April 7, 2020 – Aculabs will immediately begin performing COVID-19 screenings via the BioGX SARS-CoV-2 Reagents for BD MAX™ System, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2. The ability to perform screenings will allow for result reporting within 24 hours, vital to the high-risk populations Aculabs services as the largest diagnostic service provider to long term care and assisted living facilities across the Mid-Atlantic.
The BD MAX™ System also allows for Aculabs to process 24 samples simultaneously and analyze hundreds of samples per day. All testing is to be done at the Aculabs East Brunswick, New Jersey laboratory, where our team has worked diligently to obtain the latest instrumentation for rapid testing and satisfying all stringent state and federal regulations.
The BD SARS-CoV-2 Reagents for BD MAX System utilizes multiplexed primers and probes targeting RNA from the nucleocapsid phosphoprotein gene (N1 and N2 regions) of the SARS-CoV-2 coronavirus, and the human RNase P gene. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for specific detection of SARS-CoV-2 by amplifying two unique regions of the N gene (i.e., N1 and N2).
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swab samples during infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.
The usage of the BioGX SARS-CoV-2 Reagents for BD MAX™ System became available to CLIA-certified laboratories and hospitals across the country when BD and BioGX announced on April 3rd that they were granted emergency use authorization by the FDA for their new diagnostic test for screening for COVID-19. This new access will allow for more timely reporting.
Aculabs has been approved to use the EUA to perform the testing and will begin implementing testing immediately.