PRODUCT FOCUS :: :NEW PRODUCTS
Best of AACC M
any vendors showcased new products during the Ameri- can Association for Clinical Chemistry’s (AACC) Annual Scientific Meeting & Clinical Lab Expo, which was held
in Atlanta September
26-30.The staff members at Medical Labora- tory Observer describe some of those products below.
Beckman Coulter launched its urinalysis analyzer Beckman Coulter launched a urinalysis analyzer at the 2021 AACC Annual Scientific Meeting & Clinical Lab Expo. The DxU Iris Workcell is a fully automated system that streamlines urinalysis workflow and reduces manual reviews to 4%, the company said.
A routine urinalysis is one the most frequently ordered tests, representing up to 30% of all samples received in the lab, the company said. Given the volume, “the most important thing is to minimize disruptions in the workflow,” explained Matthew Rhyner, PhD, MBA, Vice President and General Manager of Urinalysis Beckman Coulter. However, that is typically not the case in urinalysis because lab techni- cians often perform manual inspections of samples, which
at
causes the process to take up to six times longer than would be the case with an automated system. To solve that problem, the DxU Iris Workcell allows urinalysis
operators to automatically classify sediment particles, minimiz- ing the need for manual inspections. The DxU Iris Workcell pairs the DxU 850m Iris or DxU 840m Iris urine microscopy analyzer with the Arkray AUTION MAX 4030 urine chemistry analyzer to create a scalable, fully automated urinalysis solution. The workcell was developed with proprietary Digital Flow Morphology technology with Auto-Particle Recognition (APR) Software, which enables laboratories to deliver standardized results using artificial intelligence (AI). The analyzer integrates with Beckman Coulter’s infor- matics software solutions: PROService remote service tool, DxONE Command Central remote monitoring, and REMISOL Advance middleware. “We have taken what people like about the iQ (Series Urinaly- sis Workcell) and added a lot of enhancements,” Rhyner said.
Seegene launched an automated MDx system Seegene demonstrated a fully automated PCR testing (MDx) system at the 2021 AACC Annual Scientific Meeting & Clinical Lab Expo.
STARlet-AIOS, an automated MDx system, provides high- throughput real-time PCR workflows, starting from nucleic acid extraction, followed by real-time PCR, and finally result interpretation. AIOS is a fully automated syndromic MDx system. AIOS is composed of independent and detachable modules together with the company’s proprietary SW architecture. AIOS is designed with an extraction/liquid handler and PCR instrument integrated with an in-house developed robotic arm module. Hos- pitals and laboratories can either pur-
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chase the full package of the ‘AIOS’ system or integrate their existing instruments on-site if they already have Seegene’s liquid handler and real-time PCR instrument. The system can run a variety of Seegene’s syndromic assays that are currently available in the market, allowing for symptom- based testing.
FDA clears test to distinguish between bacterial and viral infections MeMed, based in Haifa, Israel, said the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of an assay and testing platform to help healthcare providers distinguish between bacterial and viral infections. The company showcased the product during the conference. The technology, which has been cleared for both children and adults, is called MeMed MV. It runs on the MeMed Key platform, which the company describes as a “point of need,” or point of care, device.
Bacterial and viral infections are often clinically indistinguish- able, leading to the prescription of antibiotics for the treatment of viral infections, for which they are ineffective. Antibiotic misuse drives the emergence of antimicrobial resistance (AMR). MeMed’s technology decodes the body’s immune response to infection, the ‘host re- sponse,’ rather than focusing on detecting the presence of a microbe. The company says that this allows for diagnosis even when the infection site is inaccessible or unknown, when the pathogen is unde- tectable using conventional tests, or when the causes of infection are emerging new pathogens. MeMed BV measures and
computationally integrates the levels of three immune system proteins: TRAIL, IP-10 and CRP. When run on the MeMed Key platform, MeMed BV provides a result within 15 minutes. FDA clearance was based on a multi-center blinded clinical
validation study enrolling over 1,000 children and adults and addresses goals laid out in the U.S. National Action Plan for Combating Antibiotic Resistant Bacteria. The test provides highly accurate results with Area Under the Curve of 90% and 97% (primary and secondary endpoints). MeMed has established its U.S. base in Boston and is ramping up commercial activities.
EFK launched, demonstrated products at AACC EKF Diagnostics recently launched a STAT-Site WB dual analyte measurement system, which it demonstrated at AACC. The new handheld analyzer measures B-ketone and glucose from whole blood in seconds. EKF also introduced its newest hemoglobin analyzer for the U.S. market, the Hemo Control, which provides near patient hemoglobin and hematocrit results in one test as quickly as 25 seconds. At AACC, the company also highlighted the Lucica Glycated Albumin-L, manufactured by Asahi Kasei Pharma. It is a spe- cific test for glycated albumin (“GA”) and is cleared for sale in the U.S., where it is sold exclusively by EKF Diagnostics. The established test enables intermediate term glycemic monitoring of diabetics over the preceding 2-3 weeks. Glycated Albumin (GA) levels are not affected by the life span of red blood cells (“RBC”), and therefore it is a useful substitute
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