Rapid diagnostic could save people from dying of blood loss

Researchers from Monash University and BioPRIA (Bioresource Processing Institute of Australia), in collaboration with medical device manufacturer Haemokinesis, have developed a diagnostic using a glass slide, Teflon film and a piece of paper that can test for levels of fibrinogen concentration in blood in less than four minutes.

Described in the journal ACS Sensors, the fast, portable and cheap diagnostic could help deliver urgent treatment to the more than 2 million people at risk of dying from rapid blood loss every year.

Fibrinogen is a protein found in blood that is needed for clotting. When a patient experiences traumatic injury (such as a serious car accident), major surgery or childbirth complications, fibrinogen is required in their blood to prevent major haemorrhaging and death from blood loss. But hypofibrinogenemia (insufficient fibrinogen to enable effective clotting) in critical bleeding is common, and is experienced by more than 20% of major trauma patients. Heavily bleeding patients must therefore be transported to a hospital or emergency centre to undergo diagnostic tests before being treated — tests which require expensive equipment, specialised/trained personnel and can take up to half an hour.

“When a patient is bleeding heavily and has received several blood transfusions, their levels of fibrinogen drop,” said BioPRIA Director and study co-author Professor Gil Garnier. “Even after dozens of transfusions, patients keep bleeding. What they need is an injection of fibrinogen. However, if patients receive too much fibrinogen, they can also die.

“There are more than 60 tests that can measure fibrinogen concentration. However, these tests require importable machinery on hospital tabletops to use. This means that critical time has to be spent transporting heavily bleeding patients to a hospital — before they even undergo a 30-minute diagnosis.”

The new diagnostic removes the need for centralised hospital equipment to detect, monitor and treat fibrinogen levels — something never achieved until now. Prof Garnier said this will allow emergency doctors and paramedics to quickly and accurately diagnose low levels of fibrinogen in patients, with Monash PhD candidate and study co-author Marek Bialkower adding that the implications are significant.

“Our diagnostic can eliminate the preparation time, labour and transportation difficulties of traditional techniques used in the hospital,” Bialkower said.

“It can diagnose hypofibrinogenemia in critically bleeding patients anywhere in the world, and can drastically reduce the time to treatment needed for fibrinogen replacement therapy. The test can take less than four minutes — about five times faster than the current gold standard methods.”

The test works by placing a pre-mixed droplet of a blood sample and an enzyme solution onto a solid surface, allowing it to clot, and then dropping a paper strip on top. The further that blood moves down the strip of paper, the lower the fibrinogen concentration.

Diluting blood samples not only increases the test’s sensitivity, it also eliminates the effect of interfering substances in the blood. The diagnostic can also work with a variety of blood conditions and could be upscaled into a point-of-care tool for use in ambulances and other first responder vehicles, in regional and remote locations, and in GP clinics.

“The development of the world’s first handheld fibrinogen diagnostic is a game changer for the millions of people who die each year from critical blood loss,” said Dr Clare Manderson, a Research Fellow at Monash and co-author of the study. “It will also ease pressure on emergency departments knowing that this life-saving treatment can be delivered onsite and in quick time.

“Our capacity to develop this diagnostic using cheap and readily available materials means it can be easily commercialised for use across the world.”

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