Unlocking new potential of clinical diagnosis with artificial intelligence:Finding new patterns of clinical and lab data

Recent advancements in science and technology,coupled with the proliferation of data,have also urged laboratory medicine to integrate with the era of artificial intelligence(AI)and machine learning(ML).In the current practices of evidencebased medicine,the laboratory tests analysing disease patterns through the association rule mining(ARM)have emerged as a modern tool for the risk assessment and the disease stratification,with the potential to reduce cardiovascular disease(CVD)mortality.CVDs are the well recognised leading global cause of mortality with the higher fatality rates in the Indian population due to associated factors like hypertension,diabetes,and lifestyle choices.AI-driven algorithms have offered deep insights in this field while addressing various challenges such as healthcare systems grappling with the physician shortages.Personalized medicine,well driven by the big data necessitates the integration of ML techniques and high-quality electronic health records to direct the meaningful outcome.These technological advancements enhance the computational analyses for both research and clinical practice.ARM plays a pivotal role by uncovering meaningful relationships within databases,aiding in patient survival prediction and risk factor identification.AI potential in laboratory medicine is vast and it must be cautiously integrated while considering potential ethical,legal,and privacy concerns.Thus,an AI ethics framework is essential to guide its responsible use.Aligning AI algorithms with existing lab practices,promoting education among healthcare professionals,and fostering careful integration into clinical settings are imperative for harnessing the benefits of this transformative technology.

Harmonization of SARS-CoV-2 antigen immunoassays:are they measuring the same“thing”?

Background:This study was planned to assess the accuracy and comparability of two commercially available,laboratory-based SARS-CoV-2(severe acute respiratory syndrome)antigen(Ag)immunoassays.Methods:We studied a cohort of subjects with acute SARS-CoV-2 infection,from whom a nasopharyngeal swab was taken and tested with a molecular assay(Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit)and two laboratory-based,fully automated SARS-CoV-2 Ag immunoassays(Fujirebio Lumipulse G SARS-CoV-2 Ag and Roche Elecsys SARS-CoV-2 Ag).Results:The final population consisted in 93 subjects testing positive for SARS-CoV-2 RNA,34 with cycle threshold(Ct)values<29.5.The results of the two SARS-CoV-2 Ag immunoassays were significantly intercorrelated(r=0.77;P<0.001)in the entire cohort,though such correlation considerably improved in patients with high viral load(cycle threshold values<29.5:r=0.96;P<0.001).The accuracy for identifying samples with high viral load was excellent for both Lumipulse G SARS-CoV-2 Ag(AUC,0.99;P<0.001)and Elecsys SARS-CoV-2 Ag(AUC,0.99;P<0.001),with best cut-offs of 2.03 ng/mL for Lumipulse G SARS-CoV-2 Ag(1.00 sensitivity and 0.88 specificity)and 0.70 COI for Elecsys SARS-CoV-2 Ag(1.00 sensitivity and 0.80 specificity),respectively.Conclusion:The results of this study provide valuable support to usability of fully-automated,rapid,high throughput and accurate SARS-CoV-2 Ag immunoassays for complementing molecular assays.

Methods, units and quality requirements for the analysis of haemoglobin A_(1c) in diabetes mellitus

The formation of glycohemoglobin, especially the hemoglobin A1c(Hb_(A1c)) fraction, occurs when glucose becomes coupled with the amino acid valine in the β-chain of Hb; this reaction is dependent on the plasma concentration of glucose. Since the early 1970 s it has been known that diabetics display higher values of Hb_(A1c) because they have elevated blood glucose concentrations. Thus Hb_(A1c) has acquired a very important role in the treatment and diagnosis of diabetes mellitus. After the introduction of the first quantitative measurement of Hb_(A1c), numerous methods for glycohemoglobin have been introduced with different assay principles: From a simple minicolumn technique to the very accurate automated highpressure chromatography and lastly to many automated immunochemical or enzymatic assays. In early days, the results of the quality control reports for Hb_(A1c) varied extensively between laboratories, therefore in United States and Canada working groups(WG) of the Diabetes Controls and Complications Trial(DCCT) were set up to standardize the Hb_(A1c) assays against the DCCT/National Glycohemoglobin Standardization Program reference method based on liquid chromatography. In the 1990 s, the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC) appointed a new WG to plan a reference preparation and method for the Hb_(A1c) measurement. When the reference procedureswere established, in 2004 IFCC recommended that all manufacturers for equipment used in Hb_(A1c) assays should calibrate their methods to their proposals. This led to an improvement in the coefficient of variation(CV%) associated with the assay. In this review, we describe the glycation of Hb, methods, standardization of the Hb_(A1c) assays, analytical problems, problems with the units in which Hb_(A1c) values are expressed, reference values, quality control aspects, target requirements for Hb_(A1c), and the relationship of the plasma glucose values to Hb_(A1c) concentrations. We also note that the acceptance of the mmol/mol system for Hb_(A1c) as recommended by IFCC, i.e., the new unit and reference ranges, are becoming only slowly accepted outside of Europe where it seems that expressing Hb_(A1c) values either only in per cent units or with parallel reporting of percent and mmol/mol will continue. We believe that these issues should be resolved in the future and that it would avoid confusion if mmol/mol unit for Hb_(A1c) were to gain worldwide acceptance.

iLABMED,why now and how in the future?

Nowadays,public health is facing many challenges,mainly including non‐communicable diseases and communicable diseases.Communicable diseases,particularly emerging infectious diseases,have also attracted attention due to their enormous impact on public health and the global economy.The most prominent example is the current global Coronavirus Disease 2019(COVID‐19)pandemic.The unprece-dented and ongoing COVID‐19 pandemic has high-lighted the necessity for readily available,accurate,and rapid laboratory medicine(LM)practices.Nevertheless,current LMs and journals in particular have a window for improvement.First,there are limited numbers of professionals available in this field compared to the other disciplines.The current status quo is that most LM manuscripts must be submitted to comprehensive journals or other journals related to the research disease.Second,most LM journals are run by laboratory personnel who are often more concerned with technical advances than with clinical needs.Lastly,several young LM scientists expressed their desire to have a dedicated platform to discuss,communicate,and publish their works on LM.We were therefore motivated to launch iLABMED,an international public forum dedicated to LMs.The establishment of iLABMED adopts the“four I”strat-egy,namely“Innovation,”“Intelligence,”“Integra-tion,”and“International.”We are attempting to establish a top‐tier journal in the field of LM.