Novel HPV Tests: A Comparative Analysis of the Invader HPV and COMPLeTe Care HPV Genotyping Assays in Low Grade Cervical Cytologic Abnormalities
AK Wong, RC Chan, GE Galliano, P Manna, S Kerley, S Bose. Cedars-Sinai Medical Center, Los Angeles, CA; Physicians Reference Laboratory, Overland Park, KS
Background: High risk (HR) HPV testing is being used increasingly in screening and triaging of women with low grade cervical abnormalities in pap smears. Early indications exist that type specific HPV testing may provide useful information for better stratification of these women. The Invader HPV assay (INV) (Hologic Inc, Bedford, MA) is a recently developed pooled analyte specific reagent for detecting 14 HRHPV with additional probes for typing HPV16 and 18; while the COMPLeTe Care HPV assay (Physicians Reference Laboratory, Overland Park, KS) (CC) is a real time multiplex PCR test that simultaneously detects and types all 15 HRHPV. This study describes performance characteristics of the two tests.
Design: 73 residual SurePath samples (46 ASC-US and 27 LSIL) were tested for HR HPV by the INV and CC assays. Appropriate positive and negative controls were run. Additionally, both assays contained an internal beta-globin control for sample DNA. The analytic sensitivity of the INV HPV 16 assay is <625 copies/reaction and HPV 18 of <5000 copies/reaction. The analytic sensitivity of CC is <10 copies of HPV/reaction, and corresponds to <125 copies/ml of Pap samples. Results obtained by the two assays were correlated.
Results: Results are summarized in table 1.
Table 1: Comparison of the Invader (INV) and COMPLeTe Care (CC) Assays for Detection of High Risk HPVNA, not applicable
|Assay Method||Invader Technology||Multiplex PCR|
|Type||Two step test (initial screening wtih selection for HPV16/18 typing)||One step test|
|HRHPV Positive||49 (67%)||53 (73%)|
|Multiple Infections||NA||28 (38%)|
|HPV 16||9 (12%)||10 (14%)|
|HPV 18||4 (5%)||6 (8%)|
|Common HPV Types Detected||NA||HPV 51, 56, 59 (19% each); HPV 39 (18%)|
Conclusions: CC and INV assays showed good (85%) concordance. Differences may be explained by the greater analytic sensitivity of CC. CC offers additional advantage of a one-step type specific information with capability of future determinations of virus persistence, significance of presence of multiple infections and significance of HPV types other than 16 and 18; information that may be essential for personalized management of patients.
Monday, March 9, 2009 9:30 AM
Poster Session I Stowell-Orbison/Autopsy Award # 70, Monday Morning