Infectious Diseases in Obstetrics and Gynecology / 2019 / Article / Fig 2

Research Article

Accuracy of Curable Sexually Transmitted Infections and Genital Mycoplasmas Screening by Multiplex Real-Time PCR Using a Self-Collected Veil among Adult Women in Sub-Saharan Africa

Figure 2

(a) V-Veil-Up Gyn Collection Device (V-Veil-Up Pharma Ltd.). The V-Veil-Up Gyn Collection Device consists in a pocket (length: 75 mm, width: 45 mm, surface of contact: 6,75 cm2) in non-woven hydrophilic polyethylene having a capacity of absorption of 1.4 g of liquid, associated with a thread in cotton yarn (nm 16/4) and a transparent applicator (length: 120 mm, diameter: 10.8 mm) in low-density polyethylene (LD-PE). The plastic applicator makes possible to push the veil to the bottom of the vagina after its intrusion into the pocket, and the string allows the veil to be easily removed after use. The V-Veil-Up Gyn Collection Device is intended for the safe and non-invasive collection of cervicovaginal secretions from the vaginal canal. The device is conceived for self-sampling collection in privacy, and collected cervicovaginal fluid may be further gathered from the veil to be used for biological analysis. The V-Veil-Up Gyn Collection Device catches and retains safely and gently the genital secretions, thus harvesting cells, proteins, and nucleic acids (DNA/RNA) from the vaginal canal. By its conception, the device does not absorb the liquids that allowed full recovery of collected biological material, which is not trapped like in a vaginal tampon or sponge. (b) Successive steps of the instructions for use of V-Veil-Up Gyn Collection Device. Upon removal of the device from the vaginal canal, the sample veil is immediately protected with an opaque collection box that preserves the integrity of the genital secretions during transportation to a laboratory where downstream testing may be performed. A cap is placed on the collection box of the device to seal the unit, which is then ready for transportation to a laboratory. At least 30 minutes after taking a shower or washing the vagina, the specimens must be collected using the V-Veil-Up Gyn Collection Device. In addition, in order to avoid sampling of male genital secretions, self-sampling should be carried out after at least 2 days after unprotected sexual intercourse. In preparation for cervicovaginal collection, the contents of the device are placed on a clean and dry surface. The name or identification number of the woman and the time (date and hour) of sampling are tagged on a label sticker on the collection box. In a comfortable position, the V-Veil-Up Gyn Collection Device is taken in the dominant hand; hold the handle between the thumb and middle finger, with the index finger free above the base of the handle. With the other hand, the skin folds of the large and small lips are hold open to open the vaginal canal. The veil is then aligned with the vaginal canal by pushing the applicator. The V-Veil-Up Gyn Collection Device is then gently pressed into the vaginal canal until the contact of the cervix. It is recommended not to urinate during the time of collection. After a period of 60 minutes, the collection is considered as complete, and the veil impregnated of cervicovaginal secretions is gently removed from the vaginal canal using the string. The sample veil should then not be touched and kept clear of any other objects. Immediately after removal, the veil is placed into a 15 mL plastic box containing 10 mL of phosphate-buffered saline (PBS) solution to prevent drying of the sample, and is closed with his cap. The veil filled of secretions in its box is then placed in the cold (ice packs or crushed ice) and should be then send at best to the laboratory within 4 hours. Nota bene. The manufacturer recommends letting in place the collecting device for 30 to 60 minutes; in GYNAUTO-STI study, we arbitrarily chose the maximum time of sampling, i.e., 60 minutes.

(a) V-Veil-Up Gyn Collection device
(b) Instructions for use

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