BAR Rapid Test Cassette (Urine), 200ng/ml, Barbiturates Test Kit
(GC/MS)
Principle | Chromatographic Immunoassay |
Format | Dipstick, Cassette, Panel, Device, Cup |
Specimen | Urine,Oral Fluid,Powder,WB/S/P,Hair |
Certificate | CE/FDA |
Reading Time | 5 minutes |
Pack | 10T/25T/40T/50T |
Storage Temperature | 2-30°C |
Shelf Life | 2 Years |
Sensitivity | 96.10% |
Specificity | 98.60% |
Accuracy | 97.60% |
Cut-Off | 100 ng/mL,200 ng/mL, |
A rapid test for the qualitative detection of Barbiturates in human
urine.
For medical and other professional in vitro diagnostic use only.
INTENDED USE
The BAR Rapid Test Cassette (Urine) is a lateral flow
chromatographic immunoassay for the detection of Barbiturates in urine at a cut-off concentration of 200ng/ml.
This test will detect other related compounds, please refer to the Analytical Specificity table in this
package insert.
This assay provides only a qualitative, 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.
SUMMARY
Barbiturates are central nervous system depressants. They are used
therapeutically as sedatives, hypnotics, and anticonvulsants. Barbiturates are almost always
taken orally as capsules or tablets. The effects resemble those of intoxication with alcohol. Chronic
use of Barbiturates leads to tolerance and physical dependence. Short acting Barbiturates taken at 400
mg/day for 2-3 months produce a clinically significant degree of physical dependence. Withdrawal
symptoms experienced during periods of drug abstinence can be severe enough to cause death.
Only a small amount (less than 5%) of most Barbiturates are excreted unaltered in the urine. The
detection period for the Barbiturates in the urine is 4-7 days.
The BAR Rapid Test Cassette (Urine) is a rapid urine-screening test
that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to
selectively detect elevated levels of Barbiturates in urine. The BAR Rapid Test Cassette (Urine) yields a
positive result when the Barbiturates in urine exceeds the cut-off level.
PRINCIPLE
The BAR Rapid Test Cassette (Urine) is an immunoassay based on the
principle of competitive binding. Drugs that may be present in the urine specimen compete
against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary
action. Barbiturates, if present in the urine specimen below the cut-off level, will not saturate the
binding sites of the antibody in the test. The antibody coated particles will then be captured by immobilized
Barbiturate-protein 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 Barbiturate level exceeds the cut-off level because
it will saturate all the binding sites of anti-Barbiturate antibodies.
A drug-positive urine specimen will not generate a colored line in
the test line region because of drug competition, while a drug-negative urine specimen or a specimen
containing a drug concentration less than the cut-off will generate a line in the test line region. To
serve as a procedural control, a colored line will always appear at the control line region indicating that
proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains mouse monoclonal anti-Barbiturates antibody
coupled particles and Barbiturates-protein conjugate. A goat antibody is employed in the
control line system.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test cassette from the sealed pouch and use it within one hour.
2. Place the test device on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approx. 120 uL) to the specimen well (S) of the
test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the
illustration below.
3. Wait for the colored line(s) to appear. Read results at 5
minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
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 Barbiturate concentration is below the detectable cut-off level.
*NOTE: The shade of color in the test line region (T) may vary, but
it should be considered 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 Barbiturate
concentration exceeds the detectable cut-off 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 with a new test. If the problem persists, discontinue using
the test kit immediately and contact your local distributor.
QUALITY CONTROL
A procedural control is included in the test. A colored line
appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient
specimen volume, adequate membrane wicking and correct procedural technique. Control standards are not supplied with this kit; however, it is
recommended that positive and negative controls be tested as good laboratory testing practice to confirm
the test procedure and to verify proper test performance.
Order Information
Cat. No. | Product | Specimen | Pack |
DBA-102 | Barbiturate (BAR) Rapid Test Cassette | Urine | 40T |
DBA-114 | Barbiturate (BAR) Rapid Test Panel | Urine | 40 T |
DBA-101 | Barbiturate (BAR) Rapid Test Dipstick | Urine | 50 T |
DBA-802 | Barbiturates (BAR) Rapid Test Cassette | Oral Fluid | 25 T |
DBA-803 | Barbiturates (BAR) Rapid Test Device | Oral Fluid | 25 T |
DBA-402 | Barbiturates (BAR) Rapid Test Cassette | WB/S/P | 40 T |
DBA-X14 | Barbiturate (BAR) Rapid Test Panel | Powder | 25 T |
DBA-H902 | Barbiturate (BAR) Rapid Test Cassette | Hair | 10 T |