Assay can detect and classify DOACs

“What this means is that a person who does not have DOAC in their system should have an R-time of less than or equal to 1.95 minutes,” Dr Zaman explained.

The researchers also developed an algorithm for the detection and classification of DOACs. According to this algorithm, healthy subjects would have a short R-time in the detection channel and the classification channel.

Patients on anti-Xa would have a long R-time in the detection channel but a short R-time in the classification channel. And patients on a DTI would have a long R-time in both the detection channel and the classification channel.

The researchers found that, in the detection channel, on average, R-time was increased 66% for dabigatran, 125% for rivaroxaban, and 100% for apixaban, compared to the reference range. But the degree of elongation was dependent on the individual patient and the time from last DOAC dosage.

Using a cutoff of 2 minutes, the detection channel demonstrated 94% sensitivity and 96% specificity for all the DOACs combined.

“What this means is that, when a patient had a DOAC in their system, the assay was able to pick it up 94% of the time,” Dr Zaman explained.

In addition, the assay detected dabigatran correctly 100% of the time and anti-Xa therapy correctly 92% of the time.

“This TEG 6s DOAC assay is highly sensitive and specific for detecting and classifying DOACs,” Dr Zaman said in closing. “[T]he cutoffs for both the channels are close to 2 minutes, which means clinically relevant results are available within 5 minutes.”

“There is no reagent prep necessary, and it utilizes whole blood, so [there is] no spinning down to plasma. Therefore, it has the potential to be a point-of-care assay.”