Category: Infectious Diseases

Infectious Diseases

FDA Clears Sekisui Diagnostics Rapid COVID-19 and Flu A&B Combo Test

The CLIA-waived test detects and differentiates SARS-CoV-2, influenza A, and influenza B from a single nasal swab for point-of-care use.

Infectious Diseases

FDA Clears Multiplex PCR Panel for 13 Respiratory Pathogens

The multiplex PCR assay detects 13 viral and bacterial respiratory pathogens from a swab.

Blood Test Differentiates Bacterial and Viral Infections in Febrile Infants
Coffee Mug Powers Portable Test for Seven Mosquito-Borne Viruses
Study Finds 29.5% of Suspected Lyme Disease Patients Co-Positive for Other Tick-Borne Pathogens
FDA Clears Next-Generation Metrix COVID Test Delivering 3-Fold Higher Sensitivity
Multicenter Lab Network Evaluates Four Bundibugyo Virus PCR Assays in Two Weeks
Co-Diagnostics Deploys Vector Smart PCR Labs in Florida and Indiana Amid 73 Local Dengue Cases

Infectious Diseases

Respiratory Testing Enters a Period of Recalibration

As pandemic-era practices give way to more tailored strategies, laboratories are reconsidering how much respiratory testing is appropriate for different patients and clinical situations.

Emerging & Zoonotic Diseases

Alveo Technologies and UTMB Partner to Develop Point-of-Care Lassa Fever Diagnostics

Alveo Technologies and UTMB have partnered to develop point-of-care diagnostics for Lassa fever, deploying molecular sensing platforms at clinical sites in Nigeria and Sierra Leone to support real-time pathogen detection.

Flu & Respiratory Infections

Co-Diagnostics Submits FDA Notification for Upper Respiratory Multiplex Test

Co-Diagnostics has submitted a Dual 510(k) and CLIA waiver application to the FDA for its PCR-based flu and RSV test, aiming to enable point-of-care use on the Co-Dx PCR Pro instrument.

Gastrointestinal Infections

Roche Expands Cyclospora Research Testing Portfolio Amid US Outbreak

Roche has launched two new research PCR assays for Cyclospora cayetanensis detection, expanding lab testing options amid a US outbreak and adding flexibility for gastrointestinal pathogen research.

Sexually Transmitted Diseases

Bacterial Vaginosis Triples STI Risk in Women, Quest Diagnostics Study Finds

A Quest Diagnostics study of 1.5 million women found those with bacterial vaginosis are over three times more likely to have a non-viral STI, highlighting the need for comprehensive diagnostic testing.