Collection device for diagnostics of vaginal discharge

Abstract

A method of analyzing vaginal fluid includes collecting vaginal fluid in a vaginal fluid collecting system and transporting the collected vaginal fluid to a location for analysis. The analysis can be stored in and retrieved from a secure cloud storage data base.

1 .- 60 . (canceled) 
     
     
         61 . A vaginal fluid collection test strip comprising: a fluid absorbing layer disposed between upper and lower protective layers, the upper and lower protective layers comprising at least one opening, wherein said at least one opening is positioned to provide fluidic communication to the fluid absorbing layer and the fluid adsorbing layer comprising a plasma-separating test strip; a fluid impervious layer disposed between the upper protective layer and the fluid absorbing layer, the fluid impervious layer comprising a first opening to allow fluid flow to the fluid adsorbing layer and a second opening defining a window for viewing separated plasma. 
     
     
         62 . The vaginal fluid collection test strip of  claim 61 , wherein the upper and lower protective layers comprise a plurality of openings. 
     
     
         63 . The vaginal fluid collection test strip of  claim 61 , wherein the fluid adsorbing layer comprises a plurality of fluid adsorbing zones. 
     
     
         64 . The vaginal fluid collection test strip of  claim 61 , wherein the plurality of fluid adsorbing zones are fluidically isolated from one another and in fluidic communication with different openings in the upper and lower protective layers. 
     
     
         65 . The vaginal fluid collection test strip of  claim 61 , wherein the fluid adsorbing layer comprises at least one plasma-separating test strip and at least one whole blood test strip. 
     
     
         66 . The vaginal fluid collection test strip of  claim 61 , wherein the fluid adsorbing layer comprises two plasma-separating test strips. 
     
     
         67 . The vaginal fluid collection test strip of  claim 61 , wherein the fluid collection test strip comprises a color indicator selected to provide a visual indication of the presence of a biomarker in a vaginal fluid. 
     
     
         68 . The vaginal fluid collection test strip of  claim 61 , wherein the fluid collection test strip comprises a computer readable identifier, RFD or other kind of ID. 
     
     
         69 . A vaginal fluid collection system comprising: a fluid absorbing layer disposed between upper and lower protective layers, the upper and lower protective layers comprising at least one opening, wherein said at least one opening is positioned to provide fluidic communication to the fluid absorbing layer and the fluid adsorbing layer comprising a fluid adsorbing zone and a plasma-separating test strip; and a fluid impervious layer disposed between the upper protective layer and the fluid absorbing layer, the fluid impervious layer comprising a first opening to allow fluid flow to the fluid adsorbing layer and a second opening defining a window for viewing separated plasma. 
     
     
         70 . The collection system of  claim 69 , wherein the fluid adsorbing layer comprises a plurality of fluid adsorbing zones. 
     
     
         71 . The collection system of  claim 70 , wherein the plurality of fluid adsorbing zones are fluidically isolated from one another and in fluidic communication with different openings in the upper and lower protective layers. 
     
     
         72 . The collection system of  claim 69 , wherein the fluid adsorbing layer comprises at least one plasma-separating test strip and at least one whole blood test strip. 
     
     
         73 . The collection system of  claim 69 , wherein the fluid adsorbing layer comprises two plasma-separating test strips. 
     
     
         74 . A vaginal fluid collection system comprising: an absorbent layer having a separable absorbent portion, the separable absorbent portion in fluidic contact with the absorbent layer, wherein the absorbent layer is integrated into a tampon, panty liner or menstrual pad. 
     
     
         75 . The collection system of  claim 74 , wherein the absorbent layer comprises an opening, wherein said opening provides access to the separable absorbent portion and wherein the opening is sized to permit passage of the separable absorbent portion. 
     
     
         76 . The collection system of  claim 74 , wherein the separable absorbent portion is attached to a string accessible external to the tampon, panty liner or menstrual pad. 
     
     
         77 . The collection system of  claim 74 , further comprising packaging for use in shipping the separable absorbent portion. 
     
     
         78 . A method of analyzing vaginal fluid, the method comprising the steps of: collecting vaginal fluid in a vaginal fluid collecting system; transporting the collected vaginal fluid to a remote location for analysis and analyzing the collected vaginal fluid. 
     
     
         79 . The method of  claim 78 , further comprising receiving analytical data relating to the analysis of the vaginal fluid sample. 
     
     
         80 . The method of  claim 78 , wherein the collection device is a dried blood spot test strip and the analysis comprises screening for presence of human papilloma virus. 
     
     
         81 . The method of  claim 78 , wherein the collection device is a dried blood spot test strip and the analysis comprises detection or screening of a health related biomarker including viruses, bacteria and fungi. 
     
     
         82 . The method of  claim 78  wherein the step of collecting vaginal fluid comprises collecting the vaginal fluid in a cup with a lid and wherein the step of transporting the collected vaginal fluid comprises closing the lid. 
     
     
         83 . A urine collection system comprising: a fluid pervious top face sheet; a fluid impervious backing sheet; an absorbent pad disposed between the face sheet and hacking sheet; and a urine collection test strip having a grippable portion extending from an edge of the strip, the fluid collection test strip disposed in fluidic contact with the absorbent pad; wherein at least one of the backing sheet or the top face sheet comprises an opening sized to allow at least one of the removal and insertion of the fluid collection test strip from the fluid collection system, wherein the absorbent pad is integrated into a diaper or a feminine hygiene product. 
     
     
         84 . A vaginal fluid collection system comprising: a menstrual cup with a lid and a multi barrier pouch comprising an air-secured container for receiving collected menstrual fluid from the menstrual cup and for transporting the collected menstrual fluid to a remote location for analysis. 
     
     
         85 . The system of  claim 84  wherein said pouch further comprises a container for one or more of the following: collection tubes with menstrual blood, used menstrual-pads/panty liners, DBS-cards, DBS test strips, square from highly absorbent pad pulled out with string, sample collection devices, or used tampons. 
     
     
         86 . The system of  claim 85  wherein said container is situated inside said pouch for transporting at least one of DBS-cards and DBS test strips, said container comprising a lid for tightly sealing said container during shipment for analysis. 
     
     
         87 . The system of  claim 84  wherein said container comprises an oxidizer. 
     
     
         88 . The system of  claim 84  wherein said container comprises a desiccant. 
     
     
         89 . The system of  claim 84  wherein said multi barrier pouch comprises a barcode or ID number for tracking said multi barrier pouch during transportation. 
     
     
         90 . The system of  claim 84  wherein said container comprises barriers made of thermoplastic materials including one or more of the following rigid PVC, semi-rigid PVC, polycarbonate, acrylic, impact-modified acrylic, polystyrene, impact-modified polystyrene, ABS, polyethylene, polypropylene, and combinations thereof. 
     
     
         91 . The system of  claim 84  wherein said multi harrier pouch comprises an opening defined by a rim sealed by sliding the rim together. 
     
     
         92 . The system of  claim 91  wherein said multi barrier pouch comprises a barrier having a removable release liner and a semi-strong adhesive, wherein said barrier can be folded over said rim and sealed by said adhesive. 
     
     
         93 . The system of  claim 84  further comprising an envelope for mailing said pouch to a laboratory for analysis of the collected fluid. 
     
     
         94 . A menstrual blood collection mail-in kit comprising a vaginal fluid collection device including a fluid collection strip, instruction manuals as to how to use the device and said fluid collection strip, menstrual pads, tampons and other menstrual blood collections devices, intended to be used in a mail-in procedure. 
     
     
         95 . The kit of  claim 94  further comprising a multi barrier pouch for collection of fluid samples and an envelope for sending said pouch for remote analysis in a laboratory. 
     
     
         96 . The kit of  claim 94  having a unique identification number used to identify the kit, and be used to register online on a website, in an app or through a similar service. 
     
     
         97 . The kit of  claim 94  comprising at least one of a multi barrier pouch and a container for collection of fluid samples.