2
4.
One (1) security seal.
Kit Contents
– Dip Test format
The MEDTOX Buprenorphine Drugs of Abuse Dip Test Kit contains twenty-five (25) test devices in foil packages and one reference guide.
Each Dip Test device has test strips with drug specific reagents.
Materials Required but not provided
Timer
A urine collection container is not provided with the Dip device.
Specimen containers, disposable gloves and urine temperature strips are available from MEDTOX Diagnostics, Inc.
External Positive and Negative Controls.
Storage Conditions
The kit, in its original packaging, should be stored at 2-25°C (36-77°F) until the expiration date on the label.
5. PRECAUTIONS
1.
Urine specimens and all materials coming in contact with them should be handled and disposed of as if infectious and capable of transmitting infection. Never pipette by
mouth and avoid contact with broken skin.
2.
Avoid cross-contamination of urine samples by using a new urine specimen container for each urine sample.
3.
The device should remain in its original sealed foil pouch until ready to use. If the pouch is damaged, do not use the test.
4.
Do not store the test kit at temperatures above 25°C (77°F).
5.
If devices have been stored refrigerated, bring to ambient temperature (18-25°C/ 64-77°F) prior to opening foil pouch.
6.
Do not use tests after the expiration date printed on the package label.
7.
The device is for in vitro diagnostic use only.
6. SAMPLE COLLECTION AND PREPARATION
For a Cup Test, collect the urine sample in the provided cup. The urine volume should be between the minimum and maximum volume lines.
For a Dip Test, collect the urine sample in a clean specimen container.
Collection of 45 mL of urine is more than sufficient for testing. No preservatives should be added. Urine may be tested immediately following collection. If it is necessary to
store the urine, store under refrigeration at 2 to 8°C (36 to 46°F) for no more than two days. Urine may be frozen at -20°C (-4°F) or colder for storage. Stored urine must be
brought to ambient temperature (18 to 25°C/64 to 77°F) and mixed well to assure a homogeneous sample prior to testing.
7. TEST PROCEDURE
Cup Test
NOTE:
Read results at 5 minutes or within 15 minutes of the sample application.
1.
Bring pouched device to
room temperature before
opening it. Fill urine
sample cup between the
minimum and maximum
volume lines.
2.
Screw lid clockwise onto
the cup until very tight.
3.
Open pouch and label the
device with the patient or
sample identification.
4.
Hold cup with raised
sample port toward you.
Hold device cassette with
MEDTOX labeled end to
your left. Place device
cassette on top of cup lid
with holes aligned.
5.
Place the device
securely on to the lid---
the parts should interlock
easily and move freely
clockwise.
6.
Rotate the device
clockwise ¼ turn until it
snaps in place.
7.
Tip the cup on its side to
start flow (if less than 45
ml of urine, tilt the cup
forward to begin flow).
8.
Allow the test to sit for 5
minutes.
9.
Turn the cup upright and
read the results. Control
line must be present to
read results. Negative
results can be read as
soon as a line is visible.
Read non-negatives at 5
minutes.
Dip Test
1.
Bring pouched device to room temperature before opening it.
2.
Open one pouch for each sample to be tested. Write patient or sample identification information on the device.
3.
Pull off the clear cover to expose the fiber pads at ends of test strips.
4.
Dip the small end of the cassette into the sample so that only the white ends of the test strips are submerged.
5.
Hold the ends of the test strips in the sample until the reddish-purple solution begins to run up all of the strips.
6.
Remove the device from sample and replace the cover to protect the wet ends of the test strips.
7.
Lay cassette flat, face up for 5 minutes.
8.
Read the results. Control line must be present to read results. Negative results can be read as soon as a test line is visible, non-negative at 5 minutes.
NOTE:
See Quick Reference Guide for illustrated instructions.
