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: Kaposi sarcoma (KS) is a vascular malignancy closely associated with human herpesvirus 8 (HHV-8) infection, and its diagnosis relies on combined clinical, histopathological and molecular assessment. This study aimed to detect HHV-8 DNA in archived formalin fixed paraffin embedded (FFPE) biopsy samples of KS by real time PCR and to evaluate the diagnostic performance of PCR compared with histopathology. Meth ods: In this retrospective cross-sectional study, 98 FFPE biopsy specimens with histopathologically confirmed KS and 30 FFPE biopsy specimens with non-KS vascular lesions were included as the patient and control groups, respectively. HHV-8 DNA was analyzed in all samples using real-time PCR. Diagnostic performance parameters, including sensitivity, specificity, predictive values, and accuracy, were calculated, and agreement with histopathological diagnosis was assessed using Cohen’s kappa coefficient. Results: HHV-8 PCR was positive in 89.8% (88/98) of KS cases and negative in all controls (30/30; 100%). Sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy were 89.8%, 100%, 100%, 75.0% and 92.2%, respectively. Overall agreement between PCR and histopathology was 92.2% with a Cohen’s kappa of 0.34 (p < 0.001), indicating fair concordance. PCR positivity rates and cycle threshold values did not differ significantly between histopathological stages, or according to histopathological and immunohistochemical parameters. Conclusions: HHV-8 PCR in archived FFPE KS biopsies shows high specificity and good sensitivity and acts as a complementary diagnostic tool with fair agreement with histopathology. It is particularly valuable in diagnostic gray areas but should always be interpreted together with clinical, histopathological and immunohistochemical findings.