POC Reagents & Test Kits

Oxford Immunotec’s T-Cell Reagent Kit FDA Approved to Automate TB Detection Solution

PerkinElmer’s Oxford Immunotec says the FDA has approved the use of its T-Cell Select reagent kit for the automation of its TB test workflow.

POC Reagents & Test Kits

A Lack of COVID Testing May Increase Risky Behavior, Survey Shows

A new study found that when COVID-19 testing wasn't readily available, participants showed significantly greater intentions to engage in risky behavior.

POC Reagents & Test Kits

Co-Diagnostics Acquires At-Home, Point-of-Care COVID Platform

The company expects that the acquisition will streamline the commercialization of the Eikon platform and YourTest PCR device as it nears completion.

LA’s Unvaccinated City Workers Are Still Untested

Nov 17, 2021 | Covid 19, POC Reagents & Test Kits

A month after its October deadline, Los Angeles’ unvaccinated city workers are still not being tested for COVID-19.

Ellume Recalls COVID-19 Home Test for Potential False-Positive Results

Nov 16, 2021 | Covid 19, POC Reagents & Test Kits

Ellume has recalled its COVID-19 Home Test for potential false-positive results. The FDA has listed this recall as Class 1, it’s most serious category.

FDA Updates COVID At-Home Test Policies to Help to Ensure Accuracy and Reliability

Nov 15, 2021 | Covid 19, POC Reagents & Test Kits

The FDA has issued guidelines aimed at increasing access to accurate and reliable COVID-19 tests, particularly those that can be performed at home.

Building a Better Dipstick Test

Oct 25, 2021 | POC Reagents & Test Kits

A research team from Georgia Tech has developed flow control technology to turn simple lateral flow assays into complex biomedical assays.

September 2021 Tech Guide: Point-of-Care Assays and Analyzers

Sep 20, 2021 | POC Instruments, POC Rapid Assays, POC Reagents & Test Kits

The Tech Guide from the September 2021 issue of Clinical Lab Products includes point-of-care assays and analyzers from 17 suppliers.

Visby Medical Receives FDA Clearance for Sexual Health Test

Aug 30, 2021 | POC Reagents & Test Kits, Rapid Assays, Sexually Transmitted Diseases

Visby Medical has received a 510(k) clearance to market its fast, single-use PCR diagnostic test for the detection of STIs.

Advances Are Needed for Newborn Sepsis Screening

Aug 10, 2021 | POC Instruments, POC Reagents & Test Kits, Sepsis

In screening for sepsis in newborns, there is a need to develop sensitive, and integrated diagnostic strategies to enhance detection.

FDA Authorizes First Molecular Nonprescription, At-Home Test

Mar 5, 2021 | Covid 19, POC Reagents & Test Kits

The product is a molecular nucleic acid amplification test that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils.

First Clinical T-Cell-Based Test to Confirm Recent or Prior Covid-19 Infection

Feb 25, 2021 | Covid 19, POC Reagents & Test Kits

Patients can order Adaptive Biotechnologies’ T-Detect Covid online, have blood drawn at LabCorp locations or via mobile phlebotomists at their homes, and receive results via an online portal.

DxTerity Offers Covid-19 Tests for Sale on Amazon

Jan 8, 2021 | Covid 19, POC Reagents & Test Kits

The self-administered, noninvasive saliva kits are FDA authorized for use by both individuals with and without symptoms of covid-19.

First EUA for a Covid-19, Flu Combo Test for Use with Home-Collected Samples

Dec 6, 2020 | Covid 19, POC Reagents & Test Kits

Quest Diagnostics RC Covid-19 +Flu RT-PCR Test with the Quest Diagnostics Self-Collection Kit for Covid-19 +Flu is for prescription use by individuals who are suspected of respiratory viral infection consistent with covid-19.

Nova Biomedical Adds PT/INR Test to Allegro Analyzer

Apr 14, 2020 | Coagulation Testing, Hematology & Serology, Hematology Instrumentation, POC Instruments, POC Rapid Assays, POC Reagents & Test Kits, Point-of-Care

The Allegro and its StatStrip-A companion meter now provide 18 tests to help physicians make therapeutic decisions and adjustments at the point of care.

EKF Launches CLIA-Waived β-Ketone and Glucose Analyzer

Apr 2, 2020 | POC Instruments, POC Rapid Assays, POC Reagents & Test Kits, Point-of-Care

The FDA CLIA-waived handheld analyzer reliably and efficiently delivers results within just 5 to 10 seconds, and it can be used in point-of-care (POC) and certificate of waiver settings, such as physicians’ offices, clinics, and other nontraditional laboratory locations.