Afinion 2

"Community pharmacy-based screening proved effective, identifying numerous previously undiagnosed individuals with increased cardiovascular risk, which is especially remarkable within a comprehensive healthcare system. However, follow-up rates remained low, indicating a gap between risk detection and medical action. A stronger integration of screening interventions with primary care and follow-up pathways with medical institutions may enhance the effectiveness."

"The community-based program detected high proportion of Chinese adults at high-risk for undiagnosed DM and pre-DM. Utilizing strategies developed by NICE, or other international strategies, can enhance net benefits and potentially improve cost-effectiveness when compared to the current HKPCO guideline."

"It was found that drinking a cup of rhubarb root herbal or green tea infusion for 21 days produced beneficial effects on lipid profiles and maintained gut eubiosis without observable adverse effects in a healthy human cohort. More studies are needed to fully understand the effects of rhubarb root and green tea in fatty acid metabolism and gut microbial composition."

"Our findings indicate that utilizing continuous glucose monitoring technology can enhance glycemic control, particularly in motivated, educated, low-income patients dependent on the SUS. To achieve positive results with FreeStyle Libre, it is imperative to allocate resources for multidisciplinary support."

"The present study has offered a practical contribution to existing knowledge of PNS ISO 15189:2013 accreditation compliance management by providing the medical laboratory with a practicable tool to determine the conformity status of Afinion 2 Analyzer maintainability in accordance with PNS ISO 15189:2013 conformance requirements, manufacturer and specific requirements for accreditation."

"POC HbA1c analysers can be successfully established in community pharmacies. The target patient group responded positively to the opportunity to use a pharmacy service.".

"Pre-analytical error for three point of care venous blood testing platforms in acute ambulatory settings: A mixed methods service evaluation."

The Hb Tacoma variant (1 in 1,000 patients) significantly interferes with certain HbA1c monitoring methods, most notably causing a 40% underestimation on the Bio-Rad Variant II due to co-elution. While other chromatographic and electrophoretic methods show either positive bias or poor precision, immunoassays, affinity chromatography, and enzymatic methods remain unaffected. To ensure diagnostic accuracy in these patients, laboratories must identify abnormal chromatograms and switch to these robust alternative platforms.

"This study shows the importance of independent evaluations for assessing the performance of Hb A1c POC devices [A1CNow+, A1C EZ 2.0, A1Care, Afinion 2, Cobas b101, GPP-100, LumiraDx (7 min & 5 min), PixoTest, Quo-Lab, Quo-Test, Hb A1c 501, Spinit, Greencare A1c, Atellica DCA, On Call MultiPro, Lyofia, CareBuddy Multi Analyzer and TD-4611]. The analytical performance of the devices was very poor overall, with 74% not meeting both IFCC and NGSP criteria. These evaluations were performed under ideal conditions; performance may worsen further when used in a clinical setting."

While most tested HbA1c methods [Afinion 2, HbA1c 501 (both utilizing boronate affinity), QuikRead go, cobas b 101, DCA Atellica] show minimal bias, the Standard F immunoassay exhibits a clinically significant interference with Hb Tacoma, resulting in a 38% mean relative bias (17 mmol/mol). This discrepancy likely stems from conformational changes in the variant affecting the assay's two-antibody design. Given the regional prevalence of Hb Tacoma, these findings highlight the necessity of selecting variant-robust methods to ensure accurate glycemic monitoring and patient safety.

"The analytical performance and user-friendliness of POCT-CRP devices [QuikRead go easy, LumiraDx, cobas b 101 and Afinion 2] varies among manufacturers, emphasizing the need for quality assurance supervised by a central laboratory."

This study confirms that semi-quantitative CRP rapid diagnostic tests (RDTs) are reliable, laboratory-independent tools for guiding antibiotic treatment in resource-limited settings like Uganda. While BTNX offered higher sensitivity and Actim showed superior specificity, all three evaluated RDTs demonstrated substantial agreement with the reference standard. Implementing these point-of-care tests can effectively reduce unnecessary antibiotic use and strengthen antimicrobial stewardship where infrastructure is minimal.

This study confirms that the evaluated PoCT analysers are generally fit for purpose, particularly for CRP and serial HbA1c monitoring. While all devices showed some bias at extreme HbA1c levels, they maintained acceptable precision for clinical use. For lipid studies, the Roche cobas b 101 demonstrated superior accuracy and precision compared to the Abbott Afinion 2, though the latter’s positive bias had limited impact on calculated clinical parameters. Overall, these devices offer a reliable, high-speed alternative to central laboratory testing for routine monitoring.

While Point-of-Care (POC) devices like the Axis-Shield Afinion improve glycemic control by enabling immediate clinical decisions, they are currently better suited for monitoring than for diagnosis. The Afinion shows performance comparable to laboratory methods and the Siemens DCA, yet concerns remain regarding lot-to-lot variability and the lack of widespread proficiency testing. To ensure patient safety, clinicians must account for potential analytical interferences and the technical limitations inherent in POC testing compared to standardized laboratory HPLC methods.

"POC HbA1c testing [DCA Vantage, Afinion or A1C Now+] in community settings was associated with significantly lower HbA1c values when compared with laboratory-measured referrals. Acknowledging effects of regression to the mean, we found that these differences were also associated with POC method, location, individual patient factors and time between measurements. Compared with POC HbA1c values in the NDH range, normoglycemic POC HbA1c values were associated with lower subsequent intervention attendance."

"The POC test evaluated here is precise across its measuring range using both fingerstick and venous whole blood. The calculated total error of the test is well under the accepted quality requirement of ≤6%."

"The POCT assay performed acceptably under realistic clinical conditions, albeit with a slightly negative bias compared with the laboratory result."

"This study demonstrates that the adoption of Afinion 2 POCT for HbA1c and lipid panel can provide efficiencies to different types of healthcare systems through reducing PCP consultations, saving time and money for patients and providing cost savings for payers."