Carbapenem-resistant Enterobacterales represent a major global public health concern, and the rapid and reliable detection of carbapenemase production is of critical importance. In this study, real-time PCR was used as the reference method for carbapenemase detection, and the performance of immunochromatographic and phenotypic methods was comparatively evaluated. A total of 96 carbapenem-resistant Enterobacterales isolates were included, and all were identified as carbapenemase producers by the reference method. Diagnostic performance was assessed using positive percent agreement (PPA) and overall percent agreement (OPA); negative percent agreement and negative predictive value could not be calculated due to the absence of negative isolates. The immunochromatographic test showed complete agreement with real-time PCR in detecting carbapenemase production (PPA and OPA: 100%). At the gene level, sensitivity and specificity were 100% for OXA-48 and NDM, while sensitivity for KPC was 91.7%. In the modified carbapenem inactivation method (mCIM), PPA and OPA values were 97.9% due to false-negative results observed in two isolates producing OXA-48 and NDM by the reference method, and its performance was slightly lower than that of the immunochromatographic method. These findings indicate that the immunochromatographic method is a rapid, reliable, and practical option for carbapenemase detection, particularly in OXA-48-endemic intensive care settings where rapid identification is critical for timely infection control and appropriate antimicrobial therapy.

Background: Human papillomavirus (HPV) is the primary etiological agent of cervical cancer. Although obesity has been proposed as a factor influencing HPV acquisition and disease course through immune and metabolic mechanisms, its role remains controversial. This study aimed to evaluate the association between body mass index (BMI) and high-risk (HR)-HPV infection, including genotype distribution, infection type, and cytological findings. Methods: This cross-sectional study included women aged 21 years and older who underwent cervical sampling between August and November 2025. Participants were classified as non-obese (BMI 0.05). HPV-68 was the most frequently detected genotype. Conclusions: BMI was not independently associated with HR-HPV infection or related clinical and cytological features. These findings suggest that HPV infection is primarily influenced by viral characteristics and host immune response, while BMI appears to play a limited role. Further multicenter prospective studies are needed to clarify the impact of obesity on HPV infection.

Background: This study evaluated the inter-method agreement of an in-house qualitative CMV real-time PCR assay for the detection of cytomegalovirus (CMV) DNA in various non-plasma clinical specimen types, in comparison with a commercially available comparator assay. Methods: In this prospective comparative study, 186 clinical specimens—including bronchoalveolar lavage fluid (BALF), stool, urine, colonoscopic biopsy, amniotic fluid, and intraocular fluid—were analyzed. A total of 166 samples with valid results from both test systems were included in the inter-method comparison. CMV DNA was detected using the in-house qualitative PCR assay in parallel with the comparator assay (artus^® CMV QS-RGQ kit). Agreement was assessed using positive percent agreement (PPA), negative percent agreement (NPA), overall percent agreement (OPA), and Cohen’s kappa coefficient (κ), in accordance with CLSI EP12-A2 recommendations. Results: Substantial overall inter-method agreement was observed when all specimens were evaluated collectively (κ = 0.66). Agreement metrics were highest in stool, urine, and invasive specimens, whereas BALF samples demonstrated comparatively lower agreement, reflecting potential matrix-related analytical variability. Conclusion: The laboratory-developed qualitative CMV PCR assay demonstrated substantial inter-method agreement with the comparator assay across multiple non-plasma specimen types. The findings highlight specimen-specific variability in qualitative CMV DNA detection and represent analytical concordance between two molecular assays rather than definitive clinical diagnostic accuracy or viral load quantification.

Background: Cytomegalovirus (CMV) viral load monitoring forms the basis of preemptive treatment strategies in patients undergoing solid organ and hematopoietic stem cell transplantation. This study aimed to evaluate the analytical performance and inter-method agreement of a laboratory-developed CMV real-time PCR (qPCR) test compared to a commercial reference method using plasma samples. Methods: A total of 100 EDTA plasma samples were analyzed in parallel using a laboratory-developed CMV qPCR test and the reference method (Roche Cobas^® CMV). Analytical sensitivity was determined us-ing synthetic DNA cloned into the pUC57 plasmid backbone containing the US17 region of the CMV genome, and the limit of detection (LoD₉₅) was calculated using probit regression analysis. The relationship between the quantitative results obtained from clinical samples was evaluated using the Spearman rank correlation coefficient, while inter-method clinical agreement was assessed using the Bland–Altman method. Results: The limit of detection (LoD₉₅) of the laboratory-developed CMV qPCR test, as determined by probit regression analysis, was 63.8 copies/µL. A weak and statistically non-significant correlation was ob-served between the laboratory-developed CMV qPCR test and the reference method in Spearman rank correlation analysis of samples for which numerical quantitative results were available from both methods (ρ = 0.32; p = 0.22; n = 16). Bland–Altman analysis showed a mean difference of −0.48 log₁₀ units, with the vast majority of measurements falling within the 95% limits of agreement. Conclusions: The assay demonstrated measurable analytical performance and inter-method agreement; however, its use for quantitative viral load monitoring, particularly at low CMV DNA levels, should be interpreted with caution.