Assessing a new test for cervical cancer

Continuing with the issue of cervical cancer (you can read a previous post about virus-like particle (VLP)-based vaccines against this type of cancer), which is caused by high-risk human papillomavirus (HR-HPV), a group of researchers from the Pathology department of the Hospital del Mar (Parc de Salut MAR Biobanc), a reference laboratory for cervical cytology in Barcelona, have recently evaluated the clinical performance of a new HPV test (the cobas HPV Test).

Although the most widespread screening technique for cervical cancer is cytology (also called Papanicolaou test, or Pap smear), HPV detection has been proposed as an alternative, since it is more sensitive for the detection of precancerous lesions. However, compared to cytology, HPV testing has the risk of an excessive number of women without relevant lesions being referred for colposcopy.

 Hybrid capture 2 (HC2) is the current gold standard in HPV testing in cervical samples, but other tests have been recently launched, such as the cobas HPV Test. Since clinical sensitivity and specificity are decisive factors before the introduction of a new screening tool, the authors decided to evaluate the applicability of the new cobas HPV Test in the Catalan opportunistic screening protocol, which presently is based on cytology and HC2.

The study included samples from 958 women. According to the authors of this paper, published in PLoS One, the cobas HPV test system showed excellent results regarding both sensitivity and specificity, being at least as good as HC2. Both intralaboratory and interlaboratory reproducibility values were in the category considered almost perfect, overcoming the minimal requirements for a clinical test. The cobas HPV test has also proved to be a user-friendly system with high reproducibility and easy interpretation of results. It also has some advantages compared to HC2: it doesn’t require a specific procedure which takes time and increases the risk of contamination, and it contains an internal positive control (DNA amplification of cellular beta-globin).

“We feel confident that our results confirm a reliable clinical performance of cobas HPV Test allowing its introduction in cervical cancer screening protocols”, concludes correspondent author Sergi Serrano.

Reference:

Lloveras B, Gomez S, Alameda F, Bellosillo B, Mojal S, Muset M, Parra M, Palomares JC, Serrano S. HPV Testing by cobas HPV Test in a Population from Catalonia. PLoS One. 2013;8(3):e58153

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