Rapid Assays

Saliva Test Could be new Weapon to Fight Tetanus Worldwide

Researchers are developing a rapid, non-invasive saliva test to detect tetanus immunity in children across low-middle income countries.

Rapid Assays

Repeat At-Home COVID Antigen Tests to Curb False Negatives, FDA Says

The FDA is advising people to perform repeat testing following a negative result on home COVID tests to reduce the risk of a false negative.

Rapid Assays

Cepheid Gets Emergency Use Authorization for Rapid COVID Test

Cepheid received FDA EUA for a rapid molecular diagnostic test for qualitative detection of the virus that causes COVID-19.

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.