Validation of cobas 4800 HPV assay in SurePath Papanicolaou specimens for cervical cancer screening

The cobas (Roche Diagnostics, Indianapolis, IN) HPV assay was approved by the US Food and Drug Administration for human papillomavirus (HPV) testing in SurePath (Becton Dickinson, Franklin Lakes, NJ) Papanicolaou specimens for cervical cancer prevention. To validate the cobas HPV assay in SurePath s...

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Bibliographic Details
Published in:Journal of the American Society of Cytopathology JASC 2021-07, Vol.10 (4), p.399-405
Main Authors: Guo, Ming, Shlyakhova, Natalya, Khanna, Abha, Tinnirello, Agata A., Schmeler, Kathleen M., Hwang, Jessica, Sturgis, Erich M., Stewart, John
Format: Article
Language:English
Subjects:
Adult
Aged
Alphapapillomavirus - genetics
Cervical Intraepithelial Neoplasia - diagnosis
Cervical Intraepithelial Neoplasia - pathology
Cervical Intraepithelial Neoplasia - virology
Cervista HPV assay
Cervix Uteri - pathology
cobas HPV assay
Data Accuracy
Early Detection of Cancer - methods
Female
Follow-Up Studies
Genotype
HPV16/18 genotyping
Human papillomavirus
Humans
Mass Screening - methods
Middle Aged
Papanicolaou Test - methods
Papillomavirus Infections - diagnosis
Papillomavirus Infections - pathology
Papillomavirus Infections - virology
Real-Time Polymerase Chain Reaction - methods
Sensitivity and Specificity
SurePath papanicolaou cytology
Uterine Cervical Neoplasms - diagnosis
Uterine Cervical Neoplasms - pathology
Uterine Cervical Neoplasms - virology
Vaginal Smears - methods
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Summary:The cobas (Roche Diagnostics, Indianapolis, IN) HPV assay was approved by the US Food and Drug Administration for human papillomavirus (HPV) testing in SurePath (Becton Dickinson, Franklin Lakes, NJ) Papanicolaou specimens for cervical cancer prevention. To validate the cobas HPV assay in SurePath specimens in our institution, we compared its accuracy and clinical efficacy to that of the Cervista (Hologic, Marlborough, MA) HPV HR assay. This study used 138 Papanicolaou (Pap) cytology specimens collected in SurePath preservative fluid at our institution in 2018. After Pap cytology testing, the residual specimens were split for testing with the cobas and Cervista assays. Polymerase chain reaction (PCR)-based HPV testing (GP5+/GP6+) was performed on specimens with discrepant results. Clinical follow-up data were reviewed. The cobas HPV and Cervista HPV HR assays showed good concordance (89.1%), with a kappa value of 0.78 (95% CI: 0.675-0.885). Fifteen specimens showed discrepant results between the 2 assays. Of 7 cases with cobas+/Cervista− results, 5 (71%) were confirmed positive by PCR. Of 8 cases with cobas−/Cervista+ results, 4 (50%) were confirmed positive by PCR. cobas HPV and Cervista HPV HR showed the same HPV-positive rate in cases of pathologically diagnosed ASC-H, LSIL, or HSIL. The sensitivities and specificities for detecting high-risk HPV of cobas HPV (93.7%, 97.3%) and Cervista HPV HR (92.1%, 94.7%) were comparable. The cobas HPV assay had false-negative results in 4 cases (5.2%) including 1 false-negative case that failed to predict CIN3. The cobas HPV assay is valid in SurePath Pap cytology specimens for cervical cancer screening but has limitations of false-negative results with clinical implications. •In this split sample study, we evaluated validity of cobas HPV validation in SurePath Papanicolaou cytology specimens for cervical cancer screening in our institution by comparing cobas HPV with Cervista HPV HR for detecting high-risk HPV and predicting CIN2+.•The cobas HPV and Cervista HPV HR assays showed a good concordance (89.1%), with a kappa value of 0.78 (95% CI: 0.675-0.885).•Using PCR HPV (GP5+/GP6+) assay in cases with discrepant HPV results, we determined the false-negative HPV results and found that the false-negative case distribution for the cobas HPV assay differed from that of the Cervista HPV assay, that is, cobas HPV showed more positive results in ASC-US Papanicolaou specimens and fewer positive results in NILM Papanicolaou
ISSN:2213-2945
2213-2945
DOI:10.1016/j.jasc.2021.04.002