Point of Care Testing Options
Pennsylvania is one of the states rolling out programs, in conjunction with the federal government, to make point-of-care testing more easily available to facilities in order to allow for rapid testing where a result can be produced in as quickly as an hour right by the bedside. The federal government will send to eligible facilities the device in order to perform the waived testing, as well as the tests themselves.
POC testing can be used for diagnostic purposes or for screening. Testing is considered diagnostic when used to identify current infection in a person who has signs or symptoms consistent with COVID-19, or when a person is asymptomatic but has recent known or suspected exposure to SARS-CoV-2. Testing is considered screening when used for persons who are asymptomatic and do not have known or suspected exposure to SARS-CoV-2.
The performance of these tests is dependent on pretest probability. Pre-test probability is the chance that the patient has the disease, estimated before the test result is known. Pretest probability should be informed by using a rolling average of the positivity rate over the previous 7-10 days along with clinical context. Pretest probability needs to be considered when interpreting the results of these tests.
The Quidel Sofia and Sofia 2 Instruments, BD Veritor Plus Systems, and Abbott BinaxNOW COVID-19 Ag CARD make use of antigen tests, which detect fragments of proteins on or within the virus by testing samples collected from the nasal cavity via swab, while the Abbott ID Now is molecular testing.
Aculabs cannot provide the devices or provide the tests for the point-of-care testing, nor supply training on the devices, but encourages facilities who qualify to receive one of the POCT devices from the federal government to apply and make sure they are eligible for waived testing. We have provided a series of resources below to assist facilities who are looking into performing point-of-care testing at their building.
Pennsylvania POTC COVID-19 Resources:
- Point of Care Testing – Information & Resources (health.pa.gov)
- Clinical Laboratory Improvement Amendments (CLIA) Application for Certification* (.pdf)
*- Facilities seeking to perform POTC must complete the application for “Certificate of Waiver (Sections I – VI and IX – X)”.
Aculabs Begins Implementing SARS-CoV-2 Testing for COVID-19:
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.
On their website, Becton, Dickinson and Company (BD) describes the test screen as follows:
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.