Nucleic Acid COVID-19 Tests
The JABSOM Tropical Medicine Clinical Lab will utilize a different testing approach than the testing methods employed at the Department of Health or private laboratories in Hawaiʻi. This approach was chosen specifically to avoid competing with State or private labs in Hawaiʻi for scarce testing supplies and materials.
What type of tests are available for COVID-19?
COVID-19 is the disease caused by the SARS-CoV-2 virus. The TMCL has been authorized by the CLIA Program of the Hawaiʻi Department of Health to perform nucleic acid amplification tests (NAAT). NAAT tests are molecular tests that detect the virus’s genetic material in a sample that typically comes from a patient’s respiratory system including the nasopharynx and secretions such as sputum or saliva. Once the specimen is collected, it is delivered to a clinical lab. The SARS-CoV-2 virusʻs genetic material is RNA and once it is purified, 4 genes are amplified to determine how much of the virus is present in the patient sample.
U.S. FDA-authorized NAAT tests for SARS-CoV-2 meet the Emergency Use Authorization statutory standard, and based on the current available data, are highly accurate.
We have selected the TaqPath COVID-19 CE-IFV RT-PCR kits produced by ThermoFisher and run on the Applied Biosystems QuantStudioTM 5 Real-Time PCR System. The kit can be used by clinical and public health laboratories to quickly evaluate up to 94 patient specimens in under 3 hours. The kit is approved for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) from patients at risk of exposure to SARS-CoV-2 or with signs and symptoms of COVID-19.
Information and graphics from ThermoFisher website. Note that we are using the QuantStudioTM 5 Real-Time PCR System instead of the 7500 system.
Serological Testing (not yet available)
The TMCL is working toward making serological or antibody testing available.
Per the FDA, another type of test, called a serology or antibody test, measures the amount of antibodies present in the blood when the body is responding to a specific infection, like COVID-19. This means the test detects the body’s immune response to the infection caused by the virus rather than detecting the virus itself. In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. This limits the test’s effectiveness for diagnosing COVID-19 and explains why it should not be used as the sole basis to diagnose COVID-19.