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AMPLICOR® and LINEAR ARRAY® HPV testing in patients with CIN

Andreas Lindauer1, Ulrike Schön1, Kurt Beyser1, Gerd Böhmer2, Kathleen Menzel3,
Franziska Rinnau2, Karl Ulrich Petry2,4
Life Science Department, Synlab, Medizinisches Fachlabor, Weiden, Germany; 2Department of Gynecologic Oncology,
University of Hannover, Hannover, Germany; 3Roche Molecular Systems Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, USA;
Department of Obstetrics and Gynecology, City Hospital Wolfsburg, Wolfsburg, Germany

Introduction Objectives
● The most important factor in the development of cervical carcinoma is ● To assess the performance of a new HPV test (AMPLICOR HPV Test)
persistent infection with high-risk (HR) human papillomavirus (HPV) ● To assess a possible role for HPV typing using the LINEAR ARRAY HPV Test

● HPV testing, targeted against 13 HR types, has been used to identify women Patients and methods
with high-grade disease who have borderline (atypical squamous cells of
● A total of 103 women with biopsy-proven CIN1 (n=38), CIN2 (n=47) or CIN3
undetermined significance [ASCUS]), atypical Pap smears; HPV testing has also
(n=18) were recruited
been used in women attending primary screening
● A total of 71 women with CIN1/2 underwent conservative management, and
● To date, HPV testing has been performed most commonly using the Digene were followed-up for > 9 months
Hybrid Capture® 2 (hc2) test

● The novel, PCR-based Roche AMPLICOR® HPV Test provides a robust

alternative to hc2 (Figure 1)
● 16/17 women with confirmed CIN3 and all women with progressing CIN1/2
● We assessed the performance of the AMPLICOR HPV Test and the hc2 test in
(n=9) tested positive using the AMPLICOR HPV Test (Figure 2)
women with biopsy-proven cervical intraepithelial neoplasia (CIN)
● Negative AMPLICOR HPV Test results during follow-up (n = 19) were
● Genotyping of discrepant samples was performed using the Roche LINEAR
associated with regressing CIN1/2 (n=12), persisting CIN1/2 (n=6) and a
ARRAY® HPV Test, which is able to distinguish a broad spectrum of both HR
regressing CIN3 lesion in a pregnant woman (n=1)
and low-risk (LR) types (Table 1), including those detected by the AMPLICOR
HPV Test and the hc2 test


90 CIN2

80 CIN3

Native HPV
genome UNG 70
Samples (%)

Denature and 60

Wash, add
avidin-HRP 30


probe 0
Immobilized hybrids react Oxidized Oxidized Hybridization
with avidin-HRP TMB TMB

Figure 2. Positivity of the AMPLICOR HPV Test in samples with biopsy-confirmed

HRP produces color
upon addition of
TMB substrate
neoplasia at the initial visit
Add stop solution,
read absorbance

HPV: Human papillomavirus; UNG: Uracil-N-glycosylase; PCR: Polymerase chain reaction;

HRP: Horseradish peroxidase; TMB: 3,3',5,5'-tetramethylbenzidene

Figure 1. The AMPLICOR HPV Test
● AMPLICOR HPV Test results correlated well with the grade of associated
lesions and natural course of the disease
Table 1. HPV types distinguished by the LINEAR ARRAY HPV Test

Target types 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, References
54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 1. Bohmer G, van den Brule AJ, Brummer O et al. Am J Obstet Gynecol 2003;189:118–20
2. Petry KU, Bohmer G, Iftner T et al. Am J Obstet Gynecol 2002;186:28–34
72, 73, 81, 82, IS39, 83, 84, 89 (CP6108)
3. Walboomers JM, Jacobs MV, Manos MM et al. J Pathol 1999;189:12–9