The new protocol is expected to help laboratories deliver large volumes of accurate molecular test results and reduce turnaround times
US-based Hologic has validated its Aptima and Panther Fusion assays for molecular diagnosis of Covid-19 using pooled patient samples.
The company has also filed an emergency use notification with the US Food and Drug Administration (FDA) to make its new workflow accessible to the US laboratories.
According to the medical technology company, pooling pooling facilitates simultaneous testing of samples drawn from various individuals, enabling laboratories to rapidly deliver large volumes of accurate test results.
Hologic diagnostic solutions division president Kevin Thornal said: “By providing a pooling protocol, we are helping our lab customers meet the extraordinary demand for highly accurate molecular test results during this unprecedented time.
“Pooling will enable more samples to be tested each day, but at the same time, help test results get back to patients and their caregivers faster. I am very proud of the ingenuity and innovations that our Hologic teams continue to bring to fighting this pandemic.”
The Aptima and Panther Fusion assays detect genetic material of SARS-CoV-2
Hologic claimed that that it is the first US manufacturer to validate and launch a pooling workflow that facilitates accurate detection of the SARS-CoV-2 virus.
According to the protocol, clinical laboratories can pool up to five patient samples into a single tube for processing, in areas with lower disease prevalence.
A negative result from the test indicates that all five individuals have tested negative for SARS-CoV-2, while positive result implies re-testing of all five samples individually to identify the specific patient with infection.
The Aptima and Panther Fusion SARS-CoV-2 assays were designed to detect the genetic material of the virus and run on automated testing platforms that provide results in around three hours.
The Aptima SARS-CoV-2 test works on the company’s Panther system, while the Panther Fusion SARS-CoV-2 test runs on the Panther Fusion system.
The molecular diagnostic company said that the US FDA has not yet reviewed the pooling workflow for its Aptima and Panther Fusion SARS-CoV-2 assays, and the workflow is currently available under the FDA’s policy for diagnostic tests for Covid-19 during the public health emergency.
The Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) have supported the development of the devices, through $8.9m funding.