Statement from Marin Public Health
Issued Friday, January 8, 2021:
We are aware that the FDA has issued a safety communication regarding the risk of false negative results with the Curative SARS—CoV-2 test.
Studies have shown that people are more likely to have a positive test result when they are actively showing symptoms with all testing methods-- whether by oral swab, nasal swab, or rapid antigen test. As the FDA states, all SARS-CoV-2 tests carry a risk of a false result and all tests require clinical judgement. Marin County Public Health advises clinicians to treat all patients with a clinical history (exposure or symptoms) consistent with COVID-19 as positive cases, regardless of test result or type of test.
For Marin County, Curative provides 1,000 more tests per day to diagnose cases that might otherwise go undetected. As a self-administered test, the technique used to obtain the sample is important to gaining accurate results. Done properly Curative’s oral swabbing method has a higher clinical sensitivity than most SARS-CoV-2 tests available. Marin County Curative tests are performed under the guidance of on-site trained test administrators, to ensure the test is conducted in-line with FDA approved directions.
Curative is continuing to offer tests in Marin County. We remain in close communication with Curative as testing quality is a shared goal with Marin Public Health. Curative is working closely with FDA to address any unresolved concerns and will be providing additional updates and information as it becomes available.
Statement from Curative:
Provided to Marin Public Health on January 11, 2021:
Curative’s test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with specific warnings, precautions, and limitations that FDA reiterated in the Safety Communication. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization process.
We understand that the Safety Communication seeks to ensure that Curative’s test is administered and performed according to the labeling and limitations in the EUA. The Curative test must be observed and directed by a healthcare worker and self-collected by the patient. To view the process, please see the sample collection video here.
Curative will continue to work actively with FDA to provide additional data required to address the limitations and precautions. Curative remains committed to following FDA and CMS regulations in the development, testing, and use of our Emergency Use Authorized test, and in providing medical devices and services that meet or exceed our customer's expectations operating in accordance with these requirements.
Additional data considerations:
The data below compares test positivity rate from Curative testing in California to that reported by California Public Health. You can see on average Curative detects slightly more cases than the rest of California's testing. While all tests have the potential for false negative results, public data suggests Curative’s positivity rate largely agrees with other labs.
Please see the EUA statement here for our COVID-19 test and the patient factsheet here. As noted in the EUA, the Curative test is 100% clinically sensitive and 100% specific relative to the CDC assay.