HOW TO PERFORM THE OrAlert^TM SIX SUBSTANCE TEST

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HOW TO PERFORM THE CLIA WAIVED SIX SUBSTANCE TEST

***Do not open pouches until ready to perform the test***

1. Remove the test device from its protective pouch (bring the device and test sample to room temperature prior to testing). Label the device with patient ID info, if needed. Use the testing device as soon as possible.

2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine to both sample wells (S) of the test device. Avoid trapping air bubbles in the sample (S) wells. See illustration on this page. Start timing so that you read the results at 5 minutes.

3. Wait for the colored line(s) to appear. The results should be read at 5 minutes but not later than 4 hours after test began.

RESULT INTERPRETATION

Positive: A colored line appears in the control region ( C ). NO line appears in the test region next to the name of a specific drug tested. The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

Negative: * A colored line appears in the control region ( C ) and a colored line appears in the test region ( T ). Up to four colored lines may appear in each result window. One line will be in the control region ( C ). Up to three lines will be next to the drug names in the test region. This negative result means that the drug concentration in the urine sample is below the designated cut-off for a specific drug.

Invalid: No Line appears in the control region ( C ). If this occurs read the directions again and repeat the test with a new device. If the result is still invalid stop using the test devices and contact our company at 1-719-594-0854

*Note: The shade of color in the test region ( T ) may vary. The result should be considered negative whenever there is even a faint colored line.

HOW TO PERFORM THE TEN SUBSTANCE TEST

HOW TO PERFORM THE FIVE SUBSTANCE TEST

HOW TO PERFORM THE THREE SUBSTANCE TEST

HOW TO PERFORM THE TWO SUBSTANCE TEST

***Do not open pouches until ready to perform the test***

1. Remove the test device from its protective pouch (bring the device and test sample to room temperature prior to testing)

2. Label the device with patient identification, operator and date, if needed. Remove the cap to expose the sample strips.

3. Immerse the sample strips in the urine sample (as shown in the diagram above) until you observe a pink color migrating across the result windows (approximately 30 seconds). Do not allow the urine sample to touch the plastic device.

4. Remove device from the sample cup and replace cap. Place the device on a flat surface.

5. Read Results within 3 to 8 minutes. Do not read after 8 minutes. Record results immediately after testing.

HOW TO PERFORM THE SINGLE SUBSTANCE TEST

***Do not open pouches until ready to perform the test***

1. Remove the test device from its protective pouch (bring the device and test sample to room temperature prior to testing)

2. Open the sealed pouch for the test being conducted. (M-AMP, THC, PCP, OPI, or COC)

3. Remove the cassette and pipette. Place the cassette on a flat surface. Then take the pipette and squeeze the bubble end. Then immerse the pointed, open end into the urine sample. Release the pressure on the bubble and the pipette will fill with urine.

4. Put 4-6 drops into the well (S) as shown in the diagram above.

5. Wait for the lines to appear. Two lines indicate a negative result, and one line is a positive result, as seen in the diagram above.

6. A pink/rose colored band will form in the Control Zone if the test is working properly. Another pink/rose band will form in the Test Zone if the test is negative. If the test is positive, no band will appear in the Test Zone.

7. Read Results within 3 to 8 minutes. Do not read after 8 minutes. Record results immediately after testing.

HOW TO PERFORM THE COTININE SMOKE CHECK TEST

1. Remove the test device from its protective pouch. Make sure the urine specimen and test device are at room temperature. Place the device on a flat surface.
   
   
2. Take the pipette and squeeze the bubble end. Then immerse the pointed, open end of the pipette into the urine sample. Draw the urine sample to the line marked on the pipette (approximately 0.2 ml). Dispense the entire contents into the sample well. Use a separate pipette and device for each sample tested.
   
   
3. Wait for lines to appear. Read the results in three minutes. DO NOT read the results after eight minutes. See the diagram above for reading results.

HOW TO INTERPRET RESULTS

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatograpraphy/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are indicated.

• Negative: Two colored lines appear adjacent to each other in the result window. This indicates that no drug above the cut-off level has been detected. The test line intensity may be any shade of pink and weaker or stronger than that of the control line. All five tests are independent of each other, it is not recommended to compare the results or color intensity of the test lines.
• Positive: Only one colored line appears in the control region (C). No test line appears in the test region (T). A positive result should not be considered conclusive and should be confirmed with a more specific alternative to chemical method such as GC/MS.
• Invalid: If no control line appears in the result window, the test should be considered void. Improper testing procedures, sample tampering or deterioration of reagents probably occurred.

***One line on a CLEAR WHITE background is a positive.***
Two lines, INCLUDING A VERY FAINT SECOND LINE,
is a negative.

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