Hybrid Capture 2 Test Results After an Initial Equivocal RLU/CO Value Are Dependent on Age

Elkins, Camille T.; Vries, C. E. De; Suarez, Adrian A.

doi:10.1309/ajcparhtb40dtvfv

Cited by 3 publications

(6 citation statements)

References 29 publications

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“…14 The range of the “grey zone” varied from 0.8 to 3.0 RLU/CO. Some authors have found that the majority of their specimens retained the original positive (87%–97%) HC2 result 11, 12, 13, 14. These results are comparable to our results for the STM specimens, which showed that 87.5% of specimens retained the original HC2 test result after retest, even though our “grey zone” was wider.…”

Section: Discussionsupporting

confidence: 87%

“…reported 6.8% CIN2+ among cases with low-grade cytology and 1.0–3.0 RLU/CO. Interestingly, Elkins et al 14. demonstrated that the clinical relevance of the HC2 test is age dependent.…”

Section: Discussionmentioning

confidence: 99%

“…Since the manufacturer recommends retesting PreservCyt specimens with results within the “grey zone”, several authors have already evaluated whether the retesting algorithm is effective 11, 12, 13, 14, 15, 16. Some authors have performed one retest15, 16, while others have reported two retests13, and some retested only those samples where the results were found within the “grey zone” after the first retest11 or below 1.0 RLU/CO.…”

Section: Discussionmentioning

confidence: 99%

“…Several authors9, 10, 11, 12, 13, 14, 15, 16 have investigated the reproducibility and clinical significance of retesting PreservCyt samples with borderline HC2 results. However, we have not found a single study where the same problem was addressed for specimens collected in STM.…”

Section: Introductionmentioning

confidence: 99%

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Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium

Varl

Ivanuš

Marinsek

et al. 2019

Radiology and Oncology

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Background The Hybrid Capture 2 (HC2) High-Risk HPV DNA assay serves as a triage test in the Slovenian national cervical cancer screening programme ZORA. To improve the limited analytical accuracy of HC2 test results near the cut-off value (1.0 relative light units/cut-off (RLU/CO)), we follow an internal protocol of repeating the test on all samples with borderline results within the 0.7-2.0 RLU/CO interval. The aim of the study was (i) to determine the clinical relevance of HC2 test results within three different “grey zones” for samples stored in Specimen Transport Medium (STM) and (ii) to determine whether the current algorithm of retesting “grey zone” STM specimens with the HC2 assay is clinically relevant. Patients and methods The study included 594 women between 20 and 65 years of age. All participating women were referred for colposcopy, and in cases of abnormal results, biopsy was performed. We assessed the distribution of HC2 test results and the corresponding proportion of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) lesions in three different “grey zones” (1.0–2.5, 0.4–4.0 and 0.7–2.0 RLU/CO), retested specimens with results within a 0.4–4.0 RLU/CO interval and calculated the sensitivity and specificity for HC2 at different RLU/CO values. Results The proportion of specimens within 1.0–2.5, 0.4–4.0 and 0.7–2.0 RLU/CO intervals was 3.9%, 10.8% and 4.5%, respectively. The proportion of CIN2+ lesions within these “grey zones” was 2.5%, 5.6% and 1.2%, respectively. Retesting the samples did not detect any additional CIN2+ cases. Within the 1.0–2.5 RLU/CO interval, the sensitivity decreased from 93.8% to 91.4%, while the specificity increased from 63.3% to 67.5%; for the 0.4–4.0 RLU/CO interval, the sensitivity decreased from 95.1% to 89.5%, while the specificity increased from 56.8% to 69.4%; and for the 0.7–2.0 RLU/CO interval, the sensitivity remained nearly constant (94.4 vs. 93.2%), while the specificity increased from 60.6% to 66.4%. Conclusions Our results show that retesting STM samples within the “grey zones” is not necessary. Retesting samples in the negative “grey zone” does not increase sensitivity, and retesting in the positive “grey zone” is not followed by a less intensive management of women, since these women are recalled regardless of the results of the retest. Furthermore, the majority of samples retain the original HC2 results after retest, and the number of CIN2+ lesions among women with “grey zone” HC2 results is low.

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Section: Discussionsupporting

confidence: 87%

“…reported 6.8% CIN2+ among cases with low-grade cytology and 1.0–3.0 RLU/CO. Interestingly, Elkins et al 14. demonstrated that the clinical relevance of the HC2 test is age dependent.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium

Varl

Ivanuš

Marinsek

et al. 2019

Radiology and Oncology

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“…Conversely, Knoepp et al [18] found relatively similar SIL rates amongst women with ASCUS in the HC2 equivocal range (RLU/CO 1-2.5) compared to those with unequivocally positive tests. We found that the likelihood of specimens with initial equivocal RLU/CO values leading to final positive HC2 decreases with age [19]. An ageadjusted cutoff may appear reasonable at a population level when HPV prevalence curves are known.…”

Section: Discussionmentioning

confidence: 75%

Postmenopausal Squamous Atypia: Cytologic Features, Hybrid Capture 2 Tests and Contribution to the ASCUS Pool

2018

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Objective: Postmenopausal squamous atypia (PSA) mimics squamous intraepithelial lesion (SIL). We investigate the PSA contribution to the atypical squamous cells of undetermined significance (ASCUS) pool, its cytologic features and Hybrid Capture 2 (HC2) relative light unit/cutoff (RLU/CO) values. Study Design: 658 ASCUS Pap tests in women ≥55 years were reviewed to select those with koilocyte-like cells and/or atypical parakeratosis. Follow-up was positive when a biopsy showed SIL or carcinoma or a later HC2 test was positive. Results: Sixty-nine cases (10.5%) were selected. Forty-two (60.9%) were HC2 negative, and 27 (39.1%) were HC2 positive. Follow-up was available for 23 (54.7%) HC2-negative and 19 (70.3%) HC2-positive cases. No HC2-negative (0%) and 8 HC2-positive (42.1%) cases were positive on follow-up. Within cases negative on follow-up, 3 were PSA on biopsy. PSA was characterized by perinuclear halos, mild nuclear enlargement, smooth nuclear contours, and smooth chromatin. PSA-associated RLU/CO values were 0.25–2.95. Cases with SIL or carcinoma had RLU/CO values from 3.78 to 1,241.59. Conclusions: PSA contributes 0.5–2.3% to the ASCUS pool in women ≥55 years old. HC2 testing with RLU/CO of ≥1 may result in PSA occasionally testing positive. A different cutoff is not recommended but awareness of this caveat is important.

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Cervical cancer screening by high risk HPV testing in routine practice: results at one year recall of high risk HPV-positive and cytology-negative women

Mistro

Frayle

Ferro³

et al. 2014

J Med Screen

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Objective: Cervical cancer screening by human papillomavirus (HPV) testing requires the use of additional triage and follow-up analyses. We evaluated women's compliance with and the performance of this strategy in a routine setting. Setting: Five cervical service screening programmes in North-East Italy. Methods: Eligible women aged 25-64 invited for a new screening episode underwent HPV testing for high risk types (hrHPV by Hybrid Capture 2) and cytology triage. Women with positive HPV and cytology results were referred for colposcopy; women with positive HPV but negative cytology results were referred to 1-year repeat hrHPV testing. Results: Of 46,694 women screened by HPV testing up to December 2011, 3,211 (6.9%) tested hrHPV positive; 45% of these had a positive triage cytology. Those with negative cytology were invited for 1-yr repeat testing. Compliance with invitation was 61.6% at baseline and 85.3% at 1-yr repeat. Rate of persistent hrHPV positivity was 58% (830/1,435). Colposcopy performed in women with a positive hrHPV test at 1-yr repeat accounted for 36% of all colposcopies performed within the screening programmes. Cumulatively, a histological high-grade lesion was detected in 276 women (5.9% detection rate), 234 at baseline (85%), and 42 (15%) at 1-yr repeat. Conclusions: Compliance with hrHPV-based screening programmes was high both at baseline and at 1-yr repeat. Compared with the randomized trials, a higher proportion of triage cytology was read as positive, and only a small number of high-grade lesions were detected among the group of hrHPV positive cytology negative women who repeated testing 1-yr after baseline.

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Hybrid Capture 2 Test Results After an Initial Equivocal RLU/CO Value Are Dependent on Age

Cited by 3 publications

References 29 publications

Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium

Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium

Postmenopausal Squamous Atypia: Cytologic Features, Hybrid Capture 2 Tests and Contribution to the ASCUS Pool

Cervical cancer screening by high risk HPV testing in routine practice: results at one year recall of high risk HPV-positive and cytology-negative women

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