Morphine Test vs. Opiate Test Comparison Chart

Intended Use

The MOP One Step Opiate Test Strip is a lateral flow chromatographic immunoassay for the detection of opiates in urine at a cut-off concentration of 300 ng/mL. This test will detect other opiates. Please refer to analytical specificity table in this package insert.

This assay provides only a 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

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, 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.

The MOP One Step Opiate Test Strip 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 opiates in urine. The MOP One Step Opiate Test Strip yields a positive result when the concentration of opiate exceeds the 300 cutoff level.

Principle

The MOP One Step Opiate Test Strip is an 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. Opiates, if present in the urine specimen below the cutoff concentration, will not saturate the binding sites of the antibody in the test strip. The morphine conjugate will be captured by antibody 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 opiates level exceeds the cutoff concentration 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 because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition. 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 strip contains monoclonal anti-morphine antibody-coupled particles and morphineprotein conjugates. A goat antibody is employed in the control line system.

Precautions

• For healthcare professionals including professionals at point of care sites.
• For professional in vitro diagnostic use only. Do not use after the expiration date.
• The test strip should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
• The used test strip should be discarded according to federal, state and local regulations.

Storage and stability

Store as packaged in the sealed pouch at 2-30°C. The test strip is stable through the expiration date printed on the sealed pouch. The test strips must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

Specimen collection and preparation

Urine Assay

The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.

Specimen Storage

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.

Materials

Materials Provided

• Test strips
• Package insert

Materials Required But Not Provided

• Specimen collection container
• Timer
• External controls

Directions for use

Allow the test strip, 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 strip from the sealed pouch and use it as soon as possible.
2. With arrows pointing toward the urine specimen, immerse the test strip vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip. See the illustration below.
3. Place the test strip on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
4. Certain medications containing opiate derivatives may produce a positive result. Additionally, foods and tea containing poppy products (the origin of the opiate) may also produce a positive result.
5. A Positive Result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in urine.
6. A Negative Result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cutoff level of the test.
7. Test does not distinguish between drugs of abuse and certain medications.

Performance characteristics

Accuracy

A side-by-side comparison was conducted using the MOP One Step Opiate Test Strip and a leading commercially available MOP rapid test. Testing was performed on specimens previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Eighty (80) of these samples were also run using the MOP One Step Opiate Test Strip by an untrained operator at a different site. Based on GC/MS data, the operator obtained a statistically similar Positive Agreement, Negative Agreement and Overall Agreement rate as the laboratory personnel.

Analytical Sensitivity

A drug-free urine pool was spiked with Morphine at the following concentrations:

0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL and 450 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:

Specificity

The following table lists compounds that are positively detected in urine by the MOP One Step Opiate Test Strip at 5 minutes.

Precision

A study was conducted at 3 physician’s offices by untrained operators using 3 different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens were blind labeled and tested at each site. The results are given below:

Effect of Urinary Specific Gravity

Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with 150 ng/ml and 450 ng/ml of Morphine respectively. The MOP One Step Opiate Test Strip was tested in duplicate using the fifteen neat and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.

Effect of the Urinary pH

The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with Morphine to 150 ng/ml and 450 ng/ml. The spiked, pHadjusted urine was tested with the MOP One Step Opiate Test Strip in duplicate and interpreted according to the package insert. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.

Cross-Reactivity

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or morphine positive urine. The following compounds show no cross-reactivity when tested with the MOP One Step Opiate Test Strip at a concentration of 100 μg/mL. Non Cross

Non Cross-Reacting Compounds