CHIL COVID-19 Rapid Antigen Test Demonstrates High Accuracy in U.S. Clinical Study

On 15 June 2022, an observational and prospective clinical performance study of the CHIL™ COVID-19 Rapid Antigen Test received approval from the Institutional Review Board (IRB) covering the following institutions:

• Albert Einstein College of Medicine
• Montefiore Medical Center
• North Bronx Healthcare Network
• Yeshiva University
• White Plains Hospital

The study, conducted at Montefiore Medical Center in New York, evaluated respiratory swab samples from subjects with either positive or negative RT-PCR results for SARS-CoV-2 infection.

After nearly one year of comprehensive testing, the results demonstrated outstanding performance: 29 of 31 RT-PCR positive samples were correctly identified by the CHIL Rapid Antigen Test, yielding a sensitivity of 93.5%, while no false positives were observed, resulting in a specificity of 100%.

These findings were confirmed against state-of-the-art, high-sensitivity RT-PCR reference assays, validating the CHIL test’s reliability and accuracy in real-world clinical conditions.

The study underscores CHIL’s commitment to delivering high-quality, dependable diagnostic solutions that meet the rigorous standards of clinical and regulatory evaluation in international markets.