The Prevo-Check rapid test is a rapid test procedure for the diagnosis of HPV16-related carcinomas and their corresponding precursors, which can arise in the oral pharynx as well as in the cervix, vagina, vulva, penis, and anal area (cervix, vagina, external genitals, penis, and anal area). With early detection and treatment, the chance of survival is significantly higher. The suspicion of an HPV16-related change can be raised by the qualitative and quantitative detection of specific DRH1 antibodies. Due to its very high sensitivity (95%; percentage of diseased patients in whom the disease is detected by the use of the test, i.e., a positive test result occurs) and specificity (99.3%; probability that actually healthy individuals who do not have the disease in question are also detected as healthy in the test), DRH1 detection is classified as a highly specific tumor marker. The antibodies circulating freely in the blood are thus a reliable indicator of the presence of HPV16-related carcinomatosis (cancerous disease), which occurs almost exclusively in the mouth, throat and anogenital region (area of the body surrounding the anus (anus) and genitals). There are gender-specific differences here. More than 80% of men develop the disease in the mouth and throat area and less than 20% in the anogenital region, with anal carcinomas (anal cancer) being more prevalent in homosexual men. In women, the situation is reversed. About 93% of the diseases are localized in the anogenital region and only 7% in the mouth and pharynx.
Indications (areas of application)
- Suspected oral and pharyngeal carcinoma or other HPV16-related carcinoma (anus, penis, vulva, vagina, cervix) in symptomatic patients
- Exclusion of HPV16-related anal or genital carcinomas in the presence of high-risk patients (including partners).
- Exclusion of oral pharyngeal carcinoma in the presence of risk factors such as HPV infection (including partners).
- Exclusion of recurrence (reappearance of tumor) in patients with HPV16-related carcinoma – in clinical trials, the value of DRH1 tumor marker for recurrence control was investigated in addition to the detection of new-onset pharyngeal carcinoma. All patients who showed a therapy-related decrease in the antibody lived ‘disease free’. Single case reports also confirm this observation for HPV16-related cervical and anal cancers.
- Partnership examinations: Hundreds of thousands of abnormal smears are diagnosed annually as part of cervical cancer screening. Due to the human papillomaviruses (HPV) transmissible through sexual contact, many women wonder whether their partner could also be affected by the infection or disease.
- Positive test result for HPV16 DNA: HPV DNA determinations have become increasingly popular in recent years, including on the cervix (neck of the womb). However, these methods cannot distinguish between HPV infection and acute HPV-related disease. Recent data from the U.S. demonstrate the very poor specificity (likelihood that actual healthy individuals who do not have the disease in question will be identified as healthy in the test) of these detections for the oral and pharyngeal situation as well. About 14.2 million U.S. citizens have HPVDNA in the mouth and throat, and about 8.4 million are HPV high-risk positive. This rate compares with 11,600 HPV-related carcinomas. That is, only one in 1,000 HPV-positive individuals will fail to control the infection and develop a tumor.
Contraindications
- Vaccinated individuals should be excluded from the study because HPV vaccination also induces DRH1 antibodies, as HPV vaccines use HPV16 L1 proteins.
Before the examination
Before performing the Prevo-Check rapid test, a detailed medical history should be taken, which in all circumstances must include a detailed discussion of possible symptoms, pre-existing conditions and risk factors such as smoking and alcohol consumption. The indication for performing the procedure must be given by the attending physician.
The procedure
DRH1 detection requires only one drop of blood to detect HPV16-related disease in the head and neck as well as the anogenital region. The blood can be taken from the fingertip or earlobe, and serum is also suitable.The presence of elevated DRH1 antibodies in non-HPV-vaccinated individuals (see contraindication) specifically indicates altered cells and is to be taken as an indicator for precancerous lesions or tumors. This is of particular importance in apparently healthy individuals as part of a screening examination. For this procedure a special antibody clone Anti-HPV16 L1 DRH1 is used. This clone is directed against a protein that is only produced by cells in which HPV-16 has already actively intervened in cell division. Similarly, this means that this antibody only occurs when subclinical HPV16 infection has already progressed to precancer or carcinoma.
After the examination
Depending on the results of the procedure and clinical symptoms, further diagnostic methods must be performed to confirm HPV16-related carcinoma or the corresponding precancerous lesions. Because men present with oral and pharyngeal disease in more than 80% of cases, presentation to an otolaryngologist is recommended. In less than 20% of men, the anogenital region is affected, with anal carcinomas being the most common in homosexual men. In women, more than 90% of the diseases are localized in the anogenital region and only 7% in the mouth and pharynx. Therefore, presentation to a gynecologist is recommended first.
