Cervista HPV HR. 2. , Rev. General Information. Intended Use. The Cervista HPV HR test is an in vitro diagnostic test for the qualitative detection of. Consecutive cervical cytology specimens (n = ) were tested using HC2, Cervista HR, and Cervista HPV 16/18 with analysis of only. Part #, Document name, Country-Language, Files. ; PRD Cervista HPV HR assay. US - English. __pdf KB.


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For clinical screening, Cervista HR and HC2 are comparable and, by extension, should provide excellent negative predictive value cervista hpv histologically relevant disease.

High-risk human papillomavirus HR-HPV is a risk factor for cervical carcinogenesis and is routinely assessed in combination with cytologic evaluation of Papanicolaou Pap smears. The novel inclusion of an internal DNA control was promoted to reduce false-negatives incurred by insufficient cellularity.

Limitations in these early studies included use of a precursor to the FDA-approved assay, 7cervista hpv low sample numbers, 13—15 indirect comparison, 10 and the use cervista hpv borderline or atypical HC2 cases.

To address this question, we analyzed results from negative cervical cytology NILMwhich represent the majority of this population, to determine if HC2 or Cervista HR would have a greater impact on clinical intervention.

Clinical Experience with the Cervista HPV HR Assay

Materials and Methods The institutional review board at the University of Massachusetts, Worcester, approved this study. Cervista hpv majority of cases are from Massachusetts, with cases also coming from Connecticut, New Hampshire, and Rhode Island.


A negative diagnosis was given for 63, cases, with ancillary HR-HPV testing performed on 24, of these cases during this time interval. To obtain an unbiased estimate of the HPV prevalence in our patient population, serially accessioned cases were obtained regardless of clinician-ordered testing ie, Pap only, HPV if atypical squamous cells of undetermined significance, HPV cotesting or genotyping cervista hpv blinded to the cytologic diagnosis.

cervista hpv

The sample number was selected to provide a number comparable to the reported cohort in the TWT trial. HR-HPV DNA testing for triage of patients with atypical squamous cells of undetermined significance ASC-US cytological interpretations decreases colposcopic referrals by roughly half without sacrificing screening sensitivity.

Women in this group with both normal cytological interpretations ie, negative for intraepithelial lesion or malignancy [NILM] and negative HR-HPV test results cervista hpv at extremely low risk of developing cervical cancer over the next several years. Both tests involve hybridization of nucleic acid probes that are complimentary to the viral genome, followed by a signal amplification method for detection.

Given its recent approval for clinical use, few cervista hpv about Cervista clinical test performance are available. Herein we present our experience using the Cervista HPV HR platform in a commercial laboratory, along with an indirect comparison with previous experience using the hc2 assay.

Identified were 56, samples analyzed cervista hpv August and April using the Cervista platform and 53, samples analyzed during using the hc2 platform. Papanicolaou tests for all patients were evaluated using manual cytotechnologist review or the ThinPrep Imaging System Hologic, Inc.

  • Associated Data

Papanicolaou tests suspicious for reactive, reparative, or dysplastic changes were cervista hpv by board-certified anatomic pathologists G. Cytologic findings were classified according to the Bethesda System terminology for reporting results of cervical cytology.

These flaps bind to a universal hairpin fluorescence cervista hpv energy transfer oligonucleotide, creating a second substrate for the Cleavase enzyme.

Clinical Experience with the Cervista HPV HR Assay

Cleavage of the fluorescence resonance energy transfer oligonucleotide results in production of a fluorescent signal. Oligonucleotides specific for the human cervista hpv 2 gene are cervista hpv in each mixture and act as an internal control Cervista HPV-HR package insert.

cervista hpv Some cross-reactivity of the probes with other HPV types including type 66 also occurs. In the detection step, multiple signaling antibodies conjugated to alkaline phosphatase bind to each hybrid.

Before commencing the present study, liquid-based cytologic specimens were analyzed, 79 in SurePath medium and 97 in PreservCyt medium, using both the Cervista and hc2 assays. Four specimens yielded a low internal control signal using the Cervista assay, and tested negative for HR-HPV using cervista hpv hc2 assay.

Of the remaining specimens, cervista hpv One specimen tested HR-HPV positive using the Cervista assay and negative using the hc2 assay, and 24 specimens tested negative using Cervista and positive using hc2.

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