Barbiturates (BAR) Rapid Test Urine Rapid Diagnostic Kit Cassette and Strip

Barbiturates (BAR) Rapid Test Urine Rapid Diagnostic Kit Cassette and Strip

Barbiturates (BAR) Rapid Test is a rapid, screening test for the qualitative detection of Barbiturates and metabolites in human urine at specified cut off levels.

For professional use only.

For in vitro diagnostic use only.

【INTENDED USE】

Barbiturates (BAR) Rapid Test is an immuno-chromatographic assay for the qualitative determination of the presence of Barbiturates (BAR) listed in the table below.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to Barbiturates (BAR) of abuse test result, particularly when preliminary positive results are indicated.

【SUMMARY】

Barbiturates are central nervous system depressants. They are usually administered orally but are sometimes injected intramuscularly and intravenously. Barbiturates range from short-acting (approximately 15 minutes, such as secobarbital) to long-acting (24 hours or longer, such as Phenobarbital). Short-acting barbiturates are extensively metabolized in the body, while the long-acting ones are secreted primarily unchanged. Barbiturates produce alertness, wakefulness, increased energy, reduced hunger, and an overall feeling of well being. Large doses of Barbiturate could develop tolerance and physiological dependency and lead to its abuse.

【PRINCIPLE】

Barbiturates (BAR) Rapid Test is a competitive immunoassay that is used to screen for the presence of Barbiturates (BAR) and metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.

When the test is activated, the urine is absorbed into test by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test Test. This produces a colored Test line in the Test Region (T) of the Test, which, regardless of its intensity, indicates a negative test result.

When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C) of Test, if the test has been performed properly.

【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.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

【OPERATION】

Test must be in room temperature (15ºC to 30ºC)

• Donor collects urine specimen in a urine cup.
• Open the sealed pouch by tearing along the notch. Remove the test from the pouch and place it on a level surface.
• Hold the sample dropper vertically, and add exactly three drops of the urine specimen into the sample well.
• The result should be read at 5 minutes. Do not interpret the result after 10 minutes. 

【INTERPRETATION OF RESULTS】

Preliminary positive (+)

Only one colored band appears, in the control region (C). No colored band appears in the test region (T).

Negative (-)

Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

Invalid

Control band fails to appear. Results from any test which has not produced a control band at the specified read 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.

【PERFORMANCE CHARACTERISTICS】

Accuracy

The comparison studies were conducted using Rapid Barbiturates (BAR) Test and commercially available rapid drugs of abuse tests. The studies were performed on approximately 600 clinical specimens previous collected from the clinical settings. Presumptive positive results were confirmed by GC/MS. Results were as follows:

Specificity and cross reactivity

To test the specificity and cross reactivity of the test, the test device was used to tes Barbiturates (BAR) , metabolites and other components of the same class that are likely to be present in urine. All the components were added to drug-free normal human urine. The following structurally related compounds produced positive results with the test when tested at levels equal to or greater than the concentrations listed below.

Interfering substances

Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine or drug positive urine with the concentration 50% below the cutoff and 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100µg/mL (All concentrations were confirmed with GC/MS). The urine specimens were tested with the Rapid Barbiturates (BAR) Test. None of the urine samples showed any deviation from the expected results.

Effect of Urinary Specific Gravity

The specific gravity studies were conducted on different specific gravity including 1.002,1.010, 1.020, 1.030, 1.040 specimens with drug free urine or drug positive urine with the concentration at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS). Each sample was tested by the corresponding Rapid Barbiturates (BAR) Test. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result.

Effect of Urinary PH

The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (All concentrations were confirmed with GC/MS). Each sample was tested by the corresponding Rapid Barbiturates (BAR) Test . The result demonstrate that varying ranged of PH do not interfere with the performance of the test.