In terms of analytical performance, there is solid evidence that there is good agreement between a set of patients who self-collected sample and a clinician collected sample.
The analytic perimeters, such as agreement, tend to be approximately 90% and k-values tend to be approximately 0.7 or 0.8. The clinical performance of HPV testing using self-collected specimens is less sensitive and less specific than using clinician collected specimens, but more sensitive than cervical cytology.
As many places in the world do not currently have high-coverage, effective cervical cytology programs, the use of self-collected samples and HR-HPV testing could potentially take screening from virtually 0 to 70–90% sensitivity, which could have a major impact on the population risk of cervical cancer, if implemented widely.
In terms of the (FTA™ Elute sample collection) card specifically, there has been a series of pilot studies demonstrating that the card, like any self-collection medium, has very good agreement with the clinician-collected sample. In a recently published study, we demonstrated that there was good 90% total agreement, 68% positive agreement and k-value of 0.75 between a standard specimen medium and paper/card-based medium for HR-HPV detection [11]. The next step will be to demonstrate that the card, used with self-collection in a large population, can achieve the clinical performance that is needed for effective screening, for example, a range of 70–90% sensitivity and 80–90% specificity.
What do you think?
This exert has been taken from "An interview with Philip Castle: Current status and future trends in Cervical cancer screening" (Future Science Group, December 2013). Download the full article here
11) Guan YY, Gravitt PE, Howard R et al.
Agreement for HPV genotyping detection between self-collected specimens on a FTA cartridge and clinician-collected specimens. J. Virol. Methods, 189, 167–171 (2013).
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