Rapid and highly sensitive detection of MYD88/CXCR4 mutations in Waldenström macroglobulinemia by MAS-qPCR: A pilot study​​on May 11, 2026 at 2:32 pm

Publication date: August 2026 Source: Clinical Biochemistry, Volume 144 Author(s): Yuki Kunimune, Mitsuaki Nishioka, Haruka Namba, Kimika Todaka, Tomohiro Fujii, Nayu Kiso, Yukiko Nakahara, Kanae Shinkawa, Yumiko Kumano, Masaki Kodama, Tomoya Ebisui, Ryoga Nishimoto, Naoko Okayama, Yutaka Suehiro, Takahiro Yamasaki, Toshiaki Yujiri

Analytical agreement and platform-specific decision thresholds for plasma p-tau217 measured on Lumipulse G600II and Cobas e801 in a paired CSF-plasma cohortMaría Martínez-Bujidoson May 5, 2026 at 10:00 am

Clin Chem Lab Med. 2026 May 5. doi: 10.1515/cclm-2026-0395. Online ahead of print. ABSTRACT OBJECTIVES: Plasma phosphorylated tau at threonine 217 (p-tau217) has emerged as a highly accurate blood-based biomarker of Alzheimer’s disease (AD) pathology. As disease-modifying anti-amyloid therapies enter clinical practice, scalable biomarkers with robust and clinically interpretable decision thresholds are required. However, evidence … Read more

Pseudovirus reference material and RT-digital PCR reference method for the quantification of human rhinovirus RNA with metrological traceabilityHuijie Lion May 6, 2026 at 10:00 am

Clin Chem Lab Med. 2026 May 7. doi: 10.1515/cclm-2025-1137. Online ahead of print. ABSTRACT OBJECTIVES: This study developed a pseudoviral human rhinovirus (HRV) reference material using pseudovirus technology and integrating RT-dPCR with HPLC-IDMS to achieve accurate HRV RNA quantification, aiming to standardize HRV detection across labs and platforms. METHODS: We developed an RT-digital PCR (RT-dPCR) … Read more

EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5Christa Cobbaerton May 6, 2026 at 10:00 am

Clin Chem Lab Med. 2026 May 7. doi: 10.1515/cclm-2026-0580. Online ahead of print. ABSTRACT Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was introduced to enhance patient safety and ensure the availability of safe and effective diagnostics across the European Union. However, its implementation has led to substantial unintended consequences, including certification bottlenecks, … Read more

From research to reality: real-world effectiveness of point-of-care testing in the emergency departmentSalomón Martin-Pérezon May 5, 2026 at 10:00 am

Clin Chem Lab Med. 2026 May 6. doi: 10.1515/cclm-2026-0289. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the real-world impact of Point-of-Care Testing on care timeliness and patient flow in the emergency department. METHODS: A before-and-after, matched-cohort study was conducted involving 25,291 patients with Emergency Severity Index levels 3-4. A POCT group (n=8,746) was compared … Read more

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