Search Results (100)

Background: Carbohydrate antigen 19-9 (CA19-9) is widely used as a tumor marker for pancreatic and hepatobiliary malignancies. However, inter-assay variability may affect the interpretation of results. This study compared the analytical performance, reference values, diagnostic accuracy, and clinical concordance of CA19-9 measured by chemiluminescent microparticle immunoassay (CMIA) and electrochemiluminescence immunoassay (ECLIA) in a Thai population. Methods: Serum CA19-9 concentrations were measured using both CMIA and ECLIA in 398 subjects comprising 145 healthy individuals, 115 patients with benign conditions, and 138 patients with malignancies. Method comparison, reference interval assessment, receiver operating characteristic (ROC) analysis, and concordance analysis were performed. Population-specific cut-off values were established and compared with manufacturer-recommended thresholds. Results: CMIA produced modestly but significantly higher CA19-9 concentrations than ECLIA in healthy individuals, resulting in higher upper reference limits. The two assays showed strong correlations across the study population (R² = 0.922). Among malignant conditions, CMIA generally yielded higher CA19-9 values than ECLIA, with significant differences observed in pancreatic cancer and cholangiocarcinoma (p < 0.001). Values in benign conditions were largely comparable, except in cirrhosis, where ECLIA produced higher values. Diagnostic performance was similar between CMIA and ECLIA (AUC 0.856 vs. 0.840). Population-derived cut-off values (34.945 kU/L for CMIA and 34.395 kU/L for ECLIA) showed diagnostic performance comparable to manufacturer-recommended cut-offs and improved inter-assay concordance, particularly in cholangiocarcinoma. Conclusions: CMIA and ECLIA demonstrated strong analytical correlation and comparable diagnostic performance for CA19-9. Nevertheless, systematic inter-assay differences indicate that results should be interpreted using assay-specific reference intervals and clinical decision thresholds. Population-specific cut-off values may further improve clinical interpretation, particularly in regions with a high prevalence of hepatobiliary malignancies. Full article

Over the past decade, the incidence of infectious syphilis has been on the rise in the general Chinese population. Consequently, Treponema Pallidum (TP) testing has been proposed as a surrogate marker for sexually transmitted pathogens and for monitoring risky sexual behaviors among blood donors globally. In addition, sexual contact with individuals chronically infected with hepatitis B virus (HBV) is recognized as one of the primary routes of HBV transmission. Blood donors may acquire HBV infection through sexual contact with chronically infected partners, particularly with occult hepatitis B infections (OBIs), which are characterized by intermittent and extremely low viral loads. Therefore, the prevalence of OBIs among syphilis-positive blood donations and the corresponding risks to blood safety require further investigation. This study aimed to investigate the prevalence of OBIs among syphilis-positive blood donors and assess the surrogate value of TP testing for evaluating OBI-related risks to blood supply. After routine screening using serological assays and nucleic acid testing (NAT), blood donation samples with positive anti-TP enzyme-linked immunosorbent assay (ELISA) results were collected and further confirmed by the Treponema Pallidum Particle Agglutination Assay (TPPA). For blood donations confirmed positive for syphilis, further tests were performed to characterize whether the donations had HBV co-infection, including electrochemiluminescence immunoassay (ECLI) for the detection of hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs), hepatitis B e antigen (HBeAg), anti-hepatitis B e antibody (anti-HBe), and anti-hepatitis B core antibody (anti-HBc). Additionally, quantitative real-time polymerase chain reaction (qPCR) was used for HBV DNA quantification, and nested PCRs for the S and basal core promoter/precore (BCP/PC) region were conducted in combination with high-volume nucleic acid extraction. Subsequently, molecular characterization of HBV DNA in these co-infected samples was carried out by DNA sequencing to analyze the viral genetic features. Of 252 anti-TP ELISA+ donations screened from 64,871 blood samples, 138 (138/250, 55.2%) donations were confirmed syphilis-positive but NAT−, among which 78 (78/138, 56.5%) were anti-HBc-positive, and 88 (88/138, 63.7%) had anti-HBs. Notably, seven donations (7/138, 5.1%) were diagnosed as OBI co-infections, and available sequence analysis revealed that three cases were genotype B and one case was genotype C. In addition, several mutations in the S region of the HBV genome were identified, including Q101R, K122R, Q129H, T131N, M133T, G145R, and Y161F mutations. Furthermore, nucleotide mutations such as T1719G, A1752T, G1896A, and A1762T/G1764A in the BCP/PC regions were also detected in these OBI donations. These mutations may contribute to the extremely low HBV viral loads and/or failure in HBsAg detection, collectively leading to OBIs. These data indicate that syphilis screening of blood donors has potential to serve as an additional safeguard measure for excluding donations co-infected with OBIs. The high prevalence of undetected OBIs in syphilis-positive blood donors further supports that syphilis screening has the potential to serve as a surrogate marker for HBV-related risks in the blood supply. Full article

Background/Objectives: Variability between routine laboratory immunoassays for total 25-hydroxyvitamin D (25(OH) vitamin D) measurement may impact clinical interpretation, particularly around clinical decision thresholds. The aim of the study was to evaluate the analytical comparability and clinical interchangeability between three automated immunoassay platforms using chemiluminescent assays (CLIA) and electrochemiluminescent assay (ECLIA) principles for total 25(OH) vitamin D and to evaluate the assay-dependent impact on patient reclassification. Methods: A total of 83 serum samples were analyzed using three automated immunoassay platforms and the between method comparability was assessed. Additionally, clinical agreement and reclassification rate were evaluated at two clinical decision thresholds, 20 ng/mL for insufficiency and 12 ng/mL for severe deficiency. Results: The comparability analysis revealed a systematic difference between methods, with a high reclassification rate between ECLIA compared to CLIA methods. Additionally, the expanded measurement uncertainty generates a clinically relevant gray zone around the clinically relevant thresholds. Conclusions: Routinely used immunoassays for total 25(OH) vitamin D measurement in clinical laboratories are not fully interchangeable, furthermore the measurement uncertainty contributes to patient reclassification, especially around the threshold of 20 ng/mL. Full article

Alzheimer’s disease (AD) is increasingly recognized as a biological continuum characterized by early neuropathological and molecular changes that precede the onset of clinical symptoms. Fluid biomarkers have transformed the diagnostic landscape by enabling the in vivo detection of core AD pathologies, particularly amyloid-β deposition and tau-related neurodegeneration. Despite the rapid expansion of candidate biomarkers, however, only a limited number have successfully translated into clinical practice. Discovery-phase approaches, primarily driven by mass spectrometry-based proteomics, enable the unbiased identification of novel biomarker candidates across multiple biological pathways. Research-phase methods, including immunoassays such as enzyme-linked immunosorbent assay (ELISA), electrochemiluminescence immunoassays (ECLIA), microfluidic platforms, and ultrasensitive technologies such as single-molecule array (SIMOA), support analytical and clinical validation in well-characterized cohorts. Clinical implementation has been advanced by fully automated platforms, including Lumipulse and Elecsys, which have obtained regulatory approval for cerebrospinal fluid biomarkers and, more recently, blood-based biomarkers. These developments represent a paradigm shift toward minimally invasive and scalable diagnostic strategies that may reduce dependence on neuroimaging techniques. Nevertheless, major challenges remain, including assay standardization, inter-platform variability, demonstration of clinical utility, and barriers to widespread clinical adoption. This review provides a comprehensive overview of analytical methods used to measure AD fluid biomarkers in cerebrospinal fluid and plasma, structured according to the biomarker development pipeline from discovery to clinical implementation. Overall, the review highlights a fit-for-purpose approach to biomarker development and emphasizes the complementary roles of diverse analytical technologies across the different phases of biomarker translation. Full article

Background: Asthma is a heterogeneous chronic inflammatory airway disease characterized by recurrent exacerbations and variable airflow limitation. Epithelial-derived alarmins, particularly interleukin-33 (IL-33) and its receptor ST2, play key roles in type 2 inflammation. The soluble form of ST2 (sST2) acts as a decoy receptor regulating IL-33 signaling. Vitamin D is an important immunomodulator influencing airway inflammation, but its interaction with the IL-33/ST2 pathway remains unclear. Objective: To evaluate the association between serum IL-33, sST2, and 25-hydroxyvitamin D [25(OH)D] levels with asthma severity and exacerbation status, and to assess their potential as clinical biomarkers. Methods: This study enrolled 52 adult asthma patients (27 experiencing exacerbation and 25 in remission) and 28 healthy controls. Serum levels of IL-33 and sST2 were measured using enzyme-linked immunosorbent assays, while 25(OH)D concentrations were determined via electrochemiluminescence immunoassay. Results: Serum sST2 levels were significantly higher and 25(OH)D levels significantly lower in asthma patients compared with controls (p < 0.000 for both). Serum IL-33 levels did not differ significantly between groups (p > 0.05). During exacerbation, sST2 levels were markedly elevated compared with remission (p < 0.001), whereas vitamin D levels were significantly reduced (p = 0.038). A significant negative correlation was identified between sST2 and 25(OH)D (r = −0.333, p = 0.016). Conclusions: The presence of asthma and the severity of exacerbations are associated with elevated circulating sST2 levels and reduced vitamin D levels. These findings suggest a regulatory interaction between vitamin D and the IL-33/ST2 axis in airway inflammation and indicate that targeting this axis could be a potential therapeutic strategy. Full article

Background: Hematological patients have a high risk of developing severe COVID-19 (37%). Most mRNA vaccine trials in hematological patients showed a low immunogenicity after two doses, while long-term data are scarce. Methods: In this monocentric retrospective observational study, we evaluated humoral and T cell-mediated immune responses in 230 hematological patients after three doses of the Pfizer-BioNTech mRNA COVID-19 vaccine. Patients were stratified by age, disease type/state, prior COVID-19 infection, and treatment status and regimens (anti-CD20 monoclonal antibodies, BTK and BCL-2 inhibitors, and treatment line). Antibody titer to SARS-CoV-2 was assessed by electrochemiluminescence immunoassay and T cell response by QuantiFERON interferon-γ release assay (IGRA). Data were analyzed using univariate (Fisher’s exact test) and Firth’s bias-reduced penalized-likelihood logistic regression. Results: A robust humoral response was observed with 91.55% of patients developing anti-spike antibodies (GMT 988.83 U/mL). Anti-CD20-bendamustine treatment was associated with a significantly lower antibody positivity compared to untreated subjects. Prior COVID-19 infection significantly boosted both antibody positivity (95.9% vs. 85.2%) and GMT (847.02 U/mL vs. 258.79 U/mL). Conversely, T cell response was suboptimal (36.1% positive), particularly in anti-CD20-bendamustine-treated and multi-treated patients (27.1%), but highest in those treated with BTK inhibitors (50%). Multivariable logistic regression analysis linked multiple treatments to lower T cell response. Following vaccination, 29.1% of patients contracted SARS-CoV-2, but only 0.89% developed severe COVID-19. Conclusions: Three doses of mRNA vaccine elicit a strong humoral but a low T cell response, as detected by IGRA, in hematological patients. These findings underscore the importance of completing vaccination before initiating immunosuppressive therapies. Full article

Background: Test descriptions from major diagnostic manufacturers do not include ferritin reference intervals (RIs) for individuals aged 60 and older. The absence of older adults-specific RIs contrasts with the widespread use of serum ferritin testing in older adults. We aimed to establish and verify RIs using two common analytical methods. Methods: For this study, 1467 older adults were prospectively enrolled and monitored for morbidity and mortality, and exclusion criteria were applied. Ferritin was measured using chemiluminescent microparticle immunoassay (CMIA) and transferred to an electrochemiluminescence immunoassay (ECLIA) using method comparison. RIs were evaluated using a direct method with a prospective observational study based on healthy individuals according to the Clinical and Laboratory Standards Institute (CLSI) 28-A3c guideline and compared with RIs obtained using an indirect approach based on data obtained in clinical routine outpatients, where normal and abnormal values are supposed to be statistically differentiated to determine RIs. When applied within a countrywide population-based setting in Liechtenstein, the impact of novel RIs on the frequency of abnormal values was analyzed. Results: A total of 386 men and 532 women were included in the direct RI determination. Women (W) had significantly lower ferritin levels than men (M), while age over the age of 60 years had no significant association with ferritin in men and women. RIs were 23–241 ng/mL (W) and 19–396 ng/mL (M) for CMIA and 27–293 ng/mL (W) and 23–480 ng/mL (M) for ECLIA. These RIs are higher than those mentioned in the test descriptions in both tests. In comparison, the indirect method for both assays showed comparably lower reference limits, whereas upper reference limits were only approximately similar. The prevalence of high abnormal ferritin levels was considerably lower with this study’s RIs compared with manufacturer RIs. Conclusions: Employing older adults-specific RIs in clinical routine seems to be advisable. This reduces the frequency of abnormal high values in comparison with the widely applied practice of extrapolating RIs obtained from younger age groups to older adults and therefore leads to fewer follow-up investigations. Full article

Background: Pacemakers enable continuous long-term surveillance of atrial fibrillation detected by implanted devices. Circulating biomarkers reflecting endothelial dysfunction, inflammation, and myocardial stress may help identify patients at risk for atrial fibrillation (AF) progression and higher arrhythmic burden. Methods: This analysis included patients from the prospective ACaSA study (NCT05127720) with a dual chamber pacemaker (Microport^® BOREA DR or TEO DR) and monitored weekly via remote monitoring technology (SMARTVIEW^®). Individuals with permanent AF or single-chamber systems were excluded. Baseline plasma concentrations of angiopoietin-2 (ANGPT2), growth differentiation factor-15 (GDF-15), fibroblast growth factor-23 (FGF-23), bone morphogenetic protein-10 (BMP10), and tumor necrosis factor–related apoptosis-inducing ligand receptor-2 (TRAIL-R2) were quantified using enzyme-linked immunosorbent assays. N-terminal pro-B-type natriuretic peptide (NT-proBNP) was measured using electrochemiluminescence immunoassay. Biomarkers were log₂-transformed, with values below assay detection limits imputed at half the lower limit of detection. Two endpoints were assessed following a 30-day blanking period: (1) progression to persistent AF, defined as ≥7 consecutive days with >99% daily AF burden, analyzed using Cox regression; and (2) AF burden, calculated as total AF time normalized to monitored days and categorized as <25%, 25–75%, or >75%, analyzed using multinomial logistic regression. Multivariable models were adjusted for age, sex, heart failure, diabetes, and prior myocardial infarction; Cox models were limited to age, sex, and heart failure due to fewer events. Results: A total of 223 patients were included (median age 75 years; 37.2% women). During follow-up, 28 patients (13.3%) progressed to persistent AF. Higher baseline ANGPT2 was the strongest predictor of progression (HR per doubling 1.83, 95% CI 1.27–2.66, p = 0.001), followed by GDF-15 (HR 1.52, 95% CI 1.03–2.24, p = 0.036). In the burden analysis, ANGPT2 demonstrated a pronounced graded relationship with arrhythmic load, with markedly increased odds of high (>75%) AF burden (OR 8.31, 95% CI 2.63–26.26, p < 0.001). GDF-15 independently predicted both medium (OR 2.05, p = 0.025) and high burden (OR 2.32, p = 0.037). NT-proBNP displayed a borderline association with high burden (OR 2.02, p = 0.061). No significant associations were observed for FGF-23, BMP10, or TRAIL-R2. Conclusions: In continuously monitored pacemaker patients, ANGPT2 and GDF-15 emerged as key biomarkers associated with AF disease severity. ANGPT2 was strongly linked to both progression to persistent AF and high AF burden, whereas GDF-15 consistently predicted higher AF burden and also contributed to risk of progression. These findings highlight endothelial and inflammatory pathways as potential markers of atrial disease progression. Full article

Background: Anemia is a major public health issue, particularly among women of reproductive age (WRA) in low- and middle-income countries (LMICs). Pakistan’s National Nutrition Survey (NNS) 2011 showed a high prevalence of vitamin B₁₂ (B₁₂) and folate deficiency among WRA, necessitating further investigation in subsequent surveys. Methods: Blood samples from 31,828 WRA (15–49 years old) were collected using a stratified multi-stage sampling technique in NNS-2018. We conducted a secondary analysis using population-weighted logistic regression to assess the association of potential factors with B₁₂ and folate deficiency. B₁₂ (n = 4442) and folate (n = 12,662) samples were measured using an electrochemiluminescence immunoassay and a Centers for Disease Control and Prevention, USA (CDC)-approved microbiologic assay, respectively. Results: Folate deficiency was present in 44.7% WRA, and 20.2% had B₁₂ deficiency. Provincial distribution was associated with folate deficiency, i.e., Sindh (OR = 1.140, 95% CI 1.018, 1.285), Baluchistan (OR = 1.237, 95% CI 1.052, 1.453), and Islamabad (OR = 1.524, 95% CI 1.109, 2.092), while B₁₂ deficiency was prevalent in Islamabad (OR = 1.673, 95% CI 1.122, 2.497), Gilgit Baltistan (OR = 2.472, 95% CI 1.197, 5.106), and newly merged districts of KPK (OR = 1.584, 95% CI 0.977, 2.570). Rural residence (OR = 1.407, 95% CI 1.125, 1.760), obesity (OR = 1.649, 95% CI 1.282, 2.122), and overweight (OR = 1.560, 95% CI 1.262, 1.928) were associated with B₁₂ deficiency. Conclusions: Our results show regional and demographic differences in the prevalence of folate and B₁₂ deficiencies among WRA. This underscores the need for targeted nutritional interventions and further longitudinal studies to identify potentially associated factors. Full article

Autoantibodies targeting islet antigen 2 (IA2) are critical diagnostic and prognostic markers for type 1 diabetes (T1D). Standard clinical assays do not differentiate between IgG and IgM isotypes, yet these antibodies have distinct roles in the T1D autoimmunity. We therefore adapted electrochemiluminescence (ECL) assays to separately detect IgG and IgM antibodies against the IA2 intracellular domain (AA601-979). Assay specificity was confirmed by indirect immunofluorescence, which showed autoantibody binding to IA2-overexpressing cells. Plasma samples were analyzed from two independent cohorts: organ donors of the Human Pancreas Analysis Program (HPAP, n = 69) and children from a Janssen–Breakthrough T1D-funded study (n = 65). Diabetics had significantly higher levels of IA2 IgG (p < 0.001) but not IgM (p > 0.05) compared with controls. Notably, IgM and IgG IA2 antibody levels were not correlated. However, IgM modulates IgG detection: IgM depletion increased detected IgG levels to IA2 in some donors, and sera from donors with high IA2-specific IgM levels reduced monoclonal IgG anti-IA2 antibody binding to IA2. Purified IgM from healthy individuals also suppressed monoclonal IgG binding. These findings support distinct, non-redundant roles for IA2-specific IgG and IgM in T1D serology. Isotype-specific autoantibody analysis may improve risk stratification and monitoring of T1D individuals receiving immunomodulatory therapies. Full article

Electrochemiluminescence immunoassay (ECLIA) is widely used in clinical diagnostics owing to its high sensitivity, broad dynamic range, and excellent analytical stability. However, the influence of magnetic bead deposition behavior on electrochemiluminescence (ECL) signal performance remains insufficiently characterized. In this study, a quantitative evaluation method for magnetic bead distribution uniformity on the electrode surface was established and applied to optimize fluidic parameters in an ECLIA measurement system. By combining microscopic imaging with image analysis, magnetic bead spreading behavior under different flow conditions was systematically characterized and correlated with luminescence signal intensity. Optimization of the flow rate (18.46 µL·s⁻¹) improved bead distribution uniformity and resulted in a 26.32% increase in luminescence intensity without altering bead coverage or assay chemistry. The optimized system was further validated using thyroid-stimulating hormone (TSH) detection, showing a linear response over 0.016–120 µIU·mL⁻¹ (R² > 0.996) and high consistency with a commercial analyzer (R² = 0.998) from Roche. These results demonstrate that quantitative control of magnetic bead distribution provides an effective strategy for improving ECLIA performance and offers a general optimization framework for bead-based electrochemiluminescence systems. Full article

Type 1 diabetes (T1D) is a common chronic autoimmune disease in childhood, often presenting abruptly and frequently complicated by diabetic ketoacidosis at diagnosis. T1D develops through well-defined presymptomatic stages characterized by islet autoimmunity and progressive dysglycemia, offering a window for early identification. This narrative review summarizes current evidence on screening for T1D in children and adolescents, focusing on target populations, screening strategies, and methodological approaches for autoantibody detection. Data from major international programs involving familial, high-risk, and general population screening are discussed, highlighting their impact on reducing diabetic ketoacidosis at onset, improving metabolic outcomes, and facilitating structured follow-up and family education. Advances in assay technologies, including electrochemiluminescence, multiplex platforms, and novel ultrasensitive methods, have enhanced the feasibility and accuracy of large-scale screening. The review also examines the public health implications, cost-effectiveness, and ethical considerations of implementing population-based screening, particularly in light of emerging disease-modifying therapies such as teplizumab. Overall, available evidence supports screening as a meaningful strategy to shift T1D diagnosis from an acute emergency to a predictable clinical trajectory, with potential benefits extending from individual patient outcomes to healthcare system sustainability. Full article

(1) Background: Testosterone plays a key role in spermatogenesis and in maintaining semen quality and sperm DNA integrity. Consequently, reduced testosterone levels may disrupt these processes and contribute to male infertility. This study aimed to evaluate the impact of low testosterone levels on semen parameters, sperm DNA fragmentation, and chromatin condensation; (2) Methods: This was a prospective study that included 214 men aged 25–45 years undergoing infertility evaluation. Participants were classified into two groups according to serum testosterone levels: low testosterone and normal testosterone. Total testosterone was determined using electrochemiluminescence immunoassay. Semen analysis was carried out according to the WHO 2021 guidelines. The DNA fragmentation index was assessed using the TUNEL assay. The sperm decondensation index was evaluated by aniline blue staining; (3) Results: Men with low serum total testosterone levels (<2.64 ng/mL) exhibited significantly impaired semen parameters compared with those with normal testosterone levels. Serum total testosterone was positively correlated with sperm concentration (rs = 0.43, p < 0.001), total motility (rs = 0.20, p = 0.005), normal morphology (rs = 0.25, p < 0.001), and sperm vitality (rs = 0.173, p = 0.014). In contrast, testosterone levels were negatively correlated with the DNA fragmentation index (rs = −0.221, p = 0.0017) and the chromatin decondensation index (rs = −0.19, p = 0.0086). A higher proportion of pathological DFI (>15%) was observed in the low testosterone group. (4) Conclusions: These findings support the essential role of testosterone in sustaining spermatogenesis, semen quality, and sperm DNA integrity and highlight the crucial importance of testosterone assessment in the diagnosis and pathophysiological understanding of male infertility. Full article

Objective: To determine the prevalence of and risk factors for congenital toxoplasmosis in neonates treated in the public health network of the eastern region of the Brazilian Amazon, northern Tocantins state. Methods: A retrospective cohort study was conducted with neonates born to mothers with gestational toxoplasmosis who received care between 2017 and 2024. The outcome under analysis was positivity for immunoglobulin M in the electrochemiluminescence assay (CLIA). We estimated the prevalence of transplacental infection and respective 95% confidence intervals (95% CI) and its association with risk factors using the odds ratio (or) with a p-value < 0.05 in infected neonates before and after 16 gestational weeks at maternal infection diagnosis. Results: A total of 1142 neonates were surveyed, in which 496 were diagnosed with congenital toxoplasmosis (IgM positive), thus obtaining a prevalence of vertical transmission of 45.4%. The main risk factors for vertical transmission were the mother’s education level equal to or less than eight years, (OR = 1.5; 95% CI 1.2; 2.0) and having less than six prenatal consultations (OR = 22.8; 95% CI 3.0; 172.6). Conclusions: A high prevalence of congenital toxoplasmosis was observed, with higher rates of infection in neonates born to mothers with lower levels of education. Full article

Objective: This retrospective cohort study aimed to identify independent clinical predictors specifically associated with the laterality of ovarian torsion, rather than examining potential associations with patient age or serum hormonal profiles. The analysis sought to improve diagnostic accuracy and preoperative risk stratification in ovarian torsion, a gynecologic emergency where fertility preservation is a priority. Materials and Methods: Data from 64 patients with surgically confirmed ovarian torsion between January 2018 and June 2025 were retrospectively reviewed at Harran University Faculty of Medicine. Demographic, clinical, ultrasonographic, and hormonal data were collected. Hormonal assays were performed using electrochemiluminescence immunoassays (Roche Diagnostics). Univariate and multivariate logistic regression analyses were employed to identify factors independently associated with torsion laterality. Results: The median age of the 64 patients included in the study was 22 years (IQR: 20–33). Right ovarian torsion was detected in 65.6% of the cases. In the final multivariate logistic regression model, nulliparity (VIRGO) (OR: 0.22; 95% CI: 0.07–0.75; p = 0.015) and the presence of a cyst (OR: 0.10; 95% CI: 0.02–0.53; p = 0.007) were found to be independent and significant predictors of torsion laterality. Both variables demonstrated an effect that reduced the probability of left ovarian torsion. No significant association was found between patient age, parity, other clinical features, and hormonal profiles (progesterone, E2, FSH, LH). The main reason for the lack of backing for the hormonal hypothesis was that hormone measurements in 95.3% of the patients were conducted during the follicular phase, a time at which progesterone and estrogen levels are typically low compared to the luteal phase. Conclusions: This study demonstrates that, in addition to the anatomical predisposition for right ovarian torsion, nulliparity (VIRGO) and cyst presence are independent clinical indicators of ovarian torsion laterality. The absence of these features (VIRGO and cyst presence) increases the risk of right-sided torsion. The findings offer valuable information to enhance the index of clinical suspicion in the differential diagnosis of patients presenting with ovarian torsion symptoms. The importance of prompt detorsion and a conservative surgical approach to preserve ovarian viability and secure long-term reproductive health is emphasized. Full article