Principles and analytical performance of Abbott RealTime High Risk HPV test.
BACKGROUND
Abbott RealTime High Risk (HR) HPV is a new automated, qualitative real-time PCR test for detection of DNA from 14 high-risk human papillomavirus (HPV) types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) in cervical specimens. The test can also differentiate between HPV 16, HPV 18 and non-HPV 16/18 types in a single reaction.


OBJECTIVE
This article describes the principles of assay design and the analytical performance of Abbott RealTime HR HPV.


METHODS
The analytical performance characteristics of Abbott RealTime HR HPV were evaluated in terms of its sensitivity for each of the 14 high-risk types included in the test, specificity (cross-reactivity), potential for interference by substances that may be present in cervical specimens, and reproducibility.


RESULTS
Abbott RealTime HR HPV provided sensitive detection of the 14 high-risk HPV types included in the test. It was also highly specific to the HPV types targeted by the test and did not show cross-reactivity with 15 low-risk HPV types tested, or non-specific reactivity with other common microorganisms that may be present in the female anogenital tract. Test results were not impacted by potential interfering substances evaluated in the study. The test generated highly reproducible results in an in-house study and in studies carried out at 13 external evaluation sites.


CONCLUSIONS
Abbott RealTime HR HPV demonstrated a robust analytical performance with reproducible and reliable results.
Huang
Shihai
S
Abbott Molecular Inc., Des Plaines, Illinois 60018-3315, USA. shihai.huang@abbott.com
Tang
Ning
N
Mak
Wai-Bing
WB
Erickson
Brian
B
Salituro
John
J
Li
Yuhong
Y
Krumpe
Evelyn
E
Schneider
George
G
Yu
Hong
H
Robinson
John
J
Abravaya
Klara
K
D003429:Cross Reactions; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification; D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
D004279:DNA, Viral