|
INTENDED USE
DOA Panel Test Cup and DOA Panel Test Cup Plus are One-Step In Vitro test devices consisting of Drugs of Abuse and UrineCheck strips. It is designed for qualitative determination of drug substances in human urine specimens. UrineCheck can be also built-in as an option to validate the integrity of the urine specimen examined This assay may be used in the point of care setting. Below is a list of cut-off concentrations for each drug.
|
Drugs of Abuse
|
Cut-off Level
|
|
Amphetamine
|
1000 ng/ml of d-amphetamine
|
|
Barbiturate
|
300 ng/ml of secobarbital
|
|
Benzodiazepine
|
300 ng/ml of oxazepam
|
|
Buprenorphine
|
10 ng/ml of Buprenorphine-3-β-d-glucoronide
|
|
|
300 ng/ml of benzoylecgonine
|
|
EDDP
|
100 ng/ml of EDDP
|
|
Methadone
|
300 ng/ml of methadone
|
|
Methamphetamine ( )
|
1000 ng/ml of (+)methamphetamine
|
|
Opiate*
|
300 ng/ml of morphine
|
|
Opiate II*
|
2000 ng/ml of morphine
|
|
Oxycodone
|
100 ng/ml of oxycodone
|
|
Phencyclidine
|
25 ng/ml of phencyclidine
|
|
Cannabinoid (THC)
|
50 ng/ml of 11-nor-D9-THC-9-COOH
|
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The optional built-in UrineCheck: Adulteration Test is for validation of urine specimen’s integrity and must not be used for In Vitro diagnostic use.
*SAMHSA recommends a cut-off concentration of 2000 ng/ml for Opiates Test
STORAGE AND STABILITY
The test device should be stored at 2 to 30oC and will be effective until the expiration date stated on the package. The product is humidity-sensitive and should be used immediately after being open. Any improperly sealed product should be discarded.
PRECAUTIONS
1. For in vitro diagnostic and forensic use only. UrineCheck is ONLY for validating the integrity of urine specimen and MUST not be used for diagnostic use.
2. Do not use the product beyond the expiration date.
3. Handle all specimens as potentially infectious.
4. Humidity sensitive product. Do not open foil pouch until it is ready to be tested.
5. Use a new urine specimen cup for each sample to avoid cross contamination.
SPECIMEN COLLECTION AND PREPARATION
Fresh urine does not require any special handling or pretreatment. Specimen should be collected in a clean, dry, plastic or glass container. If the assay is not performed immediately, urine specimen may be refrigerated at 2-8°C or frozen up to 7 days. Specimens should be brought to room temperature before testing. Urine specimens shall not be centrifuged nor added preservatives. Commercially available controls that contain sodium azide or other preservatives that will inhibit the enzyme activity may results in failure of Alcohol and UrineCheck test(s). Avoid contact with skin by wearing gloves and proper laboratory attire.
QUALITY CONTROL
Good Laboratory practice recommends the daily use of control materials to validate the reliability of device. Control materials should be assayed as clinical specimen and challenging to the assay cutoff concentration, e.g., 25% above and below cutoff concentration. If control values do not fall within establish range, assay results are invalid. Control materials which are not provided with this test kit are commercially available.
Drugs of Abuse
DOA Panel Test provides a built-in process control with a different antigen/antibody reaction at the control region (C) in Drugs of Abuse Tests. This control line should always appear regardless the presence of drug or metabolite. If the control line does not appear, the test device should be discarded and the obtained result is invalid. The presence of this control band in the control region serve as 1) verification that sufficient volume is added, 2) that proper flow is obtained.
UrineCheck: Adulteration Test(s)
For best results, performance of UrineCheck test should be confirmed by testing known negative and positive specimens or controls whenever a new test is performed or whenever a new bottle is first opened.
PROCEDURE
1. Bring test devices and specimens to the room temperature (15-28ºC) if they have been refrigerated.
2. Remove the urine test cup from the sealed foil pouch.
3. Remove the lid and collect the sample, ensuring that the sample is above the minimum fill line.
4. Secure the lid tightly and place the urine test cup on a flat surface.
5. Remove key from lid and insert in the side chamber, push to release the sample into the test zone.
6. At 5 minutes, remove the result window cover and observe the results.
Do not interpret the results after 10 minutes.
|
