WCCT Shares COVID-19 Test Data
Aggregated at its Clinical Pharmacology Unit
[Monday, October 12, 2020]
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 three 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 26 weeks of testing, the full-service early phase CRO is sharing the COVID-19 test data regarding the prevalence of SARS-CoV-2 in the staff, visitors, and research volunteers screened at its facility.
Results from CoronaCheck COVID-19 Rapid Antibody Test
Number of Tests Performed (Staff): 4,122
Number of Tests Performed (Volunteers): 4,736
Number of Tests Performed (Total): 8,858
Negative Results: 8,788
IgG/IgM Positive Results: 12
IgM Positive Results: 0
IgG Positive Results: 58
Results from ELISA Testing:
Number of ELISA Tests IgM: 4,012
Number of ELISA Tests IgG: 598
Number of Tests Performed (Staff): 2,462
Number of Tests Performed (Volunteers): 1,550
Negative Results: 4,003
IgM Positive Results: 6
IgG Positive Results: 3
Results from PCR Testing:
Number of Tests Performed: 961
Negative Results: 951
IgM Positive Results: 10
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. The ELISA test, which quantifies antibodies, is being utilized primarily to detect the upward progression of antibodies, which allows WCCT to detect, early-on, that an individual is at risk of developing the disease and moving towards becoming symptomatic. Both tests are performed every three days on staff that are returning or volunteers that are confined to the facility for that length of time. The number of ELISA tests performed on subjects will increase as additional subjects are confined in-house for trial activities and monitoring.
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.