2 hours
2-3 days
Oxycodone (OXY)
Oxycodone
100 ng/mL
4 hours
1-3 days
Phencyclidine (PCP)
Phencyclidine
25 ng/mL
4-6 hours
7-14 days
Propoxyphene (PPX)
Propoxyphene
300 ng/mL
8-12hours
5-10days
Notriptyline (TCA)
Notriptyline
1000 ng/mL
8-12hours
2-7 days
Cannabinoids (THC) 11-nor-Δ9-THC-9-COOH 50 ng/mL 2 hours
Up to 5+
days
WARNINGS AND PRECAUTIONS
1. This kit is for external use only. Do not swallow.
2. Discard after first use. The test cannot be used more than once.
3. Do not use test kit beyond expiry date.
4. Do not use the kit if the pouch is punctured or not well sealed.
5. Keep out of the reach of children.
6. Do not read after 5 minutes
7. This kit is for in vitro diagnostic use.
CONTENT OF THE KIT
1. Test devices, one test in one pouch. One pouch containing a test cup with a desiccant. The desiccant
is for storage purposes only, and is not used in the test procedures.
2. Security sealed labels.
3. Leaflet with instructions for use.
4. Adulteration&Adulteration Color Chart (Provided with Kits including Adulterants)
MATERIAL REQUIRED BUT NOT PROVIDED
Timer or clock
STORAGE AND STABILITY
Store at 4ºC-30ºC (40ºF-86ºF) in the sealed pouch up to the expiration date.
Keep away from direct sunlight, moisture and heat.
DO NOT FREEZE.
SPECIMEN COLLECTION
WHEN TO COLLECT URINE FOR THE TEST?
Collect the urine sample for the test in the minimum detection time after the suspected drug use. Exactly when
the urine sample is collected is very important in detecting any drug of abuse. This is because each drug is
cleared by the body and is detected in the urine at different times and rates. Please refer to the section “WHAT
IS THE CUT-OFF VALUE AND APPROXIMATE DETECTION TIME?” in this instruction for use for the
minimum/ maximum detection time for each drug.
HOW TO COLLECT URINE?
1. Remove the test cup from the foil pouch by tearing at the notch and use it as soon as possible. Open
the cap of the test cup and urinate directly into the test cup. Fill the cup to above 25mL mark. It’s
acceptable to have some extra sample. Wipe off any splashes or spills that may be on the outside of
this cup.
2. You may observe the temperature strip affixed on the test cup between 2 to 4 minutes to see if the urine
is diluted by water or liquid other than urine. The temperature range from 32°C-38°C (90ºF-100ºF) is
acceptable.
IMPORTANT: The residual urine sample in the test cup should be enough to reach the 25mL (see the
Minimum Fill Volume scale on the cup label). The residual urine sample in the test cup is for your
self-testing.
CLIA WAIVED
CLIA Screen Multi-Drug Urine Test Cup
Catalogue No. See Box label