Deployment of a suitable rapid test for detection of antibodies to COVID-19 is a key element in the fight against the Corona Virus. There is currently no effective rapid immunoassay that is recommended by the WHO for deployment in clinical practice. Easing of lockdowns globally (with the caveat that the immunological response to SARS-CoV-2 is still being studied) will be greatly assisted by the deployment of an effective rapid test, preferably validated for home use.
ARC regulatory has developed a globally compliant clinical performance protocol for the validation of diagnostic sensitivity and specificity of lateral flow immunoassays that assures compliance with GCP and WHO/MHRA requirements.
Contact us to discuss your study objectives. Our biostatistics group can tailor our protocol design to meet your study objectives, giving your study the best possible chance of success.