ADVERTISEMENT
  • News
  • Technology
  • Culture
  • Entertainment
  • Sport
  • Travel
  • Music
  • More
    • Politics
    • Lifestyle
    • TV
    • Games
Wednesday, May 31, 2023
  • Login
No Result
View All Result
NEWSLETTER
FINCHANNEL
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • America
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • CityLife
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • America
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • CityLife
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE
No Result
View All Result
FINCHANNEL
No Result
View All Result
Home Coronavirus

Abbott releases interim clinical study results on COVID-19 PCR tests

by The FINANCIAL
October 9, 2020
in Coronavirus
0
Abbott releases interim clinical study results on COVID-19 PCR tests
Share on FacebookShare on Twitter

The FINANCIAL — In a continuing effort to provide the facts about ID NOW to support public health interests, Abbott (NYSE: ABT) is sharing new interim clinical data results on its ID NOW COVID-19 rapid test. The results confirm the data submitted to the U.S. Food and Drug Administration (FDA) in March for Emergency Use Authorization (EUA) and the interim results that Abbott shared in its May 21 press release. The data also speak to the important role played by reliable point-of-care testing that is available in convenient and accessible locations where people can get immediate results.

ADVERTISEMENT

“We recognize there is a lot of discussion about testing and ID NOW, and we want to make sure the public has the facts and real-world data,” said Robert B. Ford, president and chief executive officer, Abbott. “The facts we’re seeing from one of the largest clinical studies of any COVID-19 test, conducted at some of the nation’s leading academic centers, show that ID NOW delivers effective, consistent and reliable performance.”

“In the beginning of the pandemic, the scientific community had to rely on samples and modeling to predict test performance,” said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott’s diagnostics business. “But now we have a significant body of real-world, clinical data that support the critical role ID NOW is playing in identifying infection rapidly in places where people show up for care.”

RelatedPosts

How many people have had COVID-19? The challenge of reinfections

Boulder Man Sentenced to Prison for Covid Fraud

5 things to know about COVID-19 vaccines and boosters

Racism is ‘fundamental cause’ of COVID-19 vaccine hesitancy among ethnic minorities

“Tests are taken at a moment in time and they detect the virus once there’s enough viral material in a person to be able to detect it,” continued Dr. Hackett. “While there’s no perfect test, to fight a pandemic, we need a combination of gold standard lab-based PCR and accurate, reliable rapid tests like ID NOW to help reduce risk in society and slow the spread of the virus.”

Post-Authorization Study Data
Abbott has completed an interim analysis of its ID NOW post-authorization study. A total of 1,003 people were evaluated across two care environments: urgent care clinics (acute care) and hospitals and nursing homes (in-patient care). In these two care environments, the ID NOW delivered the following agreement to lab-based molecular PCR tests:

  • Overall performance of 93.3% positive agreement (sensitivity) and 98.4% negative agreement (specificity). Further, in the 161 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.0% positive agreement (sensitivity).
  • Performance of 95.0% positive agreement (sensitivity) and 97.9% negative agreement (specificity) in subjects within seven days post symptom onset. Further, in the 129 patients with high viral titers (Ct <33), and therefore most likely to transmit virus,
    ID NOW showed performance of 98.4% positive agreement (sensitivity).
  • Performance of 94.6% positive agreement (sensitivity) and 97.6% negative agreement (specificity) in symptomatic subjects. Further, in the 136 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.8% positive agreement (sensitivity).

Updates to May 21 Interim Data (Previous Studies)
In addition to the post-authorization data, Abbott is providing an update to three studies that were covered in its May 21 interim study press release:

  • Multi-Site Urgent Care. In a completed analysis from a multi-site urgent care clinical setting of 430 symptomatic patients with two or more symptoms, including 53 PCR positive subjects, ID NOW demonstrated performance of 96.2% in positive agreement (sensitivity) and 99.5% negative agreement (specificity) compared to lab-based molecular PCR tests.
  • Everett Clinic. In a completed study at The Everett Clinic in Washington of 974 people, including 23 PCR positive subjects, in partnership with Yuan-Po Tu, M.D., ID NOW demonstrated 91.3% positive agreement (sensitivity) and 100% negative agreement (specificity) compared to lab-based molecular PCR tests.
  • In-patient. In an in-patient care study (hospitals and nursing homes), a total of 518 symptomatic patients were evaluated, including 94 PCR positive subjects. ID NOW demonstrated 79.8% positive agreement (sensitivity) and 94.3% negative agreement (specificity) compared to lab-based molecular PCR tests.
    • In the 494 subjects who reported days from symptom onset, the median number of days from symptom onset was 10 days with 71.1% of people presenting >7 days post symptom onset. In 45 patients with high viral titers (Ct <33), and therefore more likely to transmit virus, ID NOW showed performance of 100% positive agreement (sensitivity).
    • In a further analysis of this data, the subset of 143 symptomatic patients within seven days of symptom onset were evaluated, of which 30 were PCR positive. ID NOW demonstrated 86.7% positive agreement (sensitivity) and 96.5% negative agreement (specificity) compared to lab-based molecular PCR testing.

Cycle times (Ct) are the number of times a PCR instrument must cycle through to amplify enough genetic material to be detected. So, the greater amount of virus present (viral load), the fewer cycles required to detect the virus. A person is more likely to be contagious the higher their viral load (and the lower their Ct count). The Centers for Disease Control and Prevention (CDC) shares available data on its website indicating that at a Ct of 33 and above, replication competent virus has not been reliably recovered and infectiousness is unlikely.

These findings are also consistent with a study published in the Annals of Internal Medicine, where researchers from Johns Hopkins found that even the most sensitive lab-based molecular tests can have false negatives when viral load levels are ramping down, near the end of the infection cycle, when viral load decreases and patients may no longer be infectious.

Abbott’s Research Continues
Abbott has continued to study ID NOW in a variety of settings in people who are at different stages of infection with more than 1,000 people, making it the most studied rapid COVID-19 test on the market today. Abbott has shared this data with the FDA throughout the research process and will continue doing so.

Tags: AbbottAbbott. fda. coronavirusCoronaviruscoronavirus pcr testcoronavirus pcr testscoronavirus testcoronavirus testscovid-19covid19FDApcrpcr testpcr testsStudytests
ADVERTISEMENT
The FINANCIAL

The FINANCIAL

Related Posts

FDA said it did not authorize any test for COVID-19 to use at home
Coronavirus

How many people have had COVID-19? The challenge of reinfections

by The FINANCIAL
February 15, 2023
0

Since the appearance of Omicron variants in December 2021, the number of people being reinfected with COVID-19 has increased markedly....

Read more
COVID-19: Staying cyber secure

Boulder Man Sentenced to Prison for Covid Fraud

February 8, 2023
5 Things to Know About the COVID-19 Vaccines

5 things to know about COVID-19 vaccines and boosters

December 24, 2022
COVID-19 was third leading cause of death in the United States in both 2020 and 2021

Racism is ‘fundamental cause’ of COVID-19 vaccine hesitancy among ethnic minorities

December 21, 2022
Next Post
Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization

EU gives green light to Johnson & Johnson to supply 200M doses of COVID-19 vaccine candidate

Please login to join discussion
ADVERTISEMENT
  • Trending
  • Comments
  • Latest
Find Social Security Number by Name Free

Find Social Security Number by Name Free

November 23, 2022
Most Northwest Drivers Aren’t Worried about Car Prowls

The Illinois-based insurer remains the largest US private auto writer

May 8, 2023
Humana shares on the up as earnings show Medicare growth

Humana shares on the up as earnings show Medicare growth

May 8, 2023
How to Check KRA Pin Using ID Number

How to Check KRA Pin Using ID Number

June 25, 2018
EasyJet to fly to London from Stockholm Arlanda

The London Diplomatic List, Addresses, Contacts & Working Hours

January 23, 2023
How to optimize business costs with Intranet implementation?

Protected: 5 Key Advantages of Contact Center Solutions Every Business Must Know

May 30, 2023
New direction in the construction and development market of Georgia – “Prestige” series from “Maqro Construction”

New direction in the construction and development market of Georgia – “Prestige” series from “Maqro Construction”

May 26, 2023
Long-term international migration, provisional: year ending December 2022

Long-term international migration, provisional: year ending December 2022

May 26, 2023
putin_copy_copy.jpg

Blow for Putin as UK marks one year free from Russian gas

May 25, 2023
About a third of Americans would tell a high schooler seeking career advice to enter a STEM-related field

Recruitment firms are not effective if you want to make a big career change

May 25, 2023

Popular Last 24h

  • Find Social Security Number by Name Free

    Find Social Security Number by Name Free

    0 shares
    Share 0 Tweet 0
  • The London Diplomatic List, Addresses, Contacts & Working Hours

    0 shares
    Share 0 Tweet 0
  • A new study has named Montana the best state in America to start a business

    0 shares
    Share 0 Tweet 0
  • The Illinois-based insurer remains the largest US private auto writer

    0 shares
    Share 0 Tweet 0
  • Swedish banks’ commercial property problem loans lowest in Europe – EBA

    0 shares
    Share 0 Tweet 0
  • New culinary collaboration, “Tekuna in Bazzar”

    0 shares
    Share 0 Tweet 0
  • Humana shares on the up as earnings show Medicare growth

    0 shares
    Share 0 Tweet 0

LATEST POSTS

How to optimize business costs with Intranet implementation?

Protected: 5 Key Advantages of Contact Center Solutions Every Business Must Know

May 30, 2023
New direction in the construction and development market of Georgia – “Prestige” series from “Maqro Construction”

New direction in the construction and development market of Georgia – “Prestige” series from “Maqro Construction”

May 26, 2023
Long-term international migration, provisional: year ending December 2022

Long-term international migration, provisional: year ending December 2022

May 26, 2023
putin_copy_copy.jpg

Blow for Putin as UK marks one year free from Russian gas

May 25, 2023
About a third of Americans would tell a high schooler seeking career advice to enter a STEM-related field

Recruitment firms are not effective if you want to make a big career change

May 25, 2023
Home values in U.S. decline for second month as competition eases

Understanding The True Cost of Buying a Home Warranty

May 25, 2023
Formal Credit Channels Remain a Double-Edged Sword for Consumers

Formal Credit Channels Remain a Double-Edged Sword for Consumers

May 25, 2023
Hassan Jameel

Protected: Abdul Latif Jameel Energy’s FRV Expands Operations in Europe

May 23, 2023
First wiring map of neurons in insect brain complete

Brain signatures for chronic pain identified in a small group of individuals

May 22, 2023
New York Allows Sale Of Alcoholic Beverages During Coronavirus Shutdown As Market Shrinks To $528 Billion

Scrapping retained EU red tape on wine to unlock £180 million

May 21, 2023

LATEST INTERVIEWS

“EU membership might attract European banks and other financial institutions to enter Georgia” – NBG Vice Governor Papuna Lezhava

“EU membership might attract European banks and other financial institutions to enter Georgia” – NBG Vice Governor Papuna Lezhava

by The FINANCIAL
May 15, 2023
0

“As a member of the ProCredit Group, we provide significant advantages to SME’s, by partnering with EU organizations” – Giorgi Kardenakhlishvili, Head of Medium Business Development, ProCredit Bank Georgia

“As a member of the ProCredit Group, we provide significant advantages to SME’s, by partnering with EU organizations” – Giorgi Kardenakhlishvili, Head of Medium Business Development, ProCredit Bank Georgia

by The FINANCIAL
May 15, 2023
0

‘Russia cannot be treated as a reasonable and reliable trade partner

‘Russia cannot be treated as a reasonable and reliable trade partner

by The FINANCIAL
February 13, 2023
0

We should increase our joint efforts to assist the growing tech sector here in Georgia

We should increase our joint efforts to assist the growing tech sector here in Georgia

by The FINANCIAL
February 13, 2023
0

‘Georgia has much to offer to UK investors

‘Georgia has much to offer to UK investors

by The FINANCIAL
February 13, 2023
0

‘The best way for the Georgian economy to prosper is to join the EU

‘The best way for the Georgian economy to prosper is to join the EU

by The FINANCIAL
February 13, 2023
0

‘The Kremlin wants Georgia to fail or abandon its European path

‘The Kremlin wants Georgia to fail or abandon its European path

by The FINANCIAL
February 13, 2023
0

Russian Patriarch Kirill Says Dying In Ukraine ‘Washes Away All Sins’

Interview: Why Putin Might Prefer A Stalemate To Going Nuclear On Ukraine

by The FINANCIAL
October 22, 2022
0

Newsletter

ADVERTISEMENT

GET IN TOUCH

E-mail your company news at:

news (at) financial.ge Letters to the Editor: editor (at) finchannel.com

Local Marketing contact:

(+99532) 2252 275 | 76 EXT: 1 (+995 558) 03 03 03 (mobile) marketing (at) finchannel.com

Requests from abroad:

(+99532) 2252 275 | 76 EXT: 7 (+995599) 96 52 52 Email: zviadi (@) finchannel.com Contact video editor: E-mail: video (at) financial.ge

Postal address: 17 Mtskheta str. Tbilisi, Georgia 0179 The FINANCIAL

RESOURCE

  • Work at the FINANCIAL
  • ePaper
  • Advertise in The FINANCIAL
  • Access ePaper
  • Guest posts
  • Contributed articles
  • AmericanStockNews
  • Coupon Codes
  • GLOSSY MAG
American Culture Center
ACC Partner

GUIDEBOOK

  • Meet our team
  • Invest in Georgia
  • Become contributor
  • Archive

FOLLOW US

  • Facebook
  • Twitter
  • Google+
  • Youtube
No Result
View All Result
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • America
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • CityLife
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE

© 2023 JNews - Premium WordPress news & magazine theme by Jegtheme.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
This website uses cookies. By continuing to use this website you are giving consent to cookies being used. Visit our Privacy and Cookie Policy.