Fentanyl/Norfentanyl Rapid Test
The ETERBI0 Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassayintended for the qualitative detection of Fentanyl(FTY)/Norfentany(NFTY)in human urine.
SPECIFICATION:
Method: Competitive binding lateral flow immunochromatographic assay
Time to Result: 5-10 minutes
Storage Condition: Do not freeze(below 32°F (0°C)).
Shelf Life:
Sample Type: Urine
Cut-Off Level: Fentanyl 1ng/mL, Norfentanyl 5ng/mL
Fentanyl (FYL) Sensitivity: 95.8% Specificity: 97.5%
Norfentanyl (NFYL) Sensitivity: 95.8% Specificity: 95.8%
Kit Sizes: 1/3/5/10/20/25 Tests
Kit Contents:
1 x Test Card
1 x IFU
HOW TO USE:
➀Bring the sample and reagent to room temperature.
➁Tear open the foil bag, remove and mark the test card.
➂Remove the cap and dip the test strip vertically into the urine with the arrow pointing down and urine sample should not touch the plastic device. After 10-15 seconds, when the liquid reaches the top of the window, remove the test card, lay it flat, and start timing.
➃Read the results at 5 minutes. Do not interpret results before 5 minutes or after 10 minutes.
INTERPRET THE RESULTS:
NEGATIVE (-): Two colored lines appear, One at (C) and one at (T).
*Note: The color and intensity of the lines do not affect the result.
A test is negative regardless of the test line (T) color intensity.
PRELIMINARY POSITIVE(+): One colored line appears at (C). No line appears at (T).
INVALID: No line appears at (C)
Q&A:
What is the purpose of the test card?
This test checks for fentanyl above 1ng/mL and Norfentanyl above 5ng/mL in urine. There may be two steps: a quick at-home test and, if needed, sending the sample to a lab for confirmation.
What is Norfentanyl?
Norfentanyl is the main metabolite of fentanyl after it is metabolized in the body. In other words, when the body processes fentanyl, enzymes in the liver break it down into simpler chemical structures, and norfentanyl is one of them. Norfentanyl itself has no obvious analgesic effect or pharmacological activity. It is mainly used as a metabolic marker and is often used in toxicology tests to determine whether someone has used fentanyl.
Why Test for Norfentanyl?
Because fentanyl is metabolized by the liver in the human body to produce norfentanyl, and this metabolite usually stays in the body longer and is easier to detect past fentanyl use.
What are the benefits of dual dipping?
Dual dipping can more accurately identify actual ingestion, improve detection reliability, and reduce the risk of false positives/false negatives. Although the fentanyl content in the sample may have dropped to a difficult-to-detect level (false negative) when testing for fentanyl alone, norfentanyl can still be detected.
POTENTIAL ISSUES:
No bands appear on the strip (Replace the test card and retest according to the instructions):
The product has expired, and the C line does not appear.
During sample application, the sample exceeds the MAX line, causing the gold-labeled antibodies to enter the sample well and disrupting the chromatographic flow. This prevents the antigen-antibody reaction from forming.
Only the T line appears, and the C line is absent (Replace the test card and retest according to the instructions):
The product is damp, rendering the absorbent end of the test strip ineffective, and the chromatographic flow cannot fully form.
The drug user does not test positive (Collect a new sample the next day and retest):
The drug was recently used, and the substance has not yet been metabolized into the sample.
No recent drug use; collect alternative samples such as hair for testing.
Cross-reaction with other drugs (Check the manual to see if cross-reaction is mentioned; if not, contact the manufacturer):
Different products may cross-react with different drugs.
The discrepancy between drug users and confirmation results:
False Positive:
The sample contains cross-reactive substances.
Check the composition of drug metabolites. During confirmation analysis, ensure that protein-bound metabolites have been preprocessed.
False Negative:
Differences between the product and confirmation standards (commonly occur near the CUTOFF threshold).
Conduct a quantitative analysis of the sample to determine the drug concentration range.
T line appears, but the color is faint:
The sample contains a small amount of the drug, and the concentration does not reach the CUTOFF value. This is generally interpreted as a negative result.
