Drug Test kits OPI Rapid Test strip ,4mm test strip. Urine Specimen for Opiates, Gold colloidal method

Drug Test kits OPI Rapid Test strip ,4mm test strip. Urine Specimen for Opiates, Gold colloidal method


Intended Use


Opiate refers to any drug that is derived from the opium poppy, including the natural products, Morphine and Codeine, and the semi-synthetic drugs such as heroin. Opioid is more general, referring to any drug that acts on the opioid receptor.
Opioid analgesics comprise a large group of substances which control pain by depressing the central nervous system. Large doses of Morphine can produce higher tolerance levels and physiological dependency in users, and may lead to substance abuse. Morphine is excreted unmetabolized, and is also the major metabolic product of codeine and heroin. Morphine is detectable in the urine for several days after an opiate dose.1
The OPI One Step Opiate Test Strip (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 Morphine in urine. The OPI One Step Opiate Test Strip (Urine) yields a positive result when the Morphine in urine exceeds 2,000 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).

Test Principle

The OPI One Step Opiate Test Strip (Urine) is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which 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. Morphine, if present in the urine specimen below 2,000 ng/mL, will not saturate the binding sites of antibody-coated particles in the test strip. The antibody-coated particles will then be captured by immobilized Morphine 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 Morphine level exceeds 2,000 ng/mL because it will saturate all the binding sites of anti- Morphine antibodies.
A drug-positive urine specimen will not generate a colored line in the test line region, while a drug-negative urine specimen or a specimen containing a drug in a concentration less than the cut-off will generate a colored 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.

DIRECTIONS FOR USE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes

INTERPRETATION OF RESULTS

(Please refer to the illustration above)
NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.


QUALITY CONTROL

A procedural control is included in the test. A line appearing in the control 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 practice to confirm the test procedure and to verify proper test performance.

performance characteristics

Analytical Sensitivity
A drug-free urine pool was spiked with Opiate at the following concentrations: 0 ng/mL, 1,000 ng/mL, 1,500 ng/mL, 2,000 ng/mL, 2,500 ng/mL, 3,000 ng/mL and 4,000 ng/mL. The result demonstrates > 99% accuracy at 50% above and 50% below the cut-off concentration. Results are presented in Table 2 below.


Table 2: Analytical Sensitivity Summary

Conclusion: As indicated in table above: all specimens with OPI concentration equal to or lower than 1,000ng/mL show negative results, all specimens with OPI concentration of 2,000ng/mL are identified as “+/-”, and all specimens with OPI concentration equal to or higher than 3,000ng/mL showed positive results. Therefore, the cut-off concentration of the OPI One Step Opiate Test Strip (Urine) is determined to be 2,000ng/mL OPI.