In Infectious Disease/Vaccine, News, Phase 1 Clinical Trials

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

[Monday, August 10, 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 17 weeks of testing, the full-service early phase CRO is sharing the testing 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): 1,922

Number of Tests Performed (Volunteers): 2,290

Number of Tests Performed (Total): 4,212

Negative Results: 4,186

IgG/IgM Positive Results: 7

IgM Positive Results: 0

IgG Positive Results: 19

 

Results from ELISA Testing:

Number of ELISA Tests IgM: 2,814

Number of ELISA Tests IgG: 323

Number of Tests Performed (Staff): 2,460

Number of Tests Performed (Volunteers): 354

Negative Results: 2,805

IgM Positive Results: 6

IgG Positive Results: 3

 

Results from PCR Testing:

Number of Tests Performed: 401

Negative Results: 393

IgM Positive Results: 8

 

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 tests correlated and ready for use in its facility and under the supervision of trained laboratory and medical staff.

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