Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared With a Standard Clinically Collected Sampling Method
| Autor: | Michael E. Hagensee, Jerry McLarty, Susan Loyd, Donna L. Williams |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty MEDLINE Uterine Cervical Neoplasms Cervix Uteri Dermatology Self collection Sensitivity and Specificity Specimen Handling law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Surveys and Questionnaires Internal medicine medicine Humans 030212 general & internal medicine Human papillomavirus Papillomaviridae Menstrual Hygiene Products Pelvic examination Early Detection of Cancer Vaginal Smears 030505 public health medicine.diagnostic_test biology business.industry Papillomavirus Infections Public Health Environmental and Occupational Health Middle Aged Louisiana biology.organism_classification Clinical method Self Care Infectious Diseases Multicenter study DNA Viral Vagina Female 0305 other medical science business |
| Zdroj: | Sexually Transmitted Diseases. 46:670-675 |
| ISSN: | 1537-4521 0148-5717 |
| Popis: | The purpose of this study was to compare the outcomes of 2 self-collection methods to detect cervical human papillomavirus (HPV) DNA with outcomes from a standard clinical method. The standard method samples were collected by a clinician at a routine pelvic examination. Self-samples were taken at home and mailed to the clinical laboratory.The 2 self-collection methods were a tampon-based method and a swab-based method using a commercial device, an Eve Medical HerSwab. All HPV samples were processed by a clinical laboratory using the Food and Drugs Administration approved Roche Cobase HPV method, which specifically identifies HPV 16, HPV 18, and a set of 12 other high-risk subtypes. Patients were recruited from 2 cancer screening clinics 2015 to 2017. All patients signed an informed consent. Screening outcomes, such as prevalence, percent agreement with standard, sensitivity, and specificity, were calculated for each self-collection method. Measures of similarity between self and standard collection outcomes, Cohen's κ, percent concordance, McNemar equivalence, and others were tested statistically.One hundred seventy-four patients were randomized. The prevalence of 1 or more positive HPV high-risk subtypes from the standard clinical specimens was 13.5%. All clinical specimens were sufficient for valid HPV detection. For the tampon method, 15 (27%) of the specimens were insufficient quality. Only 1 (2%) swab specimen was insufficient. Only the swab self-collection method was found to be statistically noninferior to the clinical method. The tampon method had an unacceptably high rate of insufficient quality specimens and also failed the equivalency tests.The swab home collection samples were equivalent to the clinical samples, but the tampon method had an unacceptably high rate of specimens insufficient for HPV detection. |
| Databáze: | OpenAIRE |
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