Summary
UCLA researchers in the Department of Bioengineering have developed an easy-to-use diagnostic test for the rapid detection of SARS-CoV-2 in serum.
Background:
The nucleocapsid protein (N-protein) is a major protein found in coronaviruses like SARS-CoV-2 (COVID-19) which is involved in the packing of RNA within the virus. During the first week of infection, N-proteins are shed into serum and nasal fluid and are an early indicator of infection. Commonly used for pregnancy tests, many lateral-flow immunoassays (LFAs) have recently received emergency use authorization (EUA) from the FDA for at-home detection of SARS-CoV-2 antigens in nasopharyngeal and nasal swabs. However, there is currently no LFA that has received an EUA for detection of SARS-CoV-2 antigens in serum. Relative to nasopharyngeal and nasal swabs, a finger prick blood sample is a more reproducible application of a sample to the LFA. Moreover, swabs need to be inserted into a buffer prior to applying the resulting sample to an LFA, and this buffer significantly dilutes the antigens present, thereby affecting detection.
Innovation:
UCLA researchers in the Department of Bioengineering have developed an LFA device that can detect the N-protein of SARS-CoV-2 in serum. They have created an innovative design that incorporates novel reagents for improving detection limits while eliminating liquid handling steps so that this sensitive test can be easily performed at home. Their device has been able to improve the detection of the N-protein by 10-fold compared to a conventional LFA while keeping the simple colorimetric output of LFAs. This rapid, sensitive, inexpensive, and easy to-use test will allow for the detection of early stages of coronavirus infections for accurate clinical diagnoses and monitoring.
Potential Applications:
- SARS-CoV-2
- Protein biomarker detection
- At home
- Point of care
- Screening of patients for coronavirus
Advantages:
- Low sample volume
- Rapid detection
- Cost effective
- Easy-to-use
- Sensitive detection
Status of Development:
First successful demonstration by detection of nucleocapsid protein of SARS-CoV-2 in serum.