The federal government wants U.S. diagnostics companies to develop rapid point-of-care COVID-19 antibody tests — using only materials made in the USA.
The Department of Health and Human Services (HHS) on Thursday issued the call for submissions from companies that can quickly begin production of more than 20 million such tests per month. The tests must be suitable for use by non-professionals, accurate and low-cost. Specifications include:
- A clear regulatory path, such as to an FDA emergency use authorization.
- Rapid, one-step analysis.
- Requirement of small sample volume without pretreatment.
- Simple instrumentation.
- User-friendly format.
- No interferences due to chromatographic separation.
- Long-term stability under different environmental conditions.
The U.S.-made caveat extends to all components, sub-components and chemical compounds used in the device. Producers who cannot find domestic suppliers must have a plan to quickly do so. Suppliers from China will not be considered, in keeping with the latest trend in deteriorating relations between the Trump administration and China, a major medtech and diagnostics manufacturing source.
HHS said it may be able to provide some support to help manufacturers increase the scale of their production within the United States. However, preference will be given to companies that are already able to produce tests at scale.
People who have fully recovered from COVID-19 have antibodies in their plasma that can attack the virus, which is surging or resurging in several U.S. states.
The request for bedside antibody tests comes in the same week as a letter to the editor of the New England Journal of Medicine suggests that the levels of antibodies in people who have mild COVID-19 — which includes most people — may drop by half within 36 days of contracting the infection. The letter by a team of physicians and researchers at the David Geffen School of Medicine at the University of California.
The sample size was small — only 34 participants. The first measurement of antibodies was obtained at a mean of 37 days after the onset of symptoms, and the last measurement at a mean of 86 days after symptom onset.
“The protective role of antibodies against SARS-CoV-2 is unknown, but these antibodies are usually a reasonable correlate of antiviral immunity, and anti–receptor-binding domain antibody levels correspond to plasma viral neutralizing activity,” the team wrote. “Given that early antibody decay after acute viral antigenic exposure is approximately exponential, we found antibody loss that was quicker than that reported for SARS-CoV-1” — the SARS virus identified in 2003.
“The results call for caution regarding antibody-based ‘immunity passports,’ herd immunity, and perhaps vaccine durability, especially in light of short-lived immunity against common human coronaviruses,” the authors concluded. “Further studies will be needed to define a quantitative protection threshold and rate of decline of antiviral antibodies beyond 90 days.”