When collecting a Pap sample using the ThinPrep® Pap Test it is very important to use the proper lubricant in order to avoid unsatisfactory smears and the need to retake samples. This will additionally increase the level of care that you provide to your patients, improve patient outcomes and avoid unnecessary costs.

Please find below instructions for speculum lubrication for collection of ThinPrep® Pap Test samples:

1. Use of lukewarm water

For a patient that does not have physical or physiological reasons to use a lubricant, lukewarm water may be used to warm and lubricate the speculum. This protocol ensures the lowest risk for the quality of the Pap sample collected.  Professional organizations including ACOG and CLSI recognize that excessive use of lubricant may contaminate or obscure the Pap sample.  

2. Use of lubricant gels only in case lubricant must be used due to patient discomfort or other circumstances

The “PAP TEST Lubricating Jelly” manufactured by Aseptic Control Products INC, is the only lubricant that should be used as evaluated by Hologic.  If a lubricant must be used due to patient discomfort or other circumstances, it should be used sparingly and applied only to the exterior sides of the speculum blades, avoiding contact with the tip of the speculum 1,2,3,4 (see pictures below). When used sparingly and appropriately, it poses little risk to the quality of the Pap sample. However, when a lubricant is used in excess, it can adversely affect the Pap sample. Hologic evaluated a variety of popular lubricants and found those containing carbomer or carbopol polymers (thickening agents) interfere with the ThinPrep® Pap test when found in the sample vial.
The “PAP TEST Lubricating Jelly” evaluated by Hologic is safe and effective for use with Pap tests and is the only recommended lubricant to use with the ThinPrep® Pap Test as it:

  • Eases the insertions of speculum
  • Does not contain carbomers
  • Has 510(k) FDA approval
  • Is transparent and greaseless
  • Tested and approved for use with the ThinPrep® Pap Test by Hologic, Inc.

Patient Education:

Women should be counseled to refrain from intercourse, douching, using tampons, or using intravaginal medication for at least 48 hours before the examination to decrease the possibility that the number of exfoliated cells will be diminished or obscured by personal lubricants or spermicides1,2. In addition, the patient should avoid scheduling her appointment during heavy menstrual bleeding.



Please note that National Reference Laboratory provides the clients with the approved “PAP TEST Lubricating Jelly”manufactured by Aseptic Control Products INC free of charge with the supply of the ThinPrep® vials.  In addition, we will be happy to provide the necessary training on the proper sample collection techniques for your staff.

Should you need further information please contact your National Reference Laboratory representative.

Dr. Basel Altrabulsi
Anatomic and Clinical Pathologist
Medical Director

References:

  • Davey et al, 2008, “Cervical Cytology Specimen Adequacy: Patient Management Guidelines and Optimizing Specimen Collection”;American Society for Colposcopy and Cervical Pathology Journal of Lower Genital Tract Disease, Volume 12, Number 2, 2008, 71‐81
  • Amies, AE.; Miller, L; Lee, Shu‐Kuang; Koutsky, L, The Effect of Vaginal Speculum Lubrication on the Rate of Unsatisfactory Cervical
  • Cytology Diagnosis, Obstet Gynecol. 100(5, Part 1):889‐892, November 2002.  
  • “Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved Guideline – Third Edition”, Clinical and Laboratory Standards
  • Institute (formerly NCCLS), Vol. 28 No. 28, 2008.
  • ACOG Practice Bulletin, Clinical Management Guidelines for Obstetrician Gynecologists, Number 109, December 2009, pg 2.
  • Hologic internal study, Data on file.

Proper use of lubricants for sample collection for ThinPrep Pap Test

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