Referral population studies underestimate differences between human papillomavirus assays in primary cervical screening
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Referral population studies underestimate differences between human papillomavirus assays in primary cervical screening. / Rebolj, M.; Njor, S.; Lynge, E.; Preisler, S.; Ejegod, D.; Rygaard, C.; Bonde, J.
In: Cytopathology, Vol. 28, No. 5, 10.2017, p. 419-428.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Referral population studies underestimate differences between human papillomavirus assays in primary cervical screening
AU - Rebolj, M.
AU - Njor, S.
AU - Lynge, E.
AU - Preisler, S.
AU - Ejegod, D.
AU - Rygaard, C.
AU - Bonde, J.
PY - 2017/10
Y1 - 2017/10
N2 - Objective: We studied how representative cytologically abnormal women (“referral populations”) are with respect to uncovering differences between human papillomavirus (HPV) assays in the primary screening where most women are cytologically normal. Methods: A total of 4997 women were tested with SurePath® cytology, and Hybrid Capture 2 (HC2), cobas, CLART and APTIMA HPV assays. Women with positive test results were offered a follow-up. For all detected HPV infections and HPV-positive high-grade cervical intraepithelial neoplasia (≥CIN2), we studied the distributions of assay-specific signal strengths in the baseline samples as documented by the assays’ automatically generated reports. We calculated the likelihood of test result discordance as the proportion of HPV-positive samples that were not confirmed by all four assays. Results: Median signal strengths for HPV infections were weaker in normal than abnormal cytology (P<.001, adjusted for women's age, multiple infections and the reason for taking the sample). For HC2, they were RLU/CO 11.0 (interquartile range, IQR: 3.3-52.8) vs 124.2 (IQR: 22.8-506.9), respectively; for cobas, Ct 33.5 (IQR: 29.6-37.5) vs 26.9 (IQR: 23.7-31.3), respectively; for APTIMA, S/CO 10.2 (IQR: 5.8-11.3) vs 11.1 (IQR: 9.4-15.5), respectively. Similar patterns were observed for HPV-positive ≥CIN2. The four HPV assays more frequently returned discordant test results in normal than in abnormal cytology. Relative frequency of discordance in detecting HPV infections was 0.39 (95% confidence interval: 0.33-0.48) for abnormal vs normal cytology. Conclusions: These data suggest that referral population studies, by not including sufficient numbers of cytology normal women, underestimate the differences between HPV assays that would become apparent in primary screening.
AB - Objective: We studied how representative cytologically abnormal women (“referral populations”) are with respect to uncovering differences between human papillomavirus (HPV) assays in the primary screening where most women are cytologically normal. Methods: A total of 4997 women were tested with SurePath® cytology, and Hybrid Capture 2 (HC2), cobas, CLART and APTIMA HPV assays. Women with positive test results were offered a follow-up. For all detected HPV infections and HPV-positive high-grade cervical intraepithelial neoplasia (≥CIN2), we studied the distributions of assay-specific signal strengths in the baseline samples as documented by the assays’ automatically generated reports. We calculated the likelihood of test result discordance as the proportion of HPV-positive samples that were not confirmed by all four assays. Results: Median signal strengths for HPV infections were weaker in normal than abnormal cytology (P<.001, adjusted for women's age, multiple infections and the reason for taking the sample). For HC2, they were RLU/CO 11.0 (interquartile range, IQR: 3.3-52.8) vs 124.2 (IQR: 22.8-506.9), respectively; for cobas, Ct 33.5 (IQR: 29.6-37.5) vs 26.9 (IQR: 23.7-31.3), respectively; for APTIMA, S/CO 10.2 (IQR: 5.8-11.3) vs 11.1 (IQR: 9.4-15.5), respectively. Similar patterns were observed for HPV-positive ≥CIN2. The four HPV assays more frequently returned discordant test results in normal than in abnormal cytology. Relative frequency of discordance in detecting HPV infections was 0.39 (95% confidence interval: 0.33-0.48) for abnormal vs normal cytology. Conclusions: These data suggest that referral population studies, by not including sufficient numbers of cytology normal women, underestimate the differences between HPV assays that would become apparent in primary screening.
KW - assays
KW - cervical cancer
KW - cytology
KW - human papillomavirus
KW - mass screening
UR - http://www.scopus.com/inward/record.url?scp=85029329407&partnerID=8YFLogxK
U2 - 10.1111/cyt.12451
DO - 10.1111/cyt.12451
M3 - Journal article
C2 - 28901682
AN - SCOPUS:85029329407
VL - 28
SP - 419
EP - 428
JO - Cytopathology
JF - Cytopathology
SN - 0956-5507
IS - 5
ER -
ID: 188745383