Kuvat T. Momynaliev

Retrospective back-tests are often used to argue that a forecasting method, including one built on large language models (LLMs), can anticipate technological change. Such tests are exposed to look-ahead problems: public prior art at the simulated cut-off T₀, cueing by the information supplied to the forecaster, hindsight in assembling that information, broad enumeration of competing branches, post-hoc choice of the resolution at which predictive credit is assigned, and latent post-T₀ knowledge in the model. We integrate these threats into an ordered validity protocol. It fixes the credited object and its architectural resolution first (Step 0) and uses that resolution unchanged when auditing public availability at T₀ (Step 1) and the construction and contents of the forecast input (Step 2); it then records forecast commitment and breadth (Step 3) and treats realization, selection and ranking as descriptive endpoints (Steps 4–6). For an LLM trained after T₀, a historically correct forecast is compatible both with inference from pre-T₀ information and with latent post-T₀ knowledge, so retrospective performance — for emergence, selection or ranking — is not identifiable without an independently controlled temporal knowledge boundary. We apply the protocol to nine medical-technology histories (27 locked assessments) from the Innovation DNA dossier. No case froze its credit object and resolution before outcome review, so, by construction, none can be confirmed as a clean emergence test (0 of 9). This is not a forecasting score: it means the series offers no valid denominator for estimating emergence-forecasting performance. The case-level audit is informative in a different way. In four cases the forecasts stayed within branches or architectures the input already supplied; in the other five, exclusion of at least one assessment depends on the resolution chosen, on a post-hoc recombination rule or on unresolved pack provenance. Retrospective foresight claims should be audited as information-boundary problems before they are scored for accuracy. A prospective feasibility implementation of the protocol was publicly registered on OSF Registries on 29 September 2026, before candidate extraction, case selection, case-specific question setting or forecasting; it is not part of the forecasting-performance evidence reported here.

Objective. Determination of the species identity of saliva samples dried on gauze based on total human IgG using quantitative enzyme immunoassay. Material and methods. Saliva samples taken from 10 donors and dried on gauze. The samples were tested by quantitative ELISA using the IgG-total-ELISA-HEMA test kit. Results. The optical density and concentration of total IgG in whole saliva extracts were determined in 1:10 and 1:50 dilutions. The sensitivity limit of the method was established. Conclusion. The experimental data obtained indicate a reliable identification of the origin of the studied saliva samples on gauze from humans, both in undiluted extracts and in a 1:10 dilution. This variant of quantitative ELISA has absolute specificity, sufficient sensitivity and high productivity, which determines the prospect of its use to establish the species identity of saliva traces.

The aim of this study was to develop a structured method for forecasting the next major architectural transition in medical technologies and to evaluate it under historically constrained information conditions. Innovation DNA separately generates an Evolutionary Vector, Forecast A (Next Realized Variant), and Forecast B (Durable Selected Branch). Following four pilot/development cases, version 2.0 was frozen and a protocol-fixed main historical series was conducted. Of 12 prespecified slots, nine underwent historical assessment and formal comparison with the subsequent technological trajectory, while three were retained as VACANT because the integrity of the historical information boundary could not be maintained. For each valid case, three separately generated structured assessments were completed before outcome disclosure. At the individual-assessment level, a full Hit was observed in 21/27 assessments for Direction (77.8%), 20/27 for the next realized variant (74.1%), and 21/26 adjudicable forecasts for the durable selected branch (80.8%); one Forecast B assessment was classified as Not yet adjudicable. In a post hoc descriptive composite, concordance across all three principal endpoints was observed in 6/9 cases (66.7%). Exploratory Full/Strong pre-outcome concordance across the three assessments was 7/9 (77.8%), 6/9 (66.7%), and 5/9 (55.6%) for Direction, Forecast A, and Forecast B, respectively. Thus, the high descriptive Hit frequency for Forecast B did not imply high reproducibility in selecting the durable branch. The findings are consistent with a predictive signal at the level of architectural direction; however, purposive case selection, within-case clustering, the absence of concurrent historical comparators, and the residual risk of latent outcome knowledge preclude claims of universal accuracy or superiority. A prospectively locked real-time validation is required to assess accuracy, reproducibility, and the incremental predictive value of Innovation DNA.

Background: Continuous glucose monitoring (CGM) systems are used not only for retrospective assessment of the glycemic profile but also for real-time decision-making, including automated insulin delivery. Accordingly, CGM performance characterization must capture not only the agreement of individual paired values but also the system’s ability to reproduce the direction, rate, amplitude, and shape of glucose concentration change. Summary metrics, most notably MARD, cannot establish whether an observed deviation reflects an error in the formation of the test profile itself, a constant sensor offset, amplitude compression, a change in response rate, temporal misalignment, or hysteresis. Objective: To adapt a programmable flow-based in vitro platform for the separate assessment of the experimentally delivered glucose profile and the dynamic response of CGM systems, and to propose a set of metrics that decomposes dynamic error into its components. Methods: GLU profiles were generated by programmable mixing of solutions at a constant total flow rate of 2 mL/min. Actual GLU concentration was independently measured with a SUPER GL2 glucose analyzer. Four static levels, three repeats of a 5.5→12.0→5.5 mmol/L profile, three repeats of a 6.0→3.0→6.0 mmol/L hypoglycemic profile, three 5.0→15.0→5.0 mmol/L profiles at different rates, one complex 4→18→3→12→5.5 mmol/L profile, and two proof-of-concept sensor experiments at 100- and 200-min transitions were investigated. Dynamic response was characterized by bias, MAE, RMSE, MARD, amplitude transfer coefficient K_A, rate transfer coefficients K_up and K_down, normalized shape RMSE, residual shift, and hysteresis loop area. Results: At the static levels, measured GLU exceeded the programmed value by 0.234–0.780 mmol/L. In the repeated 5.5→12.0→5.5 profiles, the ratio of actual to programmed rate was 0.978–1.083 on the rising phase and 0.987–1.157 on the falling phase, while the amplitude transfer coefficient was 0.967–1.066. In the hypoglycemic profile, minimum GLU was 2.55– 2.96 mmol/L, and time below 3.0 mmol/L was 15.2–72.6 min. The measured rates of 0.0519, 0.1045, and 0.2027 mmol/L/min preserved the intended ratio of approximately 1:2:4. In the complex profile, the programmed plateau of 18 mmol/L was not reached: mean measured GLU was 16.20 mmol/L. For CGM-A, K_A was 0.682 and 0.650, and K_up/K_down were 0.666/0.730 and 0.634/0.626; the corresponding values for CGM-B were 1.228 and 1.128, and 1.564/1.328 and 1.276/1.145. Hysteresis loop area differed 5- to 10-fold between the two sensor responses, exceeding an order of magnitude at the 100-min transition. Conclusion: The programmed concentration should be treated as a control setpoint, rather than as a reference measurement. The “programmed trajectory — measured glucose — CGM output” cascade first allows quantitative assessment of the agreement between the programmed and actually realized profile and only then separate characterization of sensor response. Decomposition of dynamic error into amplitude, rate, shape, and hysteresis components reveals differences that a single MARD value or correlation coefficient cannot capture.

Objective. To analyze international approaches to lot‑by‑lot quality control of high‑risk in vitro diagnostic medical devices and to assess the feasibility of implementing lot verification in the Russian Federation. The review also considers lot‑to‑lot variability as a factor affecting the reliability of laboratory testing. Materials and methods. An analytical review was conducted, including scientific publications, international models of lot‑by‑lot control applied across various regulatory jurisdictions, and data from Russian state surveillance reports on substandard lots of in vitro diagnostic devices for the period 2015–2025. International models were compared according to independence of expertise, organizational feasibility, throughput capacity, and the ability to prevent the release of lots with deviating performance characteristics. Results. Lot‑by‑lot verification of third‑risk‑class in vitro diagnostic medical devices is a key mechanism for ensuring the reliability of laboratory testing and reducing the likelihood of diagnostic errors. International and Russian data indicate that lot‑to‑lot variability is a significant risk factor capable of reducing the sensitivity and specificity of diagnostic assays. Despite the existing mechanisms of state registration and post‑market surveillance, in the Russian Federation lot‑related defects are predominantly detected only during clinical use. Conclusion. The implementation of independent lot‑by‑lot verification represents a justified and necessary measure for improving the quality of diagnostic devices and enabling timely prevention of clinically significant deviations.

Objective. Establishing the species origin of microparticles of striated cardiac muscle tissue according to human total IgG by the method of quantitative solid-phase enzyme-linked immunosorbent assay using the IgG-total-ELISA-HEMA kit. Material and methods. Myocardial microparticles taken from the corpses of eight people. The samples were analyzed using the quantitative solid-phase ELISA method using the IgG-total-ELISA-HEMA test kit. Results. The optical density and concentration of total IgG in whole extracts were determined, and the optimal values of the minimum and maximum calibration samples were obtained: 0.082±0.015—2.581±0.017. Conclusion. The obtained data can be used by experts of forensic biological units to establish the species affiliation of microparticles of striated cardiac muscle tissue found on trauma tools using the quantitative solid-phase ELISA method for human total IgG.

Objective. Establishment of the dynamics of PSA total activity and stability in human semen samples dried on gauze and diluted with deionized water. Material and methods. We studied samples of human seminal fluid, dried on gauze and diluted with deionized water. Measurements in the samples were carried out 5 times during the working day. The study was carried out using a quantitative enzyme-linked immunosorbent assay using the domestic «Alcorbio». Results. Quantitative indicators of a decrease in PSA total activity in the studied samples for 6 hours at a temperature of +18—20 °C and the suitability of the samples for research by enzyme-linked immunosorbent assay were established. Conclusion. The data obtained can be used when conducting forensic biological examinations and studies to determine the presence of sperm on physical evidence using PSA total using quantitative enzyme-linked immunosorbent assay.

Accurate quantification of HIV-1 p24 antigen depends on the availability of reference materials whose values are traceable to the International Unit (IU). The long-standing WHO International Standard 90/636 is now largely depleted, while access to more recent VLP-based standards remains limited, creating a practical need for locally produced materials supported by a robust and internationally traceable value-assignment procedure. We developed a streamlined, two-component framework for assigning p24 activity to a VLP-derived material using (i) single-point calibration against the WHO standard and (ii) verification through an internal dilution control prepared from the same material. A multi-laboratory study involving 16 laboratories and 37 fourth-generation Ag/Ab assays demonstrated that the approach yields stable relative-response measures and supports the use of robust statistics for activity estimation. Phylogenetic analysis confirmed that the VLP material corresponds to HIV-1 subtype B, ensuring biological alignment with existing WHO standards. The combined procedure produced an assigned value of 32 IU per vial, with dilution-control behaviour indicating correct preparation and consistent analytical parallelism across platforms. This methodology provides a reproducible, resource-efficient route for establishing traceable VLP-based p24 reference materials in settings where access to international standards or large collaborative studies is limited.

BCR-ABL1 is a chimeric oncogene underlying chronic myeloid leukemia (CML) and serves as a key marker for monitoring minimal residual disease. Quantitative RT-qPCR analysis of BCR-ABL1 transcripts enables assessment of molecular response depth and timely detection of treatment failure or resistance. In international practice, the introduction of the International Scale (IS), along with method standardization, has significantly improved the comparability of results between laboratories. Participation in external quality assessment (EQA) programs is a mandatory accreditation requirement in countries with established CML monitoring systems, allowing laboratories to evaluate analytical accuracy and to adjust protocols when deviations are detected. Until recently, Russia lacked both standardized IS calibration and a national EQA program for BCR-ABL1 testing, which hindered the assessment of interlaboratory precision. This pilot study represents the first interlaboratory comparison of quantitative BCR-ABL1 measurement in the Russian Federation. Two panels of lyophilized control samples (five levels each, from M1 to M4.5) were distributed and analyzed by 14 laboratories (15 datasets) using their routine protocols without IS conversion. Interlaboratory variability was high: the overall coefficient of variation ranged from approximately 40 percent to 50 percent, with individual laboratory results at the high level (about 10 percent) varying from 3 percent to 27 percent. Most laboratories’ results were within plus/minus 3 standard deviations of the consensus median, but two laboratories showed consistent overestimation (bias about +3.8 percentage points) or underestimation (bias about −1.7 percentage points), leading to multi-fold errors at level M1. These findings highlight the urgent need to implement IS calibration and to establish a national EQA program for BCR-ABL1 testing in Russia to improve result comparability. Adoption of these measures will help align molecular monitoring of CML in Russia with international standards and strengthen clinician confidence in laboratory testing

The article presents the results of an experimental study of the stability of total PSA in samples from sperm dried on gauze, diluted with distilled water. The goal of the work was to establish the dynamics of activity and stability of total PSA samples in the prepared extracts. The research material included samples of seminal fluid dried on gauze. The study was carried out using a quantitative enzyme-linked immunosorbent assay. Measurements in the samples were carried out 5 times during the working day. The results obtained allowed us to prove a significant decrease in total PSA activity in extracts from sperm stains on gauze for 6 hours at room temperature (+18—20 °C). The results of the study, confirmed by statistical analysis data, can be taken into account in the case of using the quantitative enzyme immunoassay method to determine the presence of sperm on material evidence during forensic biological examinations.