cobas b 101

"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."

"A few methods showed interference from one or more variants. Laboratories need to be aware of potential HbA1c assay interferences."

"There is a high prevalence of prediabetes, a significant predictor of T2D, among PLHIV in Central Kenya. Point-of-care HbA1c may help identify PLHIV with prediabetes in a single screening visit and provide an opportunity for early intervention."

"POC testing must be conducted within stringent quality assurance processes prior to and while in use. Within such a system, POC testing for HbA1c can be sufficiently accurate for screening and diagnosis of diabetes."

"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 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.

"This unique and comprehensive study shows that out of six POC analyzers studied only two (The Lab 001 and Cobas B101) met international quality criteria (IFCC and NGSP), two (A1Care and Innovastar) were borderline and two (QuikReadgo and Allegro) were unacceptable. It is essential that the scientific and clinical community are equipped with this knowledge in order to make sound decisions on the use of these analyzers."

"The cobas CRP Test on the cobas b 101 system demonstrates robust analytic performance when used by healthcare professionals in the POC setting."