The ANSI Federation and standardization community are stepping up with guidance, resources, and initiatives to support public health, safety, and infrastructure during the COVID-19 outbreak. ANSI is monitoring, sharing, and promoting appropriate news to highlight these efforts. Suggestions for news items may be submitted to [email protected]. All submissions are published at ANSI's discretion.
New Material from NIST Measures the Sensitivity of COVID Tests
The National Institute of Standards and Technology (NIST) reports that its scientists have produced synthetic gene fragments from SARS-CoV-2, the virus that causes COVID-19. The material, which is non-infectious and safe to handle, will help manufacturers produce more accurate and reliable diagnostic tests for the disease.
Although a nasal swab test may detect COVID-19, research has shown that a negative test result does not always mean a person is disease-free. As NIST explains, a negative result could mean that the virus is "too low for the test to detect," which can happen during the first days after catching the virus. NIST has created synthetic fragments of the virus's genes, which are written in RNA, a molecule that encodes information much like DNA. NIST reports that researchers can measure sensitivity by running tests against known quantities of viral RNA, and they can also utilize it to develop "more sensitive tests or new types of tests that are faster or easier to administer."
"Having better data on test sensitivity will help us understand how often tests for COVID-19 produce a negative result for people that are actually infected," said NIST research scientist Megan Cleveland.
NIST recently published an article describing how the synthetic RNA material from can be used to measure sensitivity.
NIST Awards 3.4 Million in Grants for Pandemic Response, Supports Manufacturing USA Institutes
NIST has awarded $3.4 million in grants to support high-impact projects for the pandemic response. The Coronavirus Aid, Relief, and Economic Security (CARES) Act, which was signed by the president in March 2020 has authorized funding. NIST reports that the grant will help support Manufacturing USA institutes, public-private partnerships that work with academic and private sector manufacturing organizations on applied research and development, and advanced manufacturing skills training.
Each institute focuses on an advanced manufacturing specialty such as biopharmaceuticals, 3D printing, or wearable sensors. Among others, the grant will support America Makes, in partnership with fellow Manufacturing USA institute MxD, to expand production of medical countermeasure components such as personal protective equipment (PPE) using additive and digital manufacturing technologies.
Read more about the other efforts and theNIST grant in its announcement.
Kaiser Permanente Joins Late-Stage COVID-19 Vaccine Study
Kaiser Permanente has announced its plans to enroll approximately 1,400 participants at four sites in California and Oregon in a phase 3 clinical trial to test an investigational vaccine against SARS-CoV-2.
During the double-blind study, half of the participants will receive the vaccine and the other will receive a placebo. Neither the participants nor clinicians will know who receives the vaccination or the placebo. Data will be gathered about safety, immune response, and efficacy as required for regulatory review.
According to Kaiser Permanente, the goal for this trial is to enroll up to 30,000 participants at more than 120 sites around the world.
"Our researchers and physicians are eager to contribute to the independent science that will ultimately lead to the development of a vaccine for COVID-19," said Stephen Fortmann, MD, senior science director and principal investigator for the trial at the Kaiser Permanente Center for Health Research. "We are working in partnership with researchers globally to ensure timely, safe, and effective vaccines can be developed so that we can prevent illness and save lives."
Read more about Kaiser's COVID-19 vaccine study in the company's August 12 news announcement.
Personal Care Products Council Launches Hand Sanitizer Ingredient Connection Program
The Personal Care Products Council (PCPC) has launched a new program to accelerate production of hand sanitizer as part of its COVID-19 relief efforts.
The Hand Sanitizer Ingredient Connection program connects buyers and sellers of materials in order to facilitate the manufacture and marketing of hand sanitizers in the United States. Program participants can publish information about their business needs and view other participants who may be able to meet these needs according to material type and quantity. The program is a public service that is free of charge.
"We have been working closely with our members to support their efforts over the past several months," said PCPC president and CEO Lezlee Westine. "Our hope is that the Hand Sanitizer Ingredient Connection will help expedite production and increase supply of these essential products."
Read more in PCPC's news release.
See more ANSI member efforts in the ANSI COVID-19 Resource Webpage Highlighting Standardization Community Response Efforts.