Le Lézard
Classified in: Health, Covid-19 virus
Subject: AVO

The Nation Needs More Evidence Before Relying on Home Test Collection Kits for COVID-19


WASHINGTON, April 30, 2020 /PRNewswire/ --

Statement attributable to:
Carmen L. Wiley, PhD
President, American Association for Clinical Chemistry

"We share the FDA's goal of expanding access to critical COVID-19 testing and encourage the agency to continue using its full authority to ensure laboratories are able to increase capacity as quickly as possible to flatten the curve of the pandemic. However, the FDA's authorization of LabCorp's home test collection kit for COVID-19 on April 20, 2020 raises questions for scientific accuracy and public health. FDA's authorization means consumers literally will take their health into their own hands by using swabs to collect specimens from their own nasal passages and then by returning these swabs to a laboratory for testing. We are confident in LabCorp's ability to perform the testing of the samples once they reach their laboratories. But we are concerned that consumers will not carefully follow directions, which could lead to incorrect sample collection.

"AACC recommends that the FDA recognize the preanalytical problems with this type of home collection and consider issuing a warning about its use for COVID-19 testing. False negative test results could give false reassurance to concerned members of the public, and may soften their adherence to social distancing guidelines."

To speak to Dr. Wiley about this issue, please contact Molly Polen, AACC Senior Director of Communications & PR, at [email protected] or 202-420-7612.

About AACC

Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

Christine DeLong
AACC
Senior Manager, Communications & PR
(p) 202.835.8722
[email protected]

Molly Polen
AACC
Senior Director, Communications & PR
(p) 202.420.7612
(c) 703.598.0472
[email protected] 

SOURCE AACC


These press releases may also interest you

at 16:32
The wishes that Make-A-Wish grants wouldn't be possible without the support of countless "WishMakers" such as donors, volunteers, corporate partners, community advocates and more. "WishMakers" ? a term for anyone who steps up to take action...

at 16:30
Today, the Honourable Ya'ara Saks, Minister of Mental Health and Addictions and Associate Minister of Health, announced a new appointment to the Canadian Centre on Substance Use and Addiction (CCSA) Board of Directors. Scott Elliott is appointed as...

at 16:28
The Rett Syndrome Research Trust (RSRT) is proud to announce its partnership with PMD Solutions, a leading provider of innovative healthcare technologies, in their upcoming biosensor validation study called VIBRANT. PMD Solutions will generously...

at 16:20
Pulse Biosciences, Inc. , a company leveraging its novel and proprietary CellFX® Nanosecond Pulsed Field Ablationtm (nsPFAtm) technology, today announced business updates and financial results for the fourth quarter and full year ended December 31,...

at 16:20
AN2 Therapeutics, Inc. , a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today reported financial results for the fourth quarter and year ended...

at 16:20
Pulse Biosciences, Inc. , a company leveraging its novel and proprietary CellFX® Nanosecond Pulsed Field Ablationtm (nsPFAtm) technology, today announced that its Board of Directors has unanimously approved plans to initiate a rights offering. The...



News published on and distributed by: