Frequently asked questions

A: The human papilloma virus (HPV) is a common virus that infects almost all men and women within their lifetime. There are more than 100 types of HPV. Most of the HPV types are not causing disease in humans. Some types of HPV can cause common warts on hands and feet. About 30-40 types of HPV spread through direct genital contact. Some of these may cause genital warts. Three types of HPV (16, 18 and 45) are responsible for the development of 80-90 % of all cases of cervical cancer in women below 50 years of age. It is therefore very important to screen for oncogenic activity in cells in the cervix, related especially to these three types of HPV, to prevent development of cervical cancer.

A: Research over the last decades indicate that as many as 80 % of women will be infected at least one time with “genital” HPV during their lifetime. However, 98-99 % of the infections will not develop into cervical cancer and the majority will be eliminated by the women’s own immune system within 1-2 years. It is therefore important not to test for these common and mostly benign HPV infections since the vast majority of test positive women are and will continue to be healthy

A: If an HPV infection is incorporated into the human DNA (integration of virus DNA), an unregulated high production of the E6/E7 oncoproteins may be initiated. These oncoproteins cause a massive breakdown in normal cell functions. Such unregulated production of the E6/E7 oncoproteins may be included in the term oncogenic activity.

 A: Less than 10 % of women having cancer developing activity in cells in their cervix may develop cervical cancer if the cells are not identified and removed. However, it normally takes 10-20 years of continuous oncogenic activity in cells in the cervix to develop cervical cancer. Screening for oncogenic activity related to the three most dangerous types of HPV (16, 18 and 45) would identify and prevent 80-90 % of all cervical cancer cases worldwide in women below 50 years of age.

A: PreTect SEE is the most accurate and only HPV test that identifies oncogenic activity in cells in the cervix related directly to the three most carcinogenic HPV types. 80-90 % of all cases of cervical cancer in women below 50 years of age are related to these three types of HPV (16, 18 and 45). It is therefore very important to screen for oncogenic activity in cells in the cervix, related especially to these three types of HPV, to prevent development of cervical cancer.

A: PreTect SEE identifies cancer development caused by the three most important HPV types documented to be related to cervical cancer. Munoz (2004) documents that these three HPV types is related to >90 % of all cervical cancer cases in women <35 years of age and > 80 % of all cervical cancer cases in women aged 35 to 49 years. Over 20 other HPV types have also been associated with cervical cancer. However, the number of women developing cervical cancer related to all these other HPV types is very limited, especially in women below 50 years of age.

A: Cervical cancer related to other HPV types normally develops over a much longer period of time compared to cervical cancer related to HPV 16, 18 and 45 (Tjalma 2013). Cervical cytology is the only test methodology that has documented a significant effect in cervical cancer in women older than 40 years of age. Therefore, a combination of PreTect SEE and cervical cytology, e.g. at age 45 and age 55 will identify the absolute majority of cervical cancer cases under development also related to other HPV types

A: Other DNA/RNA tests have significantly lower specificity than cytology. PreTect SEE has significantly higher accuracy and specificity than cytology. This implies that the number of women in need of follow-up, and thereby the follow-up cost, will be reduced by 60-70 % compared to the use of other DNA/RNA tests. Because of the low accuracy and specificity, other DNA/RNA tests will need e.g. cytology triage before referring women to colposcopy compared to direct referral for PreTect SEE positive women.

A: No testing technologies have demonstrated the ability to identify all cervical cancer cases in a population. Even the most comprehensive tests will test negative on 10-20 % of all cervical cancer cases. Testing technologies identifying the presence of HPV infections normally identifies 20-50 % of women as positive for HPV. This creates a huge number of women, of which 80-90 % are healthy women with no risk of developing cervical cancer, which will need lengthy, complex and costly follow-up. Normally 20-40 % of all women in such follow-up schemes will drop out for different reasons, making it even more difficult to succeed in preventing cervical cancer in a population.  

A: A DNA test only detects the presence of HPV while PreTect SEE detects the oncogene activity (full length E6/E7 transcript) from HPV 16, 18, and 45.

A: PreTect SEE is clinically validated according to the EU IVD regulations. 

A: Yes. PreTect SEE is linked to oncogene activity and not only presence of the virus. PreTect SEE has high specificity and high positive predictive value, also in women younger than 30 years of age.

A: Yes. In follow-up of women with minor cervical lesions or in follow-up of women with a negative cervical biopsy a positive PreTect SEE can be an indication of treatment in women older than 40 years of age (Sorbye 2010, Sorbye 2011).

A: Usually rescreening of the PAP-smears in women with a positive PreTect SEE will disclose abnormal cells which were overlooked in the first screening, but even though rescreening is normal, the risk of CIN2+ is elevated and the woman should be referred to colposcopy.

A: Yes. PreTect SEE can be used in combination with cytology in follow-up after treatment. Women with two double negative results (HPV-/Cyt-) at 6 and 18 months can be returned to screening.

A: Yes. Women over 60 years of age with a negative PreTect SEE and normal cytology (HPV-/Cyt-) can be released from the screening program.

A: Yes, using the PreTect Collector tampon, PreTect SEE will identify the women with the highest risk of cervical cancer.

A: Our kits utilise E-labelling. Each kit includes a label with a scannable QR code that links directly to our webpage containing product specific technical information.

A: Yes. PreTect X has been validated for isolating viral RNA such as SARS-CoV-2. The kit is based on the well-established Booms extraction method resulting in high quality total nucleic acids.

A: Yes, the process can be automated on open platforms. Please get in touch with PreTect for advice on this topic and bulk supply. For manual handling standard magnetic equipment can be used, or PreTect can provide recommended equipment.

A: Yes, in combination with optimised pre-treatment procedures depending on kind of biological material, most sample types can be processed. Please get in touch with PreTect for advice if customization is needed.

A: No. Due to unknown differences in chemistry it is not recommended to combine PreTect X Lysis Buffer with other extraction kits.

A: No. The chemical composition of the lysis buffer is sufficient to inactivate any DNases/RNases in your sample.

A: Yes. The formation of a precipitate has no permanent effect on the quality of buffers. If a precipitate has been formed, warm the buffer at 50°C until it becomes clear.

A: No. Even PreTect TM is a methanol-based preservative like most LBC solutions, it has not been validated for the purpose of Liquid Based Cytology and evaluation of cell morphology.

A: Samples kept in PreTect TM solution intended for molecular testing has been documented stabile up to 6 weeks from collection if stored between 4 - 30°C. Our further experience data suggest prolonged stability for several months, controlled by positive amplification of housekeeping genes.

A: Yes. PreTect TM can be delivered either in prefilled 10 mL`s vials ready to use, or as stock solution for customized use.

A: In addition to the QR code, a written web address will direct you to the relevant product specific webpage. You may also request the user guides and other technical information in paper version by contacting our support team at support@pretect.no.