What’s new at Abbott?
Brain injury biomarkers likely to save time in ED

The Abbott commitment to helping people live healthy and active lives speaks to a dedicated approach to patient care. Reducing waiting times for patients and freeing up clinicians in emergency departments is one example of this, and that is what one of our latest innovations has the potential to offer.

When patients present to hospital with head trauma, doctors need to quickly decide how best to diagnose and treat them to avoid complications and damage to the brain.

Traumatic brain injury (TBI) is a sudden injury caused by a bump, blow, or jolt to the head, disrupting normal brain function and may result in bleeding in the brain.[1],[2]

TBI is classified into mild, moderate and severe categories based on the Glasgow Coma Scale, which measures verbal responses, motor responses and eye opening.

Mild TBI (mTBI), sometimes referred to as concussion, is the most common form of TBI, accounting for more than 80% of all TBI cases.[3]

mTBI symptoms are potentially caused by the brain swelling and can include headache, sluggishness, nausea, balance problems and confusion or memory issues. The main treatment approach is physical and mental rest, followed by rehabilitation.

In cases of head trauma, it is important for the healthcare team to rule out a bleed in the brain which presents in a small percentage of patients with mTBI. A bleed can cause a patient to deteriorate quickly and may require surgery, so it is vital for doctors to diagnose this.

However, definitive diagnosis of TBI where a bleed is present requires a CT scan. This is potentially time consuming for both the patient and hospital staff, as well as posing issues for patients in rural locations who may need to travel long distances to a centre where a CT scan is available.

Fortunately, there are now blood biomarkers that can be tested in patients with head trauma to assess whether a bleed on the brain is present. Abbott has released a TBI biomarker test; a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) that measures glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) for the Alinity i system.

Measuring GFAP and UCH-L1 aids the diagnosis of mTBI. The test has a high negative predictive value meaning a negative result for both biomarkers is associated with the absence of an intercranial lesion. So those patients who test negative may not need to be referred for a CT scan. This could help reduce wait times and overcrowding in emergency departments, as well as avoiding radiation exposure for the patient.   

Although the test is not yet validated for everyday use in Australian pathology laboratories, those working in emergency departments can see the potential benefits of testing, once the appropriate patient group is well defined.

Dr Gary Mitchell is a Staff Specialist, Emergency and Trauma Unit at the Royal Brisbane and Women's Hospital, he said; “In a big hospital like this, it could prevent maybe an hour or an hour and a half of the patient’s journey within the emergency department. In rural communities that may prevent patients being medevac-ed out, put on a helicopter or a plane to be taken to imaging.”

Dr Mitchell notes that there is still work to be done to refine the most appropriate use of the test, to ensure its benefit to patients, clinicians and the health system. He said, “We need more understanding of the blood test, to use it in the right population. We need to understand it's utility within the Australian healthcare system as we practice medicine very differently to America and other countries.

What we would love eventually is a point of care test, that we can perform at the bedside and be able to diagnose a concussion or a bleed, otherwise you have to wait for a blood test result then organise a CT which would actually slow the patient’s journey down’.

While a point of care test to definitely diagnose an mTBI or a bleed on the brain is not yet available, utility of the biomarkers GFAP and UCH-L1 can help hospitals treating patients with head trauma, and will no doubt become a widely used tool throughout Australian emergency departments into the future.


Other exciting news: Abbott MPX test gets FDA emergency authorisation

As well as our contribution to the fight against HPV and cervical cancer Abbott has worked hard to address the latest infectious disease threat; monkeypox.

In October 2022, Abbott became the first company to obtain an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a commercial monkeypox (MPX) test kit.

The FDA granted Abbott the EUA for the real-time polymerase chain reaction (PCR) Alinity m MPXV test after examining the results of a study of 36 contrived clinical samples.

Every step of the test, including sample preparation and PCR assembly, are performed automatically by the Alinity m System, which was designed by Abbott to increase the throughput of infectious disease testing.

To validate the MPXV test, Abbott undertook a clinical evaluation study, which assessed the test’s ability to correctly identify the presence of monkeypox virus at two and four times the limit of detection. Alinity m MPXV detected the virus in all 36 positive samples and also reported that the virus was absent from the 35 negative samples.


[1] Capizzi A, Woo J, Verduzco-Gutierrez M. Traumatic Brain Injury: An Overview of Epidemiology, Pathophysiology, and Medical Management. Med Clin North Am. 2020;104(2):213-38.

[2] Wang KK, Yang Z, Zhu T, et al. An update on diagnostic and prognostic biomarkers for traumatic brain injury. Expert Rev Mol Diagn. 2018;18(2):165-80.

[3] Silverberg ND, Duhaime AC, Iaccarino MA. Mild Traumatic Brain Injury in 2019-2020. Jama. 2020;323(2):177-8