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Evaluation of adjunctive HPV testing by Hybrid Capture II in women with minor cytological abnormalities for the diagnosis of CIN2/3 and cost comparison with colposcopy.

Guyot A, Karim S, Kyi MS, Fox J - BMC Infect. Dis. (2003)

Bottom Line: Specificity was low at 37% at a cut-off of 1 pg/ml and 46% at a cut-off of 3 RLU.The negative likelihood ratio (NLR) was of good diagnostic value with 0.089 at 1 RLU and 0.072 at 3 RLU, which reduces the post-test probability for CIN2/3 to 2% in this population.Women with minor cytological disorders can be excluded from colposcopy on a negative HR HPV result.Specificity can be improved by restricting HR HPV testing to women with persistent borderline cytological changes or to women over 30 years.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Microbiology of West Middlesex University Hospital and Quest Diagnostics, Twickenham Rd, Isleworth W7 6AF, UK. andrea@guyot.fsnet.co.uk

ABSTRACT

Background: As a proportion of high grade cervical intraepithelial neoplasia (CIN2/3) are associated with equivocal cervical smears, which show borderline or mild dyskaryosis, follow up with repeat smears, colposcopy and biopsy is required. Since infection with oncogenic Human Papilloma Virus (HR HPV) has been found to be associated with the development of cervical cancer, HRHPV testing appears to be an alternative.

Objective: The present study assesses if HRHPV testing can predict CIN2/3 in women referred for mild dyskaryosis and borderline cytological changes in an health authority with a referral policy to colposcopy after one single mild dyskaryotic Pap smear.

Study design: The HPV DNA Hybrid Capture II (Digene/Abbott, Maidenhead) was evaluated on 110 consenting women with mild dyskaryosis and 23 women with persistent borderline changes, who were referred for colposcopy between May and November 2001. A cost comparison between two referral policies was performed.

Results: CIN2/3 was diagnosed histologically in 30 of 133 women (22%) with minor cytological abnormalities. As the Receiver Operator Characteristics plot suggested a cut-off of 3 pg/ml the HRHPV HCII was evaluated at 3 RLU (relative light units) and at the manufacturer's recommendation of 1 RLU. At both cut-offs sensitivity and negative predictive value were high at 97%. Specificity was low at 37% at a cut-off of 1 pg/ml and 46% at a cut-off of 3 RLU. To remain cost neutral in comparison to immediate colposcopy the costs for one HR HPV HC II must not exceed pound 34.37 per test at a cut off of 3 pg/ml.

Conclusion: The negative likelihood ratio (NLR) was of good diagnostic value with 0.089 at 1 RLU and 0.072 at 3 RLU, which reduces the post-test probability for CIN2/3 to 2% in this population. Women with minor cytological disorders can be excluded from colposcopy on a negative HR HPV result.Specificity can be improved by restricting HR HPV testing to women with persistent borderline cytological changes or to women over 30 years.

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Receiver Operator Characteristic curve of high risk HPV HC II for the diagnosis of CIN2/3 in women with minor cytological abnormalities (red triangles show performance of Pap smears according to KC61 part C, RLU = ratio of relative light units of specimen to positive controls)
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Figure 1: Receiver Operator Characteristic curve of high risk HPV HC II for the diagnosis of CIN2/3 in women with minor cytological abnormalities (red triangles show performance of Pap smears according to KC61 part C, RLU = ratio of relative light units of specimen to positive controls)

Mentions: To determine a cut-off for a positive result a receiver-operator characteristics (ROC) plot was constructed (see figure 1). At 1 RLU, which is the cut-off recommended by the manufacturer, the sensitivity amounted to 97% but the false positive rate yielded 63%. At 3 RLU the sensitivity was still 97% and specificity improved to 46%. At higher concentrations sensitivity dropped below 90%. As HPV testing is a screening test the sensitivity should be high in order not to miss any precancerous lesions. False positive results will be corrected by biopsy results. Thus the assay performance was evaluated at the manufacturer's recommended threshold of 1 RLU and at the apparent optimal cut-off of 3 RLU.


Evaluation of adjunctive HPV testing by Hybrid Capture II in women with minor cytological abnormalities for the diagnosis of CIN2/3 and cost comparison with colposcopy.

Guyot A, Karim S, Kyi MS, Fox J - BMC Infect. Dis. (2003)

Receiver Operator Characteristic curve of high risk HPV HC II for the diagnosis of CIN2/3 in women with minor cytological abnormalities (red triangles show performance of Pap smears according to KC61 part C, RLU = ratio of relative light units of specimen to positive controls)
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC222910&req=5

Figure 1: Receiver Operator Characteristic curve of high risk HPV HC II for the diagnosis of CIN2/3 in women with minor cytological abnormalities (red triangles show performance of Pap smears according to KC61 part C, RLU = ratio of relative light units of specimen to positive controls)
Mentions: To determine a cut-off for a positive result a receiver-operator characteristics (ROC) plot was constructed (see figure 1). At 1 RLU, which is the cut-off recommended by the manufacturer, the sensitivity amounted to 97% but the false positive rate yielded 63%. At 3 RLU the sensitivity was still 97% and specificity improved to 46%. At higher concentrations sensitivity dropped below 90%. As HPV testing is a screening test the sensitivity should be high in order not to miss any precancerous lesions. False positive results will be corrected by biopsy results. Thus the assay performance was evaluated at the manufacturer's recommended threshold of 1 RLU and at the apparent optimal cut-off of 3 RLU.

Bottom Line: Specificity was low at 37% at a cut-off of 1 pg/ml and 46% at a cut-off of 3 RLU.The negative likelihood ratio (NLR) was of good diagnostic value with 0.089 at 1 RLU and 0.072 at 3 RLU, which reduces the post-test probability for CIN2/3 to 2% in this population.Women with minor cytological disorders can be excluded from colposcopy on a negative HR HPV result.Specificity can be improved by restricting HR HPV testing to women with persistent borderline cytological changes or to women over 30 years.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Microbiology of West Middlesex University Hospital and Quest Diagnostics, Twickenham Rd, Isleworth W7 6AF, UK. andrea@guyot.fsnet.co.uk

ABSTRACT

Background: As a proportion of high grade cervical intraepithelial neoplasia (CIN2/3) are associated with equivocal cervical smears, which show borderline or mild dyskaryosis, follow up with repeat smears, colposcopy and biopsy is required. Since infection with oncogenic Human Papilloma Virus (HR HPV) has been found to be associated with the development of cervical cancer, HRHPV testing appears to be an alternative.

Objective: The present study assesses if HRHPV testing can predict CIN2/3 in women referred for mild dyskaryosis and borderline cytological changes in an health authority with a referral policy to colposcopy after one single mild dyskaryotic Pap smear.

Study design: The HPV DNA Hybrid Capture II (Digene/Abbott, Maidenhead) was evaluated on 110 consenting women with mild dyskaryosis and 23 women with persistent borderline changes, who were referred for colposcopy between May and November 2001. A cost comparison between two referral policies was performed.

Results: CIN2/3 was diagnosed histologically in 30 of 133 women (22%) with minor cytological abnormalities. As the Receiver Operator Characteristics plot suggested a cut-off of 3 pg/ml the HRHPV HCII was evaluated at 3 RLU (relative light units) and at the manufacturer's recommendation of 1 RLU. At both cut-offs sensitivity and negative predictive value were high at 97%. Specificity was low at 37% at a cut-off of 1 pg/ml and 46% at a cut-off of 3 RLU. To remain cost neutral in comparison to immediate colposcopy the costs for one HR HPV HC II must not exceed pound 34.37 per test at a cut off of 3 pg/ml.

Conclusion: The negative likelihood ratio (NLR) was of good diagnostic value with 0.089 at 1 RLU and 0.072 at 3 RLU, which reduces the post-test probability for CIN2/3 to 2% in this population. Women with minor cytological disorders can be excluded from colposcopy on a negative HR HPV result.Specificity can be improved by restricting HR HPV testing to women with persistent borderline cytological changes or to women over 30 years.

Show MeSH
Related in: MedlinePlus