OraSure^® Oral Specimen Collection Device

1. When a subject is ready to begin the test, pull open the collection package and have the subject remove the collection pad from the package. Do not touch the absorbent pad with your finger!
2. Instruct the patient to place the white collection pad inside the mouth between the lower gum and the cheek and gently rub the pad back and forth along the gum until it is moist.
3. Begin timing (minimum time 2 minutes, maximum time 5 minutes).
4. Remove the collection vial from the package and label with the patient’s full name and date of birth, or if ordering in Excellian/Beaker, the barcode label.
5. Open the collection vial being careful not to spill the liquid.
6. At the end of the 2 to 5 minutes, have the subject remove the pad and insert it into the collection vial, then break the shaft off at the score mark. Do not touch the absorbent pad with your finger!
7. Snap the cap into place.

OraSure^® Oral Specimen Collection Device

Refrigerated (preferred) - 28 days

Ambient - 21 days

• Improper labels (unlabeled or mislabeled)
• Delay in transport
• Improper storage temperature affecting results
• Improper container
• Leaking container resulting in compromised specimen
• Quantity not sufficient (QNS)

Enzyme-linked Immunosorbent Assay (ELISA)

Negative

Medical necessity