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Diagnostics
On-Site® CupKit™
OnTrak TesTcup®
OnTrak TesTcup® II
OnTrak TesTstik™
OnTrak TesTcard™ 9
On-Site® Alcohol
On-Site® OraLab®
OnTrak OraTube™
SMARTdata Solutions



The step-by-step On-Site® OraLab® process


Collect saliva & start the test

Before the test is administered, instruct the donor to drink 4 ounces of water, and to place nothing else in the mouth(such as food, drink, gum, and tobacco products) for 10 minutes prior to collection.

During the minute or two prior to collection, instruct the donor to draw a pool of saliva into the mouth with a "puckering" action.

1. Gently open the foil pouch and remove the contents. Record the donor name and collection date on the designated area of the test cassette.

2. Collect (and observe) fresh saliva specimens as follows; no preservative, special handling, or pretreatment is required.

3. Instruct the donor to open the collector bag, place the collector foam inside mouth for three minutes, and completely saturate the collector foam with saliva. Specifically, instruct that the donor:
• Bathe the collector foam in the pool of saliva
• Alternatively, stimulate salivation by continuously moving the collection foam along the sides and lower margin of the tongue
• Not chew, compress, or suck on the collector foam

4. Place the OraLab cassette on a flat surface and lift the confirmation well cap to assure that the flow of saliva into the well is not obstructed.


5. Remove the collection foam from the mouth. It should be very wet when removed from the mouth, and must not be compressed when removed.
• Place the collector foam vertically into the sample well on top of the device, and push the collector slowly (approximately 5 seconds) and firmly downward until it comes to a stop.
• Saliva flows directly into the test cassette.

Interpret test validity and results

Test validity and results must be interpreted between 10 and 15 minutes after initiating the test.

Seal the confirmation well 10 minutes after initiating the test by firmly pushing the cap down. The "click" confirms that the well is properly sealed. Remove the label covering the result windows.


 

1. Interpret test validity: A valid test is indicated by a band in the Test Valid window. Both of the COC/OPI/AMP and MET/PCP/THC reagent strips pictured below (Figure 3) are valid. Since a valid test may give a faint or incomplete band, any Test Valid band confirms that the test is valid. Due to the high viscosity and variability of some saliva samples, test results may require up to 15 minutes to form.

An invalid test is indicated by the absence of a distinct band in the Test Valid window or by a reddish background in the Results or Test Valid windows which obscures the presence of bands 15 minutes after the test is initiated. If an invalid result is obtained, see Step 3 below.

2. Immediately interpret test results as either negative or preliminary positive.

a. A negative result for a given drug (i.e., drug absent or below the cutoff) is the presence of a band in the Results window adjacent to the drug name. The intensity of the bands in the Results windows may vary. Since a negative sample may give a faint or incomplete band, any band in the Result window indicates a negative result. The test results pictured below (Figure 3) are negative for Cocaine, Morphine, Amphetamine, Methamphetamine, PCP, and THC.
 

b.
A preliminary positive result for a given drug (i.e., drug present above the cutoff, suggesting current drug use) is the absence of a band in the test result window adjacent to the drug name. The adjacent area appears off-white.

c.
If all drug results are negative, or if no further confirmation tests are required, properly discard the test cassette and collector.

d. When confirmation of a preliminary positive screen result is required:
• Verify that the volume of saliva in the confirmation well is sufficient for laboratory testing by observing the transparent bottom of the confirmation well. A sufficient specimen will fill at least half of the well.
• Observe any chain of custody procedures in effect at the collection site.

3.
If test did not run, if invalid test results are obtained, or if the confirmation well is less than half full, do not add additional sample to the same device. Properly discard the original test cassette and collector. Using a second OraLab device collect the additional sample by following these instructions:

a. Collect the second sample within a few minutes of the first.

b.
Instruct the donor to drink 4 ounces of water. Assure that this water is swallowed and that nothing else is placed in the mouth for 3-5 minutes.

c. During the minute or two prior to collection, instruct the donor to draw a pool of saliva into the mouth with a "puckering" action.

d. Provide a second packaged collector to the donor, and repeat collection instructions with emphasis on:
• Bathing the collection foam in saliva(and/or
• Continuous gentle movement of the collector over the tongue throughout the collection

e. Observe a 4-minute collection and perform the test according to the instructions in "Collect Saliva & Start Test" section.

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