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Home/Biologics/Diagnostics Company Appeals for COVID-19 Volunteers
Biologics

Diagnostics Company Appeals for COVID-19 Volunteers

June 4, 2020 2 min read Premium comments

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Diagnostics Company Appeals for COVID-19 Volunteers
Finger Prick /Source: Kephera Diagnostics, LLC
Secondary#covid19#diagnostics

Experts insist that increased testing is necessary for successful reopening of global economies during the coronavirus pandemic. In addition to knowing who has the disease through PCR testing (polymerase chain reaction), it is also important to learn who has had the disease to inform health policy, to better understand how the immune system responds to the virus, and to determine the amount and duration of immunity generated after infection or a future vaccine administration.

In order to validate a new serology test that detects antibodies to SARS-CoV-2, the virus that causes the COVID-19 disease, positive samples are required. Samples of positive plasma are also required to be included in test kits as a positive control for laboratories.

The only way to obtain positive samples is to take blood from patients with confirmed positive SARS-CoV-2 tests obtained by nasal or throat swab. Diagnostic companies source samples from blood brokers, which pay and collect plasma from “donors,” or negotiate the collection of remnants destined for disposal from samples used by laboratories running tests. Earlier in the pandemic blood brokers have quoted diagnostic firms over $1,000 for 1mL of antibody-rich plasma, today that amount has dropped to $100-$300, but supply is still short, especially in areas with declining case counts.

A diagnostics company based in Framingham, Massachusetts, Kephera Diagnostics, LLC., is trying to avoid depending on blood brokers for all of their supply to develop their enzyme-linked immunosorbent assay (ELISA) to detect IgG and IgM antibodies.

The company reached out to OTW with a plea to our readers seeking finger-prick blood from adult volunteers 18 years or older with confirmed positive tests for COVID-19. Participation is not compensated, but test kits will be mailed and returned at no cost with supplies and instructions for submitting a sample from a finger prick. “As a volunteer blood sample donor, you are making an important contribution that will bring us closer to the development of a sensitive and specific COVID-19 antibody test,” reads the request for volunteers.

In an interview with the Wall Street Journal the company’s President and Scientific Director Andrew Levin, Ph.D. described the sourcing of COVID-19 blood as “a land grab…. It became a fairly high value commodity.”

Link to request for volunteers.

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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