CLIA Waived Fentanyl Single Panel Dip Test

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 and stored below -4°F (-20°C). Specimens can be frozen and thawed up to 3 times
when stored at -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). Both MIN and MAX are indicted on the test strip.
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 and after 10 minutes. See the illustration
below.
5. If preliminary positive results are observed, send the urine sample to the laboratory for confirmation testing.

INTERPRETATION OF RESULTS
(Please refer to the illustration above)
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 t there is no Fentanyl
in the specimen, or the concentration is below the detectable level (1.0 ng/mL).
*NOTE: 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 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 procedure using a new test. If
the problem persists, discontinue using the lot immediately and contact your local supplier.
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. 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 testing practice to confirm the test procedure and to 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. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen
may cause erroneous results.
3. A confirmed positive result indicates presence of the drug but does not indicate 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 drug
is present but below the cutoff level of the test.
5. This test does not distinguish between drugs of abuse and prescription medications.