Rapid Assays

Rapid Immunoassays Rise in Emergency Diagnostics Use

Rapid immunoassays have emerged as a valuable tool for providing quick information that can be crucial in life-threatening situations.

Rapid Assays

Antigen Testing for COVID Can Be Useful for Healthcare Return-to-Work Guidance

A new study demonstrated how rapid antigen test can be used to triage healthcare workers for returning to work during staffing shortages.

Rapid Assays

New COVID Rapid-Test Tech Performs PCR Faster than Similar Tests

Researchers built an RT-PCR platform that gives results in 23 minutes that match the longer laboratory-based tests.

Pathogenomix Bacteria Diagnosis Assay Granted FDA Breakthrough Device Designation

Jan 24, 2022 | Anatomic Pathology, Rapid Assays

The FDA has granted Pathogenomix with a Breakthrough Device Designation for its Patho-Seq assay due to its methodologies of pathogenic bacteria diagnosis.

GS Lab Sees 65% Surge in COVID Tests Since Thanksgiving

Jan 17, 2022 | Covid 19, Rapid Assays

GS Labs rapid antigen tests also had a 26% positivity rate, up from 22% the previous week and was only 8% during Thanksgiving week.

Low Incident of False Positive Test Results from Rapid Antigen Tests, Study Finds

Jan 17, 2022 | Covid 19, Rapid Assays

A study that screened asymptomatic workers for SARS-CoV-2 via rapid tests showed the rate of false-positive results among the total screens was very low.

Meridian Bioscience’s Campylobacter Assay Receives FDA Clearance

Jan 6, 2022 | Gastrointestinal Infections, Rapid Assays

Meridian Bioscience says its Curian Campy assay—an immunoassay for the detection of a Campylobacter-specific antigen—received FDA clearance.

Portable Prostate Cancer Test Aims to Reach Underserved Men

Jan 6, 2022 | Prostate, Rapid Assays

A portable and rapid prostate cancer screening kit could provide early warning to populations with higher incidence of prostate cancer.

COVID-19 Vaccination May Trigger False Reactivity in Certain RPR Test

Dec 21, 2021 | Covid 19, Rapid Assays, Sexually Transmitted Diseases

The FDA alerted that false reactivity Rapid Plasma Reagin test results in a Bio-Rad RPR kit can occur for some who received a COVID-19 vaccine.

LumiraDx Offers At-Home, Self-Collection Kit for COVID Test Solution

Dec 16, 2021 | Covid 19, Rapid Assays

LumiraDx’s SARS-CoV-2 assay will now offer a self-collected COVID-19 nasal specimen collection kit through a new partnership with Audere.

COVID-19 Rapid Antigen Tests More Effective Than Expected

Dec 8, 2021 | Covid 19, Immunoassay Reagents & test Kits, Rapid Assays

A new study found COVID-19 rapid antigen detection tests proved more effective than expected when compared to the polymerase chain reaction (PCR) assay.

FDA Reissues High Throughput COVID-19 Testing Solution for Emergency Use

Dec 3, 2021 | Covid 19, Rapid Assays

The LumiraDx SARS-CoV-2 RNA STAR Complete has been authorized by FDA for emergency use under an EUA for use by authorized laboratories.

Anitoa Receives FDA 510(k) Clearance for Portable qPCR Instruments

Oct 27, 2021 | Covid 19, Rapid Assays

The Maverick line of qPCR instruments from Anitoa Systems has received U.S. FDA registration and device listing as class II 510(k) exempt medical devices.

Emphasis on Halting COVID Should Be On The Testing Type

Sep 22, 2021 | Covid 19, Rapid Assays

While welcoming a renewed emphasis on testing, some healthcare leaders warn that America’s path forward requires balancing testing speed with accuracy.