Analytical performance of the Investigational Use Only Cervista HPV HR test as determined by a multi-center study.
BACKGROUND
Any HPV test designed to be utilized in cervical cancer screening programs should be highly validated both analytically and clinically.


OBJECTIVE
The Investigational Use Only (IUO) Cervista HPV HR test is designed to detect 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). The analytical performance of the Cervista HPV HR test was characterized in a multi-center study.


RESULTS
Analytical sensitivity for the 14 high-risk HPV types that the test is designed to detect ranged from 1,250 copies to 7,500 copies per reaction depending on HPV type. Accuracy compared to PCR with bi-directional sequencing was 91.4% [95% CI: 86.5 95.0%]. The reproducibility, when tested at three different testing centers, resulted in an overall inter-run reproducibility (between day/within site) agreement of 98.8% [1-sided 95% Confidence Lower Limit = 96.9%] and an overall inter-site reproducibility (between site) agreement of 98.7% [1-sided 95% Confidence Lower Limit = 97.9%]. The Cervista HPV HR test showed no cross-reactivity with DNA from seven non-oncogenic HPV types or 17 different infectious agents at up to 10(7) copies per reaction.


CONCLUSIONS
The analytical performance of the Cervista HPV HR test demonstrates sufficient analytical performance for use in cervical cancer screening. As with any clinical laboratory test, analytical characteristics must be evaluated in light of the clinical performance of this assay.
Day
Stephen P
SP
Hologic, Inc., Madison, WI 53719, USA. Stephen.Day@Hologic.com
Hudson
Angela
A
Mast
Andrea
A
Sander
Tamara
T
Curtis
Michelle
M
Olson
Sarah
S
Chehak
LuAnne
L
Quigley
Neil
N
Ledford
Joellen
J
Yen-Lieberman
Belinda
B
Kohn
Debra
D
Quigley
Denise I
DI
Olson
Marilyn
M
D002584:Cervix Uteri / Q000821:virology*; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000821:virology*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*
D011933:Reagent Kits, Diagnostic