Fullife Healthcare Pvt. Ltd, a company focused on innovative pharmaceuticals, nutraceuticals and medical diagnostics for the first time will be launching an innovative product in the women’s health category, Amniotic Leak Detection Kit (ALDK), aimed at expectant mothers with a easy to use safety tool during the third trimester of their pregnancy. Fullife has entered into an alliance with three leading pharma companies namely Zydus (Sensitek), Maneesh (AmniSense) and Sandoz (SacSecure) to launch the product under their respective brands names for the first time in India.
The innovative and break-through diagnostic kit uses non-invasive and at-home screening test designed to detect amniotic fluid leaks accurately during pregnancy. ALDK consists of a test panty liner embedded with a proprietary polymer coated strip along with a drying unit that clearly distinguishes between urine and amniotic fluid thereby ensuring safety of both mother and baby. An amniotic fluid leak can be traced on the test strip that acts as a pH indicator and changes its colour from yellow to blue-green after coming in contact with a fluid of pH greater than or equal to 5.2. The presence of urine in the tested fluid, however, reverses the initial blue stain back to yellow.
Varun Khanna, Director, Fullife Healthcare Pvt. Ltd. said: “Amniotic Fluid Leak is a condition that can pose high risk to both mother and the developing foetus. Unfortunately, till date, several pregnancies were lost due to lack of non-invasive and accurate testing methods. The Amniotic Leak Detection Kit offers non invasive detection of even a minute leak, continuously and conveniently with tremendous accuracy. This is a breakthrough product and is the first choice of doctors even in Europe and USA and is a much needed solution required in the Indian Market. We believe that timely detection will help save mother and baby from complications that usually follow an undetected leak.”
Amniotic fluid is the baby’s ‘Life Support System’ and its leak is the most commonly faced problem by pregnant women. It is the liquid that protects the baby and aids in the development of muscles, limbs, lungs and digestive system. However, there is no home based easy detection method and all such testing is always hospital based. This leaves a woman very anxious and helpless, running to hospital every time she sees any kind of vaginal leak or feels any wetness; where visual examination, Microscopic test (Fern test) or Ultrasound are the usual diagnostic tools for detection. Therefore, there is a greater need for the home based ALDK diagnostic kit in order to manage PROM (premature rupture of membranes) issues.
The product boasts accreditation with US-FDA, CE(Europe), NHS-Reimbursement in UK, ISO-13485:2003, German & Japanese Approval and Korean FDA Certified.
ALDK should not be used by women experiencing vaginal bleeding / spotting or who have used vaginal products such as douches and had intercourse in the past 12 hours.
ALDK is available at all chemists across India and is prescribed by the Doctor as the first response to any pregnant woman who senses either vaginal wetness in her last trimester, high risk pregnant women or women who have experienced amniotic leaks in previous pregnancies.
The innovative and break-through diagnostic kit uses non-invasive and at-home screening test designed to detect amniotic fluid leaks accurately during pregnancy. ALDK consists of a test panty liner embedded with a proprietary polymer coated strip along with a drying unit that clearly distinguishes between urine and amniotic fluid thereby ensuring safety of both mother and baby. An amniotic fluid leak can be traced on the test strip that acts as a pH indicator and changes its colour from yellow to blue-green after coming in contact with a fluid of pH greater than or equal to 5.2. The presence of urine in the tested fluid, however, reverses the initial blue stain back to yellow.
Varun Khanna, Director, Fullife Healthcare Pvt. Ltd. said: “Amniotic Fluid Leak is a condition that can pose high risk to both mother and the developing foetus. Unfortunately, till date, several pregnancies were lost due to lack of non-invasive and accurate testing methods. The Amniotic Leak Detection Kit offers non invasive detection of even a minute leak, continuously and conveniently with tremendous accuracy. This is a breakthrough product and is the first choice of doctors even in Europe and USA and is a much needed solution required in the Indian Market. We believe that timely detection will help save mother and baby from complications that usually follow an undetected leak.”
Amniotic fluid is the baby’s ‘Life Support System’ and its leak is the most commonly faced problem by pregnant women. It is the liquid that protects the baby and aids in the development of muscles, limbs, lungs and digestive system. However, there is no home based easy detection method and all such testing is always hospital based. This leaves a woman very anxious and helpless, running to hospital every time she sees any kind of vaginal leak or feels any wetness; where visual examination, Microscopic test (Fern test) or Ultrasound are the usual diagnostic tools for detection. Therefore, there is a greater need for the home based ALDK diagnostic kit in order to manage PROM (premature rupture of membranes) issues.
The product boasts accreditation with US-FDA, CE(Europe), NHS-Reimbursement in UK, ISO-13485:2003, German & Japanese Approval and Korean FDA Certified.
ALDK should not be used by women experiencing vaginal bleeding / spotting or who have used vaginal products such as douches and had intercourse in the past 12 hours.
ALDK is available at all chemists across India and is prescribed by the Doctor as the first response to any pregnant woman who senses either vaginal wetness in her last trimester, high risk pregnant women or women who have experienced amniotic leaks in previous pregnancies.
