Collaboration between the Massachusetts Institute of Technology and manufacturer 3M has led to the development of a lateral flow immunoassay test kit to detect the presence of SARS-COV-2 antigen responsible for COVID-19.  If the kit passes initial validation for sensitivity and specificity, additional Phase 2 evaluation will be required to achieve regulatory approval.  John Banovetz Chief Technology Officer for 3M stated, “The holy grail of this would be something akin to a home pregnancy test kit.”

The system could be deployed at bedside, in the work place or at home.  The advantage of speed is self-evident.  Results could be obtained within an hour compared to the inordinate time required to submit a swab to a laboratory equipped with PCR assay capability.

From personal experience, it took three days to schedule a COVID-19 test in North Carolina and results are not anticipated for at least four days.  The objective of testing is to determine that a patient is in fact infected, with a reasonable level of sensitivity and specificity and to undertake quarantine with subsequent tracing of contacts.  The seven-day delay between requiring a test based on symptoms or exposure and receiving the results is totally inadequate in the context of controlling the disease.

Presumptive positives identified using a lateral flow immunoassay test could be immediately isolated and the diagnosis confirmed by more sensitive PCR assay during quarantine.