In Infectious Disease/Vaccine, Phase 1 Clinical Trials

WCCT Shares COVID-19 Test Data
Aggregated at its Clinical Pharmacology Unit

[Monday, January 4, 2021]

On April 13, 2020, WCCT Global resumed operations at its clinical pharmacology unit located in Cypress, CA. As a result of the COVID-19 pandemic, WCCT sourced and implemented multiple screening platforms to be utilized at its facility in order to ensure clinical research could be performed in a safe setting for both its staff and trial volunteers. After 9 months of testing, the full-service early phase CRO has generated the below SARS-CoV-2 testing data from tests performed on staff, research volunteers, and visitors to its facility.

 

COVID-19 Rapid Antibody Testing:

Number of Tests Performed (Staff): 6,802

Number of Tests Performed (Volunteers): 8,303

Number of Tests Performed (Total): 15,105

 

ELISA Testing*:

Number of ELISA Tests IgM: 4,578

Number of ELISA Tests IgG: 1,164

Number of Tests Performed (Staff): 2,462

Number of Tests Performed (Volunteers): 2,043

*As of November 1, 2020, WCCT has removed ELISA testing from the standard test menu in favor of more-frequent Rapid Tests and PCR Testing. ELISA testing remains available per Sponsor protocol requirements.

 

PCR Testing:

Number of Tests Performed (Staff and Volunteers): 2,200

 

The Rapid Antibody Test is utilized to confirm the presence of antibodies in the person being screened. If none detected, they are allowed into the facility to complete their visit or perform their duties. This test is performed every three days on staff that are returning for duty or volunteers that are confined to the facility for at least that length of time. In the event that the results of the Rapid Antibody Test are inconclusive, WCCT has the ability to deploy rapid Antigen testing as a confirmatory measure, in order to detect the presence of an active virus. Read more about the Antigen testing on our press release here.

The ELISA test, which quantifies antibodies, was being utilized primarily to detect the upward progression of antibodies, and was designed to allow WCCT to detect the risk of an individual developing the disease and moving towards  becoming symptomatic early-on.

WCCT is confident in the accuracy of its testing methodology. Prior to resuming operations, the company performed correlations in its high-complexity laboratory to ensure the validity of the tests being implemented at its facility and to authenticate the manufacturers’ claims with regards to sensitivity, specificity, and accuracy. WCCT procured 100 samples from known positive and negative patients, confirmed by PCR and ELISA testing.

The results of the correlation provided 95% accuracy against PCR-tested samples and 96% correlation against ELISA-tested samples. As per CAP and CLIA requirements, WCCT considers these COVID-19 tests correlated and ready for use in its facility and under the supervision of trained laboratory and medical staff.

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