Testing for high-risk HPVs is an invaluable part of clinical guidelines for cervical carcinoma screening, management and treatment.
As of May 2017, at least 210 distinct commercial tests for detection of alpha HPVs and at least 150 variants of the original tests are available at the global market. Unfortunately, only a subset of commercial HPV tests has documented clinical performance for agreed indications for HPV testing in current clinical practice. For more than half of HPV tests on the global market, no single publication in peer-reviewed literature can be identified. In contrast to commercial kits for “classical” molecular microbiology targets, the great majority of HPV tests currently on the market does not contain sample extraction part and number of them don’t even mention recommended nucleic acid extraction methodology in their manufacturer’s instructions. Only a minority of HPV tests on the market have internal controls.
: Manufacturers of HPV tests are urged to put more effort into evaluating their current and future products. Manufacturers should seek advice from established HPV researchers in the very early phase of development on: (i) how to properly design a novel HPV test; (ii) to define intended use of future test (clinical, epidemiological, for research only) and (iii) how to evaluate test performance in such a way that the HPV community will accept evaluation/validation results. Since extraction of nucleic acids is an invaluable part of the whole HPV testing procedure we urge manufacturers of HPV tests to put substantially more effort into this initial and crucial step of molecular testing. Manufacturers should validate sample extraction procedure for each of the recommended sample collection devices and clinical sample types and list of validated sample collection devices and specimen types should be provide in the manufacturer’s instructions. Manufacturers‘ independent evaluations and publication of results in peer-reviewed journals are also crucial. We predict that the number of commercial HPV tests will continue to increase in the near future, due to promising marketing opportunities. Namely, in contrast to “classical” molecular diagnostic microbiology testing areas which are considered very mature with expected annual growth rates of 2-5%, annual growth rates of HPV tests selling are expected to remain as high as 20% at least through 2020.