Ductal Lavage Cytology

Since collection kits are not supplied by LabCorp, the instructions supplied by the manufacturer should be followed. Procedures are outlined in the FirstCyte™ Breast Test package insert.

1. Determine the proper nipple and/or breast anesthetic that may be applied prior to initiating or during the ductal lavage procedure.

2. Dekeratinize the nipple using gauze and a small amount of mild abrasive skin prepping gel.

3. With the patient seated and her arms at her sides, wipe the nipple/areolar complex with alcohol or a suitable disinfectant and don gloves. Identify the ductal orifice by using the FirstCyte™ Aspirator (refer to the FirstCyte™ Aspirator instructions for use) and/or by firmly squeezing on the nipple from several directions to yield nipple aspirate fluid (NAF). Assist patient to a comfortable supine position.

4. Prepare the FirstCyte™ EZ MicroCatheter by attaching a 10 mL syringe containing 3 mL of 1% lidocaine without epinephrine to the green inflow port. Prime the inflow tubing with lidocaine, and close the pinch-clamp on the outflow tubing. The catheter tip may be dipped in sterile lidocaine jelly for lubrication.

5. While lifting up the nipple to two to three times its normal height, introduce the guidewire/catheter unit into NAF droplet of the desired ductal orifice. If cannulation is not readily accomplished by visual identification of NAF, employ a tactile approach to the duct. Hold the catheter perpendicular to the nipple surface and use gentle pressure (less than enough to dimple the nipple's surface) to probe for the ductal orifice.

6. Advance the guidewire/catheter unit until catheter is at nipple surface. Withdraw guidewire (not to exceed 10 mm) while slowly advancing catheter until fully seated. Remove guidewire completely.

• If entry into the orifice is difficult, a FirstCyte™ UltraSlim or Tapered Dilator may be used (refer to FirstCyte™ UltraSlim Dilator or FirstCyte™ Tapered Dilator instructions for use). After dilation of the duct, reinsert the catheter.

• If meeting resistance upon catheter insertion, as soon as the clear catheter body has entered the duct, withdraw the guidewire (approximately 6 mm), and slowly infuse 1-2 mL lidocaine (resistance is expected).

7. Slowly administer the lidocaine through the green inflow port into the breast duct. Advise the patient that the local anesthetic may sting or burn. Disconnect the empty 10 mL syringe and reattach to the outflow collection port.

8. Connect a 20 mL syringe filled with balanced electrolyte solution to the green inflow port. With the pinch clamp closed, gradually infuse 2-4 mL increments of balanced electrolyte solution, or less if the patient experiences discomfort. Open the pinch-clamp on the outflow tubing. Compress the breast towards the nipple with both hands, beginning at the base of the breast and rolling upward toward the nipple. Complete each stroke by compressing the lactiferous sinuses. Cloudy fluid and/or fine air bubbles may collect in the catheter body, indicating fluid flow. Pull back approximately 0.2 mL on the collection syringe to clear the chamber. (Pulling back more than 0.2 mL will simply transfer fluid from the inflow tubing to the outflow tubing.) Rotate hands to ensure that all quadrants of the breast are compressed. Deep compression followed by the collection of approximately 0.2 mL of ductal effluent should be repeated approximately three to four times.

9. Continue the cycles of infusing fluid into the duct, compressing the breast, and collecting ductal effluent until the duct has been lavaged with at least 20 mL of balanced electrolyte solution.

10. Pull back gently on the collection syringe plunger while removing the catheter from the patient to collect any residual effluent. Dispose of catheter appropriately.

11. Carefully mark the location of the cannulated duct on the 64 square nipple grid, drawing in any nipple landmarks that are evident. If patient indicated any areas of anesthetic inflow sensation, this may also be recorded on the nipple grid. Optional: Place a 1¹/₂” piece of 2.0 Prolene knotted at the end into each duct. Mark the 12 o'clock (cephalad) position of the nipple with a pen and photograph the nipple. The Prolene markers provide a clear picture of ductal orifice location. Remove the knotted Prolene after photography.

12. Expel effluent into a CytoLyt® solution tube. If effluent volume exceeds the unfilled volume of the CytoLyt® solution tube, divide the effluent between an appropriate number of tubes. Secure the cap tightly until the two black indicator marks meet. Using a graphite pencil, immediately label the tube with sample identification (including patient's name) before continuing with the next duct.

13. Repeat Steps 4 through 12 for other identified orifices using a new FirstCyte™ EZ MicroCatheter and a fresh collection syringe and CytoLyt® Solution tube for each orifice.

14. Repeat Steps 2 through 13 for the contralateral breast. Discard all used devices appropriately.

15. Prepare the specimens for transport in accordance with all applicable regulations for transporting biological materials.

Repeat steps for other identified orifices using a new FirstCyte™ EZ MicroCatheter and a fresh collection syringe and CytoLyt® solution tube for each orifice.

Store in a cool dry place.

Improper fixation; improper labeling; specimen submitted in vial that expired according to manufacturer's label