What is ASSURANCE VR™?

The ASSURANCE VR™ COVID-19 viral test is intended for the qualitative detection of SARS-CoV-2 coronavirus during the acute phase of COVID-19 infection. ASSURANCE VR is intended for individuals suspected of COVID-19 infection by a healthcare provider.

ASSURANCE VR uses a saliva sample to detect the presence of the SARS-CoV-2 coronavirus genetic material (RNA) using a process called RT-PCR.  The sample is processed and results delivered by Predictive Laboratories, a high-complexity CLIA laboratory.

The test results are provided via secure, online delivery within 24 – 48 hours of receipt at our laboratory.

ASSURANCE VR test accuracy

ASSURANCE VR is a highly sensitive and specific test with 98% of tests providing either a positive or negative result with only a 2% of the samples tested providing an invalid or inconclusive result.

ASSURANCE VR uses the EUA approved Thermo Fisher TaqPath COVID-19 Combo Kit for the detection of the SARS-CoV-2 virus.  Thermo Fisher’s results showed 100% sensitivity and specificity when testing 60 SAR-CoV-2 positive samples (nasopharyngeal and bronchial lavage samples) and 60 SARS-CoV-2 negative samples.  Predictive Laboratories participated in a sample exchange with an independent high-complexity CLIA laboratory.  This laboratory holds an EUA for saliva sample testing using the Thermo Fisher TaqPath™ COVID-19 assay.  In the blinded sample exchange, testing conducted at Predictive Laboratories, 60 samples, 30 SARS-CoV-2 positive and 30 SARS-CoV-2 negative, showed 100% sensitivity (95% CI 88.7-100%) and 100% specificity (95% CI 88.7-100%).

ASSURANCE VR test availability

Assurance VR is available for groups and institutions with a need for routine testing and reporting. Our laboratory is continuing to bring additional capacity online in response to the global COVID-19 pandemic.

What are the benefits of a viral test utilizing a saliva collection sample?

• ASSURANCE VR samples are collected using an EUA approved saliva sample collection kit. This collection device is easier, less intrusive and safer for health care workers than nasopharyngeal or oropharyngeal swabs and reduces the need for personal protective equipment.
• The saliva collection is more comfortable for the patient and a person can independently collect the sample, even at home.
• The collection process may help to mitigate the chances of poor sample collection.
• An ASSURANCE VR positive test almost always means that the person is infected with the virus.