Triaging abnormal cervical cancer screening tests using p16INK4a detection by ELISA on fresh cervical samples

Problem Cervical cancer screening strategies in the United States include cotesting (human papillomavirus (HPV) with cytology), primary HPV with genotyping and reflex cytology, and cytology alone. An ongoing challenge is the appropriate triage of patients to colposcopy to those at highest risk. We i...

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Bibliographic Details
Published in:American journal of reproductive immunology (1989) 2021-07, Vol.86 (1), p.e13394-n/a
Main Authors: Leung, Shuk On Annie, Feldman, Sarah, Kalyanaraman, Rajeshwari, Shanmugam, Vignesh, Worley, Michael J., Berkowitz, Ross S., Horowitz, Neil S., Feltmate, Colleen M., Muto, Michael G., Lee, Larissa J., King, Martin T., Einarsson, Jon I., Ajao, Mobolaji O., Elias, Kevin M.
Format: Article
Language:English
Subjects:
Adult
Alphapapillomavirus - physiology
Biomarkers
Cancer screening
Cellular biology
Cervical cancer
Cervix Uteri - metabolism
Cervix Uteri - pathology
Cohort Studies
Colposcopy
Cyclin-Dependent Kinase Inhibitor p16 - genetics
Cyclin-Dependent Kinase Inhibitor p16 - metabolism
Cytology
Dysplasia
Early Detection of Cancer - methods
Enzyme-Linked Immunosorbent Assay
Feasibility Studies
Female
Genotyping
HeLa Cells
Human papillomavirus
Humans
INK4a protein
Medical screening
Middle Aged
p16 Protein
p16INK4a
Papillomavirus Infections - diagnosis
Prospective Studies
Referral and Consultation
screening
Sensitivity and Specificity
Triage
Uterine Cervical Neoplasms - diagnosis
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Summary:Problem Cervical cancer screening strategies in the United States include cotesting (human papillomavirus (HPV) with cytology), primary HPV with genotyping and reflex cytology, and cytology alone. An ongoing challenge is the appropriate triage of patients to colposcopy to those at highest risk. We investigated whether incorporation of p16INK4a immunodetection by enzyme‐linked immunosorbent assay (ELISA) on fresh cervical samples obtained at the time of screening could improve appropriate referral to colposcopy. Method of Study A derivation group comprised of cervical swabs collected from subjects with high‐grade dysplasia or cancer (positive control) and from subjects with negative screening history (negative control). Samples collected from colposcopy were used to evaluate the existing screening strategies individually and with incorporation of p16INK4a ELISA. Histology was used as the gold standard. Results Among 163 subjects recruited, 138 were included. In the derivation group, mean p16INK4a level was 2.86 ng/mL (n = 31) and 0.58 ng/mL (n = 20) among positive and negative controls respectively (p = 0.002) with an area under the receiver operator characteristic curve of 0.79 (p 
ISSN:1046-7408
1600-0897
DOI:10.1111/aji.13394