Rapid bedside test for water breakage

The need

• Minimizing exposure of pregnant patients to COVID.
• Minimizing invasive vaginal exams.

Evaluation of rupture of membranes - Standard of care

• Speculum exam for visualization fluid pooling (invasive).
• Ferning test (not sensitive or specific).
• Nitrazine test (not sensitive or specific).
• FDA approved immunoassays (Amnisure, Actim PROM, ROM Plus) – (invasive, require insertion of a Q-tip into the vagina and operation by trained medical professionals).

The solution

• The modification of the FDA approved immunoassay to be non-invasive and handled by the patients on their own. 
• The assay strip is coated with a fluid protective seal. Then, the coated strip is placed in hygienic pad as shown in the following video:

The problem - exposure of pregnant patient sand their babies to COVID 

Affected people - millions (potentially): 

4M live births/year in the US

16M live births/year in China

30M live births/year in India 

• The modification of the FDA approved immunoassay to be non-invasive and handled by the patients on their own. 
• The assay strip is coated with a fluid protective seal. Then, the coated strip is placed in hygienic pad.

Advantages

• Can be easily done at home. 
• Can be performed in Labor and Delivery triage waiting area before admitting the patient into the examination room. 
• If the test is positive, the patient can be admitted to the Labor and Delivery room without going through the triage rooms (additional minimization of staff/patient exposure). 

COVID is a pandemic. 

We propose a way to minimize pregnant patients exposure to the virus. 

We have granted patents in the US and UK describing the coating of lateral flow assays with a fluid protective seal.  

A lateral flow immunoassay coated with a fluid protective seal. The seal allows submerging the assay in water while retaining the assay's functionality. 

This is important, for example, when a test for amniotic fluid leakage is exposed to an uncontrolled gush of amniotic fluid. 

The immunoassay with the fluid protective seal can now be placed inside a hygienic pad.  

Please watch the following videos: 

https://www.youtube.com/watch?v=0hsp6qsv6CY

https://www.youtube.com/watch?v=33JltzNg2RY

Costing the immunoassays allows pregnant women to use them reliably at home.

Currently - 0 people

Within a year - 1000 people

In five years - 5,000,000 people 

Within the next year - completing the product's best functional design. 

Within the next five years - mass production and distribution. 

Funding.

Securing funding - $50,000

Three total

We are ObGyn at Yale university. We know very well the unmet need. 

N/A

Partnering with a major player in the market:

Clinical Innovation

Qiagen

Cooper surgical 

Procter and Gamble 

J&J

Patent rights licensing 

Our mission

We wish to empower women to independently monitor their own health conditions. We have developed a simple detector that can be embedded in hygienic pads. This detector can accurately detect leakage of amniotic fluid and various vaginal infections such as Trichomonas, Chlamydia, Gonorrhea, bacterial vaginosis, and more.  Our goal is to make these products available to women in developing countries.

Procter and Gable 

J&J

Cooper Surgical