Liver Function Test

Diagnostics For All

Liver Function Test Contact Solution Provider

Solution Overview & Benefits

DFA’s first project is a rapid, low-cost, point-of-care diagnostic device to monitor liver function. While many of the highly potent drugs used to treat HIV/AIDS and TB are toxic to the liver, deaths due to drug-induced liver failure are very rare in countries like the United States, where a patient’s liver function is monitored regularly. Yet this is not the case in resource-poor countries, where roughly 20% of TB patients and 25% of HIV/AIDS patients, lacking access to diagnostic tools, succumb to liver complications related to their treatment.

Designed specifically for use in the developing world, DFA’s device will enable semi-quantitative determination of two key liver enzymes, AST (aspartate transaminase) and ALT (alanine transaminase), which are routinely used to measure liver toxicity amongst patients receiving antiretroviral medications. As the liver becomes damaged by potent medications, these two enzymes, usually found in the liver, are released into the blood stream. From a single drop of whole blood, this test will determine whether blood levels of these two enzymes are baseline/normal, greater than two-times baseline/normal, or greater than five-times baseline/normal. The 2x and 5x thresholds, which indicate that treatments should be “monitored closely” or “altered immediately”, correspond to protocols established by the U.S. FDA to guide treatment during clinical trials.

The liver function test is targeted to cost $0.10 or less, will be about the size of a postage stamp, and will function without external power or equipment. The output will be a straightforward, semi-quantitative colorimetric indication of enzyme levels and will be easily integrated into telemedicine networks.

History & Development

Paper is significantly less expensive than other materials typically used in diagnostic devices and is compatible with a variety of existing diagnostic tests. It inherently wicks biological samples through channels patterned in the paper to assay zones, and its mesh-like properties filter the sample of contaminants such as dust and dirt.

DFA’s devices can be brought directly to those who are unable to travel to hospitals or clinics and, with no mechanical parts, are robust enough for use even under severe environmental conditions. No auxiliary equipment, electricity, or laboratory facility is needed to use the device or process a sample. Results are quickly displayed, enabling immediate clinical decisions.

Minimal training is required to use a DFA device. It is both user-friendly and minimally invasive. A sample from a finger prick is sufficient to yield results. No syringes are involved and neither clean water nor sample preparation is needed. Results are displayed in an easily understood manner, as through a colorimetric scale.

Before distribution, devices are packaged so that they are protected from the environment and provide adequate shelf life for transport and storage in the developing world. While DFA devices are single-use, they can be easily and safely disposed of through incineration, assuring that they do not contribute to the global medical waste problem.

Availability

Publicly available: no
Countries where available: Worldwide
Price range (USD): 1 to 20 USD

Additional Information

 
Solution Providers Website (external link) Product Webpage (external link)

Updates

If you are aware of any updates to the Liver Function Test project please complete the form or send an email to [email protected]

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