The ThinPrep Difference

Additional Independent Studies:
Increased Disease Detection with
the ThinPrep Pap Test

In published, peer-reviewed studies, the ThinPrep Pap Test has been proven to provide consistent, reproducible results.1-10 Independent, multi-study reviews cited consistent, increased detection with the ThinPrep Pap Test.

Studies demonstrating statistically significant results vs. the conventional pap smear*1-10

Primary Author Journal/Date Increased HSIL + Detection
Bolick Acta Cytol/1998 173% p< 0.001
Diaz-Rosario Arch Pathol Lab Med/1999 103% p< 0.001
Ferris J Fam Pract/2000 119% p< 0.001
Guidos Diagn Cytopathol/1999 233% p< 0.001
Harkness J Reprod Med/2003 47% p< 0.006
Limaye Arch Pathol Lab Med/2003 233% p< 0.001a
Papillo Acta Cytol/1998 55% p< 0.001
Wang J Formos Med Assoc/1999 33% p< 0.006
Weintraub Diagn Cytopathol/2000 244%b
    1.85 OR p< 0.006
Yeoh Hong Kong Med J/1999 28% p< 0.001

a – Based on period 2 or a two-period study

b – Odds ratio (greater likelihood of detecting ASC-US, LSIL, or HSIL compared with the conventional pap smear)

*All studies were direct-to-vial except Wang, which was a split-sample study

The ThinPrep Pap Test is more sensitive and more specific in detecting cervical dysplasia vs. the conventional pap smear.11

Method

Meta-analysis of 10 studies published between 1990-2002 compared cytology with biopsy-proven diagnosis for 21,752 patients.

Findings

The ThinPrep Pap Test showed an 11.7% increase in sensitivity (76% vs. 68%) and an 8.9% increase in specificity (86% vs. 79%). "The increased sensitivity of ThinPrep results in increased cytologic diagnosis of cervical atypia, LGSIL, HGSIL..."

"... wide application of the ThinPrep technology potentially may result in cytological diagnosis of an additional 162,000 patients with HGSIL and 3,000 patients with invasive cervical carcinoma whom otherwise would have been missed by utilization of conventionally prepared Papanicolaou smears..."

Abulafia O, Pezzullo JC, Sherer DM

Improves sample quality and detection of abnormalities over the conventional pap smear.12

Method

Meta-analysis of 25 articles published between 1990-2000 comparing diagnostic cytology and specimen adequacy of the two tests for 67,484 patients.

Findings

Odds ratios favored the ThinPrep Pap Test over the conventional pap smear in regard to the diagnosis of LSIL and HSIL; adequacy was improved in the ThinPrep Pap Test group in all trials.

"... ThinPrep appears to be a superior method of evaluating uterine cervix cytologic abnormalities with regard to low-grade and high-grade lesions, as well as a better means of obtaining specimen adequacy for improved evaluation."

Bernstein SJ, Sanchez-Ramos L, Ndubisi B

References

  1. Bolick DR, Hellman DJ. Laboratory implementation and efficacy assessment of the ThinPrep cervical cancer screening system. Acta Cytol. 1998;42:209-13.

  2. Diaz-Rosario LA, Kabawat SE. Performance of a fluid-based, thin-layer Papanicolaou smear method in the clinical setting of an independent laboratory and an outpatient screening population in New England. Arch Pathol Lab Med. 1999;123:817-21.

  3. Ferris DG, Heidemann NL, Litaker MS, et al. The efficacy of liquid-based cervical cytology using direct-to-vial sample collection. J Fam Pract. 2000;49:1005-11.

  4. Guidos BJ, Selvaggi SM. Use of the ThinPrep Pap Test in clinical practice. Diagn Cytopathol. 1999;20:70-3.

  5. Harkness CB, Theofrastous JP, Ibrahim SN, et al. Papanicolaou and thin-layer cervical cytology with colposcopic biopsy control. A comparison. J Reprod Med. 2003;48:681-6.

  6. Limaye A, Connor AJ, Huang X, et al. Comparative analysis of conventional Papanicolaou tests and a fluid-based thin-layer method. Arch Pathol Lab Med. 2003;127:200-4.

  7. Papillo JL, Zarka MA, St. John TL. Evaluation of the ThinPrep Pap Test in clinical practice: A seven-month 16,314-case experience in northern Vermont. Acta Cytol. 1998;42:204-8.

  8. Wang TY, Chen HS, Yang YC, et al. Comparison of fluid-based, thin-layer processing and conventional Papanicolaou methods for uterine cervical cytology. J Formos Med Assoc. 1999;98:500-5.

  9. Weintraub J, Morabia A. Efficacy of a liquid-based thin layer method for cervical cancer screening in a population with a low incidence of cervical cancer. Diagn Cytopathol. 2000;22:52-9.

10. Yeoh GPS, Chan KW, Lauder I, et al. Evaluation of the ThinPrep Papanicolaou test in clinical practice: 6-month study of 16,541 cases with histological correlation.

11. Abulafia O, Pezzullo JC, Sherer DM. Performance of ThinPrep liquid-based cervical cytology in comparison with conventionally prepared Papanicolaou smears: a quantitative study. Gyn Oncol. 2003;90:137-44.

12. Bernstein SJ, Sanchez-Ramos L, Ndubisi B. Liquid-based cervical cytologic smear study and conventional Papanicolaou smears: A metaanalysis of prospective studies comparing cytologic diagnosis and sample adequacy. Am J Obstet Gynecol. 2001;185:308-17.

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