INTRODUCTION
 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.

PERFORMANCE CHARACTERISTICS
A. Accuracy
The accuracy of the OPI Rapid Test Strip (Urine) was compared and checked against commercially available tests with a threshold value at the same cut-off levels. Urine samples taken from volunteers claiming to be non-users were examined under both tests. The results were >99.9% in agreement. 
 
B. Reproducibility
The reproducibility of the OPI Rapid Test Strip (Urine) was verified by blind tests performed at four different locations. Samples with Morphine/Heroin concentrations at 50% of the cut-off were all determined to be negative, while samples with Morphine/Heroin concentrations at 200% of the cut-off were all determined to be positive.
 
C. Precision
Test precision was determined by blind tests with control solutions. Controls with Morphine/Heroin concentrations at 50% of the cut-off yielded negative results, and controls with Morphine/Heroin concentrations at 150% of the cut-off yielded positive results.
 
D. Specificity
The following tables list the concentrations of compounds (ng/mL) above which the OPI Rapid Test Strip (Urine) identified positive results at 5 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Only one colored band appears, in the control region (C). No apparent 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.

NOTE: 

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

Certifications