How BMF Can Enable Widespread Serologic Testing for COVID-191

Serologic Testing has become an increasing area of focus for government officials globally

As studies mount that show large percentages of people (15-25%) who have been exposed to SARS-Cov-2 are asymptomatic throughout the course of the disease, serologic testing has received a renewed focus.2 Serologic testing analyzes blood, serum, or plasma in an immunoassay to detect the body’s immune response to the infection. Instead of diagnosing, it can tell us who has already been infected and has recovered, the extent of herd immunity, and whether some social distancing measures can be eased. In contrast, most tests conducted today use real-time PCR to measure the presence of RNA of the virus in a human sample, detecting an active disease state.

However, there are challenges to conducting widespread serologic testing using existing testing methods

Antibodies to COVID-19, which can be detected by serologic testing, may appear between 4 and 20 days post exposure to SARS-Cov-2.3 This wide window, in combination with the large minority of patients who are asymptomatic, means that concerted efforts to test patients as they are exposed is challenging. Further, the requirement of experts to draw venous blood at a central location and ship refrigerated samples for analysis to a centralized laboratory can reduce the capacity and speed of testing.

Boston Microfluidics’ (BMF) sample storage and collection device specifically designed for non-expert home collection could increase the capacity and availability of serologic testing

The home collection device is simple to use, requiring a few drops from a finger-prick dropped into the well of the collection device. The user simply closes the device and returns via non-refrigerated mail for analysis at a centralized laboratory. Current rapid COVID-19 antibody tests require users to combine reagents and their blood sample with the use of a pipette, which can lead to widespread user error.

BMF works with laboratory partners to validate proprietary assays and lab-developed tests on the BMF device. A successful validation program with LabCorp resulted in:

  • Validation compared to venous draw for 14 analytes, including HbA1c, ALT, AST, TSH
  • Non-refrigerated shelf-stability across analytes of 7-28 days
  • Durability in shipping of product device and enclosed sample
  • Learn more at Pixel by LabCorp

BMF is offering its home collection device to assay developers to enable wider testing using blood collected from a finger-prick sample.

1 The device is not currently validated or FDA-approved for serologic testing of COVID-19
2 Kimball et. al., 2020, Government of Iceland, Italy wide-spread antibody study (NYT)
3 Scanwell Antibody Announcement (NBC), Amanat et. al., 2020