FDA offers reference panel to help validate COVID-19 diagnostics

LabPulse.com staff writers
May 27, 2020
2020 05 28 19 43 7671 Green Validate Rubber Stamp 400

The U.S. Food and Drug Administration (FDA) is now offering a reference panel that will help labs evaluate new molecular diagnostic tests for detection of SARS-CoV-2 genetic material.

The reference panel is a tool for evaluating whether a diagnostic test is accurate in the detection of SARS-CoV-2 RNA. It will be available to commercial and laboratory developers pursuing clearance through the agency's emergency use authorization (EUA) program, the agency said in a May 27 announcement. Developers with well-characterized reagents will now be able to compare different tests under the same conditions, the agency said. Reference tools have been helpful for evaluating diagnostics for other infectious diseases in the past, such as the Zika virus.

Latest in Emergency Use Authorization
3d Closeup Coronavirus Social
FDA issues EUAs for 2 POC COVID-19 tests
October 4, 2023
Visit our Molecular Diagnostics Community
Sponsored
Visit our Molecular Diagnostics Community
April 5, 2024
Fda Button Social
FDA authorizes Discover Labs to run molecular COVID-19 test at its Texas facility
July 7, 2023
Monkeypox Virus Social
Cue Health receives FDA emergency use authorization for molecular mpox test
March 20, 2023
Related Stories
2020 06 04 19 23 9275 Lab Virus Bacteria Research 400
Infectious
FDA offers guidance for labs on substituting supplies during pandemic
2020 05 29 19 30 2147 Emergency Sign
Infectious
FDA creates template for emergency clearance of at-home COVID-19 tests
2019 02 13 19 24 5396 Fda Logo V2 400
Emergency Use Authorization
FDA pulls plug on wayward coronavirus antibody tests
Visit our Molecular Diagnostics Community
Sponsor Content
Visit our Molecular Diagnostics Community
More in Emergency Use Authorization
FDA issues EUAs for 2 POC COVID-19 tests
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) granted emergency use authorizations (EUAs) for two separate point-of-care (POC) assays for SARS-CoV-2 developed by Tangen Biosciences and SD Biosensor.
October 4, 2023
3d Closeup Coronavirus Social
FDA awards EUA to Alphadera Labs’ COVID-19 test
By Nick Paul Taylor
Alphadera Labs received the EUA after evaluating its test on 60 clinical nasopharyngeal swabs specimens. ALPHADx provided the same results as a “highly sensitive” FDA-authorized molecular SARS-CoV-2 test.
August 2, 2023
Coronavirus Covid Blue Social
FDA authorizes Discover Labs to run molecular COVID-19 test at its Texas facility
By Nick Paul Taylor
Under the terms of the EUA, Discover Labs can run the COVID-19 test at its CLIA-certified Austin facility. The test is for prescription use only.
July 7, 2023
Fda Button Social
Cue Health receives FDA emergency use authorization for molecular mpox test
By Leo O'Connor
The test demonstrated high accuracy in clinical trials, achieving 100% concordance with the Center for Disease Control and Prevention’s (CDC's) mpox test on the samples tested, Cue Health said.
March 20, 2023
Monkeypox Virus Social
Mologic receives FDA EUA for at-home SARS-CoV-2 antigen test, eyes additional respiratory diseases
By LabPulse.com staff writers
The development of the rapid antigen test was funded under an $11.8 million contract through the US National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative.
February 27, 2023
Covid Test Preschool Social
Lucira Health files for bankruptcy despite receiving FDA green light
By Leo O'Connor
The firm is seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic testing products.
February 27, 2023
Business Deal Corporate Social
FDA authorizes Lucira Health OTC test, the first to detect influenza and COVID-19 viruses
By LabPulse.com staff writers
In people with symptoms, the Lucira COVID-19 & Flu Test correctly identified 99.3% of negative and 90.1% of positive influenza A samples; 100% of negative and 88.3% of positive COVID-19 samples; and 99.9% of negative influenza B samples, the FDA said.
February 24, 2023
Fda Button Social
FDA grants emergency use authorization for Anavasi LAMP-based COVID-19 test, detector
By LabPulse.com staff writers
Anavasi said its point-of-care platform will enable the rapid development of tests to detect viral and bacterial targets, including influenza, respiratory syncytial virus (RSV), and sexual health-related strains, among others.
February 13, 2023
Virus Coronavirus Covid 19 Social
FDA authorizes Cepheid molecular test to detect monkeypox virus at the point of care
The Xpert Mpox test is a real-time polymerase chain reaction assay to detect Mpox virus DNA in lesion swab specimens from individuals suspected of monkeypox by their healthcare provider.
February 10, 2023
3 D Monkeypox Infecting Cell Social
BD nabs FDA authorization for SARS-CoV-2, influenza A/B, RSV combination test
By LabPulse.com staff writers
The test uses a single nasal or nasopharyngeal swab sample to identify and distinguish whether a patient has COVID-19, the flu, RSV, or some combination of the three, with results available in two hours.
February 8, 2023
Quality Check Mark Social
LumiraDx obtains FDA authorization for test to detect flu A, flu B, SARS-CoV-2
By LabPulse.com staff writers
The test leverages a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments.
February 7, 2023
Covid 19 Antibody Social
Lucira Health applies for FDA Emergency Use Authorization of over-the-counter COVID-19, flu A, flu B molecular test
By LabPulse.com staff writers
The single-use test fits in the palm of the hand, runs on two AA batteries, and with one shallow nasal swab provides a positive or negative result for COVID-19, flu A, or flu B in less than 30 minutes.
January 3, 2023
Sars Co V 2 Covid 19 Mask Pixabay Social
Page 1 of 14
Next Page