Validation: Page 5

Delfi begins lung cancer study
By LabPulse.com staff writers
The prospective study will compare the performance of Delfi's test in diagnosing lung cancer in a group of 1,700 patients already known to have cancer with a demographically matched cohort of presumably healthy patients, according to the company.
March 31, 2021
2021 01 12 23 44 3780 Blood Test Samples Lab 400
FDA approves marketing of BioFire COVID-19 test
By LabPulse.com staff writers
The diagnostic test had emergency use authorization and received approval for marketing through the FDA's "de novo" pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The de novo request was based on additional data showing validation beyond what is needed for emergency use authorization.
March 17, 2021
2020 07 16 23 29 1615 Laboratory Scientist Biosafety 400
New AI-powered imaging tool estimates hemoglobin levels
By Joseph Constance
The microfluidic chip in combination with the AI-powered automated microscope has a turnaround time of 10 minutes, including incubation time. This biochemical assay, which can derive the total as well as differential counts of blood cells, achieved a sensitivity of 92.3% and a specificity of 53.8%, wrote lead author Lokanathan Arcot of SigTuple Technologies of Karnataka, India, and colleagues.
March 1, 2021
2021 03 01 17 59 6405 Lab On Chip Microfluidics 400
COVID-19 testing boosts molecular point-of-care market
By Bruce Carlson
Molecular POC diagnostic solutions offer improvements in the sensitivity and specificity of existing near-patient and rapid tests while expanding the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world, and are used to assess conditions or admit patients. The concept of mPOC is to combine the accessibility of POC testing with the accuracy of molecular technology. Disclosure: LabPulse.com is a sister company of Kalorama Information.
January 26, 2021
2020 07 22 17 40 2836 Financials Growth Revenue Business 400
Freenome touts ASCO study of blood test for colorectal adenomas
By LabPulse.com staff writers
The company said that results from the artificial intelligence (AI)-Emerge study will show that the company's multiomics blood test can detect colorectal advanced adenomas with 41% sensitivity and 90% specificity. Freenome said these figures are comparable to existing noninvasive tests for colorectal cancer screening.
January 11, 2021
2019 01 03 22 54 0132 Lab Blood Test1 400
Euroimmun debuts new ELISA SARS-COV-2 antigen test
By LabPulse.com staff writers
The laboratory test, which has received the CE Mark, can be applied in semiquantitative automatable detection of the SARS-CoV-2 nucleocapsid protein on a large scale. It is validated from swab samples taken from the upper respiratory tract, and it has a 93.6% sensitivity and 100% specificity, according to the vendor.
December 15, 2020
2020 04 30 22 13 6857 Coronavirus Swab Ppe 400
Eurofins debuts 2 products to test for COVID-19
By LabPulse.com staff writers
The GSD NovaGen SARS-CoV-2 antigen rapid test delivers results within 15 minutes, according to Eurofins. It works with nasopharyngeal swabs and achieved diagnostic sensitivity of 93% and diagnostic specificity of 93%, the company reported.
December 13, 2020
2020 03 18 20 13 7386 Virus Coronavirus Covid 19 400
Researchers develop new COVID-19 diagnosis technology
By LabPulse.com staff writers
The new nano polymerase chain reaction technology -- or what the researchers are calling "nanoPCR" -- can diagnose SARS-CoV-2 infection within 20 minutes with the accuracy of reverse transcription (RT)-PCR testing, according to a team led by Cheon Jinwoo, PhD, of the Center for Nanomedicine at the Institute for Basic Science in Seoul.
December 9, 2020
2020 12 10 23 09 4097 Sars Co V 2 Envelope 400
Another study finds coronavirus antibody tests lacking
By LabPulse.com staff writers
Led by researchers at the University of Tartu, the study compared sensitivity and specificity for immunoglobulin G (IgG) and total antibodies of seven commercial tests and two assays that had been developed in-house using serum samples from 97 patients with confirmed COVID-19 on polymerase chain reaction (PCR) and 100 healthy controls. Commercial products evaluated in the study included tests developed by Roche, Abbott, and DiaSorin.
December 2, 2020
2019 08 14 21 38 1605 Graph Arrow Down 400
Beckman Coulter nabs EUA for COVID-19 IgM assay
By LabPulse.com staff writers
The Access SARS-CoV-2 IgM assay has 99.9% specificity and 98.3% sensitivity, according to Beckman Coulter.
October 8, 2020
2019 08 20 21 56 4830 Beckman Coulter Aacc 2019 400
Study finds SARS-CoV-2 antibody kits have varying accuracy
By LabPulse.com staff writers
Researchers from Guy's and St. Thomas' National Health Service (NHS) Foundation Trust and King's College London developed their own sensitive and specific SARS-CoV-2 antibody test. They then used it to perform head-to-head comparisons of 10 commercial antibody test kits on an identical panel of 110 SARS-CoV-2-positive blood samples from patients admitted to hospitals with COVID-19, as well as 50 prepandemic negatives.
September 24, 2020
2020 06 17 20 35 0417 Covid 19 Antibody 400
FDA publishes performance data for COVID-19 tests
By LabPulse.com staff writers
The lower the limit of detection, the smaller amount of viral material in a sample, which is an indication of a more sensitive test. However, the data do not show a specific test's sensitivity, so it cannot be used alone to determine whether a test should be authorized. Instead, it gives labs and healthcare providers a resource to compare the relative performance of available tests, according to the FDA.
September 15, 2020
2020 05 15 21 10 5109 Fda Sign Dc 400
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