ASC-US Reflex Testing

ASC-US reflex testing improves diagnostic confidence and management of patients with inconclusive Pap results

  • The digene HPV Test is the standard of care for determining what follow-up is needed for cytology interpreted as atypical squamous cells of undetermined significance (ASC-US).

  • The digene HPV Test was first approved by the FDA for this indication in 2000.

  • The digene HPV Test is the only FDA-approved HPV DNA test and detects the 13 most clinically relevant high-risk HPV types.

ASC-US reflex HPV testing:

  • Provides a high level of diagnostic confidence.

  • Minimizes the risk of missed disease.

  • Helps determine the need for colposcopy.

  • Provides objective results and enables HPV-negative women to be returned to routine screening with a high degree of confidence that they are at little to no risk of having or developing high-grade cervical disease or cancer in the next three years.

  • Reduces anxiety of HPV-negative women with ASC-US.

  • Reduces unnecessary consultations and procedures.

Special exception for girls under 20: In its latest guidelines published in the October 2007 issue of the Journal of Obstetrics & Gynecology, the ASCCP advises against the use of HPV testing (or colposcopy) in adolescent girls with ASC-US Paps. Adolescents with ASC-US cytology should get a repeat Pap in 12 months. At that time, only those with cytology of HSIL or greater should be referred to colposcopy, says ASCCP. At the 24-month follow-up, girls with cytology results of ASC-US or greater should be referred to colposcopy.

For ASC-US reflex, HPV testing offers:
≥96% sensitivity
  • Sensitivity for the detection of high-grade cervical lesions has been shown in several studies to be higher than cytological screening.1 
  • HPV testing has a sensitivity superior to the 55-74% achieved with cytology alone.2, 3 
99% negative predictive value
  • Among women with an ASC-US Pap, the negative predictive value of the HPV DNA test for HSIL or greater as confirmed by colposcopy is 99%.4

References:

1 Clavel C, Masure M, Bory JP, et al. Hybrid Capture® II-based human papillomavirus detection, a sensitive test to detect in routine high-grade cervical lesions. Brit J Cancer 1999; 80(9): 1306-1311.

2 Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, et al. Human Papllomavirus DNA versus Papanicolau Screening Tests for Cervical Cancer. N. Engl J Med 2007; 357(16): 1579-88.

3 Ronco G, Segnan N, Giorgi-Rossi P, et al. Human papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial. J Natl Cancer Inst 2006; 98(11): 765-74.

4 Manos MM, Kinney WK, Hurley LB. Identifying women with cervical neoplasia. Using human papillomavirus DNA testing for equivocal Papanicolaou Results. JAMA 1999; 281: 1605-10.

* "The digene HPV Test" was approved by the U.S. FDA and is also known to laboratories and physicians as the "hc2 High-Risk HPV DNA Test®" and "DNAwithPap® Test." This does not refer to the QIAGEN product that tests for several types of the virus commonly referred to as "low-risk HPV," which are not associated with cervical cancer.