Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

Intended Use

A rapid test for the qualitative detection of Fentanyl (FEN) in human urine. For in vitro diagnostic use only. For medical and other professional in vitro diagnostic labeling.

The Healgen® Accurate Rapid Fentanyl Test Strip (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.

This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Summary

Fentanyl is a short-acting, synthetic narcotic analgesic approximately 100 times stronger than morphine. Originally developed in 1959 as an adjunct to anesthesia, it is also used for chronic pain management via transdermal patches or lollipop forms. In the illicit drug market, clandestine fentanyl is often added to street drugs without user knowledge, contributing significantly to fatal and nonfatal overdoses. A rapid, accurate method for detecting potential fentanyl use is crucial for patient triage and treatment. The Healgen® Accurate Rapid Fentanyl Test Strip (Urine) offers a rapid, instrument-free urine screening test that yields a positive result when Fentanyl in urine exceeds 1.0 ng/mL.

Principle

The Healgen® Accurate Rapid Fentanyl Test Strip (Urine) is a competitive binding immunoassay. Drugs present in the urine specimen compete with a drug conjugate for binding sites on antibodies. As the urine specimen migrates upward by capillary action, Fentanyl, if present below 1.0 ng/mL, will not saturate the antibody-coated particles. These particles are then captured by immobilized FEN conjugate, forming a visible colored line in the test line region (T). If the FEN level exceeds 1.0 ng/mL, it saturates the anti-FEN antibody binding sites, preventing the colored line from forming in the test line region. A drug-negative specimen or one with Fentanyl below the cutoff will generate a line in the test line region. A colored line always appears in the control line region (C) to indicate proper specimen volume and membrane wicking. The test device contains mouse monoclonal antibody-conjugated particles and corresponding drug-protein conjugates, with goat antibodies used for the control line system.

Warnings and Precautions

1. For in vitro diagnostic use only. Do not use after the expiration date.
2. The test is for single-use. Do not reuse it.
3. Do not touch the test zone of the Test Strip.
4. The test should remain in the sealed pouch until use.
5. Do not ingest the desiccant; its function is to keep the Test Strip dry.
6. Every specimen should be collected using a new container to avoid contamination.
7. All specimens should be considered potentially hazardous and handled accordingly.
8. Do not immerse the strip past the maximum line (MAX). If this occurs, retest with a new strip.
9. Discard the used test device according to local regulations.
10. Users should not make medical decisions without consulting a healthcare practitioner.

Storage and Stability

Store as packaged in the sealed pouch at 36-86°F (2-30°C). The test is valid for 24 months and remains stable through the expiration date printed on the sealed pouch. Keep Test Strips in the sealed pouch until use. DO NOT FREEZE. The lot number and expiration date are printed on the foil packaging and outer package. Do not use beyond the expiration date.

Materials

Materials Provided

• Test Strip
• Instructions For Use

Materials Required But Not Provided

• Timer, clock, or watch
• Specimen Collection Containers (with container lid, if applicable)

Reagents / Reactive Ingredients

The Test Strip is packaged in a sealed aluminum foil pouch with a desiccant. The test device contains mouse monoclonal antibody-conjugated particles and corresponding drug-protein conjugates. Goat antibodies are employed in the control line system.

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.

Specimen Storage

Urine specimens may be stored at 36-46°F (2-8°C) for up to 48 hours prior to testing. For long-term storage, specimens may be frozen below -4°F (-20°C). Specimens can be frozen and thawed up to 3 times when stored below -4°F (-20°C). Frozen specimens should be thawed and mixed before testing.

Directions for Use

If refrigerated, allow the test, urine specimen, and/or controls to reach room temperature [59-86°F (15-30°C)] prior to testing.

1. Remove the Test Strip from the sealed pouch and use within one hour.
2. With arrows pointing toward the urine specimen, immerse the Test Strip vertically in the urine specimen for at least 15 seconds. The urine level should be above the minimum line (MIN) on the test strip but below the maximum line (MAX).
3. Set a timer for 5 minutes.
4. Place the Test Strip on a non-absorbent flat surface and wait for the colored line(s) to appear. Read the results at 5 minutes. Do not interpret the result before 5 minutes or after 10 minutes.
5. If preliminary positive results are observed, send the urine sample to the laboratory for confirmation testing.

Diagram Description: Illustration shows a test strip being dipped into a urine sample, with arrows indicating the correct immersion depth (above MIN, below MAX lines) and a timer set to 5 minutes.

Interpretation of Results

This product can only perform qualitative analysis.

NEGATIVE (-)

Two colored lines appear. One colored line should appear in the control line region (C) and another colored line should appear in the test line region (T). A negative result indicates that there is no Fentanyl in the specimen, or the concentration is below the detectable level (1.0 ng/mL). 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). A positive result indicates that the Fentanyl concentration exceeds the detectable level (1.0 ng/mL).

INVALID

Control line (C) 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 using a new strip. If the problem persists, discontinue using the lot immediately and contact your local supplier.

Diagram Description: Illustration depicting the interpretation of test results: NEGATIVE shows two lines (C and T), POSITIVE shows one line (C only), INVALID shows no control line (C).

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, confirming 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 verify proper test performance. The recommended quality control material available to users is Fentanyl Cerilliant F-013 at 1.0 mg/mL. Users should follow federal, state, and local guidelines for testing quality control materials. Laboratories should comply with all federal, state, and local laws, as well as any other applicable guidelines and regulations.

Limitations

1. The Healgen® Accurate Rapid Fentanyl Test Strip (Urine) provides only a qualitative, preliminary result.
2. Technical or procedural errors, as well as other interfering substances in the urine specimen, may cause erroneous results.
3. A confirmed positive result indicates the presence of the drug but does not indicate the level of intoxication, administration route, or concentration in urine.
4. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when the drug is present but below the cutoff level of the test.
5. This test does not distinguish between drugs of abuse and prescription medications.

Performance Characteristics

Accuracy

Eighty clinical urine specimens previously quantitated by LC-MS were tested with the Healgen® Accurate Rapid Fentanyl Test Strip (Urine). Each test was performed by three operators. Results were as follows:

Analytical Specificity

The following table lists compounds that are positively detected in urine by the Healgen® Accurate Rapid Fentanyl Test Strip (Urine).

Precision

This study was performed by three point of care (POC) personnel at each of 3 POC sites using masked samples. Three lots were run at each concentration for each lot per day. The results are as follows:

Effect of Urinary Specific Gravity and pH

A total of 12 urine samples with specific gravities (SG) ranging from 1.000-1.035 were collected. Target drugs were spiked to these urine samples at +50% cutoff and -50% cutoff concentrations. The results demonstrate that varying ranges of urinary specific gravity do not affect the test results.

The pH of an aliquoted negative urine pool was adjusted to a pH range of 4 to 9 in 1 pH unit increments and spiked with Fentanyl at +50% cutoff and -50% cutoff concentrations. The spiked, pH-adjusted urine was tested with the Healgen® Accurate Rapid Fentanyl Test Strip (Urine) in duplicate. The results demonstrated that varying ranges of pH do not interfere with the performance of the test.

Non-Interfering Compounds

Potential interfering substances from physiological or pathological conditions known to be found in human urine were added to drug-free urine and target drug fentanyl urine with concentrations at 50% below and 50% above cutoff levels. These urine samples were tested using three batches of each test device. Compounds that showed no interference at a concentration of 100 µg/mL are summarized in the following tables.

Opioid Compounds with No Cross-Reactivity (tested at 100 µg/mL)

Other Compounds with No Cross-Reactivity (tested at 100 µg/mL)

Bibliography and Suggested Reading

1. Drug Enforcement Administration (DEA) - Drug Fact Sheet of Fentanyl: https://www.dea.gov/sites/default/files/2020-06/Fentanyl-2020_0.pdf
2. Wilson N, Kariisa M, Seth P, Smith H IV, Davis NL. Drug and Opioid-Involved Overdose Deaths -- United States, 2017-2018. MMWR Morb Mortal Wkly Rep 2020;69:290-297.
3. LI Ze-hua, WANG Kai, XU Bin, ZHUANG Xiao-mei, ZHAO Jin, GUO Lei, XIE Jian-wei. Advances in metabolic transformation of fentanyls. Chinese Journal of Pharmacology and Toxicology. 2021, 35(3): 223-234.
4. Baselt, Randall, Disposition of Toxic Drugs and Chemicals in Man. 12th edition.

Index of Symbols

• ?♻️ Do not reuse
• ? See Instruction for Use
• ? Expiration Date
• ? Tests per Kit
• ?️ Store between 2°C - 30°C (36-86°F)
• ?? Keep Dry
• ☀️? Keep Away from Sunlight
• ? LOT / Batch Number
• ?️ REF / Catalog#
• ? UDI (Unique Device Identifier)
• ? IVD (For in vitro diagnostic use only)
• ? Manufacturer

Assistance

If you have any questions regarding the use of this product, please call our Technical Support Number 1-866-982-3818 (8:30 a.m. to 5 p.m. CDT).

Healgen Scientific Limited Liability Company

Address: 3818 Fuqua Street, Houston, TX 77047, USA.
Tel: +1 713-733-8088
Fax: +1 713-733-8848
Website: www.healgen.com

Distribution

TransMed Co, LLC

3482 Keith Bridge Rd, Suite 196
Cumming, GA 30041
Tel: 404-840-8900
Website: https://transmedco.com

Revision Date

2023-11-02