What is SalivaClear?
SalivaClear is a three-stage surveillance and individual reflex testing protocol to monitor and detect SARS-CoV-2 infection in populations and identify infected individuals by testing people in groups called pools.
Stage 1: Test pools of up to 24 samples
Stage 2: Test positive pools in smaller subpools of 2 – 3 samples
Stage 3: Reflex test positive subpool samples as individual diagnostic tests
What are SalivaClear result turnaround times?
Stage 1: 24 hours from receipt of samples at the lab
Stage 2: 12 additional hours from Stage 1 results
Stage 3: 6 additional hours from Stage 2 results
Is SalivaClear a PCR test?
Yes, SalivaClear is a real-time polymerase chain reaction (RT-PCR) test.
What is pool testing?
Pool testing means combining respiratory samples, such as saliva from several people and conducting one laboratory test on the combined pool of samples to detect SARS-CoV-2, the virus that causes COVID-19.
Why is pooling used?
Pooling allows Mirimus to test more samples with fewer testing materials and achieve faster result turnaround times.
What is your saliva sample collection method?
We use a simple self-collection method that is composed of a 2 mL cryogenics vial and saliva collection aid (straw). The saliva straw fits into a cryogenic vial and the testing individual deposits 1 mL of saliva through the straw into the vial. 1 mL of saliva is required for pool testing, subpool testing, and individual diagnostic testing.
Is a saliva sample stable at room temperature?
Saliva samples are stable at room temperature without any buffer or refrigeration required for storage or transport.
What test system is used for SalivaClear testing?
Global 7 uses the Thermo Fisher TaqPath COVID-19 Combo Kit for pool and individual diagnostic testing. It is a fast, highly sensitive multiplex diagnostic solution that contains the assays and controls needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus. Thermo Fisher TaqPath COVID-19 Combo Kit received emergency use authorization (EUA) from the U.S. Food and Drug Administration on March 13, 2020.
What is SalivaDirect?
SalivaDirect is a process developed at the Yale School of Public Health to test persons suspected of having COVID-19 for the virus, SARS-CoV-2. SalivaDirect received emergency use authorization (EUA) from the U.S. Food and Drug Administration on Aug. 15, 2020.
Yale has designated Global 7 as an authorized laboratory to provide SalivaDirect as a method for individual diagnostic testing.
What happens if the pooled test result is not detected (presumptively negative)?
If a pool test result is negative, then all the samples can be presumed negative with the single test. In other words, all the people who provided samples can be assumed to test negative for SARS-CoV-2 infection.
What happens if a pool test result is detected (positive)?
If a stage 1 pool test detects the presence of SARS-CoV-2 infection, the samples in the pool will be tested in smaller stage 2 subpools of 2 -3 samples. The positive stage 2 subpools will then be individually reflex tested as a diagnostic to identify the positive individual.