Laboratory Test Request

Performance Evaluations of COVID-19 Rapid Tests (500)

Project Description

EUROPEAN UNION OR UNITED KINGDOM LABORATORIES
LONG-TERM TESTING
MULTIPLE TESTS
MULTIPLE PRODUCTS
UK or EU Clinical Laboratories needed for CE Marking and IVRD Submission Performance Evaluations of Covid-19 Antigen/antibody rapid tests for verification of the sensitivity and specificity of the test-kits for clinical use (professional-use) by conducting a clinical trial with the PCR-Test . Also usability /laypersons study intended for self-use ( NB: PCBC NB 1314).
A typical cñient could require the following standard studies:

Research purpose
The study aims to evaluate the clinical performance of Cvoid-19 Antigen rapid test Performance Evaluation:
using saliva samples when compared to PCR as the gold standard detection of COVID-19 infection. Sensitivity and specificity
a) Clinical performance evaluation: 480 samples(240 positive/240 negative)
b) Laypersons study (50 positive /50 negative samples)

Project Information

Number:21-01532

Industry:Biotechnology

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Antigens and Antibodies,Antivirals,Biologics,Biopharmaceuticals,Biotechnology,Blood and Blood Products,Clinical Diagnostic,Healthcare and Medical,Hospitals and Medical Centers,Immunotherapy and Immunotherapeutics,In-Vitro Diagnostics,Laboratory Equipment,Life Sciences,Medical Devices,Pharmaceuticals ,Saliva,Serum,

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