One of the least invasive sampling methods suitable for self-sampling is saliva spitting. The aim of this study is to evaluate the suitability of saliva self-sampling for unsupervised testing. Two self-sampling strategies were compared on the basis of visual evaluation of samples, measurement of cortisol levels in samples and questionnaire survey. The saliva samples obtained by supervised self-sampling were found to be fully suitable for further analysis. In contrast, not all saliva samples obtained from unsupervised self-collection can be used: 13% non-compliance with the minimum required sample volume, 8% with some food/drink residues and 26% taken at the wrong day time. About 42% of the unsupervised probands made at least one significant error in the saliva self-collection procedure. These results indicate that the accuracy of the results based on the analysis of samples received from saliva self-sampling is limited. For clinical investigation, the presence of an inner standard (referring to the reliability of the sampling procedure) is required.
Cíle studie: Získat prvotní zkušenosti s alternativním odběrem vzorku (samoodběrem) pro testování přítomnosti HPV za účelem skríninku karcinomu děložního čípku. Typ studie: Původní práce. Název a sídlo pracoviště: Ústav molekulární a translační medicíny, LF UP a FN Olomouc. Metodika: Na základě předem projeveného zájmu o HPV vyšetření byly 215 ženám zaslány samoodběrové sady Evalyn? Brush. Cervikovaginální stěry obdržené poštou byly analyzovány v naší laboratoři na přítomnost HPV infekce systémem Cobas 4800 HPV (Roche) s následnou genotypizací pomocí PapilloCheck? HPV-Screening (Greiner Bio-One). Náhodně vybraným 60 ženám z našeho souboru byl společně se samodběrovou sadou zaslán dotazník zaměřený na jejich zkušenost se samoodběrem. Výsledky: Z rozeslaných 215 samoodběrových sad bylo k analýze doručeno 174 (81 %) cervikovaginálních stěrů. Všechny vzorky byly odebrány správně a bylo možné je vyšetřit Cobas 4800 HPV testem. PapilloCheck? HPV-Screening systémem bylo možné za zisku validního výsledku vyšetřit 98 % vzorků (171/174). Z vyšetřených 174 vzorků bylo 125 vzorků (72 %) HPV negativních, u 7 vzorků (4 %) byla detekována pouze přítomnost nízkorizikové HPV infekce a u 42 vzorků (24 %) jsme detekovali přítomnost vysokorizikové HPV infekce. Nejčastěji detekovanými vysoce rizikovými genotypy byly HPV 16 (11/42; 26 %) a HPV 53 (6/42; 14 %). V 10 případech byla detekována současná infekce několika hrHPV, v 5 z nich byla nalezena současně infekce lrHPV. Z 60 odeslaných dotazníků bylo zasláno zpět 48 (80 %). Z této skupiny ohodnotilo svou zkušenost se samoodběrovou sadou jako dobrou až výbornou 47 (98 %) dotázaných žen. Návod k použití Evalyn? Brush byl považován za dobrý až vynikající všemi ženami (100 %). Všechny ženy také ohodnotily použití samoodběrové sady jako dobré až vynikající. Podle očekávání většina žen z našeho souboru (n = 42 [88 %]) dává přednost samoodběru před odběrem vzorku lékařem. Závěr: Samoodběr cervikovaginálního stěru vede při použití dvou testovaných molekulárně genetických metod k validním výsledkům a byl českými ženami velmi dobře přijat. Zavedení samoodběru jako způsobu účasti na cervikálním skríninku by mohlo vést ke zvýšení návštěvnosti skríninkového programu karcinomu děložního čípku, a napomohlo by tak ke snížení incidence i mortality tohoto onemocnění v české populaci.
Objective: To get initial experience with alternative sampling (self-sampling) for HPV testing as the means of cervical cancer screening program. Design: Original work. Setting: Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University in Olomouc. Methods: Based on expression of interest, 215 self-sampling kits were posted to women. Evalyn? Brush Vaginal swabs obtained by self-sampling were analyzed for the presence of HPV infection by Cobas 4800 HPV (Roche) followed by genotyping using PapilloCheck? HPV-Screening (Greiner Bio-One). Sixty women randomly chosen from our sample were sent a questionnaire focused on their experience with self-sampling. Results: One hundred seventy-four of 215 (81%) distributed self-sampling devices have been delivered to analysis. All cervicovaginal swabs were sampled correctly and it was possible to analyze them by Cobas 4800 HPV test. Similarly, 98% (171/174) samples were analyzable by PapilloCheck? HPV-Screening. One hundred twenty-five (72%) of 174 tested samples were HPV negative. Low risk HPV infection was detected only in 7 samples (4%), and high risk HPV (hrHPV) infection was present in 42 samples (24%). The most frequently detected hrHPV genotypes were HPV16 (11/42; 26%) and HPV53 (6/42; 14%). HrHPV co-infection was detected in 10 cases, in 5 of them lrHPV infection was find also. Of the 60 questionnaires, 48 (80%) were returned. From this group, 47 (98%) women rated their experience with self-sampling device as good to excellent. User manual of self-sampling device was considered good to excellent by all women (100%). All women also rated the convenience of self-sampling device using as good to excellent. As expected, most of the women (n = 42 [88%]) preferred self-sampling to physician sampling. Conclusion: Cervicovaginal self-sampling leads to valid results of HPV screening using two molecular genetics methods and was accepted by Czech women very well. The self-sampling as an opportunity to participate in cervical cancer screening could increase the attendance of the screening program and would help to reduce the incidence and mortality for this disease in the Czech population.
- MeSH
- Self Administration methods MeSH
- Early Detection of Cancer methods instrumentation MeSH
- Cervix Uteri virology MeSH
- Genotyping Techniques MeSH
- Papillomavirus Infections * diagnosis prevention & control MeSH
- Clinical Laboratory Techniques * instrumentation MeSH
- Humans MeSH
- Uterine Cervical Neoplasms diagnosis prevention & control MeSH
- Specimen Handling methods MeSH
- Papillomaviridae * isolation & purification MeSH
- Pilot Projects MeSH
- Mass Screening MeSH
- Reverse Transcriptase Polymerase Chain Reaction utilization MeSH
- Prevalence MeSH
- Surveys and Questionnaires MeSH
- Patient Satisfaction MeSH
- Statistics as Topic MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
UNLABELLED: The prevalence of high-risk human papillomavirus (hrHPV) types varies across countries, making it essential to estimate prevalence using nationwide samples. Data on hrHPV prevalence in the Czech Republic are very limited. This study aimed to determine the prevalence of various hrHPV types in an unselected screening population of Czech women aged 30-65 years, using paired clinician-obtained cervical swab (CS) and self-collected cervicovaginal swabs (CVS). A total of 1026 eligible women were recruited into two study arms. In arm A, the digene® HC2 DNA Collection Device was used for both CS and CVS. In arm B, the Evalyn Brush was used for CVS, while the Cervex Brush was used for CS. All samples were tested for hrHPV using the digene® HC2 High-Risk HPV DNA Test and genotyped with the PapilloCheck® HPV-Screening assay. The overall hrHPV prevalence was 14.8%, based on positive results from either CVS or CS samples. hrHPV positivity was detected in 10.8% of clinician-obtained CSs and 11.8% of self-collected CVSs. A combined analysis of CS and CVS samples identified the five most prevalent hrHPV genotypes: HPV16, HPV31, HPV39, HPV56, and HPV68. The comparison of hrHPV detection in paired CS and CVS samples showed an overall concordance of 93%. These findings highlight the importance of detecting hrHPV genotypes alongside conventional Pap testing in national cervical screening programs. Furthermore, the results confirm that self-sampling kits represent a suitable alternative to clinician-collected samples. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier (NCT04133610).
- MeSH
- Early Detection of Cancer * methods MeSH
- Adult MeSH
- Papillomavirus Infections * epidemiology diagnosis MeSH
- Middle Aged MeSH
- Humans MeSH
- Uterine Cervical Neoplasms * diagnosis virology epidemiology MeSH
- Specimen Handling * methods MeSH
- Papillomaviridae * isolation & purification genetics MeSH
- Mass Screening methods MeSH
- Prevalence MeSH
- Aged MeSH
- Vaginal Smears methods MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Comparative Study MeSH
- Geographicals
- Czech Republic MeSH
BACKGROUND: A population-based cervical cancer screening programme is implemented in the Czech Republic. However, participation is insufficient among women over 50 years. This study aimed to estimate the potential improvement in participation through directly mailed HPV self-sampling kits (HPVssk) compared with standard invitation letters in women aged 50-65 non-participating in screening. METHODS: The study recruited 1564 eligible women (no cervical cancer screening in the last 3 years or more, no previous treatment associated with cervical lesions or cervical cancer). Eight hundred women were mailed with an HPVssk (HPVssk group), and 764 women were sent a standard invitation letter (control group) inviting them to a routine screening (Pap test). The primary outcome was a comparison of the overall participation rate between study groups using a binominal regression model. RESULTS: The participation rate in the HPVssk group was 13.4% [95% confidence interval (CI) 11.2-15.9%; 7.4% of women returned the HPVssk and 6.0% attended gynaecological examination] and 5.0% (95% CI 3.6-6.8%) in the control group. Using the binominal regression model, the difference between the groups was estimated as 7.6% (95% CI 5.0-10.2%; P < 0.001). In the HPVssk group, 22% of women who returned HPVssk had a positive result and 70% of them underwent a follow-up examination. CONCLUSIONS: Compared with traditional invitation letters, the direct mailing of the HPVssk achieved a significantly higher participation rate, along with a notable HPV positivity rate among HPVssk responders. This approach offers a potentially viable method for engaging women who have not yet attended a cervical screening programme.
- MeSH
- Early Detection of Cancer methods MeSH
- Papillomavirus Infections * diagnosis MeSH
- Humans MeSH
- Uterine Cervical Neoplasms * diagnosis prevention & control MeSH
- Mass Screening methods MeSH
- Vaginal Smears MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Czech Republic MeSH
- MeSH
- Child MeSH
- Research Support as Topic MeSH
- Intelligence Tests statistics & numerical data MeSH
- Data Interpretation, Statistical MeSH
- Humans MeSH
- Adolescent MeSH
- Child, Gifted psychology MeSH
- Self Concept MeSH
- Sampling Studies MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Adolescent MeSH
- Geographicals
- Czech Republic MeSH
Maskovaná hypertenzia predstavuje novú jednotku v klinickej praxi hypertenzie. Znamená vyšší krvný tlak pri holterovskom monitorovaní krvného tlaku, ako pri konvenčnom meraní krvného tlaku v nemocničnom zariadení. V blízkom budúcom období budú prebiehať sledovania jej reproducibility a určenia klinickej významnosti.
Masked hypertension represents nowadays the new entity in clinical practice of hypertension. Represents higher ambulatory blood pressure, than conventionally measured office blood pressure. In the near future follow-up of its reproducibility and its clinical significance are going to be estimated.
BACKGROUND: Testing of pooled samples is an effective strategy for increasing testing capacity while saving resources and time. This study aimed to validate pooled testing and gather real-life data on its use for Covid-19 surveillance with a gargle lavage (GL) self-sampling strategy. METHODS: Two-stage pooled testing with pools of 6 and 12 samples was used for preventive testing of an asymptomatic population and Covid-19 surveillance in Czech schools. Both GL and nasopharyngeal swabs were used for sampling. RESULTS: In total, 61,111 samples were tested. The use of pooled testing for large-scale Covid-19 surveillance reduced consumable costs by almost 75% and increased testing capacity up to 3.8-fold compared to standard methods. RT-PCR experiments revealed a minimal loss of sensitivity (0-2.2%) when using pooled samples, enabling the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) genes with Ct values >35. The minor loss of sensitivity was counterbalanced by a significantly increased throughput and the ability to substantially increase testing frequencies. CONCLUSIONS: Pooled testing is considerably more cost-effective and less time-consuming than standard testing for large-scale Covid-19 surveillance even when the prevalence of SARS-CoV-2 is fluctuating. Gargle lavage self-sampling is a non-invasive technique suitable for sample collection without a healthcare worker's assistance.
- MeSH
- COVID-19 * diagnosis epidemiology MeSH
- Humans MeSH
- Nasopharynx * virology MeSH
- Specimen Handling * methods MeSH
- SARS-CoV-2 * genetics isolation & purification MeSH
- Sensitivity and Specificity MeSH
- COVID-19 Nucleic Acid Testing methods MeSH
- COVID-19 Testing methods MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Czech Republic MeSH
