We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

Download Mobile App





First COVID-19 Antibody Test Receives FDA EUA for Use with Home Collected Dried Blood Spot Samples

By LabMedica International staff writers
Posted on 08 Apr 2021
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the first antibody test for use with home collected dried blood spot samples.

Symbiotica, Inc. More...
(Vacaville, CA, USA) has received FDA EUA for its COVID-19 Self-Collected Antibody Test System for prescription use with a fingerstick dried blood sample that is self-collected by an individual age 18 years or older or collected by an adult from an individual five years of age and older. Samples collected at home are then sent to a Symbiotica laboratory for analysis.

The test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The COVID-19 Self-Collected Antibody Test System is not meant to be used to diagnose or exclude acute SARS-CoV-2 infection.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.”

Related Links:
Symbiotica, Inc.


Gold Member
Universal Transport Solution
Puritan®UniTranz-RT
Portable Electronic Pipette
Mini 96
New
ESR Analyzer
TEST1 2.0
New
Alcohol Testing Device
Dräger Alcotest 7000
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: The Ultrasensitive NeXT Personal Test detects the earliest molecular signs of recurrence in breast cancer patients (Photo courtesy of Personalis)

Ultrasensitive Test Could Identify Earliest Molecular Signs of Metastatic Relapse in Breast Cancer Patients

HR+ (hormone receptor-positive) HER2- (human epidermal growth factor receptor 2-negative) breast cancer represents over 70% of all breast cancer cases and carries a significant risk of late recurrence.... Read more

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Pathology

view channel
Image: An adult fibrosarcoma case report has shown the importance of early diagnosis and targeted therapy (Photo courtesy of Sultana and Sailaja/Oncoscience)

Accurate Pathological Analysis Improves Treatment Outcomes for Adult Fibrosarcoma

Adult fibrosarcoma is a rare and highly aggressive malignancy that develops in connective tissue and often affects the limbs, trunk, or head and neck region. Diagnosis is complex because tumors can mimic... Read more

Technology

view channel
Image: Conceptual design of the CORAL capsule for microbial sampling in the small intestine (H. Mohammed et al., Device (2025). DOI: 10.1016/j.device.2025.100904)

Coral-Inspired Capsule Samples Hidden Bacteria from Small Intestine

The gut microbiome has been linked to conditions ranging from immune disorders to mental health, yet conventional stool tests often fail to capture bacterial populations in the small intestine.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.