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J Clin Virol. 2016 Feb;75:33-6. doi: 10.1016/j.jcv.2015.12.007. Epub 2015 Dec 24.

Laboratory audit as part of the quality assessment of a primary HPV-screening program.

Author information

1
Department of Laboratory Medicine, Karolinska Institutet, Sweden.
2
Department of Laboratory Medicine, Karolinska University Hospital, Sweden.
3
Department of Laboratory Medicine, Karolinska Institutet, Sweden. Electronic address: joakim.dillner@ki.se.

Abstract

BACKGROUND:

As primary HPV screening programs are rolled out, methods are needed for routine quality assurance of HPV laboratory analyzes.

OBJECTIVE:

To explore the use of similar design for audit as currently used in cytology-based screening, to estimate the clinical sensitivity to identify women at risk for CIN 3 or worse (CIN3+).

STUDY DESIGN:

Population-based cohort study conducted within the cervical screening program in Stockholm, Sweden, in 2011-2012. All women with histopathologically confirmed CIN3+ in the following two years were identified by registry analysis. Primary HPV and cytology screening results were collected. For women who had not been HPV tested, biobanked cytology samples were HPV-tested. If the original HPV result had been negative, the sample and subsequent biopsies were analyzed with broad HPV typing (general primer PCR and Luminex).

RESULTS:

154 women had a biobanked prediagnostic cytology sample taken up to 2 years before a histopathologically confirmed CIN3+. The high-risk HPV-positivity was 97% (148/154 women), whereas 143/154 (94%) women had had a cytological abnormality. Among the six HPV-negative samples, one sample was HPV 33 positive in repeat testing whereas the other five cases were HPV-negative also on repeat testing, but HPV-positive in the subsequent tumor tissue.

CONCLUSIONS:

A sensitivity of the HPV test that is higher than the sensitivity of cytology suggests adequate quality of the testing. Regular audits of clinical sensitivity, similar to those of cytology-based screening, should be used also in HPV-based screening programs, in order to continuously monitor the performance of the analyzes.

KEYWORDS:

Audit; HPV; Primary screening; Sensitivity

PMID:
26748032
DOI:
10.1016/j.jcv.2015.12.007
[Indexed for MEDLINE]

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