The New Jersey Department of Health has announced, starting on February 28, 2020, that the CDC SARS-CoV-2 real-time RT-PCR test will now be available at New Jersey Public Health and Environmental Laboratories. For the convenience of client facilities, Aculabs will participate in shipping the patient specimen to appropriate NJ PHEL qualified laboratories if called-in.
The test kit is used in the detection of severe acute respiratory syndrome coronavirus 2, the virus which causes COVID-19, more commonly referred to in the news as simply “coronavirus”. According to the CDC’s website, the test kit will only be sent to specific public laboratories and will not be available to hospitals or other primary care providers:
CDC has developed a new laboratory test kit for use in testing patient specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The test kit is called the “Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.” It is intended for use with the Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS 1.4 software. This test is intended for use with upper and lower respiratory specimens collected from persons who meet CDC criteria for COVID-19 testing. CDC’s test kit is intended for use by laboratories designated by CDC as qualified, and in the United States, certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. The test kits also will be shipped to qualified international laboratories, such as World Health Organization (WHO) Global Influenza Surveillance Response System (GISRS) laboratories. The test will not be available in U.S. hospitals or other primary care settings.
The NJ DoH will only accept test kits for patients deemed a person under investigation – PUI – for COVID-19.
NJ PHEL has completed verification of the CDC real-time RT PCR diagnostic panel for SARS- CoV-2 which was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA). Testing for SARS -CoV-2 will only be performed on specimens collected from patients who meet criteria as Persons Under Investigation (PUI) for COVID-19 AND who have been approved for testing by state public health authorities. Turn-around time for testing will be dependent on testing volumes. Information about the interpretations of findings will accompany the test result.
To request an evaluation of a patient for PUI status, contact the local health department (LHD) in the jurisdiction where the patient resides.
To read The NJ DoH’s Interim Guidelines for Specimen Collection, Labeling, Storage and Shipping
At present, no commercial test by Aculabs is currently available for SARS-CoV-2 and the COVID-19 virus cannot be detected through any of our currently offered testing profiles.
Aculabs is offering to help in the shipping of test kits already received, collected, and labeled by an active client facility and will continue to observe all state and federal updates as they are made available.